(214 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of a ligation clip, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a non-active implantable for ligating vessels or tissue structures, typically used during surgical procedures, not for treating or preventing a disease or condition in the therapeutic sense.
No
This device is used for ligation of vessels or tissue structures, which is a therapeutic intervention rather than a diagnostic one. It does not mention any function related to identifying or analyzing medical conditions.
No
The device description explicitly states it is a "non-absorbable, nonactive implantable device" made of acetal homopolymer, which are physical materials, not software. The description also mentions physical components like clips, cartridges, and appliers.
Based on the provided information, the Vesocclude Polymer Ligation Clips are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the ligation of vessels or tissue structures within the body during surgical procedures. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is described as a non-absorbable, nonactive implantable device. IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect specific analytes, or provide diagnostic information based on laboratory testing.
Therefore, the Vesocclude Polymer Ligation Clips are a surgical device used for physical ligation, not an IVD.
N/A
Intended Use / Indications for Use
Intended Use: The Vesocclude Polymer Ligation Clips are in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Contraindications: Vesocclude polymer ligs are not intended for use as a fallopian contraceptive tubal occlusion device. Vesocclude polymer ligation clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The Vesocclude™ ligating clips are non-absorbable, nonactive implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or tissue structures, fallopian, renal artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons
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)
Performance testing consisting of dimensional analysis, clip applier compatibility, post aging performance and functional testing for resistance to leakage and migration were completed and demonstrate equivalence to the predicate device. And biocompatibility testing in accordance to ISO 10993-1 standards was conducted.
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.
K030311, K003337, K993157, K902108
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/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
Vesocclude Medical, LLC Mr. Freddy Cannady President and Founder 7429 ACC Blvd., Suite 101 Raleigh, NC 27617
Re: K152082
Trade/Device Name: Vesocclude Polymer Ligating Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: December 5, 2015 Received: January 28, 2016
Dear Mr. Cannady:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152082
Device Name Polymer Ligating Clip
Indications for Use (Describe)
Intended Use: The Vesocclude Polymer Ligation Clips are in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Contraindications: Vesocclude polymer ligs are not intended for use as a fallopian contraceptive tubal occlusion device. Vesocclude polymer ligation clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (Per 21 CFR 807.92)
| Date: | February 13th 2016 |
|---|---|
| Company Name: | Vesocclude Medical, LLC |
| Company Address: | 7429 ACC BLVD |
| Suite 101 | |
| Raleigh, NC 27617 | |
| Contact Person: | Freddy Cannady |
| President and Founder | |
| 919-201-3142 | |
| Device Trade Name: | Vesocclude™ Polymer Ligating Clip |
| Regulation Name: | Implantable Clip |
| Regulation Number: | 21 CFR 878.4300 |
| Product Code: | FZP |
| Predicate Device: | Teleflex Medical Hem-o-lok® Ligating Clips |
| (K030311, K003337, K993157, K902108) |
Device Description: The Vesocclude™ ligating clips are non-absorbable, nonactive implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use.
Intended Use: The Vesocclude Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Contraindications: Vesocclude polymer ligation clips are not intended for use as a fallopian contraceptive tubal occlusion device. Vesocclude polymer ligation clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
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Technological Characteristics: The technological characteristics of the proposed device are similar or the same as those of the predicate devices. The shape, sizes offered, material, method of application and mechanical function of the Vesocclude clip are the same as the predicate device.
Performance Data (Nonclinical): Performance testing consisting of dimensional analysis, clip applier compatibility, post aging performance and functional testing for resistance to leakage and migration were completed and demonstrate equivalence to the predicate device. And biocompatibility testing in accordance to ISO 10993-1 standards was conducted.
Statement of Substantial Equivalence: The Vesocclude™ Polymer Ligating Clips are substantially equivalent to their predicate device; the Teleflex Medical Hem-olok® Ligating Clips, based upon similarities in intended use, design, principles of operation and performance specifications.