REPROCESSED FEMORAL COMPRESSION DEVICE

K012574 · Sterilmed, Inc. · NMF · Jul 18, 2002 · Cardiovascular

Device Facts

• Record ID: K012574
• Device Name: REPROCESSED FEMORAL COMPRESSION DEVICE
• Applicant: Sterilmed, Inc.
• Product Code: NMF · Cardiovascular
• Decision Date: Jul 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The reprocessed femoral compression device is intended for use in the compression of the femoral artery or vein after catheterization.

Device Story

Reprocessed femoral compression device; used for applying pressure to femoral artery or vein post-catheterization. Device is a reprocessed version of single-use OEM equipment (FemoStop). Operated by clinicians in clinical settings to achieve hemostasis. Reprocessing involves cleaning and sterilization to restore device to original functional specifications. Benefits include waste reduction and cost-effective access to established compression technology.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and validation of the reprocessing process to ensure the device meets original manufacturer specifications.

Technological Characteristics

Mechanical femoral compression device. Materials and design are identical to the OEM predicate. Sterilization performed via diffusion or chamber methods. No software or electronic components.

Indications for Use

Indicated for compression of the femoral artery or vein following catheterization procedures in patients requiring hemostasis.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• FemoStop System (K915280)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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

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### Attachment 1

USCI ® C.R. Bard®, Inc. / RADI Medical Systems AB Model Number: 017500

OEM Trade Name: FemoStop® Femoral Compression System

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## 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

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K012574

# 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 /<br>Distribution Facility:<br>SterilMed, Inc.<br>11400 73rd Avenue North<br>Minneapolis MN, 55369<br>ERN: 2134070 | Sterilization Facility<br>Diffusion Method:<br>SterilMed, Inc.<br>11400 73rd Avenue North<br>Minneapolis MN, 55369<br>ERN: 2134070<br>Or<br>SterilMed Inc.<br>3650 Annapolis Lane North<br>Suite 170<br>Minneapolis, MN 55447<br>ERN: 2134070 | Sterilization Facility<br>Chamber Method:<br>Steris Isomedix Services<br>380 90th Avenue NW,<br>Minneapolis, MN 55433<br>ERN: 2183744 |
|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|

SterilMed, Inc. Femoral Compression Device Confidential

Premarket Notification

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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