REPROCESSED FEMORAL COMPRESSION DEVICE

K120204 · Sterilmed, Inc. · NMF · Apr 3, 2012 · Cardiovascular

Device Facts

• Record ID: K120204
• Device Name: REPROCESSED FEMORAL COMPRESSION DEVICE
• Applicant: Sterilmed, Inc.
• Product Code: NMF · Cardiovascular
• Decision Date: Apr 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reprocessed Femoral Compression Device is intended for use in the compression of the femoral artery or vein after catheterization.

Device Story

Device consists of arch, sterile pneumatic pressure dome, connection tubing, and belt. Applied to patient with dome positioned over femoral artery or vein; belt secures device around patient. Sterile wound dressing placed between device and patient; device is non-patient contacting. User controls dome inflation via external manual pump (not provided). Dome applies mechanical pressure to bleeding site; arch and belt distribute opposing force. Used in clinical settings post-catheterization to achieve hemostasis; benefits patient by providing controlled compression to femoral access site.

Clinical Evidence

Bench testing only. Validation included cleaning, sterilization (ISO 11135, USP <71>), biocompatibility (ISO 10993-1), ethylene oxide residuals (ISO 10993-7), packaging (ASTM D4169, F88, F1929, F2096), and shelf life (ASTM 1980-07). Functional performance verified via simulated use, visual inspection, and fatigue testing.

Technological Characteristics

Consists of arch, pneumatic pressure dome, tubing, and belt. Materials validated for biocompatibility per ISO 10993-1. Sterilization via ethylene oxide. Bench testing includes fatigue and functional performance. No electronic components; manual operation via external pump.

Indications for Use

Indicated for compression of the femoral artery or vein following catheterization procedures.

Regulatory Classification

Identification

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

Predicate Devices

• SterilMed Femoral Compression Device (K012574)
• St. Jude Medical FemoStop™ Gold Femoral Compression System (K080206)

Submission Summary (Full Text)

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K120204

APR - 3 2012

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510(K) PREMARKET NOTIFICATION SUBMISSION 20 JANUARY 2012 For Reprocessed Femoral Compression Devices

#### II. SUMMARY AND CERTIFICATION

#### 510(k) Summary A.

SterilMed, Inc.

Contact Person:

Submitter:

Jason Skramsted 11400 73td Avenue North Maple Grove, MN 55369 Phone: [phone] Fax: [phone]

| Date Prepared: | 20 January 2012 |
|------------------------|----------------------------------------|
| Trade Name: | Reprocessed Femoral Compression Device |
| Classification Name: | Clamp, Vascular, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.4450 |
| Product Code: | NMF |

| Predicate<br>Devices: | The reprocessed femoral compression device is substantially equivalent to the SterilMed Femoral Compression<br>Device (K012574) with secondary substantial equivalence to the St. Jude Medical FemoStop™ Gold Femoral<br>Compression System(K080206). |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | The femoral compression device consists of an arch with a sterile pneumatic pressure dome and a connection<br>tubing and belt. The device is applied on the patient with the dome over the femoral artery or vein and the belt<br>around the patient. A sterile wound dressing is to be placed between the device and the patient making the<br>device a "non-patient contacting device". The user controls the inflation of the dome by increasing or<br>decreasing the pressure with a connected, manual pump (not provided). The dome applies a mechanical pressure<br>over the spot where there is bleeding, while the arch and belt absorb and evenly distribute the opposite force<br>from the dome. Only the femoral compression device is the subject of this submission; the integrated pump with<br>a manometer is not included in the scope of this submission. |
| Intended<br>Use: | The Reprocessed Femoral Compression Device is intended for use in the compression of the femoral artery or<br>vein after catheterization. |
| Functional<br>and Safety<br>Testing: | Representative samples of reprocessed femoral compression devices were tested to demonstrate appropriate<br>functional characteristics. Process validation testing was performed to validate the cleaning and sterilization<br>procedures as well as device packaging. In addition, the manufacturing process includes visual and validated<br>functional testing of all products produced. |
| Summary of<br>Non-clinical<br>Tests<br>Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP<br><71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging<br>validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-<br>07). In addition, validation of functional performance (bench testing) was performed through simulated use,<br>visual inspection, fatigue testing, and function testing. Performance testing shows the reprocessed femoral<br>compression device to perform as intended. |
| Conclusion: | The reprocessed femoral compression device is substantially equivalent to SterilMed's Femoral Compression<br>Device with secondary substantial equivalence to the St. Jude Medical's FemoStop™ Gold Femoral<br>Compression System. This conclusion is based upon the devices' similarities in functional design (principles of<br>operation), materials, indications for use and methods of construction. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR - 3 2012

SterilMed. Inc. c/o Mr. Jason Skramsted Regulatory Affairs Specialist 11400 73rd Avenue North Maple Grove, MN 55369

Re: K120204

Trade/Device Name: Reprocessed Femoral Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Clamp, Vascular, Reprocessed Regulatory Class: Class II Product Code: NMF, DXC Dated: January 20, 2012 Received: January 23, 2012

Dear Mr. Skramsted:

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 in microsite
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, include of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Mr. Jason Skramsted

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 r Rase be devised alat I bermination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I oderal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of K Fart 607); ideeinig (21 CFR 803); good manufacturing practice requirements as set de rice-related adverse overse) (QS) regulation (2) CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 800) ), please 11 you desire specific ad resolved by Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to map. Power Radiological Health's (CDRH's) Office of Compliance. Also, please the Concertified, "Misbranding by reference to premarket notification" (21CFR Part note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may of amall Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M. A. Hillemann

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K120204

Medical Device Reprocessing
Small Equipment & Instrument Repair

## 510(K) PREMARKET NOTIFICATION SUBMISSION 20 JANUARY 2012 For Reprocessed Femoral Compression Devices

# Indications for Use

510(k) Number (if known):

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.

Prescription Use X (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)

M.A. Killebrew

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K120204