← Product Code [NON](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NON) · K042594 # VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS (K042594) _Vanguard Medical Concepts, Inc. · NON · Jan 25, 2005 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NON/K042594 ## Device Facts - **Applicant:** Vanguard Medical Concepts, Inc. - **Product Code:** [NON](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NON.md) - **Decision Date:** Jan 25, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 1 - **Review Panel:** Gastroenterology, Urology ## 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. ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K042594 Page 1 of 2 ## 510(k) Summary of Safety & Effectiveness | Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, FL 33815 | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Heather Crawford, RAC
Director of Regulatory Affairs
863-683-8680 [voice]
863-683-8703 [facsimile]
hcrawford@safe-reuse.com [email] | | Date | September 23, 2004 | | Device | | | Predicate Devices | 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 {1}------------------------------------------------ K042594 Page 2 of 2 ## 510(k) Summary of Safety & Effectiveness, Continued | 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. | | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Contra-
indications | This GI biopsy forceps should not be used:
for pulmonary biopsy procedures; when contraindications to GI endoscopy are present, e.g. acute abdominal
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
Description | Vanguard Reprocessed Non-Electric Biopsy Forceps consist of a flexible
sheath with distal grasping cups controlled by a proximal control handle.
When used with a compatible endoscope, GI biopsy forceps are intended for
removal of polyps and/or tissue within the gastrointestinal tract. Biopsy
forceps are designed for insertion through a predetermined diameter biopsy
channel.
Vanguard receives previously used non-electric GI biopsy forceps from
healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the
devices; and returns them to a healthcare facility for subsequent use. | | | Technological
Characteristics | Vanguard Reprocessed Non-Electric Biopsy Forceps are essentially identical
to the Original Equipment Manufacturer (OEM) devices. No changes are
made to the device materials or specifications and the reprocessed forceps
possess identical technological characteristics. | | | Test Data | Cleaning, sterilization, packaging validations, and performance and
biocompatibility testing demonstrate that the reprocessed devices perform as
intended and are safe and effective. | | | Conclusion | Based upon the information provided herein and the 510(k) "Substantial
Equivalence" Decision Making Process Chart, we conclude that Vanguard
Reprocessed Non-Electric Biopsy Forceps are substantially equivalent to their
predicate devices under the Federal Food, Drug and Cosmetic Act. | | {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 {4}------------------------------------------------ ## 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 Page 1 of __1__ 0011 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NON/K042594](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NON/K042594) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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