INVESTIGATOR'S BROCHURE (IB) 1. General 1.1 Introduction Information Brochure shall contain, as a minimum, information on all topics listed in this Table. 1.2 Identification of the IB (a) Name of the investigational medical device. (b) Document reference number, if any. (c) Version or date of the IB. (d) Confidentiality statement, if appropriate. (e) Summary of the revision history in case of amendments, if appropriate. (f) A version or issue number and reference number, if any, with page number and the total number of pages on each page of the IB. 1.3 Sponsor or manufacturer Name and address of the sponsor or manufacturer of the investigational medical device. 2. Investigational medical device information (a) Summary of literature and evaluation supporting the rationale for the design and intended use of investigational medical device. (b) Statement concerning regulatory classification of investigational medical device, if relevant. (c) General description of the investigational medical device and its components including materials used. (d) Summary of relevant manufacturing processes and related validation processes. (e) Description of the mechanism of action of investigational medical device, along with supporting scientific literature. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 179 of 248 (f) Manufacturer's instructions for installation and use of investigational medical device, including any necessary storage and handling requirements, preparation for use and any intended re-use (e.g. sterilization), any pre-use safety or performance checks and any precautions to be taken after use (e.g. disposal), if relevant. (g) Description of the intended clinical performance.