(94 days)
This device is indicated for use to provide hemostasis of the femoral vascular access site following catheterization or cannulation procedures.
This device is similar to the EZ Hold handle. The Compass device provides an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following femoral vascular catheterization procedures. A sterile SuperComfort disc is affixed to the handle. Then the disc is manually positioned at the femoral vascular access site. The medical practitioner then applies holding force sufficient to obtain hemostasis. Use of the handle and disc by a medical practitioner avoids prolonged direct contact with bodily fluids, and alleviates bio-mechanical stress which may occur during traditional direct digital compression of the femoral artery post-cardiac catheterization. The handle and disc provide a mechanical means for a medical practitioner to hold external pressure at or near the site of femoral vascular access. Direct pressure is used to obtain and maintain hemostasis on the access site or at a pressure point. Unlike the predicate device, the Compass handle mates with the SuperComfort™ Disc. The predicate device is made of stainless steel; the Compass handle is made of polycarbonate.
The provided text describes a 510(k) premarket notification for the Compass™ Compression Assist Handle. The submission aims to demonstrate substantial equivalence to a predicate device, the EZ Hold Femoral Compression Device (K973731).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical fit to the CompressAR® SuperComfort™ Disc. | "Multiple assembly/extraction cycles verified proper fit and acceptable insertion/removal forces." |
| Ability to be used to apply pressure. | "Testing was conducted to determine that the Compass device... may be used to apply pressure." (Implied acceptance - the study confirmed its ability, suggesting this was the criterion). |
| Equivalence to the predicate device (EZ Hold Femoral Compression Device - K973731). | "It was concluded that the Compass Compression Assist Handle, used with the SuperComfort™ Disc, is equivalent to the predicate device." This equivalence is based on the mechanical fit and pressure application, and the fact that the device provides an alternative to mechanical clamping or direct hand pressure for hemostasis, similar to the predicate. The FDA's substantial equivalence determination also implies this criterion was met. |
| User comfort and reduced stress for caregivers (compared to direct digital compression). | "Market testing determined that use of a handle and disc for holding manual pressure, rather than use of fingers directly on the access site, was more comfortable and less stressful to the care giver." (While not an explicit "acceptance criterion," this was a stated benefit and a finding from market testing). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Multiple assembly/extraction cycles verified proper fit and acceptable insertion/removal forces." However, it does not specify the exact sample size (number of devices or cycles performed) for this test. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It appears to be part of internal testing done by Advanced Vascular Dynamics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention any experts being used to establish ground truth for the mechanical fit or pressure application testing. The "market testing" about comfort and stress reduction for caregivers implies feedback from medical practitioners, but the number or qualifications of these practitioners are not specified.
4. Adjudication Method for the Test Set:
No adjudication method is described. The tests appear to be physical/mechanical evaluations with results based on observed performance (proper fit, acceptable forces).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study was done or mentioned. The comparison is primarily against a predicate device based on functional similarity and intended use, not a clinical study comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable as the device is a mechanical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the mechanical fit and pressure application, the "ground truth" was likely engineering specifications and observed performance against those specifications. For the market testing related to comfort and stress, the "ground truth" was subjective feedback from caregivers.
8. The Sample Size for the Training Set:
This question is not applicable as the device is a mechanical instrument and does not involve AI or algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
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MAR 1 0 2006
Image /page/0/Picture/2 description: The image is a black and white logo. The logo features a black square with a white outline of a person in a dynamic pose. The person appears to be dancing or moving energetically, with arms outstretched and legs bent. The word "AVDA" is written in the bottom right corner of the square.
ADVANCED VASCULAR DYNAMICS
A Semler Technologies Company
510(k) Summary
Herbert J. Semler Official Correspondent 6 March 2006
Trade name - Compass™ Compression Assist Handle Common name - femoral access compression device Classification name - Clamp, Vascular (21 CFR 870.4450 DXC) Predicate device - EZ Hold Femoral Compression Device (K973731)
This device is similar to the EZ Hold handle. The Compass device provides an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following femoral vascular catheterization procedures.
A sterile SuperComfort disc is affixed to the handle. Then the disc is manually positioned at the femoral vascular access site. The medical practitioner then applies holding force sufficient to obtain hemostasis.
Use of the handle and disc by a medical practitioner avoids prolonged direct contact with bodily fluids, and alleviates bio-mechanical stress which may occur during traditional direct digital compression of the femoral artery post-cardiac catheterization.
The Compass Compression Assist Handle with the SuperComfort™ Disc is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.
The handle and disc provide a mechanical means for a medical practitioner to hold external pressure at or near the site of femoral vascular access. Direct pressure is used to obtain and maintain hemostasis on the access site or at a pressure point.
Unlike the predicate device, the Compass handle mates with the SuperComfort™ Disc. The predicate device is made of stainless steel; the Compass handle is made of polycarbonate.
Market testing determined that use of a handle and disc for holding manual pressure, rather than use of fingers directly on the access site, was more comfortable and less stressful to the care giver.
Testing was conducted to determine that the Compass device provides mechanical fit to the CompressAR® SuperComfort™ Disc and may be used to apply pressure. Multiple assembly/extraction cycles verified proper fit and acceptable insertion/removal forces. It was concluded that the Compass Compression Assist Handle, used with the SuperComfort™ Disc, is equivalent to the predicate device.
2326 NW EVERETT ST., PORTLAND, OR 97210 P 503-223-2333, P 800-525-2555, F 503-223-8448, WWW.COMPRESSAR.COM
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2006
Advanced Vascular Dynamics c/o Herbert J. Semler, M.D. Official Correspondent 2326 NW Everett Street Portland, OR 97210
Re: K053398
Compass™ Manual Femoral Access Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (Two) Product Code: DXC Dated: February 24, 2006 Received: February 27, 2006
Dear Dr. Semler:
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.
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Page 2 - Herbert J. Semler, M.D.
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
R. Vachner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _K053398
Device Name:
Indications for Use:
This device is indicated for use to provide hemostasis of the femoral vascular access site following catheterization or cannulation procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. kchner
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of 1
510(k) Number K6533 9 8
(Posted November 13, 2003)
§ 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).