(11 days)
Not Found
No
The summary describes a purely mechanical device with no mention of software, algorithms, or any features that would suggest AI/ML capabilities.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is used to temporarily occlude a blood vessel during a procedure, which is a procedural aid rather than a direct treatment for a disease.
No
The device is described as a surgical tool used to temporarily occlude blood vessels, not to diagnose a condition or disease. It is an interventional device.
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 describes a device used to physically manipulate blood vessels during surgical procedures (occlusion, clamping). This is an in vivo (within a living organism) application.
- Device Description: The description details a surgical instrument with a handle, shaft, and jaws designed for physical interaction with blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with structures within the body during a procedure.
N/A
Intended Use / Indications for Use
The Allegiance Flexible Vascular Clamp, Version 2 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 cardio-thoracic procedures such as occlusion of the aorta and vena cava, cross-clamping of the aorta, etc.
Product codes
DXC
Device Description
The Allegiance Flexible Vascular Clamp, Version 2 is a reusable device which features a stainless steel handle, flexible shaft and jaws. This 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 (pulmonary, gastrointestinal, peripheral, aorta, vena cava)
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 Flexible Vascular Clamp, Version 2 were subjected to performance and physical tests to evaluate the safety, effectiveness and
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
MAY 1 8 1999
Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a plus sign made up of small circles. The word is in black and the background is white.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085
847.473.1500 FAX: 847.785.2461
SUMMARY OF SAFETY AND EFFECTIVENESS Attachment E
Manufacturer:
Allegiance Healthcare Corporation V. Mueller Business Unit 1430 Waukegan Road McGaw Park, IL 60085
Patricia Sharpe-Gregg Regulatory Affairs Contact 1500 Waukegan Road McGaw Park, Illinois 60085
Telephone:
Date Summary Prepared:
Product Trade Name:
Common Name:
Classification:
Predicate Device: (K974769)
Description:
(847) 578-3636
April 9, 1999
Flexible Vascular Clamp, Version 2
Vascular Clamp
Vascular Clamp
Cosgrove™ Clamp
The Allegiance Flexible Vascular Clamp, Version 2 is a reusable device which features a stainless steel handle, flexible shaft and jaws. This 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.
1
| Intended Use: | The Allegiance Flexible Vascular Clamp,
Version 2 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 cardio-thoracic
procedures such as occlusion of the aorta and
vena cava, cross-clamping of the aorta, etc. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Allegiance Flexible Vascular Clamp,
Version 2 is substantially equivalent to the
Allegiance Cosgrove™ Clamp in that: |
| | Intended use is the same Performance attributes are the same Atraumatic Jaw design characteristic is the same Materials are the same |
| Summary of Testing: | All materials used in the composition of the
Flexible Vascular Clamp, Version 2 were
subjected to performance and physical tests to
evaluate the safety, effectiveness and |
| Common Name: | Vascular Clamp |
| Classification: | Vascular Clamp |
| Predicate Device:
(K974769) | Cosgrove™ Clamp |
| Description: | The Allegiance Flexible Vascular Clamp,
Version 2 is a reusable device which features
a stainless steel handle, flexible shaft and
jaws. This 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. |
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 18 1999
Ms. Patricia Sharpe-Gregg Manager, Requlatory Affairs Allegiance Healthcare Corporation V. Mueller Business Unit 1430 Waukegan Road McGaw Park, IL ୧୦୦୫ ମ
K991589 Re: Flexible Vascular Clamp, Version 2 Trade Name: Requlatory Class: II Product Code: DXC May 6, 1999 Dated: Received: May 7, 1999
Dear Ms. Sharpe-Greqq:
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 reqistration, listinq 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Reqister. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices
3
Paqe 2 - Ms. Patricia Sharpe-Gregg
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) 594-4586. 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. Callaha Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. The word is black and slightly slanted to the right. To the left of the word is a symbol that looks like a plus sign made up of small dots. The dots are arranged in a grid-like pattern, with the center dot being the largest and the surrounding dots decreasing in size as they move away from the center.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA FAX: 847-785-2461 78-3636
Special 510(k) Device Modification: Flexible Vascular Clamp, Version 2 V. Mueller Business Unit Page 1 of 1
510(k) Number (if known):
Unknown
Device Name:
Flexible Vascular Clamp, Version 2
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.
(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
tolem. Re-for TJC
vision Sign=Off) Division of Cardiovascular, Respiratory, and Neurological Dev
510(k) Number