VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS

K042594 · Vanguard Medical Concepts, Inc. · NON · Jan 25, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K042594
• Device Name: VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NON · Gastroenterology, Urology
• Decision Date: Jan 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 1

Intended Use

GI forceps are designed for insertion through an appropriate sized endoscopy channel for removal and histological sampling of tissue. Biopsy forceps are intended for removal of polyps and/or tissue within the gastrointestinal tract.

Device Story

Reprocessed non-electric biopsy forceps; consists of flexible sheath with distal grasping cups and proximal control handle. Device inserted through endoscope channel; physician operates handle to actuate distal cups for tissue/polyp sampling. Vanguard cleans, inspects, tests, and sterilizes previously used OEM forceps for clinical reuse. Output is histological tissue sample for diagnostic evaluation. Benefits include cost-effective access to biopsy instrumentation for GI procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing including cleaning, sterilization, and packaging validations, as well as performance and biocompatibility testing.

Technological Characteristics

Non-electric biopsy forceps; flexible sheath with distal grasping cups and proximal control handle. Materials and specifications identical to OEM devices. Sterilization performed as part of the reprocessing cycle.

Indications for Use

Indicated for removal of polyps and/or tissue within the gastrointestinal tract via insertion through an appropriately sized endoscope. Contraindicated for pulmonary biopsy, patients with bleeding disorders, side-viewing endoscopes, or when GI endoscopy is contraindicated (e.g., acute abdominal peritonitis, toxic megacolon, active colitis, or presence of combustible gases).

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Bard Precisor XL Coated non-electric biopsy forceps
• Microvasive MultiBite non-electric biopsy forceps
• Microvasive Radial Jaw non-electric biopsy forceps
• Microvasive Radial Jaw 3 non-electric biopsy forceps
• Microvasive Radial Jaw Large Capacity non-electric biopsy forceps
• Microvasive Radial Jaw 3 Max Capacity non-electric biopsy forceps
• Wilson Cook Medical The Shark non-electric biopsy forceps

Submission Summary (Full Text)

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K042594
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## 510(k) Summary of Safety & Effectiveness

| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC<br>Director of Regulatory Affairs<br>863-683-8680 [voice]<br>863-683-8703 [facsimile]<br>[e-mail] [email] |
| Date | September 23, 2004 |
| Device | <ul><li>Trade Name: Vanguard Reprocessed Non-Electric Biopsy Forceps</li><li>Common Name: Reprocessed Non-Electric Biopsy Forceps</li><li>Classification: 21 CFR, 876.1075(b)(2) – Forceps, Biopsy, Non-Electric, Reprocessed - Class I</li><li>Product Code: NON</li></ul> |
| Predicate Devices | <ul><li>Trade Names: <ul><li>Bard Precisor^TM XL Coated non-electric biopsy forceps</li><li>Microvasive® MultiBite® non-electric biopsy forceps</li><li>Microvasive® Radial Jaw® non-electric biopsy forceps</li><li>Microvasive® Radial Jaw® 3 non-electric biopsy forceps</li><li>Microvasive® Radial Jaw® Large Capacity non-electric biopsy forceps</li><li>Microvasive® Radial Jaw® 3 Max Capacity non-electric biopsy forceps</li><li>Wilson Cook Medical The Shark^TM non-electric biopsy forceps</li></ul></li><li>510(k) numbers: Not applicable</li></ul> Original equipment manufacturer (OEM) non-electric GI biopsy forceps are Class I 510(k) exempt devices (21 CFR 876.1075, product code FCL). Therefore premarket notifications for the legally marketed predicate devices are not applicable for citation. |
| | Continued on next page |

JAN 2 5 2005

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K042594
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## 510(k) Summary of Safety & Effectiveness, Continued

| Indications<br>for Use | GI forceps are designed for insertion through an appropriate sized endoscopy<br>channel for removal and histological sampling of tissue. Biopsy forceps are<br>intended for removal of polyps and/or tissue within the gastrointestinal tract. | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contra-<br>indications | This GI biopsy forceps should not be used:<br>for pulmonary biopsy procedures; when contraindications to GI endoscopy are present, e.g. acute abdominal<br>peritonitis, toxic megacolon, or active colitis; in the possible presence of combustible gases (e.g. anesthetic); in patients with bleeding disorders; or in a side viewing endoscope. | |
| Device<br>Description | Vanguard Reprocessed Non-Electric Biopsy Forceps consist of a flexible<br>sheath with distal grasping cups controlled by a proximal control handle.<br>When used with a compatible endoscope, GI biopsy forceps are intended for<br>removal of polyps and/or tissue within the gastrointestinal tract. Biopsy<br>forceps are designed for insertion through a predetermined diameter biopsy<br>channel.<br>Vanguard receives previously used non-electric GI biopsy forceps from<br>healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the<br>devices; and returns them to a healthcare facility for subsequent use. | |
| Technological<br>Characteristics | Vanguard Reprocessed Non-Electric Biopsy Forceps are essentially identical<br>to the Original Equipment Manufacturer (OEM) devices. No changes are<br>made to the device materials or specifications and the reprocessed forceps<br>possess identical technological characteristics. | |
| Test Data | Cleaning, sterilization, packaging validations, and performance and<br>biocompatibility testing demonstrate that the reprocessed devices perform as<br>intended and are safe and effective. | |
| Conclusion | Based upon the information provided herein and the 510(k) "Substantial<br>Equivalence" Decision Making Process Chart, we conclude that Vanguard<br>Reprocessed Non-Electric Biopsy Forceps are substantially equivalent to their<br>predicate devices under the Federal Food, Drug and Cosmetic Act. | |

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

Public Health Service

JAN 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vanguard Medical Concepts, Inc c/o Ms. Heather Crawford 5307 Great Oak Drive LAKELAND FL 33815

RE: K042594 Trade/Device Name: Vanguard Reprocessed Non-electric Biopsy Forceps (Enclosure 1) Regulation Number: 21 CFR § 876.1075 Regulation Name: Gastroenterology-urology Biopsy instrument Regulatory Class: II Product Code: 78 NON Dated: December 21, 2004 Received: December 22, 2004

Dear Ms. Crawford:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreases)76, the enactment date of the Medical Device Amendments, or to conniner of they 20, 1778, in secordance with the provisions of the Federal Food, Drug, de nees may been rout do not require approval of a premarket approval application (PMA). and Cosmetor For (110) has the device, subject to the general controls provisions of the Act. The r ou may, dierefore, thanks of the Act include requirements for annual registration, listing of general connologic provisions 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 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 that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or un) I vaturer that 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 (21 CFR Part 807) assemms (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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication. - The 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 rr you the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Croxton

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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## Indications for Use

510(k) Number (if known):

K042594

Device Name: Vanguard Reprocessed Non-Electric Forceps

Indications For Use: GI forceps are designed for insertion through an appropriate sized endoscopy channel for removal and histological sampling of tissue. Biopsy forceps are intended for removal of polyps and/or tissue within the gastrointestinal tract.

Prescription Use × (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)

Daniel A. Layman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

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