REPROCESSED ENDOSCOPIC TROCAR

• K Number: K043592
• Device Name: REPROCESSED ENDOSCOPIC TROCAR
• Manufacturer: STERILMED, INC.
• Date Cleared: 2005-05-23 ( 145 days)
• Product Code: NLM
• Regulation Number: 876.1500
• Type: Traditional
• Panel: Gastroenterology/Urology
• Reference & Predicate Devices: K922608 , K925860
• Predicate For: K052299

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 Description

Reprocessed endoscopic trocars are devices that 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 such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs. Reprocessed endoscopic trocars are of varying lengths and diameters, and may have either a blunt or bladed obturator tip.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Appropriate functional characteristics	Bench testing demonstrated appropriate functional characteristics.
Biocompatibility	Biocompatibility testing demonstrated compatibility of the device materials.
Validated cleaning and sterilization procedures	Process validation testing validated the cleaning and sterilization procedures.
Validated device packaging	Process validation testing validated the device packaging.
Visual and functional quality (during manufacturing)	The manufacturing process includes visual and functional testing of all products produced.

Note: The document states that the reprocessed endoscopic trocars are "substantially equivalent" to predicate devices. This implies that the acceptance criteria are met if the reprocessed device performs comparably to the original, legally marketed devices. Specific numerical thresholds or detailed performance metrics for "appropriate functional characteristics" or "biocompatibility" are not provided.

Study Details

This submission is for a reprocessed device, and the "study" described focuses on demonstrating equivalence to predicate devices through functional, biocompatibility, and process validation testing rather than a traditional comparative clinical trial with human subjects.

1. Sample sizes used for the test set and the data provenance:

   • Test set sample size: Not explicitly stated as a single numerical value. The document mentions "Representative samples of reprocessed endoscopic trocars" were used for bench testing. The specific number of trocars tested is not provided.
   • Data provenance: Not specified, but likely from internal laboratory testing conducted by SterilMed, Inc. It is retrospective in the sense that they are re-evaluating existing devices after reprocessing, but the testing itself is prospective (performed for this submission).
   • Country of origin of the data: Not explicitly stated, but the submitter (SterilMed, Inc.) is based in Minneapolis, Minnesota, USA, implying the data is likely from the USA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This type of information is generally not applicable to a premarket notification (510(k)) for a reprocessed device where the focus is on functional equivalence and safety rather than a diagnostic performance study. The "ground truth" here is the established performance and safety profile of the predicate devices. Experts involved would likely be those conducting the functional, biocompatibility, and process validation testing (e.g., engineers, microbiologists, quality control specialists), but their number and specific qualifications are not detailed.

3. Adjudication method for the test set:

   • Not applicable/described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, which is not the nature of this submission. The "adjudication" here would be the scientific assessment by the testing personnel and quality assurance to determine if the test results meet internal and regulatory standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. An MRMC comparative effectiveness study is not applicable as this is a medical device for surgical procedures (trocars), not an AI-powered diagnostic tool for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No. This is a physical medical device, not an algorithm or AI system.

6. The type of ground truth used:

   • The "ground truth" for this submission is implicitly the established performance and safety of the predicate devices (Ethicon Endopath EP Disposable Surgical Trocar and AutoSuture Surgiport® Endoscopic Trocar). The reprocessed device is deemed acceptable if its functional characteristics, biocompatibility, and sterilization/packaging validation data demonstrate that it performs substantially equivalently to these legally marketed devices.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the reprocessing procedures would involve process development and validation, but not in the context of a dataset for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

Summary

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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. LesterSterilMed, Inc.11400 73rd Avenue NorthMinneapolis, MN 55369Ph: 763-488-3400Fax: [phone]
Date Prepared:	December 28, 2004
Trade Name:	Reprocessed Endoscopic Trocar
Classification Name:and Number:	Laparoscope, General and Plastic SurgeryClass II 21CFR 876.1500
Product Code:	NLM
Predicate Device(s):	The reprocessed endoscopic trocar is substantiallyequivalent to the Endopath EP Disposable Surgical Trocar(K922608), manufactured by Ethicon and AutoSutureSurgiport® Endoscopic Trocar (K925860) manufacturedby US Surgical.
Device Description:	Reprocessed endoscopic trocars are devices that provide apathway for entry of minimally invasive instruments to abody organ or cavity during general, abdominal, thoracic,gynecologic or other minimally invasive surgicalprocedures such as observation, dissecting, cutting,repairing, and removal or manipulation of internal tissuesand/or organs. Reprocessed endoscopic trocars are ofvarying lengths and diameters, and may have either a bluntor bladed obturator tip.

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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.

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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.

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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 [phone] or [phone] 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

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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

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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

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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.

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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

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.