(124 days)
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.
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.
The provided text describes the 510(k) summary for the Vanguard Reprocessed Non-Electric Biopsy Forceps and does not contain the specific information requested about acceptance criteria, device performance tables, study designs (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone), or training set details.
The document focuses on:
- Device Description: Reprocessed non-electric GI biopsy forceps.
- Intended Use: Removal and histological sampling of tissue/polyps within the GI tract.
- Technological Characteristics: "Essentially identical" to OEM devices with no changes to materials or specifications.
- Predicate Devices: Various OEM non-electric biopsy forceps (Class I, 510(k) exempt).
- Test Data: States that "Cleaning, sterilization, packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective."
Therefore, I cannot fulfill your request for the detailed acceptance criteria and study information as it is not present in the provided text.
The document only broadly states that "performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective," but does not give any specifics on:
- Quantitative acceptance criteria (e.g., minimum tensile strength, maximum residual protein).
- Reported device performance against those criteria.
- Sample sizes for test sets.
- Data provenance.
- Number/qualifications of experts.
- Adjudication methods.
- MRMC or standalone studies.
- Types of ground truth.
- Training set details.
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K042594
Page 1 of 2
510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Heather Crawford, RACDirector of Regulatory Affairs863-683-8680 [voice]863-683-8703 [facsimile]hcrawford@safe-reuse.com [email] |
| Date | September 23, 2004 |
| Device | Trade Name: Vanguard Reprocessed Non-Electric Biopsy ForcepsCommon Name: Reprocessed Non-Electric Biopsy ForcepsClassification: 21 CFR, 876.1075(b)(2) – Forceps, Biopsy, Non-Electric, Reprocessed - Class IProduct Code: NON |
| Predicate Devices | Trade Names: Bard PrecisorTM XL Coated non-electric biopsy forcepsMicrovasive® MultiBite® non-electric biopsy forcepsMicrovasive® Radial Jaw® non-electric biopsy forcepsMicrovasive® Radial Jaw® 3 non-electric biopsy forcepsMicrovasive® Radial Jaw® Large Capacity non-electric biopsy forcepsMicrovasive® Radial Jaw® 3 Max Capacity non-electric biopsy forcepsWilson Cook Medical The SharkTM non-electric biopsy forceps510(k) numbers: Not applicable 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
Page 2 of 2
510(k) Summary of Safety & Effectiveness, Continued
| Indicationsfor Use | GI forceps are designed for insertion through an appropriate sized endoscopychannel for removal and histological sampling of tissue. Biopsy forceps areintended 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 abdominalperitonitis, 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. | |
| DeviceDescription | Vanguard Reprocessed Non-Electric Biopsy Forceps consist of a flexiblesheath with distal grasping cups controlled by a proximal control handle.When used with a compatible endoscope, GI biopsy forceps are intended forremoval of polyps and/or tissue within the gastrointestinal tract. Biopsyforceps are designed for insertion through a predetermined diameter biopsychannel.Vanguard receives previously used non-electric GI biopsy forceps fromhealthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes thedevices; and returns them to a healthcare facility for subsequent use. | |
| TechnologicalCharacteristics | Vanguard Reprocessed Non-Electric Biopsy Forceps are essentially identicalto the Original Equipment Manufacturer (OEM) devices. No changes aremade to the device materials or specifications and the reprocessed forcepspossess identical technological characteristics. | |
| Test Data | Cleaning, sterilization, packaging validations, and performance andbiocompatibility testing demonstrate that the reprocessed devices perform asintended and are safe and effective. | |
| Conclusion | Based upon the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that VanguardReprocessed Non-Electric Biopsy Forceps are substantially equivalent to theirpredicate 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 | (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
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Indications for Use
510(k) Number (if known):
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
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.