Flowtron DVT5 Small Calf Garment

K172103 · Getinge (Suzhou) Co., Ltd. · JOW · Mar 2, 2018 · Cardiovascular

Device Facts

• Record ID: K172103
• Device Name: Flowtron DVT5 Small Calf Garment
• Applicant: Getinge (Suzhou) Co., Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Mar 2, 2018
• 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 DVT5 Small Calf Garment is a wraparound limb sleeve consisting of a bladder and outer material; designed to apply cyclic compression to the calf to improve venous blood flow and reduce DVT risk. The device is a passive component that connects to an ArjoHuntleigh Flowtron pneumatic pump. The pump provides the active mechanism, delivering air to inflate and deflate the garment in a cyclic manner. The garment features a custom connector ensuring compatibility exclusively with ArjoHuntleigh pumps. It is intended for use in clinical settings where pneumatic compression therapy is prescribed. By facilitating venous return, the device aids in preventing thrombus formation, benefiting patients at risk of DVT.

Clinical Evidence

Bench testing only. Testing included pressure cyclic performance with Flowtron pumps, garment fastening durability, environmental stress testing, shelf life evaluation, shipping/distribution validation, and biocompatibility assessment. All tests passed.

Technological Characteristics

Passive compressible limb sleeve; wraparound design with internal bladder. Dimensions: designed for calf circumferences up to 14 inches. Connectivity: custom pneumatic connector for ArjoHuntleigh Flowtron pumps. Non-sterile. Materials: unspecified textile/bladder construction.

Indications for Use

Indicated for the prevention of Deep Vein Thrombosis (DVT) in patients requiring limb 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

• DVT10(S) Limb Compression Sleeves Calf Garments (K925717)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

March 2, 2018

Getinge (Suzhou) Co., Ltd. % David Movnham Regulatory Compliance Manager ArjoHuntleigh AB 35 Portmanmoor Road Cardiff, cf24 5hn Gb

Re: K172103

Trade/Device Name: Flowtron DVT5 Small Calf Garment Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: January 10, 2018 Received: January 19, 2018

Dear David 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 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 device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Nicole G. Ibrahim -S

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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Image /page/2/Picture/0 description: The image shows the logo for ArjoHuntleigh, a Getinge Group company. The text "ARJOHUNTLEIGH" is displayed in two colors, with "ARJO" in blue and "HUNTLEIGH" in gray. Below the company name, the text "GETINGE GROUP" is written in gray, indicating that ArjoHuntleigh is part of the Getinge Group.

## Indications For Use

510(k) Number: K172103

Device Name: Flowtron DVT5 Small Calf Garment

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)

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# 510(k) Summary Flowtron DVT5 Small Calf Garments

ARJOHUNTLEIGH

GETINGE GROUP

K172103 page 1 of 2

| Name & Address: | Getinge (Suzhou) Co., Ltd.<br>No. 158 Fangzhou Road<br>Sip, Suzhou, Jiangsu,<br>Suzhou Jiangsu, CHINA 215024 | | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------|
| Telephone: | +(44) 29 2044 7084 | | |
| Fax: | +(44) 29 2049 2520 | | |
| Prepared: | 01 December 2017 | | |
| Contact: | David Moynham – Regulatory Compliance Manager | | |
| Device Name: | Flowtron DVT5 Small Calf Garment | | |
| Common Name | Sleeve, Limb, Compressible | | |
| Classification | Class | Product Code | Classification Regulation |
| | II | JOW | 21 CFR 870.5800 |
| Classification Name: | Sleeve, Limb, Compressible | | |
| Predicate Device: | K925717, DVT10(S) Limb Compression Sleeves Calf Garments | | |
| Indications for Use: | • To help prevent Deep Vein Thrombosis (DVT) | | |
| Description : | The Flowtron Small Calf Garment is a wraparound Calf garment<br>comprising of a bladder and surrounding material intended to apply<br>cyclic compression to calf to improve return venous blood flow to<br>prevent and reduce the risk of Deep Vein Thrombosis (DVT). | | |
| | The Flowtron Small Calf Garment is connected to an ArjoHuntleigh<br>Flowtron pneumatic pump. The pump controls and generated the<br>delivery of air to inflate and deflate the Calf Garment in a cyclic<br>manner. | | |
| | Flowtron Calf Garments are configured with a custom design connector<br>that means that they are only compatible with ArjoHuntleigh Flowtron<br>pneumatic pumps | | |

### Models

| Model REF | Device | Feature |
|-----------|-----------------------------------------------|--------------|
| DVT5 | Flowtron Small Calf Garment Up to 36 cm (14") | Smaller Size |

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Image /page/4/Picture/0 description: The image contains the logo for ARJOHUNTLEIGH GETINGE GROUP. The text "ARJOHUNTLEIGH" is displayed in two colors, with "ARJO" in blue and "HUNTLEIGH" in gray. Below this, the words "GETINGE GROUP" are written in gray, indicating that ArjoHuntleigh is part of the Getinge Group.

Substantial Equivalence: The Flowtron DVT5 Small Calf Garment and the DVT10(S) Calf Garment included in the predicate device clearance are identical in materials, function and indications for use.

The only difference being the size of the Flowtron Calf Garment.

Full details of the verification and validation of the smaller calf garments have been included in the submission.

Testing to demonstrate equivalence included:

| Testing conducted | Result |
|------------------------------------------------------------------------------------------|--------|
| Performance testing of garments – Pressure cyclic<br>test with Flowtron pneumatic pumps. | Passed |
| Evaluation of durability of garment fastening. | Passed |
| Evaluation at environmental extremes. | Passed |
| Evaluation of shelf life | Passed |
| Evaluation of shipping and distribution | Passed |
| Evaluation of biocompatibility | Passed |

Technologies Summary: DVT garments are compression sleeves intended to be wrapped around patient calf. They inflate and deflate in a cyclic manner when connected to a Flowtron pneumatic pump. The garments are passive devices and do not contain any technologies. The Flowtron pneumatic pump is the active part of the system but is outside the scope of this application. The subject garment DVT5 is non-sterile and the predicate device is sterile. The differences in garments are the size aspect. The difference being

the size from DVT10(S) (Sleeves are extended in width, so that are suitable to fit a patient's calf of up to 17 inches circumference) to that of DVT5 (Small garment designed to fit calf circumferences up to 14inches).

#### Conclusion: The submission device and the predicate device are identical in in materials, function and indications for use.

The differences are the width and the height of the submission device.

The data detailed within submission including that drawn from the nonclinical tests demonstrate that the predicate and the submission device are substantially equivalent.