(31 days)
This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.
This device handle is similar to the Compass handle, but of a different shape. The ComfortPress device provides an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following femoral vascular catheterization procedures. The ComfortPress handle mates with the SuperComfort™ Disc, one of which is provided with each handle. The device is provided as sterile, with a SuperComfort disc attached. The handle with the disc is manually positioned at the femoral vascular access site. The medical practitioner then applies holding force sufficient to obtain hemostasis.
The provided document is a 510(k) summary for the ComfortPress™ Vascular Compression Assist Handle. It describes the device and its intended use, and states that it is substantially equivalent to a predicate device. However, it does not contain the detailed acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or performance study report typically would.
The "testing" mentioned is very limited and focused on mechanical fit and applying pressure, rather than broader clinical effectiveness.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, sample sizes, expert involvement, or comparative effectiveness with AI assistance, as this information is not present in the provided text.
Here's what I can extract based on the limited information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance Statement |
|---|---|
| Mechanical fit to SuperComfort™ Disc | "determined that the ComfortPress device provides mechanical fit to the CompressAR SuperComfort™ Disc" |
| Ability to apply pressure | "may be used to apply pressure." |
| Equivalence to predicate device (Compass™ Compression Assist Handle) | "It was concluded that the ComfortPress Compression Assist Handle, used with the SuperComfort™ Disc, is equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not specified.
- Data provenance: Not specified. The document states "Market testing determined that the use of a handle and disc for holding manual pressure...was more comfortable and less stressful to the care giver," implying some form of user feedback, but no details on the participants or methodology.
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)
- Not specified.
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 MRMC study was done, and AI assistance is not mentioned or relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a mechanical device; a standalone algorithm study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the equivalence claim appears to be based on the assessment that it effectively performs the same mechanical function (applying pressure and fitting the disc) as the predicate device. For the "more comfortable and less stressful" claim, the ground truth was "Market testing" which likely involved user feedback, but the specifics are not provided.
8. The sample size for the training set
- Not applicable/not specified. There's no mention of a training set in the context of an algorithm or machine learning.
9. How the ground truth for the training set was established
- Not applicable/not specified.
Summary of Device Performance Test and Conclusion:
The document states: "Testing was conducted to determine that the ComfortPress device provides mechanical fit to the CompressAR SuperComfort™ Disc and may be used to apply pressure. It was concluded that the ComfortPress Compression Assist Handle, used with the SuperComfort™ Disc, is equivalent to the predicate device."
This suggests the testing was a functional assessment of the device's ability to mate with its intended consumable and to physically allow pressure application. The conclusion of equivalence is based on these functional aspects being comparable to the predicate device, the Compass™ Compression Assist Handle. No detailed study protocols, results, or statistical analyses are provided in this 510(k) summary.
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Image /page/0/Picture/1 description: The image shows the logo for Advanced Vascular Dynamics, a Semler Technologies Company. The logo features a stylized graphic of a person in motion above the company name. The text "ADVANCED VASCULAR DYNAMICS" is in a bold, sans-serif font, and "A Semler Technologies Company" is in a smaller, lighter font below.
SEP - 6 2007
510(k) Summary
Herbert J. Semler 31 July 2007
Trade name - ComfortPress™ Vascular Compression Assist Handle Common name - femoral access compression device Classification name - Clamp, Vascular (21 CFR 870.4450 DXC) Predicate device - Compass™ Compression Assist Handle (K053398)
This device handle is similar to the Compass handle, but of a different shape. The ComfortPress device provides an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following femoral vascular catheterization procedures. The ComfortPress handle mates with the SuperComfort™ Disc, one of which is provided with each handle.
The device is provided as sterile, with a SuperComfort disc attached. The handle with 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 ComfortPress Compression Assist Handle with the SuperComfort™ Disc is intended for use during and 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.
Market testing determined that the 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 ComfortPress device provides mechanical fit to the CompressAR SuperComfort™ Disc and may be used to apply pressure. It was concluded that the ComfortPress Compression Assist Handle, used with the SuperComfort™ Disc, is equivalent to the predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2007
Advanced Vascular Dynamics Division Mr. Gary Mills 2326 N.W. Everett St. Portland OR 97210
Re: K072167
Trade/Device Name: ComfortPress Vascular Compression Assist Handle Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: July 31, 2007 Received: August 6, 2007
Dear Mr. Mills:
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.
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
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Page 2 - Mr. Mills
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bermuda for
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):
Device Name: ComfortPress™ Vascular Compression Assist Device ______________________________________________________________________________________________________________________________________________________________________________
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 X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Bumme
Division Sign-Off) Division of Cardlovascular Devices 510(k) Number
§ 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).