(173 days)
Not Found
No
The description focuses on the material, calibration, and sizing of the clamps, with no mention of AI or ML capabilities.
No
The device aids in surgery by clamping blood vessels but does not directly treat a disease or condition; it is a surgical tool.
No
Explanation: The device is described as a surgical clamp used for temporary occlusion of blood vessels during surgery, which is a therapeutic function, not a diagnostic one. It does not analyze data or provide insights into a patient's condition.
No
The device description explicitly states the device is made from Grade 5 titanium and describes physical characteristics and sizes, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Function: The description clearly states these titanium clamps are used for "temporarily occlusion of blood vessels during surgery." This is a surgical instrument used on the body during a procedure.
- Lack of Diagnostic Purpose: The clamps do not analyze samples or provide diagnostic information. Their function is purely mechanical – to temporarily stop blood flow.
Therefore, based on the intended use and device description, these titanium clamps are not an In Vitro Diagnostic device. They are a surgical instrument.
N/A
Intended Use / Indications for Use
These titanium clamps are used for temporarily occlusion of blood vessels during surgery.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
Vitalcor Featherweight clamps are made from Grade 5 titanium, Vitalcor Featherweight clamps are calibrated to have a clamping pressure that will minimize the possibility of vessel damage. As a guide, the following Vitalcor Featherweight sizes should be used for the vessels size range indicated.
- VA079-06 0.4mm-1.0mm .
- . VA115−09 0.6mm−1.5mm
- VA140-09 1mm-2mm .
- VA240-18 1.5mm-3mm .
- VA300-24 2mm-4mm .
- VA375-30 3mm-5mm .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels
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)
The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices. Biocompatibility and sterilization studies were successfully completed.
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
AUG 2 9 2007
510(k) Summary Vitalcor. Inc 100 E. Chestnut Ave Westmont, IL 60559 (800) 874-8358 630-325-5500 Fax 630-325-0257 Contact: R Gregory Huck, President Prepared July 21, 2007
1. Identification of the Device:
Proprietary-Trade Name: Vitalcor Featherweight Vascular Clamps Classification Name/Product Codes: DXC Common/Usual Name: Vascular Clamp
-
- Equivalent legally marketed devices: S&T Micro Anastomosis Clamp, K022754
-
- Indications for Use (intended use) : These titanium clamps are used for temporarily occlusion of blood vessels during surgery.
-
- Description of the Device: Vitalcor Featherweight clamps are made from Grade 5 titanium, Vitalcor Featherweight clamps are calibrated to have a clamping pressure that will minimize the possibility of vessel damage. As a guide, the following Vitalcor Featherweight sizes should be used for the vessels size range indicated.
- VA079-06 0.4mm-1.0mm .
- . VA115−09 0.6mm−1.5mm
- VA140-09 1mm-2mm .
- VA240-18 1.5mm-3mm .
- VA300-24 2mm-4mm .
- VA375-30 3mm-5mm .
-
- Comparison to predicate device. The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices. Biocompatibility and sterilization studies were successfully completed.
1
6. Substantial Equivalence Chart
| Item | Predicate S&T, K022754 | Vitalcor Featherweight |
|---|---|---|
| Indications | The S&T Micro | |
| Anastomosis Clamp is a | ||
| hand held surgical | ||
| instrument that is designed to | ||
| be used in Microvascular | ||
| Surgery to either temporarily | ||
| occlude or approximate | ||
| blood vessels during the | ||
| anastomosis process. The | ||
| clamps are used to facilitate | ||
| surgical procedures that are | ||
| typically called "free flaps" | ||
| or replants. Once the micro | ||
| anastomosis has been | ||
| completed the micro clamp is | ||
| removed from the patient. | These titanium clamps are | |
| used for temporarily | ||
| atraumatic vascular | ||
| occlusion of blood vessels | ||
| during surgery. | ||
| Vessel size range | The clamps are available in | |
| three different size ranges and | ||
| are to be used on vessels that | ||
| range in size from 0.4mm to | ||
| 2.25mm. | VA079-06 0.4mm-1.0mm | |
| VA115-09 0.6mm-1.5mm | ||
| VA140-09 1mm-2mm | ||
| VA240-18 1.5mm-3mm | ||
| VA300-24 2mm-4mm | ||
| VA375-30 3mm-5mm | ||
| Material | ||
| employed | Stainless steel (multi-use) | |
| Plastic (single use) | Titanium only, multi-use | |
| Appearance | Image: Predicate S&T clamp | Image: Vitalcor Featherweight clamp |
| Range of | ||
| pressure on | ||
| vessel | ||
| (Maximum | ||
| recommended in | ||
| literature is | ||
| 30g/mm²) | 15g/mm² | 15g/mm² |
| Magnetic | Yes (stainless steel) | No (Titanium) |
| Sterilization | Autoclave presumed | Steam autoclave. |
-
- Conclusion: After analyzing bench and non-clinical testing data, it is the conclusion of Vitalcor that the Featherweight Vascular Clamps are comparable to the predicate device in form and function, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate device. The ability to steam autoclave these clamps was validated by an independent laboratory. Biocompatibility verified by independent lab.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2007
Vitalcor, Inc. c/o Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K070661
Vitalcor Featherweight Vascular Clamps Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: August 21, 2007 Received: August 24, 2007
Dear Mr. Kamm:
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 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.
3
Page 2 -- Mr. Daniel Kamm
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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
R. Vachner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ___K070661 ________
Vitalcor Featherweight Vascular Clamps Device Name:
Indications For Use:
These titanium clamps are used for temporarily occlusion of blood vessels during surgery.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
suma R.Vachmes
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_603066
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