(343 days)
Not Found
No
The summary describes a reprocessed mechanical compression device and contains no mention of AI, ML, or related concepts.
Yes
The device is used for compression of the femoral artery or vein, which is a therapeutic action to manage blood flow after catheterization. The intended use describes a direct clinical intervention for patient care.
No
The device is described as a "femoral compression device" intended for "compression of the femoral artery or vein after catheterization." This function is therapeutic (to apply pressure), not diagnostic (to identify or analyze a medical condition).
No
The device description explicitly states "Reprocessed Femoral Compression Device," which is a physical medical device used for compression. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "compression of the femoral artery or vein after catheterization." This is a physical intervention performed on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The function of this device is to apply external pressure to a blood vessel, which is a therapeutic or post-procedural action, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The reprocessed femoral compression device is intended for use in the compression of the femoral artery or vein after catheterization.
Product codes
NMF
Device Description
Reprocessed Femoral Compression Device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral artery or vein
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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the wings and head of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2004 NOV
SterilMed, Inc. c/o Dr. Bruce R. Lester Vice President of R & D 11400 73td Avenue, North Minneapolis, MN 55369
Re: K012574 - Supplemental Validation Submission Trade/Device Name: Reprocessed Femoral Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Clamp, Vascular Regulatory Class: II (2) Product Code: NMF Dated: April 30, 2002 Received: May 2, 2002
Dear Dr. Lester:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on July 18, 2002. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.
1
Page 2 - K012574
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120 (DOEB). 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/dsma/dsmamain.html.
Sincerely yours,
B.Brimmer for
Brash D. Zuckerman, M.D. Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
Attachment 1
USCI ® C.R. Bard®, Inc. / RADI Medical Systems AB Model Number: 017500
OEM Trade Name: FemoStop® Femoral Compression System
3
Indications for use Page
Device Name: Reprocessed Femoral Compression Device
Indications for Use:
The reprocessed femoral compression device is intended for use in the compression of the femoral artery or vein after catheterization.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
VCe Carter
(Division Sign-Off) Division of Cardiovascular and Respiratory Devices 510(k) Number
SterilMed, Inc. Femoral Compression Device Confidential
Premarket Notification
l
4
ப்பட 1.8 2002
SECTION 1. GENERAL INFORMATION
| Submitter's Name | SterilMed, Inc. |
|---|---|
| Address | 11400 73rd Avenue North, |
| Minneapolis, MN 55369 | |
| Contact Person | Patrick Fleischhacker |
| Telephone | 763-488-3400 |
| Fax | 763-488-3350 |
| Date of Submission | August 7, 2001 |
Proprietary Name: a.
Reprocessed Femoral Compression Device
Common Name: b.
-
Femoral Compression Device
Class II 21 CFR 870.4450 -
Establishment Registration C. Number (ERN):
2134070
DXC
Classification Status: d.
Product Code: e.
- f. Addresses:
| Manufacturing /
Distribution Facility:
SterilMed, Inc.
11400 73rd Avenue North
Minneapolis MN, 55369
ERN: 2134070 | Sterilization Facility
Diffusion Method:
SterilMed, Inc.
11400 73rd Avenue North
Minneapolis MN, 55369
ERN: 2134070
Or
SterilMed Inc.
3650 Annapolis Lane North
Suite 170
Minneapolis, MN 55447
ERN: 2134070 | Sterilization Facility
Chamber Method:
Steris Isomedix Services
380 90th Avenue NW,
Minneapolis, MN 55433
ERN: 2183744 |
| ---------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------- |
|---|
SterilMed, Inc. Femoral Compression Device Confidential
Premarket Notification
5
012574/
Reason for Submission: g.
To seek clearance to market reprocessed femoral compression devices that are substantially equivalent to other similar devices made by other manufacturers that are currently distributed in the United States.
Substantial Equivalence: b.
SterilMed, Inc. considers the reprocessed femoral compression device to be substantially equivalent to:
- The Femostop System® (K915280), manufactured by RADI Medical Systems .
i. Performance Standards:
There are no specific standards promulgated by the FDA that apply to this product under Section 514 of the Act. However, SterilMed complied, wholly or in part, with several guidance documents and standards in preparation of this submission for their reprocessed femoral compression device and processes. These guidance documents and standards are listed in detail in Section 10 of this document.
SterilMed, Inc. Femoral Compression Device Confidential
Premarket Notification