(172 days)
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.
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.
The provided document describes the Allegiance Cosgrove™ Clamp, a reusable device for temporary occlusion of blood vessels. However, it is a Premarket Notification 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with acceptance criteria and detailed performance metrics as would be found in a Premarket Approval (PMA) application.
Therefore, many of the specific questions regarding acceptance criteria, study details, and ground truth establishment cannot be fully answered from this document. The submission states that testing was performed but provides a summary rather than detailed results or the methodology for establishing acceptance criteria for specific performance metrics.
Here's what can be extracted and inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical study. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All materials used in the composition were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability. | "All test results were acceptable." |
This statement indicates that internal testing was conducted, and the device met the manufacturer's internal criteria for safety, effectiveness, and reliability. The specific quantitative acceptance criteria and the detailed test results are not provided in this summary.
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 does not provide information on the sample size used for the "performance and physical tests" or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This type of detail is typically found in full test reports, which are not part of this summary document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided. The testing described appears to be engineering/ bench testing, not a clinical study where expert-established ground truth would be relevant for diagnostic accuracy or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this was not a clinical study involving human assessment that would require adjudication of expert opinions.
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
Not applicable. This device is a surgical clamp, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "performance and physical tests," the ground truth would be engineering specifications, material standards, and perhaps simulated use conditions for mechanical integrity and functionality. It would not typically involve expert consensus, pathology, or outcomes data in the way these terms are used for diagnostic or therapeutic efficacy studies.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
Not applicable.
Summary from the provided text:
The core of the submission focused on demonstrating substantial equivalence to predicate devices (Fogarty-Hydragrip® Surgical Clamps and Applied Vascular Atraumax™ Surgical Clamps) based on:
- Same Intended Use: "to be used for the temporary occlusion of blood vessels and other delicate vessels during surgery."
- Same Performance Attributes: General statement.
- Same Atraumatic Jaw design characteristic: General statement.
The document states: "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." This indicates that internal design verification and validation (DV&V) testing was performed to meet internal acceptance criteria, which were deemed satisfactory by the FDA for the purpose of 510(k) clearance based on substantial equivalence. However, the specifics of these tests and their acceptance criteria are not detailed in this public summary.
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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:
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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.
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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 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
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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
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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 _________________________________________________________________________________________________________________________________________________________
§ 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).