REPROCESSED ENDOSCOPIC TROCAR

K043592 · Sterilmed, Inc. · NLM · May 23, 2005 · Gastroenterology, Urology

Device Facts

Record IDK043592
Device NameREPROCESSED ENDOSCOPIC TROCAR
ApplicantSterilmed, Inc.
Product CodeNLM · Gastroenterology, Urology
Decision DateMay 23, 2005
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.1500
Device ClassClass 2
AttributesTherapeutic

Intended Use

The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures.

Device Story

Reprocessed endoscopic trocars provide a pathway for minimally invasive surgical instruments to access body organs or cavities; used during general, abdominal, thoracic, and gynecologic procedures. Devices consist of varying lengths and diameters with blunt or bladed obturator tips. Operated by surgeons in clinical/OR settings. Reprocessing involves cleaning and sterilization of previously used disposable trocars to restore functionality for reuse. Healthcare providers use the device to facilitate observation, dissection, cutting, repair, and tissue/organ manipulation. Benefits include enabling minimally invasive access for surgical interventions.

Clinical Evidence

Bench testing only. Representative samples underwent functional testing and biocompatibility testing. Manufacturing process includes visual and functional testing of all products. No clinical data provided.

Technological Characteristics

Device consists of varying lengths and diameters with blunt or bladed obturator tips. Materials are validated for biocompatibility. Functional characteristics verified via bench testing. Sterilization and cleaning processes are validated.

Indications for Use

Indicated for patients undergoing general, abdominal, thoracic, gynecologic, or other minimally invasive surgical procedures requiring a pathway for instrument entry into a body organ or cavity.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ ## KO43592 ( Cop ) of 2 SUMMARY AND CERTIFICATION SECTION 2. ## 2.A. 510(k) Summary MAY 2 3 2005 | Submitter: | SterilMed, Inc. | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Dr. Bruce R. Lester<br>SterilMed, Inc.<br>11400 73rd Avenue North<br>Minneapolis, MN 55369<br>Ph: 763-488-3400<br>Fax: 763-488-3350 | | Date Prepared: | December 28, 2004 | | Trade Name: | Reprocessed Endoscopic Trocar | | Classification Name:<br>and Number: | Laparoscope, General and Plastic Surgery<br>Class II 21CFR 876.1500 | | Product Code: | NLM | | Predicate Device(s): | The reprocessed endoscopic trocar is substantially<br>equivalent to the Endopath EP Disposable Surgical Trocar<br>(K922608), manufactured by Ethicon and AutoSuture<br>Surgiport® Endoscopic Trocar (K925860) manufactured<br>by US Surgical. | | Device Description: | Reprocessed endoscopic trocars are devices that provide a<br>pathway for entry of minimally invasive instruments to a<br>body organ or cavity during general, abdominal, thoracic,<br>gynecologic or other minimally invasive surgical<br>procedures such as observation, dissecting, cutting,<br>repairing, and removal or manipulation of internal tissues<br>and/or organs. Reprocessed endoscopic trocars are of<br>varying lengths and diameters, and may have either a blunt<br>or bladed obturator tip. | {1}------------------------------------------------ K043592 (pg 2 of 2) | Intended Use: | The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures. | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Functional and Safety Testing: | Representative samples of reprocessed endoscopic trocars underwent bench testing to demonstrate appropriate functional characteristics and biocompatibility testing to demonstrate compatibility of the device materials. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced. | | Conclusion: | The reprocessed endoscopic trocars are substantially equivalent to the Endopath EP Disposable Surgical Trocar (K922608), manufactured by Ethicon and the AutoSuture Surgiport® Endoscopic Trocar (K925860), manufactured by US Surgical. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction. | 1 : : : : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 3 2005 Dr. Bruce R. Lester Vice President, Research and Development SterilMed, Inc. 11400 73td Ave. North Minneapolis, Minnesota 55369 Re: K043592 Trade/Device Name: Reprocessed Laparoscope, General and Plastic Surgery (See enclosed list) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: NLM Dated: April 14, 2005 Received: April 18, 2005 Dear Dr. Lester: 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 adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 240-276-0115. 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 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/industry/support/index.html. Sincerely yours, -Miriam C. Provost Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 3 – Dr. Bruce R. Lester Reprocessed Laparoscope, General and Plastic Surgery (Trocar) Models found to be Substantially Equivalent: - 1. Ethicon, 350L - 2. Ethicon, 350S - 3. Ethicon, 35NST - 4. Ethicon, 35NLT - 5. Ethicon, 5110 - 6. Ethicon, 511NT - 7. Ethicon, 512ON - 8. Ethicon, 512NT - 9. Ethicon, 355NA - 10. Ethicon, 35LNA - 11. Ethicon, 511NA - 12. Ethicon, 512NA - 13. Ethicon, 512B - 14. Ethicon, 512HA - 15. Ethicon, 355SD - 16. Ethicon, 355LD - 17. Ethicon, 578SD - 18. Ethicon, 355SM - 19. Ethicon, 355LM - 20. Ethicon, 511SM - 21. Ethicon, 512SM - 22. Ethicon, 511SD - 23. Ethicon, 512SD - 24. Ethicon, 512XD - 25. Ethicon, 355DA - 26. Ethicon, 35LDA 27. Ethicon, 511DA - 28. Ethicon, 355S - - 29. Ethicon, 355L - 30. Ethicon, 511S - 31. Ethicon, 512S - 32. Ethicon, 512X - 33. Ethicon, 355ST - 34. Ethicon, 35LST - 35. Ethicon, 511ST - 36. Ethicon, 512ST - 37. Ethicon, 355SL - 38. Ethicon, 35LSL - 39. Ethicon, 511SL - 40. Ethicon, 512SL {5}------------------------------------------------ Page 4 – Dr. Bruce R. Lester Reprocessed Laparoscope, General and Plastic Surgery (Trocar) Models found to be Substantially Equivalent contd.: 41. Ethicon, 355HR 42. Ethicon, 511HR 43. Ethicon, 512HR 44. AutoSuture, 179776 45. AutoSuture,179777 46. AutoSuture,179770 47. AutoSuture,179771 48. AutoSuture,179074 49. AutoSuture,179076 50. AutoSuture,179077 51. AutoSuture,179070 52. AutoSuture,179071 53. AutoSuture,179078 54. AutoSuture,179070P 55. AutoSuture,179071P 56. AutoSuture,179074P 57. AutoSuture,179076P 58. AutoSuture,179077P 59. AutoSuture,179078P 60. AutoSuture,179770P 61. AutoSuture,179771P 62. AutoSuture,179776P 63. AutoSuture,179777P 64. AutoSuture,179775 65. AutoSuture,179075 66. AutoSuture,176626 67. AutoSuture,179075P 68. AutoSuture,176626P 69. AutoSuture,179775P {6}------------------------------------------------ K043592 ## Indications for Use Page Device Name: Reprocessed Endoscopic Trocars Indications for Use: The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures. ﺒ ri Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR ಿ Over-The-Counter Use (21 CFR 807 Subpart C) :: (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Muriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices K043592 510(k) Number _ Original 510(k) Premarket Submission - Reprocessed Endoscopic Trocars CONFIDENTIAL SterilMed, Inc
Innolitics
510(k) Summary
Decision Summary
Classification Order
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