(85 days)
830503
Not Found
No
The document describes a reprocessing process for a mechanical clip applier and does not mention any computational or data-driven components that would suggest the use of AI or ML.
No
The device is described as a multiple clip applier for ligation of tubular structures, which is a surgical tool, not a therapeutic device.
No
Explanation: The device, a multiple clip applier, is used for ligation (tying off) of tubular structures, which is a therapeutic or procedural action, not a diagnostic one. Its purpose is to apply clips, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly states it is a physical medical device (clip appliers) that is being reprocessed. There is no mention of software as the primary component or function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ligation of tubular structures." This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "Multiple Clip Applier," which is a surgical instrument used to apply clips during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly described as a reprocessed surgical instrument used for a surgical procedure.
N/A
Intended Use / Indications for Use
Multiple clip appliers are indicated for ligation of tubular structures.
Vanguard intends to reprocess multiple clip appliers one time.
Reprocessed multiple clip appliers are single use devices.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
Vanguard Medical Concepts, Inc., intends to market Reprocessed Disposable, Multiple Clip Appliers with non changeable reloads. Reprocessing Multiple Clip Appliers is performed by Vanguard to Vanguard Potocol Number 40017.
"Reprocessed," means all operations performed to render a contaminated single-use device patient ready (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.
Appliers are sold new by the original manufacturers to the hospital. The hospital uses the appliers, collects them and ships them to Vanguard for reprocessing. Appliers are reprocessed by Vanguard as described in our reprocessing protocol Control Document Number 40017, and returns them to the hospital to be reused as a single-use device again
Vanguard believes that single-use 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
510(k) 830503
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Vanguard Medical. The logo includes the company name in a stylized font, with the address "5307 Great Oak Drive" printed below. The image also includes the date "DEC 1 8 2003" and the phone number "Tel: (863) 683-8680".
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Lakeland, FL
Fax: (413) 215-9809
510(k) SUMMARY
| Reference: | Vanguard Medical Concepts, Inc.
Section 510(k) Notification
AMI Reprocessed Multiple Clip Appliers (Non Re-loadable) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification name: | LSR Disposable Stapler
Manual Surgical Instrument |
| Common/Usual Name: | Disposable Surgical Instruments |
| Proprietary Name: | Vanguard Reprocessed Multiple Clip Appliers |
| Establishment Reg. No.: | 1649663 |
| Classification: | The FDA has classified Manual, General Surgical
Instruments as Class I devices under the General and
Plastic Surgery Panel (21 CFR 878.4800)
As an implantable clip, Class II. |
Vanguard Medical Concepts, Inc., intends to market Reprocessed Disposable, Multiple Clip Appliers with non changeable reloads. Reprocessing Multiple Clip Appliers is performed by Vanguard to Vanguard Potocol Number 40017.
"Reprocessed," means all operations performed to render a contaminated single-use device patient ready (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.
Appliers are sold new by the original manufacturers to the hospital. The hospital uses the appliers, collects them and ships them to Vanguard for reprocessing. Appliers are reprocessed by Vanguard as described in our reprocessing protocol Control Document Number 40017, and returns them to the hospital to be reused as a single-use device again
Vanguard believes that single-use 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.
Vanguard reprocessed appliers are substantially equivalent to Ethicon disposable surgical and endoscopic Ligaclip Multiple Clip Appliers currently marketed new by Ethicon under 510(k) 830503.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three birds in flight, arranged in a stacked formation.
DEC 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vanguard Medical Concepts, Inc. c/o Mr. Mark W. Aldana Adven Medical, Inc. 3706 76th Street Lubbock, Texas 79423
Re: K032980
Trade/Device Name: Reprocessed Multiple Clip Appliers Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP 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 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 the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
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
3
Indications for Use
510(k) Number (if known): K032980
Device Name: Reprocessed Multiple Clip Appliers
Indications For Use:
Multiple clip appliers are indicated for ligation of tubular structures.
Vanguard intends to reprocess multiple clip appliers one time.
Reprocessed multiple clip appliers are single use devices.
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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________