When used with a compatible electrosurgical unit, endoscope and patient grounding pad, electric biopsy forceps are intended for electrocautery and removal of polyps and/or tissue within the gastrointestinal tract. The forceps are prescription devices intended for a single patient use only.

Device Description

Biopsy forceps are devices used to collect tissue samples and/or remove polyps within the gastrointestinal tract via the operating channel of endoscopic instruments.

Electric biopsy forceps include an electrocautery function when used with a compatible electrosurgical unit.

The devices consist of flexible, electrically isolated sheaths with distal grasping cups that are controlled by a proximal handle. The forceps are guided by endoscopy through a biopsy channel with a minimum dimension of 2.8 mm. Monopolar electrocautery requires electrical connection of the forceps to a compatible electrosurgical unit and use of an appropriate patient grounding pad.

Vanguard receives previously used electric biopsy forceps from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the forceps; and returns them to the healthcare facility.

AI/ML Overview

The provided text describes a submission for reprocessed electric biopsy forceps and does not contain information about acceptance criteria, device performance, or a study design in the context of medical device AI or diagnostic performance measurements. The document is a 510(k) summary for a medical device (reprocessed electric biopsy forceps) and focuses on substantial equivalence to predicate devices, rather than a study evaluating the diagnostic performance of a device against specific acceptance criteria.

Therefore, I cannot provide the requested information. The text discusses:

Device Name: Vanguard Reprocessed Electric Biopsy Forceps
Indications for Use: Electrocautery and removal of polyps and/or tissue within the gastrointestinal tract when used with a compatible electrosurgical unit, endoscope, and patient grounding pad.
Technological Characteristics: Stated to be the same as the predicate devices, with unchanged materials and dimensions, and essentially identical physical characteristics and performance specifications.
Test Data: Mentions "Decontamination and cleaning, packaging and sterilization validations and functional/performance, shelf life and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." This is related to the reprocessing procedure's validation, not a study to establish diagnostic performance or AI effectiveness.

There is no information on:

A table of acceptance criteria and reported device performance in the context of diagnostic accuracy.
Sample sizes for test sets, data provenance, or retrospective/prospective study design for diagnostic performance.
Number or qualifications of experts for ground truth establishment.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone (algorithm-only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles facing to the right, representing people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2004 NOV

Heather Crawford, RAC Director of Regulatory Affairs Vanguard Medical Concepts, Inc 5307 Great Oak Drive LAKELAND FL 33815

K011800 - Supplemental Validation Submission Re: Trade/Device Name: See Enclosed List Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: NLU Dated: September 7, 2001 Received: September 10, 2001

Dear Ms. Crawford:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on September 10, 2001. 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.

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Page 2 - Ms. Heather Crawford

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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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·Attachment 1

The following list is the models used in this submission.

K011800: Vanguard Reprocessed Electric Biopsy Forceps

Microvasive® Radial Jaw 3, Model 1550 Bard Precisor, Model 852 Bard Precisor, Model 853 Bard Precisor, Model 854 Bard Precisor, Model 856

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Indications for Use

4011800 510(k) Number:

Device Name: Vanguard Reprocessed Electric Biopsy Forceps

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Nancy C. Brogdon

f Reproductive, Abdor rical Device

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SEP 2 7 2001

K011800
Page 1 of 2

510(k) Summary of Safety & Effectiveness

Submitter	Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815
Contact	Mike Sammon, Ph.D.Director, Research & Development(863) 683-8680, extension 228mikes@safe-reuse.com
Date	May 31, 2001
Devices	Trade Names: Vanguard Reprocessed Electric Biopsy Forceps⇒ Boston Scientific Microvasive® Radial Jaw® 3, and⇒ C.R. Bard Precisor® Electric Biopsy Forceps Common Name: Electric biopsy forceps Classification: 21 CFR 876.4300 - Endoscopic Electrosurgical Unit andAccessories - Class II Product Code KGE
PredicateDevices	Boston Scientific Microvasive® Radial Jaw® 3 Electric Biopsy Forcepsbelieved to be legally marketed under 510(k) premarket notificationK860366 C.R. Bard Precisor® Hot Biopsy Forceps believed to be legally marketedunder 510(k) premarket notification K912601
Indications forUse	When used with a compatible electrosurgical unit, endoscope and patientgrounding pad, electric biopsy forceps are intended for electrocautery andremoval of polyps and/or tissue within the gastrointestinal tract. The forcepsare prescription devices intended for a single patient use only.
DeviceDescription	Biopsy forceps are devices used to collect tissue samples and/or removepolyps within the gastrointestinal tract via the operating channel ofendoscopic instruments.Electric biopsy forceps include an electrocautery function when used with acompatible electrosurgical unit.The devices consist of flexible, electrically isolated sheaths with distalgrasping cups that are controlled by a proximal handle. The forceps areguided by endoscopy through a biopsy channel with a minimum dimension of2.8 mm. Monopolar electrocautery requires electrical connection of theforceps to a compatible electrosurgical unit and use of an appropriate patientgrounding pad.Vanguard receives previously used electric biopsy forceps from healthcarefacilities; cleans, inspects, tests, repackages and sterilizes the forceps; andreturns them to the healthcare facility.
TechnologicalCharacteristics	The technological characteristics of the Vanguard reprocessed electric biopsyforceps are the same as the predicate devices, the original equipmentmanufacturer (OEM) electric biopsy forceps. The materials and dimensionsare unchanged and the physical characteristics, performance specifications,and all other characteristics are essentially identical.
Test Data	Decontamination and cleaning, packaging and sterilization validations andfunctional/performance, shelf life and biocompatibility testing demonstratesthat the reprocessed devices perform as intended and are safe and effective.
Conclusion	Based on the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that the Vanguardreprocessed electric biopsy forceps are substantially equivalent to thepredicate device, the respective OEM biopsy forceps under the Federal Food,Drug and Cosmetic Act.

Continued on next page

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K011800

Page 2 of 2

510(k) Summary of Safety & Effectiveness, Continued

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).