(31 days)
Not Found
No
The device description and performance studies focus on mechanical function and equivalence to a predicate device, with no mention of AI or ML.
No.
The device provides mechanical assistance for applying pressure to achieve hemostasis, which is supportive care rather than a therapeutic intervention to treat a disease or condition. Its function is to facilitate a physical action (applying pressure) rather than directly affecting biological processes or treating an underlying pathology.
No
This device is designed to provide hemostasis (stop bleeding) at a vascular access site, not to diagnose a medical condition. Its function is to apply pressure to aid in post-procedure care.
No
The device description explicitly details a physical handle and disc used to apply pressure, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide hemostasis (stop bleeding) at a vascular access site. This is a direct therapeutic or procedural action performed on the patient's body.
- Device Description: The device is a manual compression tool used externally on the patient's skin. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on biological markers.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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. This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.
Product codes
DXC
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral vascular access site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioner
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)
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.
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
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.
1
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
2
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
3
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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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Bumme
Division Sign-Off) Division of Cardlovascular Devices 510(k) Number