(246 days)
Not Found
No
The description focuses on a mechanical clamp with an integrated Doppler probe for blood flow monitoring using a conventional ultrasound unit. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
Explanation: The device is described as a surgical instrument for temporary occlusion of blood vessels and for monitoring blood flow. It is not indicated for treating or preventing a disease or condition, but rather as an accessory during surgical procedures.
No
The device is a surgical clamp used for temporary occlusion of blood vessels. While it has an integrated Doppler probe for blood flow monitoring, this function is primarily for confirming occlusion during a surgical procedure rather than for diagnosing a condition or disease. The primary purpose is a surgical tool, not a diagnostic one.
No
The device description clearly states it is a "ring handled mechanical surgical instrument" made of "surgical grade stainless steel" with an "integrated Doppler probe." This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary occlusion of blood vessels during vascular surgical procedures." This is a surgical intervention performed directly on the patient's body.
- Device Description: The device is a surgical instrument (a clamp) used to physically manipulate blood vessels. While it incorporates an ultrasound Doppler for monitoring, the primary function is mechanical occlusion.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not perform any analysis on biological samples.
The ultrasound Doppler component is used for monitoring blood flow in vivo (within the living body) during the surgical procedure, not for analyzing a sample in vitro.
N/A
Intended Use / Indications for Use
The VCS-A Series Clamp is indicated for use in the temporary occlusion of blood vessels during vascular surgical procedures.
Product codes
72 DXC, 90 ITX
Device Description
The VCS-A Series Clamp with Ultrasound Doppler is a ring handled mechanical surgical instrument with a ratchet closure to adjust the tension required to occlude the target vessel. The Clamp has an integrated Doppler probe, which allows for blood flow monitoring by using an available portable Doppler Ultrasound unit. The VCS-A Series Clamp is available in various sizes and is a sterile, single use device. The method of sterilization will be Gamma Radiation with a SAL of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound Doppler
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 performance and functional testing demonstrated that the vascular clamp is substantially equivalent to the predicate devices. The VCS-A series Clamp with Ultrasound Doppler did not raise any new safety, effectiveness, or performance issues. Data are on file at Vascular Control Systems, Inc.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 1 5 2002
KO11863
510(k) SUMMARY Vascular Control Systems, Inc. VCS-A Series Clamp with Ultrasound Doppler
1. GENERAL
| Submitter: | Vascular Control Systems, Inc.
32236-E Paseo Adelanto
San Juan Capistrano, CA 92675 |
|-----------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Al Memmolo
V.P. Quality and Regulatory Affairs |
| Date Prepared: | February 6, 2002 |
2. DEVICE NAME
- Classification name: Vascular Clamp (21 CFR §870.4450) .
- Common or usual name: Vascular Clamp .
- Trade or proprietary name: VCS-A Series Clamp with Ultrasound Doppler .
3. PREDICATE DEVICES
| • 510(k) # | K973080 |
|---|---|
| • Company: | Walter Lorenz Surgical, Inc. |
| • Device Classification: | Class II |
| • Device Name: | Surgical Vascular Clamp |
| • Clearance Date: | Feb 23, 1998 |
| • 510(k) # | K935994 |
| • Company: | Koven Technologies, Inc. |
| • Device Classification: | Class II |
| • Device Name: | PW Doppler Vascular Probes |
| • Clearance Date: | May 11, 1995 |
4. DEVICE DESCRIPTION
The VCS-A Series Clamp with Ultrasound Doppler is a ring handled mechanical surgical instrument with a ratchet closure to adjust the tension required to occlude the surgical instrument with a wall integrated Doppler probe, which allows for blood targer vesser. "The Claimp has an the available portable Doppler Ultrasound unit. The Itow sching by using a contineretar areas areas and is available in various VCS-A belies claimp 16 mass. The clamp is a sterile, single use device. The method of sterilization will be Gamma Radiation with a SAL of 106.
1
510(k) Summary VCS-A Series Vascular Clamp
5. INTENDED USE
The intended use is the temporary occlusion of blood vessels during vascular surgical procedures.
6. SUBSTANTIAL EQUIVALENCE
Vascular Control Systems, Inc. believes the VCS-A Series Clamp with Ultrasound Doppler raises no new questions of safety and efficacy based upon indications for use Doppiel falses no new questions of barber and the VCS-A Series Clamp meets the and device design. Therefore, we concease many to Section 510(k) guidelines.
7. PRODUCT PERFORMANCE TESTING
The performance and functional testing demonstrated that the vascular clamp is The performance and runetional tesing devices. The VCS-A series Clamp with Substantially equivalient to the proving any new safety, effectiveness, or performance issues. Data are on file at Vascular Control Systems, Inc.
8. CONCLUSIONS
Based on the same intended use, similar technological characteristics and Dascu on the Same intended abonent of Systems, Inc. believes the VCS-A Series performatice testing, vuseum. Ochard equivalent to the predicate devices.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines above it, possibly representing the concept of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2002
Mr. Al Memmolo Vice President of Quality Assurance and Regulatory Affairs Vascular Control Systems, Inc. 32236-E Paseo Adelanto San Juan Capistrano, CA 92675
Re: K011863
Trade Name: VCS-A Series Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasound Transducer Regulatory Class: II (two) Product Code: 72 DXC and 90 ITX Dated: February 6, 2002 Received: February 8, 2002
Dear Mr. Memmolo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910((i) promativalially equivalent (for the referenced above and we nave detemmed the deviles marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed in of the Medical De indications for use stated in the choiosaro, to teenactment date of the Medical Device interstate commence pror to May 20, 1970, the end new market the provisions of the Amendments, of to devices mar liave been recurse market the device, subject to Federal Food, Drug, and Cosmetic Act (Act. Tournal) , ontrols spovisions of the Act include the general controls provisions of the Avi. " Previews vonestical volusion in practice, labeling, requirements against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for This determination of Substantials equir premarket notification:
Transducer Model Number
09-0005-01 09-0005-02 09-0005-03 09-0005-04
3
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 n may of subject to sadh addiness Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. may puonsh farmer announ's issuance of a substantial equivalence determination does not mean i fouse of actived that I Dristian that your device complies with other requirements of the Act that I Dr Has made a aond regulations administered by other Federal agencies. You must or mry 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 OF It Fat 607); incoming (21 CFR Part 820); and if applicable, the electronic rord in and quality by solide (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers m Ispendix of (enclosed) of af Diagnostic Ultrasound Systems and Transducers." If the special Decking Manteling Orcarantes or wacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
4
Page 3 - Mr. Al Memmolo
If you have any questions regarding the content of this letter, please contact O.D. Hottenstein, Ph.D. at (301) 443-8262.
Sincerely yours,
Da Tell
8- Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
VASCULAR CONTROL SYSTEMS, INC. 510(k) K011863 VCS-A Series Clamp
510(k) Number (if known):
VCS-A Series Clamp Device Name:
Indications for Use:
The VCS-A Series Clamp is indicated for use in the temporary occlusion of blood vessels during vascular surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
Division of Cardiovascular & Respiratory Devices
510(k) Number K011863
B-2