(173 days)
These titanium clamps are used for temporarily occlusion of blood vessels during surgery.
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 .
The provided text describes a 510(k) submission for the Vitalcor Featherweight Vascular Clamps. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
The document focuses on establishing substantial equivalence through a comparison of physical characteristics, indications for use, and bench testing, rather than a clinical trial or performance study against pre-defined acceptance criteria in the way one might evaluate an AI-powered diagnostic device.
Therefore, for aspects of your request related to acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies, the provided text does not contain the necessary information.
However, I can extract the relevant information from the document related to the comparison with the predicate device and the non-clinical testing performed.
Here's an attempt to answer your questions based solely on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
Based on the 510(k) summary, the device's "performance" is primarily assessed against the characteristics of the predicate device to establish substantial equivalence, rather than against explicit numerical acceptance criteria for clinical outcomes or diagnostic performance. The key performance characteristic mentioned is clamping pressure.
| Acceptance Criteria (Implied from Predicate Comparison) | Reported Device Performance (Vitalcor Featherweight) |
|---|---|
| Indications for Use: Temporary occlusion of blood vessels during surgery, specifically in microvascular surgery to facilitate procedures like "free flaps" or replants. | Indications for Use: Temporary atraumatic vascular occlusion of blood vessels during surgery. (Slightly rephrased but deemed substantially equivalent). |
| Vessel Size Range: Available for vessels from 0.4mm to 2.25mm (Predicate's range). | Vessel Size Range: Six models covering 0.4mm to 5mm. (Broader range than predicate). |
| Material: Stainless steel or plastic (Predicate). | Material: Titanium only. (Difference noted, but acceptable as it's a known biocompatible material). |
| Range of Pressure on Vessel (Maximum recommended 30g/mm²): 15g/mm² (Predicate). | Range of Pressure on Vessel: 15g/mm². (Matches predicate). |
| Magnetic: Yes (stainless steel predicate). | Magnetic: No (Titanium). (Difference noted, but acceptable). |
| Sterilization: Autoclave presumed (Predicate). | Sterilization: Steam autoclave. (Method specified and validated). |
| Biocompatibility: (Implied requirement for surgical tools). | Biocompatibility: Verified by independent lab. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "non-clinical and bench testing data." It does not specify sample sizes for these tests, nor does it describe data provenance in terms of country of origin or retrospective/prospective nature. These tests are typically performed on the device itself (e.g., mechanical testing) rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for performance data in the context of a clinical or retrospective study. The "ground truth" for this device's evaluation is primarily its adherence to established engineering principles and comparison to a legally marketed predicate device's characteristics and performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of clinical or image-based assessment as described in your request.
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
No MRMC comparative effectiveness study was reported. This type of study is not relevant for the evaluation of a mechanical vascular clamp. The submission focuses on substantial equivalence to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical instrument, not an algorithm. Therefore, "standalone algorithm-only performance" is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for safety and effectiveness is established through:
- Bench Testing: Verifying mechanical properties such as clamping pressure, material integrity, and sterility.
- Biocompatibility Testing: Ensuring the material is safe for contact with human tissue.
- Comparison to Predicate Device: Demonstrating that the new device shares fundamental technological characteristics and performance with an already legally marketed device that has a known safety and effectiveness profile.
The document states, "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."
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set.
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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 .
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- 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.
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6. Substantial Equivalence Chart
| Item | Predicate S&T, K022754 | Vitalcor Featherweight |
|---|---|---|
| Indications | The S&T MicroAnastomosis Clamp is ahand held surgicalinstrument that is designed tobe used in MicrovascularSurgery to either temporarilyocclude or approximateblood vessels during theanastomosis process. Theclamps are used to facilitatesurgical procedures that aretypically called "free flaps"or replants. Once the microanastomosis has beencompleted the micro clamp isremoved from the patient. | These titanium clamps areused for temporarilyatraumatic vascularocclusion of blood vesselsduring surgery. |
| Vessel size range | The clamps are available inthree different size ranges andare to be used on vessels thatrange in size from 0.4mm to2.25mm. | VA079-06 0.4mm-1.0mmVA115-09 0.6mm-1.5mmVA140-09 1mm-2mmVA240-18 1.5mm-3mmVA300-24 2mm-4mmVA375-30 3mm-5mm |
| Materialemployed | Stainless steel (multi-use)Plastic (single use) | Titanium only, multi-use |
| Appearance | Image: Predicate S&T clamp | Image: Vitalcor Featherweight clamp |
| Range ofpressure onvessel(Maximumrecommended inliterature is30g/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.
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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.
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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
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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
Page 1 of 1
§ 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).