(255 days)
Not Found
No
The 510(k) summary describes a mechanical ligating clip and does not mention any software, algorithms, or AI/ML components.
No
The device is a ligating clip used in surgical procedures to tie off vessels or tissue structures for hemostasis, not to treat or cure a disease or condition.
No
Ligating clips are used for vessel or tissue structure ligation to achieve hemostasis, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical medical device (ligating clips made of polyacetal material) and its packaging, sterilization, and physical characteristics. There is no mention of software as a component of the device itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Vas-Q-Clip™ Function: The Vas-Q-Clip™ is a surgical device used during a procedure to ligate (tie off) vessels or tissue structures within the body. It is a physical device used for a surgical purpose, not for analyzing biological samples.
The description clearly states its intended use is for "procedures involving ligation of vessels or tissue structures" and that it "causes hemostasis through vessel ligation." This is a direct surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Vas-Q-Clip ligating 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.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
Nanova Biomaterials Inc.'s Vas-Q-Clip causes hemostasis through vessel ligation. The technological characteristics are the same as or equivalent to the predicate device. The non-absorbable polyacetal material used in the clips is the same as the predicate device and the clips are manufactured in a similar manner.
The clips are housed in a cartridge and package in a ridged plastic plaster with Tyvek coated lidding and is sold sterile. The method of sterilization is EtO with a SAL of 10-6. The blisters are fitted into a carton in which the clips are sold.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or tissue structures
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)
Non-clinical testing was completed to assess its performance. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility risk assessment conducted and a benchtop assessment.
Tests performed:
Migration Resistance - Passed
Vessel Occlusion - Passed
Application Force - Passed
Axial Pull-Off Force - Passed
USP 85 Bacterial Endoxins Test - Passed
USP 151 Rabbit Pyrogenicity Test - Passed
Material Comparison Test - Passed
ISO 10993-10 Skin Sensitization - Passed
ISO 10993-6 Local Effects After Implantation - Passed
Visual Inspection of Seal - Passed
Bubble Emission - Passed
Dye Penetration - Passed
Peel-off Seal Strength - Passed
Accelerated and Real Time Aging - Passed
Sterility - Passed
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.
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.
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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 a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2016
Nanova Biomaterials, Inc. Mr. Andrew Ritts Senior Research Scientist 3806 Mojave Ct. Columbia. MO 65202
Re: K151943
Trade/Device Name: Vas-Q-Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: February 23, 2016 Received: February 26, 2016
Dear Mr. Ritts:
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
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Indications for Use
510(k) Number (if known) K151943
Device Name Vas-Q-Clip^TM
Indications for Use (Describe)
Vas-Q-Clip' TM ligating 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.
| 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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Section 5. 510(k) Summary
-
- Submitted By: Nanova Biomaterials, Inc 3806 Mojave Ct Columbia, MO 65202 USA 573-875-6682 Contact Person: Andrew Ritts Phone: (573) 823-3114 Secondary Contact: Richard Lebens Phone: (573) 875-6682 2) Establishment Registration No.: 3011430871 3) Date Prepared: December 14, 2015 Vas-Q-Clip™ 4) Device Trade Name: ર) Device Common Name: Ligation Clip Implantable Clip/ 878.4300/ FZP 6) Device Classification Name/ Regulation #/Product Code: Classification Panel: 7) General and Plastic Surgery Device Class: Class II 8)
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- Predicated Devices: Vas-Q-Clip™ is believed to be substantially equivalent to Hem-O-lok® Ligating Clip (K993157).
-
- Indication for Use: Vas-Q-Clip™ ligating 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.
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Section 5. 510(k) Summary - Cont.
-
- Device Description:
Nanova Biomaterials Inc.'s Vas-Q-Clip™ causes hemostasis through vessel ligation. The technological characteristics are the same as or equivalent to the predicate device. The non-absorbable polyacetal material used in the clips is the same as the predicate device and the clips are manufactured in a similar manner.
