(94 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.
Yes
The device is used to provide hemostasis, which is a therapeutic action to stop bleeding after a medical procedure.
No
The device is described as providing hemostasis by applying pressure to the femoral vascular access site, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly describes 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 femoral vascular access site. This is a mechanical action applied externally to the body.
- Device Description: The device is a handle and disc used to apply external pressure. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide information about a person's health. This device operates in vivo (on the body) to achieve a physical outcome (hemostasis).
N/A
Intended Use / Indications for Use
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.
This device is indicated for use to provide hemostasis of the femoral vascular access site following catheterization or cannulation procedures.
Product codes
DXC
Device Description
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.
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.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
It was concluded that the Compass 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
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
1
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.
2
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
3
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)