(84 days)
Not Found
Not Found
No
The description focuses on mechanical components and functions for applying pressure, with no mention of AI, ML, or related concepts.
Yes
The device is used to provide hemostasis, which is a therapeutic intervention to stop bleeding.
No
The device is indicated for providing hemostasis, which is a therapeutic function, not a diagnostic one. It applies mechanical pressure to stop bleeding.
No
The device description explicitly mentions physical components like an "elastomeric insert," "compression pad," "disk," and "supporting stand," which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is used to provide hemostasis (stop bleeding) at a femoral vascular access site during and following a procedure. It works by applying external mechanical pressure directly to the skin.
- Lack of Specimen Testing: There is no mention of this device being used to test any biological specimens. Its function is purely mechanical and applied externally to the patient's body.
Therefore, based on the provided information, the CompressAR® SuperComfort™ Disc and StrongArm™ System is a mechanical medical device used for hemostasis, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
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 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 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.
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
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CompressAR® Universal System CompressAR® Comfort™ Disc
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
'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
1
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.
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 (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
3
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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