(84 days)
This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.
The CompressAR® SuperComfort™ Disc provides an elastomeric insert in the compression pad, and is used with a modified attachment to the CompressAR @ StrongArm™ System to provide a two-step friction fit connection. The elastomer insert contacts the patient skin providing increased friction against the skin.
The disk and supporting stand provide a mechanical means of holding external pressure at or near the site of femoral vascular access. Direct pressure is used to obtain and maintain hemostasis, in a similar fashion to direct hand pressure on the access site or at a pressure point.
The provided text describes a 510(k) summary for the CompressAR® SuperComfort™ Disc and StrongArm™ SuperComfort™ System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance data in the format requested.
Therefore, many of the requested details are not explicitly present in the provided text.
Here's an attempt to extract and infer information based on the given text:
1. Table of acceptance criteria and the reported device performance:
The document states: "Testing was conducted to determine that the modified device provides mechanical clamping and holding functions, similar to the predicate device. It was concluded that the CompressAR & SuperComfort™ Disc and StrongArm™ System is equivalent to the predicate device."
This implies that the acceptance criterion was demonstrating "similar" mechanical clamping and holding functions to the predicate device. The reported performance is that the device met this criterion, as it was concluded to be "equivalent."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical clamping and holding functions | "Similar" to the predicate device |
| Overall equivalence to the predicate device | "Equivalent" to the predicate device (CompressAR® Universal System CompressAR® Comfort™ Disc) |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Testing was conducted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The assessment appears to be based on engineering or performance testing against the predicate device rather than expert-derived ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a mechanical medical device, not an AI or diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a mechanical hemostasis device, not an algorithm. However, the testing conducted would be considered "standalone" in the sense that it doesn't involve human interpretation of output from the device, but rather the device's direct mechanical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth (or more accurately, the benchmark) was the performance of the predicate device (CompressAR® Universal System CompressAR® Comfort™ Disc). The study aimed to show that the new device's mechanical functions were "similar" to this established predicate.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable (no training set for this type of device).
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'JUN = 1 2004
510(k) Summary
Herbert J. Semler 1 March 2004
Trade name - CompressAR® SuperComfort™ Disc and StrongArm™ SuperComfort™ System Common name - femoral access compression device Classification name - Clamp, Vascular
This device is similar to the CompressAR® Universal System CompressAR® Comfort™ Disc, and is a modification of this predicate device. The CompressAR® SuperComfort™ Disc provides an elastomeric insert in the compression pad, and is used with a modified attachment to the CompressAR @ StrongArm™ System to provide a two-step friction fit connection. The elastomer insert contacts the patient skin providing increased friction against the skin ..
The CompressAR @ SuperComfort™ Disc and StrongArm™ System is intended for use during and following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.
The disk and supporting stand provide a mechanical means of holding external pressure at or near the site of femoral vascular access. Direct pressure is used to obtain and maintain hemostasis, in a similar fashion to direct hand pressure on the access site or at a pressure point.
Testing was conducted to determine that the modified device provides mechanical clamping and holding functions, similar to the predicate device. It was concluded that the CompressAR & SuperComfort™ Disc and StrongArm™ System is equivalent to the predicate device.
2326 NW Everett St. Portland, Oregon 97210 (503) 223-2333 (503) 223-8585 Fax (800) 525-2555
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2004
Advanced Vascular Dynamics c/o Herbert J. Semler, M.D. Official Correspondent 2326 NW Everett Street Portland, OR 97210
Re: K040615
R040019
CompressAR® SuperComfort™ Disc and StrongArm™ SuperComfort™ System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: May 14, 2004 Received: May 14, 2004
Dear Dr. Semler:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave 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 for use stated in the encreativent of 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 r ou may, dicterer, mains 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 (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) you may obtain. 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,
Donna R. Vorhner
Image /page/2/Picture/5 description: The image contains a signature and the words "Br" and "Di". The signature is on the left side of the image and appears to be a stylized set of lines. The letters "Br" and "Di" are on the right side of the image and are stacked vertically.
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):__K040615
Device Name: CompressAR® Femoral Access Compression Device (SuperComfort)
Indications For Use:
This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dring R. Vechinel
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k040615
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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).