(85 days)
Cutters, Staplers and Appliers are indicated for resection, transection or ligation of tissue in abdominal, gynecological, pediatric and thoracic applications.
Vanguard intends to market Reprocessed Disposable Cutters and Staplers, that have removable reloads. Vanguard reprocesses only the hand held instrument. All reloads are removed and discarded before being reprocessed. Reprocessing Cutters, Staplers and Appliers is performed according to Vanguard protocol Number 40018. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. (See FDA Guidance Document: Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). Vanguard is a "third party reprocessor" and reprocesses used single-used medical devices. Vanguard does NOT reprocess the re-loads. Reloads must be supplied by the hospital. Vanguard believes that single-use Cutters, Staplers and Appliers can be considered "reusable" - by Vanguard " as defined in the Food and Drug Administration Compliance Policy Guide #7124.16; they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use. Linear staplers deliver staggered rows of staples in order to approximate internal tissues. Linear Cutters are hand held surgical devices used to deliver staggered rows of staples while simultaneously dividing the tissue. Appliers are hand held surgical instruments that litigate tubular structures and vessels.
This document is a 510(k) summary for Vanguard Medical's reprocessed disposable cutters, staplers, and appliers. It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document focuses on establishing substantial equivalence to legally marketed predicate devices rather than providing performance study details.
Therefore, I cannot provide the requested information from the given text.
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DEC 1 8 2003
K$\phi$32973
Vanguard Medical
1207 Crest Oak Drive Tel: (863) 683-8680
Page 1 of
307 Great Oak . akeland, FL
Fax: (413) 21
510(k) SUMMARY
| Reference: | Vanguard Medical Concepts, Inc.Section 510(k) NotificationReprocessed Used, Disposable Cutters, Staplers and Appliers |
|---|---|
| Classification name: | Manual Surgical InstrumentsLSR Disposable Linear Stapler |
| Common/Usual Name: | Disposable Surgical Instruments |
| Proprietary Name: | Reprocessed Used, Disposable Cutters, Staplers andAppliers |
| Establishment Reg. No.: | 1649663 |
| Classification: | The FDA has classified Manual, General SurgicalInstruments as Class I devices under the General andPlastic Surgery Panel (21 CFR 878.4800) Class II |
Vanguard intends to market Reprocessed Disposable Cutters and Staplers, that have Vanguard intends to market Reprocesses only the hand held instrument. All reloads are
removable reloads. Vanguard reprocesses only the hand held instrument. Steplers and removed and discarded before being reprocessed. Reprocessing Cutters, Staplers and removed and usearded octore oching . Vanguard protocol Number 40018.
"Reprocessed," means all operations performed to render a contaminated single-use Reprocessed, "means an operation Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). Vanguard is a "third party reprocessor" and reprocesses used single-used medical devices.
Vanguard does NOT reprocess the re-loads. Reloads must be supplied by the hospital
Vanguard believes that single-use Cutters, Staplers and Appliers can be considered "reusable" - by Vanguard " as defined in the Food and Drug Administration Compliance Policy Guide #7124.16; they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use,
Linear staplers deliver staggered rows of staples in order to approximate internal tissues. Linear Cutters are hand held surgical devices used to deliver staggered rows of staples while simultaneously dividing the tissue. Appliers are hand beld surgical instruments that litigate tubular structures and vessels.
Vanguard reprocessed devices are substantially equivalent to Ethicon Linear Cutter: 510(k) Number K843034 and K892927, Ethicon Linear Stapler 510(k) Number K821994 and Ethicon Appliers 510(k) Number K830503
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Image /page/1/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird, with three wing-like shapes stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2003
Vanguard Medical Concepts, Inc. c/o Mr. Mark W. Aldana Adven Medical, Inc. 3706 76" Street Lubbock, Texas 79423
Re: K032973
Trade/Device Name: Reprocessed Disposable Cutters, Staplers and Appliers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: September 22, 2003 Received: October 3, 2003
Dear Mr. Aldana:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 10 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 the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it 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 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 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.
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Page 2 - Mr. Mark W. Aldana
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at (301) 594-4659. 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 yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
032973 510(k) Number (if known): #032978
Device Name: Reprocessed Disposable Cutters, Staplers and Appliers
Indications For Use:
Cutters, Staplers and Appliers are indicated for resection, transection or ligation of tissue in abdominal, gynecological, pediatric and thoracic applications.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Page 1 of 1
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K032973
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.