FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS

K133119 · Arjohuntleigh Polska SP Z.O.O. · JOW · Feb 28, 2014 · Cardiovascular

Device Facts

• Record ID: K133119
• Device Name: FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
• Applicant: Arjohuntleigh Polska SP Z.O.O.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To help prevent Deep Vein Thrombosis (DVT)

Device Story

Flowtron ACS800 is a pneumatic pump system for DVT prevention; supplies compressed air to limb compression garments. System includes pump and various garments (Tri Pulse, calf/thigh, foot). Pump automatically detects connected garment type via inductor in hose connector; adjusts pressure/time cycles accordingly. Garments feature three-chamber bladders (Tri Pulse) or other configurations; inflate sequentially to apply limb pressure. Used in clinical settings; operated by healthcare professionals. Pump monitors air pressure cycles and detects faults (user setup, garment failure, system issues). Benefits patients by providing active compression to help prevent DVT.

Clinical Evidence

Bench testing only. Validation included pump software/hardware functionality (garment detection, therapy delivery), performance testing of garments (pressure cyclic tests), real-time life testing, vibration testing, electrical safety (IEC 60601-1), EMC testing (EN 60601-1-2), and biocompatibility testing for Tri Pulse garments (ISO 10993-1, -5, -10).

Technological Characteristics

System comprises pneumatic pump and compression garments. Pump: air compressor, air distribution valve, microprocessor control system, plastic casing. Garments: three-chamber bladder, polyester material, hook and eye fasteners. Connectivity: automatic garment recognition via inductor in hose connector. Standards: IEC 60601-1 (electrical), EN 60601-1-2 (EMC), ISO 10993 (biocompatibility).

Indications for Use

Indicated for the prevention of Deep Vein Thrombosis (DVT) in patients requiring external pneumatic compression therapy.

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

• Flowtron Universal AC600 (K010744)
• STS garments (K012008)

Submission Summary (Full Text)

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# ARJOHUNTLEIGH

getinge group

FEB 2 8 2014

1433119

#### 510(K) Summary

#### Flowtron ACS800 Pump and Tri Pulse Garments

| Name & Address: | ArjoHuntleigh Polska Sp z.o.o.<br>Ul. Ks Wawrsyniaka 2<br>62052 Komorniki<br>Poland | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------|
| Telephone: | +(44) 2920 485885 | | |
| Fax: | +(44) 2920 492520 | | |
| Prepared: | 2 January 2014 | | |
| Contact: | David Moynham – Regulatory Affairs Engineer | | |
| Device Name: | Flowtron ACS800 Pump and Tri Pulse Garments | | |
| Common Name | Compressible Limb Sleeve | | |
| Classification | Class | Product Code | Classification Regulation |
| | II | JOW | 870.5800 |
| Classification Name: | Sleeve, Limb, Compressible | | |
| Predicate Devices: | Flowtron Universal AC600 (K010744) cleared 26 Mar 2002, originally<br>manufactured by Huntleigh Healthcare Ltd.<br>and<br>STS garments (K012008) cleared 21 Sept 2001 originally manufactured<br>by Huntleigh Healthcare Ltd.<br>Huntleigh Healthcare was acquired by the ArjoHuntleigh AB group and<br>all rights to properties and registrations assigned to Huntleigh<br>Healthcare are now wholly owned by ArjoHuntleigh AB. | | |
| Indications for Use: | To help prevent Deep Vein Thrombosis (DVT) | | |
| Description : | The Flowtron ACS800 pump is a pneumatic pump that supplies<br>compressed air to inflate compression garments that are attached to<br>patient's limbs.<br>It is designed to work with the ArjoHuntleigh ranges of DVT calf/thigh<br>compression garments, Foot compression garments and Tri Pulse<br>calf/thigh compression garments.<br>The pump automatically senses the type of compression garment<br>connected and adjusts the pressure/time cycle accordingly.<br>Each garment is compressed alternately, applying pressure to the<br>patient's limb. to help prevent deep vein thrombosis. | | |

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# ARIOHUNTLEIGH GETINGE GROUP

Models:

| Model REF | Device | Features |
|------------------------------------------|---------------------|--------------------------------------------------------|
| 513003 | Flowtron ACS800 | AC powered pump |
| 513003OR | Flowtron ACS800 | AC powered pump with longer length connection<br>tubes |
| TRP10, TRP20,<br>TRP30, TRP40 &<br>TRP60 | Tri Pulse garments. | Sequential inflation providing active compression. |

Substantial Equivalence:

Flowtron ACS800 pump is substantially equivalent to cleared device Flowtron Universal AC600 (K010744). The Flowtron ACS800 pump has the same compression pressure / time profiles for the DVT and Foot Garments.

The equivalence of the Tri Pulse garments is demonstrated using bench testing against the predicate STS garments (K012008).

Tri Pulse garments are substantially equivalent to cleared device STS garments (K012008) having similar sequential compression profiles using three-chamber garments.

Both devices are intended to be used together as a system.

Testing to demonstrate equivalence included

| Testing conducted | Result |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Full validation of pump software / hardware functionality, including<br>- Garment detection<br>- Therapy delivery | Passed |
| Performance testing garments - Pressure cyclic test.<br>with Tri Pulse garments<br>with Foot garments<br>with DVT garments | Passed |
| Real Time - life testing - pump. | Confirms<br>specification |
| Vibration testing - pump. | Passed |
| Electrical Testing to Standard IEC 60601-1: 2005.<br>+ CORR. 1 (2006) + CORR. 2 (2007) | Complies with<br>Standard |

..

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## ARJOHUNTLEI GETINGE GROUP

| EMC testing to Standard EN 60601-1-2, 2007 | Complies with<br>Standard |
|----------------------------------------------------------------------------------------------------|----------------------------|
| Tri Pulse garment biocompatibility testing to<br>standardsISO10993-1, ISO10993-5 & ISO10993-<br>10 | Complies with<br>Standards |

Technologies Summary: The Flowtron ACS800 pump contains an air compressor, air distribution valve and a microprocessor based control system, housed in a durable plastic casing.

> The control system sets and monitors the air pressure cycle applied to the compression garments. It also monitors for faults caused by incorrect user set-up, compression garment failures and pump system problems.

> Automatic compression garment recognition is achieved by sensing a The value inductor is built into the specific value inductor. compression garment hose connector.

> Tri Pulse garments are constructed with a three-chamber bladder enclosed in a polyester garment, which is wrapped around the limb and secured with hook and eye tabs. When connected to the pump, the garment inflates through a single connecting tube to generate a sequential compression effect on the limb.

Conclusion:

The data detailed within submission including that drawn from the nonclinical tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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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 20993-0002

Image /page/3/Picture/3 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

February 28, 2014

Arjohuntleigh Polska Sp z.o.o. Mr. David Moynham Senior Regulatory Affairs Engineer ArioHuntleigh AB 35 Portmanmoor Road Cardiff, CF24 5HN UK

K133119 Re:

> Trade/Device Name: Flowtron ACS800 pump and Tri Pulse garments Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: January 22, 2014 Received: January 27, 2014

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.

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

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Page 2 - Mr. David Moynham

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21

CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M FDA

for 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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### ARJOHUNTLEIGH GETINGE GROUP

K133119 510(k) Number:

Device Name: Flowtron ACS800 and Tri Pulse garments.

Indications for Use:

To help prevent Deep Vein Thrombosis (DVT)

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)

M. A. Williams

Premarket Notification (510(k))