(58 days)
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Not Found
No
The 510(k) summary describes a purely mechanical, hand-held surgical instrument with no mention of software, data processing, or any terms related to AI or ML.
No
The device is described as a surgical instrument used to temporarily occlude or approximate blood vessels during anastomosis, and it is removed after the procedure; it does not provide any ongoing therapeutic benefit to the patient.
No
Explanation: The device is described as a surgical instrument used to occlude or approximate blood vessels during anastomosis, not to diagnose medical conditions.
No
The device description explicitly states it is a "hand held surgical instrument," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The S&T Micro Anastomosis Clamp is a surgical instrument used directly on blood vessels within the patient's body during surgery. It is a tool for manipulating tissue, not for analyzing samples.
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient, not a diagnostic test performed on a sample from the patient.
Therefore, the S&T Micro Anastomosis Clamp is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm. 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.
Product codes
DXC
Device Description
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 available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2002
S & T AG Bernard Teitz President C/O Micrins Surgical Inc 28438 Ballard Dr. Lake Forest, IL 60045
Re: K022754 Trade Name: S & T Micro Anastomosis Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Clamp, Vascular Regulatory Class: Class II (two) Product Code: DXC Dated: August 12, 2002 Received: August 19, 2002
Dear Mr. Teitz:
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.
1
Page 2 - Bernard Teitz
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Deartell
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Not assigned KOQ2754 510(k) Number (if known):
Device Name:
S&T Micro Anastomosis Clamp
Indications for Use:
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 available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm. 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K022754