- Device Description:
The clips are housed in a cartridge and package in a ridged plastic plaster with Tyvek coated lidding and is sold sterile. The method of sterilization is EtO with a SAL of 10-6. The blisters are fitted into a carton in which the clips are sold.
-
- Substantial Equivalence:
The document, "Guidance on the CDRH Premarket Notification Review Program, 6/30/86 (K86-3)" was used to determine substantial equivalence:
- Substantial Equivalence:
a) The applicant device has the same intended use as the 510(k) cleared predicate listed above.
b) The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device. This device and its predicates are substantially equivalent in material and manufacturing methods. Vas-Q-Clip™ is packaged in a similar manner to its predicate and many 510k cleared products already on the market. A summary of the comparison is shown in Table 5.1 below.
The Vas-O-Clip™ outer structure including legs, bosses, hook and latch mechanism, and hinge are the same as the Hem-o-lok® design (Shape and dimensions are the same for the corresponding sizes). The only difference is the inner closure feature designated as "teeth". Vas-Q-Clip"M triangular protrusions (teeth) are perpendicular to the vessel whereas the Hem-O-Lok teeth are parallel.
Vas-O-Clip™ has the same Intended Use as the predicate devices to which it was compared, and there are no differences in technological characteristics which raise new questions of safety and / or effectiveness. Therefore, Vas-Q-Clip™ is substantially equivalent.
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| Name | Vas-Q-ClipTM | Hem-O-Lok® (K993157). | Comparison |
|---|---|---|---|
| Indications for use | Vas-Q-ClipTM ligating 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. | Hem-O-Lok® ligating 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. | Same |
| Composition | Polyacetal | Polyacetal | Same |
| Processing | Injection Molding | Injection Molding | Same |
| Sterility | EtO at 10-6 SAL | EtO at 10-6 SAL | Same |
| Design | Triangular protrusions are perpendicular to the vessel | Triangular protrusion are parallel to the vessel | Different |
| Size | ML, L, XL | M, ML, L, XL | No M size |
| Migration Resistance | Internal Testing | Internal Testing | Higher strength |
| Vessel Occlusion | Internal Testing | Internal Testing | Higher pressure |
| Application Force | Internal Testing | Internal Testing | Higher strength |
| Axial Pull-Off Force | Internal Testing | Internal Testing | Higher strength |
| Packaging | The clips are housed in a cartridge and package in a ridged plastic plaster with Tyvek coated lidding. | The clips are housed in a cartridge and package in a ridged plastic plaster with Tyvek coated lidding. | Same |
| Table 5.1. Technical Comparison of Vas-Q-Clip™ and Hem-O-Lok® (K993157). | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------------------------------------------- |
13) Non-Clinical Performance Testing:
Non-clinical testing was completed to assess its performance. Table 5.2 shows the list of tests performed. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility risk assessment conducted and a benchtop assessment.
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| Table 5.2. Tests performed on Vas-Q-Clip™. | ||
|---|---|---|
| Name | Result |
|---|---|
| Migration Resistance | Passed |
| Vessel Occlusion | Passed |
| Application Force | Passed |
| Axial Pull-Off Force | Passed |
| USP 85 Bacterial Endoxins Test | Passed |
| USP 151 Rabbit Pyrogenicity Test | Passed |
| Material Comparison Test | Passed |
| ISO 10993-10 Skin Sensitization | Passed |
| ISO 10993-6 Local Effects After Implantation | Passed |
| Visual Inspection of Seal | Passed |
| Bubble Emission | Passed |
| Dye Penetration | Passed |
| Peel-off Seal Strength | Passed |
| Accelerated and Real Time Aging | Passed |
| Sterility | Passed |
- Clinical Performance Testing: Clinical performance data was not included.
Conclusion:
Nanova Biomaterials Inc. believes that Vas-Q-Clip™ is substantially equivalent to currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.