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 such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs.

Device Description

The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturator that is available in varying lengths and diameters. The obturator may be bladeless or dilating tip. Reprocessed 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.

AI/ML Overview

This document describes the 510(k) premarket notification for Reprocessed Endoscopic Trocars by Sterilmed, Inc. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding reported device performance metrics in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly defined by demonstrating that the reprocessed devices perform "as originally intended" and are "substantially equivalent" to the predicate device in terms of functional and safety characteristics.

The reported device performance is described qualitatively and through validation studies.

Acceptance Criteria Category	Reported Device Performance (Summary of Non-clinical Tests Conducted)
Cleaning Validation	Cleaning validation was performed.
Sterilization Validation	Sterilization validation was performed (ISO 11135, USP <71>).
Biocompatibility	Biocompatibility testing was performed (ISO 10993).
Ethylene Oxide Residual	Ethylene oxide residual testing was performed (ISO 10993-7).
Packaging Validation	Packaging validation was performed (ASTM D 4169, ASTM F 88, ASTM F 2096).
Shelf Life Validation	Shelf life validation was performed (ASTM 1980-07).
Functional Performance	Validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. "Performance testing shows the reprocessed endoscopic trocar to perform as originally intended."
Substantial Equivalence	"Sterilmed concludes that the reprocessed endoscopic trocars are safe, effective, and substantially equivalent to the predicate devices, Ethicon Endo-Surgery ENDOPATH® XCEL™ With OPTIVIEW® Technology Trocars (K032676), as described in this premarket notification submission."
Technological Equivalence	The reprocessed trocars are "identical to the predicate devices in design, materials of construction (except for the absorbent ring which is non-patient contact), and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation."

2. Sample Size Used for the Test Set and Data Provenance

The document states "Representative samples of reprocessed endoscopic trocars were tested to demonstrate appropriate functional characteristics." However, it does not provide a specific numerical sample size for the test set used for functional and safety testing. Similarly, the data provenance (country of origin, retrospective/prospective) is not explicitly stated, but the submission is from Sterilmed, Inc. in Maple Grove, MN, implying testing likely occurred in the US. The nature of the validation (cleaning, sterilization, functional bench testing) suggests these were performed in a controlled laboratory or manufacturing environment, rather than being clinical trial data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The validation of reprocessed medical devices focuses on engineering and scientific testing (e.g., microbiology for sterilization, chemical analysis for residuals, mechanical testing for function), not on expert clinical interpretation of results against a "ground truth" established by human experts in the way AI/ML medical devices are assessed.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective laboratory and bench testing rather than clinical interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically for diagnostic imaging. This submission concerns the reprocessing and functional validation of physical medical devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a submission for a reprocessed physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established through objective scientific and engineering standards and methods. This includes:

Established standards: ISO 11135, USP <71> for sterilization, ISO 10993 for biocompatibility, ISO 10993-7 for ethylene oxide residuals, ASTM D 4169, ASTM F 88, ASTM F 2096 for packaging, ASTM 1980-07 for shelf life.
Bench testing: Functional performance is assessed against the original performance specifications of the predicate device.
Visual inspection: Conformance to physical and material specifications.
Simulated use and fatigue testing: Evaluation of performance under conditions mimicking clinical use.

The ground truth is that the reprocessed device must meet the same performance, safety, and material characteristics as the new predicate device, and these are verified through the outlined non-clinical tests.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of validating a reprocessed physical medical device as there is no AI/ML model being developed. The processes (cleaning, sterilization) are validated, not trained.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated in point 8.

Summary

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JUN 1 1 2012

<121240

Image /page/0/Picture/2 description: The image shows the word "STERILMED." in all caps. To the left of the word is a circular logo with two arrows pointing in opposite directions. The logo is simple and abstract. The text is in a sans-serif font.

510(K) PREMARKET NOTIFICATION SUBMISSION 23 APRIL 2012 For Reprocessed Endoscopic Trocars

SUMMARY AND CERTIFICATION II.

510(k) Summary A.
Sterilmed, Inc.

Contact Person:

Submitter:

Jason Skramsted 11400 73td Avenue North Maple Grove, MN 55369 Phone: 763-488-3483 Fax: 763-488-4491

Date Prepared:	23 April 2012
Trade Name:	Reprocessed Endoscopic Trocars
Classification Name:	Endoscope and accessories
Classification Number:	Class II, 21 CFR 876.1500
Product Code:	NLM

PredicateDevices:	The reprocessed endoscopic trocars are substantially equivalent to Ethicon Endo-Surgery ENDOPATH®XCEL™ With OPTIVIEW® Technology Trocars (K032676).
DeviceDescription:	The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturator that is availablein varying lengths and diameters. The obturator may be bladeless or dilating tip. Reprocessed trocars aredevices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity duringgeneral, abdominal, thoracic, gynecologic, or other minimally invasive surgical procedures.
Intended Use:	The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasiveinstruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimallyinvasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulationof internal tissues and/or organs.
TechnologicalCharacteristics:	The reprocessed endoscopic trocars are identical to the predicate devices in design, materials of construction(except for the absorbent ring which is non-patient contact), and intended use. There are no changes to theclinical applications, patient population, performance specifications, or method of operation.
Functional andSafety Testing:	Representative samples of reprocessed endoscopic trocars were tested to demonstrate appropriate functionalcharacteristics. Process validation testing was performed to validate the cleaning and sterilization proceduresas well as device packaging, In addition, the manufacturing process includes visual and validated functionaltesting of all products produced.
Summary ofNon-clinicalTestsConducted:	Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP<71>), biocompatibility testing (ISO 10993), ethylene oxide residual testing (ISO 10993-7), packagingvalidation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM 1980-07). Inaddition, validation of functional performance (bench testing) was performed through simulated use, visualinspection, fatigue testing, and function testing, Performance testing shows the reprocessed endoscopic trocarto perform as originally intended.
Conclusion:	Sterilmed concludes that the reprocessed endoscopic trocars are safe, effective, and substantially equivalent tothe predicate devices, Ethicon Endo-Surgery ENDOPATH® XCEL™ With OPTIVIEW® Technology Trocars(K032676), as described in this premarket notification submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 1 2022

Sterilmed. Incorporated % Mr. Jason Skramsted, RAC 11400 73td Avenue, North Maple Grove, Minnesota 55369

Re: K121240

Trade/Device Name: Reprocessed Endoscopic Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NLM Dated: April 23, 2012 Received: April 24, 2012

Dear Mr. Skramsted:

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. Please note; CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Jason Skramsted

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Madle Al millum

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) PREMARKET NOTIFICATION SUBMISSION 23 APRIL 2012

For Reprocessed Endoscopic Trocars

Indications for Use

510(k) Number (if known):

Device Name: Reprocessed Endoscopic Trocars

Indications for Use:

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)

Neil R.P. Ogden for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121240

CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.

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K121240-List of device models included in this submission.

and the control of the country of the county of

Manufacturer	Model #	Device Description
Ethicon Endo-Surgery	2B5ST	Bladeless Trocars (D 5mm, L 75mm, StabilitySleeve)
	2B5LT	Bladeless Trocars (D 5mm, L 100mm, StabilitySleeve)
	2D5ST	Dilating Tip Trocars (D 5mm, L 75mm, StabilitySleeve)
	2D5LT	Dilating Tip Trocars (D 5mm, L 100mm, StabilitySleeve)
	2CB5ST	Universal Sleeves (D 5mm, L 75mm, StabilitySleeve)
	2CB5LT	Universal Sleeves (D 5mm, L 100mm, StabilitySleeve)

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: : : : : :

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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.