(172 days)
Not Found
No
The device description and intended use describe a mechanical surgical clamp with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is used to temporarily occlude blood vessels during surgical procedures, which is a supportive function rather than a therapeutic one like treating a disease or condition. It facilitates a medical procedure rather than directly providing therapy.
No
The device is described as a surgical clamp used to temporarily occlude blood vessels during procedures, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a reusable device with a stainless steel handle, flexible shaft, and jaws, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "occlude a blood vessel temporarily" during surgical procedures. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical clamp used to physically manipulate blood vessels. This aligns with a surgical instrument, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used during a procedure on the patient.
N/A
Intended Use / Indications for Use
The Allegiance Cosgrove™ Clamp is intended to be used for the temporary occlusion of blood vessels and other delicate vessels during surgery. Surgical applications include pulmonary and gastrointestinal procedures, peripheral clamping, minimally invasive and standard open cardiovascular and cardiothoracic procedures such as occlusion of the aorta and vena cava, cross-clamping of the aorta, etc.
Used to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.
Product codes
DXC
Device Description
The Allegiance Cosgrove™ Clamp is a reusable device which features a stainless steel handle, flexible shaft and jaws. The Cosgrove™ Clamp is designed to be used with a variety of inserts which gently surround blood vessels and offer differing degrees of atraumatic occlusion. Following the clamping of the blood vessel, the shaft of the device can be bent out of the way to enhance visualization of and access to the operative field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels and other delicate 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)
All materials used in the composition of the Cosgrove™ Clamp were subjected to performance and physical tests to evaluate the safety, effectiveness and reliability of the device. All test results were acceptable.
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
Ka74769
Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a bold, stylized font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small squares. The word "Allegiance" is written in a slightly slanted, cursive-like style, with the letters connected to each other. The overall impression is that of a logo or brand name.
Allegiance Healthcare corporation
JUN 1 2 1998
1500 Waukegan Road McGaw Park, IL 60085 847 473 1500 FAX: 847.785.2461
SUMMARY OF SAFETY AND EFFECTIVENESS Appendix F
Manufacturer:
Allegiance Healthcare Corporation V. Mueller Business Unit 1435 Lake Cook Road Deerfield, IL 60015
Patricia Sharpe-Gregg 1500 Waukegan Road McGaw Park, Illinois 60085
(847) 578-3636
December 19, 1997
Cosgrove™ Clamp
Vascular Clamp
Vascular Clamp
Allegiance Fogarty-Hydragrip® Surgical Clamp
The Allegiance Cosgrove™ Clamp is a reusable device which features a stainless steel handle, flexible shaft and jaws. The Cosgrove™ Clamp is designed to be used with a variety of inserts which gently surround blood vessels and offer differing degrees of atraumatic occlusion. Following the clamping of the blood vessel, the shaft of the device can be bent out of the way to enhance visualization of and access to the operative field.
Telephone:
Date Summary Prepared:
Regulatory Affairs Contact
Product Trade Name:
Common Name: 游--
Classification:
Predicate Device: (K951413)
Description:
1
The Allegiance Cosgrove™ Clamp is intended Intended Use: to be used for the temporary occlusion of blood vessels and other delicate vessels during surgerv. Surqical applications include pulmonary and gastrointestinal procedures, peripheral clamping, minimally invasive and standard open cardiovascular and cardiothoracic procedures such as occlusion of the aorta and vena cava, cross-clamping of the aorta, etc. Substantial Equivalence: The Allegiance Cosgrove™ Clamp is substantially equivalent to the Fogarty-Hydragrip® Surgical Clamps and the Applied Vascular Atraumax™ Surgical Clamps in that: Intended use is the same ● Performance attributes are the same ● Atraumatic Jaw design characteristic is the . same Summary of Testing: All materials used in the composition of the Cosgrove™ Clamp were subjected to performance and physical tests to evaluate the safety, effectiveness and reliability of the device. All test results were acceptable.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Public Health Service
JUN 1 2 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sharpe-Gregg Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukeqan Road, Bldg. MPWM McGaw Park, IL 60085
Re: K974769 Trade Name: Cosgrove Clamp Requlatory Class: II Product Code: DXC Dated: May 30, 1998 Received: June 14, 1998
Dear Ms. Sharpe-Gregg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any
3
Page 2 - Ms. Sharpe-Gregg
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a square made up of many small circles. The circles are arranged in a grid pattern, and the square is slightly tilted.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847-473-1500 FAX: 847-785-2461
510(k) Notification Cosgrove™ Clamp V. Mueller Business Unit Page 1 of 1
510(k) Number (if known):
Unknown
Device Name:
Indications For Use:
Used to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.
Allegiance Cosgrove™ Clamp
Tatt
(Division Sign-Off) Division of Cardiovascular, Respira and Neurological Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________