(162 days)
Vesocclude ligating clips are intended for use in procedures involving vessels or anatomic structures for which the user determines ligating clips are the best choice. Users should select the size and amount of the clips based on upon their experience, judgment, and needs.
Vesocclude ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in multiple sizes.
The provided text describes a 510(k) submission for the Vesocclude Ligating Clip, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone studies) is not present in the document.
Here's a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on substantial equivalence based on design, material, and metallurgical characteristics, rather than defined performance metrics with acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The submission does not describe a clinical performance study with a test set. The evaluation is based on non-clinical data, specifically metallurgical comparative analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As there is no clinical performance study with a test set, there are no experts involved in establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As there is no clinical performance study with a test set, there is no adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. This device is a medical implant (ligating clip), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI-related performance metrics are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is a medical implant, not an algorithm, so a standalone performance study in this context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. For this type of submission, the "ground truth" is typically established by physical and chemical properties and comparison to known predicate devices, rather than clinical outcomes or expert consensus. The "metallurgical comparative analysis" serves as the basis for comparison.
8. The sample size for the training set
This information is not applicable/not provided. The term "training set" is relevant for machine learning algorithms. This submission pertains to a physical medical device and does not involve a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As there is no training set for a machine learning algorithm, there is no ground truth established in this context.
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K091060
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SECTION 5 - 510(k) Summary
Name, Address, Phone and Fax Number of Applicant
Owner: Stephen Holmes Address: Vesocclude Medical, LLC Durham, NC Phone: 919-215-2717
Contact Person
| Name: | Diane Peper |
|---|---|
| Telephone: | 919-570-9605 |
| E-mail: | dianepeper@gmail.com |
| Address: | Triangle Quality Solutions, Inc.10419 Stallings RoadSpring Hope NC 27882 |
Date Prepared: March 16th 2009
A. Device Name
| Trade Name: | Vesocclude Ligating Clip |
|---|---|
| Common Name: | Hemostatic Clip, Ligating Clip |
| Classification Name: | Vascular Clip |
B. Predicate Device
Teleflex Medical Horizon Ligating Clips (510ks; K901303. K982313) Teleflex Medical Hemoclip Ligating Clips (510ks; K841547, K841548, K841549) Teleflex Medical Atrauclip Ligating Clips (510k; K861992)
C. Device Description
Vesocclude ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in multiple sizes.
Indications for Use
Vesocclude ligating clips are intended for use in procedures involving vessels or anatomic structures for which the user determines ligating clips are the best choice. Users should select the size and amount of the clips based on upon their experience. judgment, and needs.
Contraindications
This product is not intended for use as a contraceptive tubal occlusion device. This product is contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
D. Characteristic Comparison to Predicate Device Equivalence
The Vesocclude ligating clips are substantially equivalent to the predicate device in design (Chevron shaped clip), material (Titanium), performance characteristics and intended use. The Vesocclude ligating clips are specifically designed to be used with both the Teleflex Medical Horizon ligating clip and Vesocclude ligating clip appliers.
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The technique used to transfer both the Vesocclude and Teleflex Medical Horizon ligating clip from plastic cartridge carrier into the jaw of the reusable stainless steel applier is the same. See Appendix 7 for photographs. Clip application to the ligation site is identical to the predicate device.
E. Summary of Non-clinical Performance Data
Vesocclude ligating clips are made of an implantable grade of Titanium with similar dimensions and metallurgical characteristics as the Teleflex Medical Horizon ligating clips. A metallurgical comparative analysis demonstrates that the Vesocclude ligating clips are as safe, as effective and perform as well as the predicate device. See Appendix 4 for additional details.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The emblem is black, and the text is also in a dark color, likely black or a dark shade of gray.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 2 3 2009
Vesocclude Medical, LLC % Triangle Quality Solutions, Inc. Ms. Diane Pepers 10419 Stallings Roadn Spring Hope, North Carolina 27882
Re: K091060
Trade/Device Name: Vesocclude Ligating Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: September 1, 2009 Received: September 4, 2009
Dear Ms. Pepers:
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, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Diane Pepers
.. .. . .
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucch1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 fire (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for Nolo
N.A
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4 - Indications for Use
510(k) Number:
Device Name: Vesocclude Ligating Clip
Indications For Use: Vesocclude ligating clips are intended for use in procedures involving vessels or anatomic structures for which the user determines ligating clips are the best choice. Users should select the size and amount of the clips based on upon their experience, judgment, and needs.
Contraindications: This product is not intended for use as a contraceptive tubal occlusion device. This product is contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
Prescription Use Yes
AND/OR
Over-The-Counter Use
(PLEASE DOE NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ned RP Opher forman
vision Sign-Off) ( Division of Surgical, Orthopedic, and Restorative Devices
1091060 510(k) Number.
10
§ 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.