FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE

K122330 · Arjohuntleigh Polska SP Z.O.O. · JOW · Dec 7, 2012 · Cardiovascular

Device Facts

• Record ID: K122330
• Device Name: FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE
• Applicant: Arjohuntleigh Polska SP Z.O.O.
• Product Code: JOW · Cardiovascular
• Decision Date: Dec 7, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prevention of Deep Vein Thrombosis (DVT) Enhancement of venous & arterial circulation Prevention of venous stasis Assist healing of cutaneous ulcers Reduction of acute or chronic edema Reduction of lower limb pain due to surgery or trauma Reduction of compartmental pressures

Device Story

Flowtron Foot Garment is a wrap-around foot sleeve containing an inflatable bladder; connects to ArjoHuntleigh Flowtron pneumatic pump. Pump delivers cyclic air inflation/deflation to apply compression to foot; improves venous blood flow; prevents/reduces DVT risk. Used in clinical settings; operated by healthcare professionals. Output is mechanical compression; affects clinical decision-making by providing prophylactic DVT management. Benefits patient by reducing venous stasis and associated complications.

Clinical Evidence

Bench testing only. Validation of sterilization processing and shelf-life stability performed to address the addition of the sterile configuration.

Technological Characteristics

Wrap-around foot garment with inflatable bladder. Sterile version processed via Ethylene Oxide per ISO 11135. Compatible only with ArjoHuntleigh Flowtron pneumatic pumps via custom connector. Mechanical compression principle.

Indications for Use

Indicated for patients requiring prevention of DVT, enhancement of venous/arterial circulation, prevention of venous stasis, assistance in healing cutaneous ulcers, reduction of acute/chronic edema, reduction of lower limb pain due to surgery/trauma, and reduction of compartmental pressures.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• Huntleigh FP5000 System, Model FP5000 (K965153)

Submission Summary (Full Text)

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# 510(k) Summary

K122330

Flowtron Foot Garments – Sterile

# DEC

| Name & Address: | ArioHuntleigh AB<br>Verkstadsvägen 5<br>241 38 Eslöv, SWEDEN | | | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------|--|--|
| Telephone: | +(44) 29 2044 7084 | | | | |
| Fax: | +(44) 29 2049 2520 | | | | |
| Prepared: | 6 December 2012 | | | | |
| Contact: | David Moynham – Regulatory Affairs Engineer | | | | |
| Device Name: | Flowtron Foot Garments - Sterile | | | | |
| Common Name | Sleeve, Limb, Compressible | | | | |
| Classification | Class | Product Code | Classification Regulation | | |
| | ll | JOW | 21 CFR 870.5800 | | |
| Classification Name: | Sleeve, Limb, Compressible | | | | |
| Predicate Device: | K965153, Huntleigh FP5000 System, Model FP5000 | | | | |
| Indications for Use: | Prevention of Deep Vein Thrombosis (DVT)<br>�<br>Enhancement of venous & arterial circulation<br>Prevention of venous stasis<br>Assist healing of cutaneous ulcers<br>●<br>Reduction of acute or chronic edema<br>●<br>Reduction of lower limb pain due to surgery or trauma<br>�<br>Reduction of compartmental pressures | | | | |
| | | | | | |

# Description :

The Flowtron Foot Garment is a wrap around foot garment comprising of a bladder and surrounding material intended to apply cyclic compression to the foot to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT).

The Flowtron Foot Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Foot Garment in a cyclic manner.

Flowtron Foot Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps .

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GETINGE GROUP

#### Models

| Model REF | Device | Feature |
|-----------|----------------------------------------|---------|
| FG100S | Flowtron Foot Garment Regular - FG100S | Sterile |
| FG200S | Flowtron Foot Garment Large- FG200S | Sterile |

Substantial Equivalence:

The Flowtron Foot Garments - Sterile and the Foot Garments included in the predicate device clearance are identical in all respects including materials, construction, performance and indications for use. The only difference being the sterility of the Flowtron Foot Garments.

Full details of the validation of sterility processing and shelf life stability have been submitted for sterile garments.

#### Technologies Summary:

The Flowtron Foot Garments – Sterile and the Foot Garments included as part of the predicate device clearance are identical in all respects including materials, construction, performance and indications for use. The only difference in technology being the sterility aspect. Sterile garments being processed using Ethylene Oxide in accordance with ISO 11135.

#### Conclusion:

The Flowtron Foot Garments - Sterile and the Foot Garments of the predicate device are substantially equivalent. Issues raised by the sterilisation process have been addressed in the validation process and these demonstrate that the sterile Foot Garments remain safe and.effective.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DEC 7 2012

Arjohuntleigh C/O Mr. David Moynham 35 Portmanmoor Road Cardiff, S. Glamorgan, CF24 5HN, United Kingdom

Re: K122330

Trade/Device Name: Flowtron Foot Garment - Regular - Sterile, FG 100S and Flowtron Foot Garment - Large- Sterile, FG 200S Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: November 2, 2012 Received: November 7, 2012

Dear Mr. Moynham:

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. 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 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.

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## Page 2 - Mr. David Moynham

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease of advised that 1 Dris tosaantes over device complies with other requirements of the Act that I DIT has intates and regulations administered by other Federal agencies. You must or any 1 edelar suttates and regulations, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Clice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-related adverse ovents) (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (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 801), please 11 you desire specific advice 10: your a microsoffices/CDRH/CDRHOffices/ucm115809.htm for go to hep. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation online 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 ocain of Small 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,

Kenneth J. Cavanaugh

for

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

Enclosure

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# Indications For Use

510(k) Number:

K122330

Device Name:

Flowtron Foot Garments-Sterile

Indications for Use:

- Prevention of Deep Vein Thrombosis (DVT) ●
- Enhancement of venous & arterial circulation ●
- . Prevention of venous stasis
- Assist healing of cutaneous ulcers .
- Reduction of acute or chronic edema .
- Reduction of lower limb pain due to surgery or trauma .
- Reduction of compartmental pressures ●

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

lc

of Cardiovascular Devices

510(k) Number K122330