Flowtron ACS900

K143438 · Getinge (Suzhou) Co., Ltd. · JOW · Jun 23, 2015 · Cardiovascular

Device Facts

• Record ID: K143438
• Device Name: Flowtron ACS900
• Applicant: Getinge (Suzhou) Co., Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Jun 23, 2015
• 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 ACS900 is a pneumatic pump system for DVT prevention. Device supplies compressed air to inflate limb compression garments (calf, thigh, or foot). System automatically detects connected garment type via built-in inductors in hose connectors and adjusts pressure/time cycles accordingly. Garments are compressed alternately to apply pressure to limbs. Used in clinical settings; operated by healthcare providers. Microprocessor-based control system monitors air pressure cycles and detects faults (user setup errors, garment failures, system issues). Benefits patients by providing mechanical compression to reduce DVT risk.

Clinical Evidence

Bench testing only. Validation included pump software/hardware functionality (garment detection, therapy delivery), performance testing of pressure cycles with various garment types, electrical safety (AAMI/ANSI ES60601-1), EMC (IEC 60601-1-2), and environmental stability (storage, distribution, temperature, humidity). All tests passed.

Technological Characteristics

System includes air compressor, air distribution valve, and microprocessor-based control system in a plastic casing. Features automatic garment recognition via inductors in hose connectors. Electrical safety per AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012; EMC per IEC 60601-1-2:2007.

Indications for Use

Indicated for patients requiring prophylaxis against Deep Vein Thrombosis (DVT).

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 ACS800 pump (K133119)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

June 23, 2015

Public Health Service

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

Getinge (Suzhou) Co., Ltd % David Moynham Senior Regulatory Affairs Engineer Arjohuntleigh AB 35 Portmanmoor Road Cardiff, CF24 5HN GB

Re: K143438

> Trade/Device Name: Flowtron ACS900 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 29, 2015 Received: June 1, 2015

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 or any Federal statutes and regulations administered by other Federal agencies. You must comply

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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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. A. Hillebrand

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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# GE INGL

510(k) Number: K143438

Device Name: Flowtron ACS900

Indications for Use:

To help prevent Deep Vein Thrombosis (DVT)

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

NO (Part 21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## ARJOHUNTLE GETINGE GROUP

### 510K Summary Flowtron ACS900

| Name & Address: | Getinge (Suzhou) Co., Ltd<br>No. 158 Fangzhou Road, Suzhou, 215024<br>Jiangsu<br>China | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------|
| Telephone: | +(44) 2920 485885 | | |
| Fax: | +(44) 2920 492520 | | |
| Prepared: | 26 November 2014 | | |
| Contact: | David Moynham – Regulatory Affairs Engineer | | |
| Device Name: | Flowtron ACS900 | | |
| Common Name | Compressible Limb Sleeve | | |
| Classification | Class | Product Code | Classification Regulation |
| | II | JOW | 870.5800 |
| Classification Name: | Sleeve, Limb, Compressible | | |
| Predicate Device: | Flowtron ACS800 pump (K133119) cleared 28 Feb 2014, manufactured<br>by ArjoHuntleigh AB.<br>This predicate has not been subject to a design-related recall. | | |
| Indications for Use: | To help prevent Deep Vein Thrombosis (DVT) | | |
| Description : | The Flowtron ACS900 is a pneumatic pump that supplies compressed<br>air to inflate compression garments that are attached to patient's<br>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 deen vein thrombosis. | | |

#### Models:

| Model REF | Device | Features |
|-----------|-----------------|--------------------------------------------------------|
| 526000-01 | Flowtron ACS900 | AC powered pump |
| 526000-02 | Flowtron ACS900 | AC powered pump with longer length connection<br>tubes |

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## ARIOHUN GETINGE GROUP

Substantial Equivalence: Flowtron ACS900 is substantially equivalent to cleared device Flowtron ACS800 +Tri Pulse pump (K133119). The Flowtron ACS900 pump has the same compression pressure / time profiles for the DVT. Foot and Tri Pulse Garments.

Testing to demonstrate equivalence included:

| | Testing conducted | Result | | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--|--|
| | Full validation of pump software / hardware<br>functionality, including<br>- Garment detection<br>- Therapy delivery | Passed | | |
| | Performance testing garments – Pressure cyclic<br>test.<br>with Tri Pulse garments<br>with Foot garments<br>with DVT garments | Passed | | |
| | Electrical Testing to Standard AAMI / ANSI<br>ES60601-1:2005/(R)2012 and A1:2012 | Complies with<br>Standard | | |
| | EMC testing to Standard IEC 60601-1-2, 2007 | Complies with<br>Standard | | |
| | Environmental Stability testing. | Passed | | |
| | -Storage / Distribution Test.<br>-Operational Temperature /Humidity Test. | | | |
| Technologies Summary: | The Flowtron ACS900 contains an air compressor, air distribution valve<br>and a microprocessor based control system, housed in a durable<br>plastic casing. | | | |
| | The control system sets and monitors the air pressure cycle applied to<br>the compression garments. It also monitors for faults caused by<br>incorrect user set-up, compression garment failures and pump system<br>problems. | | | |
| | Automatic compression garment recognition is achieved by sensing a<br>specific value inductor. The value inductor is built into the<br>compression garment hose connector. | | | |
| Conclusion: | The data detailed within submission including that drawn from the<br>nonclinical tests demonstrate that the device is as safe and effective<br>as the legally marketed predicate devices. | | | |