The Reprocessed Suture Passer is a set of previously used devices that have been cleaned, tested, inspected, marked with an identifier, packaged, labeled, and sterilized by Vanguard. A "Suture Passer" is a set of three (3) devices, consisting of one (1) Carter-Thomason needle-point suture passer and two (2) suture passer guides. The Carter-Thomason needle-point suture passer is a 3mm diameter stainless steel shaft with a polycarbonate ring-grip handle that opens one side of the pointed tip of the steel shaft when activated. The polycarbonate suture passer guides have a cylindrical hub at the proximal end and a tapered shaft at the distal end. The suture passer guides taper from the junction with the cylindrical hub to the tip. Each suture passer guide has two holes in the hub; the two holes open on opposite sides of the pilot guide shaft. A Suture Passer Guide is inserted into the wound site. A Suture Passer is used to push suture through the suture passer guide and then through the tissue of the wound site. The suture is then retrieved and pulled through the opposite side of the guide. This creates a "loop" that encompasses the full depth of the wound and upon removal of the guide allows full closure of the wound. Vanguard receives previously used Suture Passers from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use. The Vanguard Reprocessed Suture Passers are essentially identical to the currently marketed Original Equipment Manufacturer (OEM) devices. Device materials, specifications, and technological characteristics are equivalent.

AI/ML Overview

This document describes the 510(k) summary for the Vanguard Reprocessed Suture Passer. It establishes substantial equivalence to existing predicate devices based on technological characteristics and performance/test data, rather than clinical studies with explicit acceptance criteria related to device performance metrics.

Here's a breakdown of the requested information based on the provided text, and where clinical study-specific details are not applicable:

1. A table of acceptance criteria and the reported device performance

The provided document describes a reprocessed medical device, not a new diagnostic or prognostic algorithm. Therefore, "acceptance criteria" in the traditional sense of a clinical performance study (e.g., sensitivity, specificity, accuracy) are not defined. Instead, the acceptance criteria for substantial equivalence are based on:

Acceptance Criteria Category	Description	Reported Device Performance/Evidence
Technological Characteristics	The reprocessed device must be essentially identical to the currently marketed Original Equipment Manufacturer (OEM) devices in terms of materials, specifications, and technological characteristics.	"The Vanguard Reprocessed Suture Passers are essentially identical to the currently marketed Original Equipment Manufacturer (OEM) devices. Device materials, specifications, and technological characteristics are equivalent."
Performance and Test Data	The reprocessed device must perform as intended and be safe and effective. This is demonstrated through various validations and testing.	"Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective."
Cleaning, Sterilization, and Packaging Validations	The reprocessing methods must ensure the device is adequately cleaned, sterilized, and packaged to maintain safety and efficacy.	Mentioned above under "Performance and Test Data". The document states these validations were performed.
Biocompatibility Testing	The reprocessed device must remain biocompatible after the reprocessing procedures.	Mentioned above under "Performance and Test Data". The document states this testing was performed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the submission is for a reprocessed surgical instrument, not a diagnostic or prognostic device requiring a "test set" in the context of a clinical performance study. The "testing" referred to is laboratory-based performance, cleaning, and sterilization validation for the reprocessed device. The document does not specify sample sizes for these validations or their provenance beyond the fact that Vanguard Medical Concepts, Inc. (Lakeland, FL, USA) performed the reprocessing and submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. There is no "ground truth" establishment by experts in the context of a clinical test set for this device. The evaluation is based on engineering and laboratory performance testing against established standards and equivalence to the original device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reasons as points 2 and 3.

5. 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

This is not applicable. This submission is for a reprocessed surgical instrument, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or is relevant.

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

This is not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable. The "ground truth" for this submission revolves around the functional equivalence and safety of the reprocessed device compared to the original, as demonstrated through engineering tests (cleaning, sterilization, physical performance) and biocompatibility, not clinical "ground truth" for a diagnostic outcome.

8. The sample size for the training set

This is not applicable. There is no training set as this is not an algorithmic device.

9. How the ground truth for the training set was established

This is not applicable. There is no training set or ground truth in the context of a clinical study for this device.

Summary

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510(k) Summary of Safety & Effectiveness

Kos 3585

Submitter	Vanguard Medical Concepts, Inc. 5307 Great Oak Drive Lakeland, FL 33815
Contact	Trish Stephens R&D Project Manager 863-683-8680 x252 [voice] 863-904-1604 [facsimile] tstephens@safe-reuse [email]
Date	December 22, 2005
Device	Trade Name: Vanguard Reprocessed Suture PasserCommon Name: Suture Passer, Carter-Thomason Needle-Point Suture Passer Classification Name: Laparoscope, General & Plastic Surgery, Reprocessed 21 CFR Section: 876.1500Reprocessed - Class IIProduct Code: NLM
Predicate Devices	Trade Names: Inlet Medical, Inc. CloseSure® Procedure Kit510(k) numbers: K980123: Louisville Laboratories, Inc. (Inlet Medical, Inc.) Carter-Thomason Needle-Point Suture Passer Instrument Kit
Indications for Use	Reprocessed Suture Passers are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.

OCT 11 2006Continued on next page

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510(k) Summary of Safety & Effectiveness, Continued

The Reprocessed Suture Passer is a set of previously used devices that have Device been cleaned, tested, inspected, marked with an identifier, packaged, labeled, Description and sterilized by Vanguard. A "Suture Passer" is a set of three (3) devices, consisting of one (1) Carter-Thomason needle-point suture passer and two (2) suture passer guides. The Carter-Thomason needle-point suture passer is a 3mm diameter stainless steel shaft with a polycarbonate ring-grip handle that opens one side of the pointed tip of the steel shaft when activated. The polycarbonate suture passer guides have a cylindrical hub at the proximal end and a tapered shaft at the distal end. The suture passer guides taper from the junction with the cylindrical hub to the tip. Each suture passer guide has two holes in the hub; the two holes open on opposite sides of the pilot guide shaft. A Suture Passer Guide is inserted into the wound site. A Suture Passer is used to push suture through the suture passer guide and then through the tissue of the wound site. The suture is then retrieved and pulled through the opposite side of the guide. This creates a "loop" that encompasses the full depth of the wound and upon removal of the guide allows full closure of the wound. Vanguard receives previously used Suture Passers from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use. The Vanguard Reprocessed Suture Passers are essentially identical to the Technological currently marketed Original Equipment Manufacturer (OEM) devices. Characteristics Device materials, specifications, and technological characteristics are equivalent. Cleaning, sterilization, and packaging validations, and performance and Test Data biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective. Based upon the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that Vanguard Reprocessed Suture Passers are substantially equivalent to their predicate devices under the Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, connected by flowing lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2006

Ascent Healthcare Solutions % Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, Arizona 85044

Re: K053585 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: January 12, 1998 Received: January 14, 1998

Dear Ms. Barton:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on March 9, 1998. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices 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 devices comply 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 applicable requirements, including, but not limited to: registration and

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Page 2 -- Ms. Moira Barton

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.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Va. Mcllroy

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

Enclosure

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Page 4 - Ms. Moira Barton

Device listing found to be substantially equivalent:

Carter-Thomason CloseSure System

(1) Carter-Thomason Need-Point Suture Passer
.

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

(1) 5mm Suture Passer
.

(1) 10/12mm Suture Passer Guide

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Indications for Use

510(k) Number (if known):

K053585

Device Name: Vanguard Reprocessed Suture Passers

Indications for Use:

Reprocessed Suture Passers are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number / K053585

012

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.