ACMI M4 TELESCOPES

{0}------------------------------------------------ K031758 510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® M4™ Telescope (Page 1 of 2) #### General Information Manufacturer: ACMI Corporation 136 Turnpike Rd. Southborough, MA. 01772-2104 FDA Establishment Registration: Contact Person: 2020483 Gabriel J. Muraca, Jr. Senior Regulatory Affairs Specialist Date Prepared: June 3, 2003 #### Device Description Trade Name: ACMI® M4™ Series Telescopes ACMI M4 Series Telescopes are optical devices that are used with endoscopic accessories in diagnostic and surgical procedures of the urological and gynecological systems. Classification Names: 21CFR 876.1500 - Endoscope and accessories and 21 CFR 884.1690 - Hysteroscope and accessories Generic/Common Name: Telescopic system used along with endoscopic accessories in diagnostic and surgical procedures of the urological and gynecological systems. #### Predicate Devices ACMI Resectoscope System and accessories K890328/B ## Intended Uses ACMI M4 Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems. {1}------------------------------------------------ K031758 510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® M4™ Telescope (Page 2 of 2) ## Product Description ACMI M4 Telescopes are optical devices that are used along with endoscopic accessories for diagnostic and therapeutic procedures in urology and gynecology. They are designed to be inserted through an endoscopic device such as an ACMI cystourethroscope, hysteroscope, or resectoscope. M4 Telescopes are (4mm diameter, 31 cm long) rigid autoclavable optical instruments available in four directions of view: M4-0A, direct (0°), M4-12A, operative (12°), M4-30A, foroblique (30°), and M4-70A, lateral (70°), to assist the physician in visualization of the anatomy during diagnostic and surgical procedures. ## Technological Characteristics and Substantial Equivalence The M4 Series Telescopes are substantially equivalent to features incorporated in the M2 and M3 telescopes, as described in K890328/B, the ACMI Resectoscope System and accessories. The M2 and M3 telescopes are legally marketed predicate devices. The M4 Series designs utilize similar telescope technology (design, materials, and performance specifications) as in the predicate devices and, therefore, are substantially equivalent to the ACMI M2 and M3 series telescopes. ## Summary of Safety and Effectiveness This 510(k) proposes several modifications in materials, design, and the manufacturing process for the M4 Series telescopes. The indications for use and principles of operation remain the same as in the predicate devices. The proposed modifications for the M4 Series Telescopes, as described in this submission, are substantially equivalent to the predicate devices. The proposed modification in materials, design, and processing are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices. In summary, ACMI believes the ACMI M4 Series telescopes are substantially equivalent to the predicate devices, because they have the same intended use and similar technological characteristics. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "Department of Health & Human Services" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 2 2003 Mr. Gabriel J. Muraca, Jr., RAC Senior Regulatory Affairs Specialist ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772-2104 Re: K031758 Trade/Device Name: ACMI® M4TM Telescopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FBP Dated: June 3, 2003 Received: June 6, 2003 Dear Mr. Muraca: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx. 1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Device Name: ACMI® M4™ Telescope 510(k) Number: Ko31758 # Indications for Use: ACMI® M4™ Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: __ X __ OR Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) Nancy Brodon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K031758