(203 days)
Not Found
No
The description focuses on pneumatic pump functionality, garment detection, and pressure/time cycle adjustment based on garment type, which are standard automated control mechanisms, not indicative of AI/ML.
Yes
The device is intended to prevent Deep Vein Thrombosis (DVT) by applying pressure to the patient's limbs, which is a therapeutic intervention.
No
The device is described as a pneumatic pump that prevents deep vein thrombosis by applying pressure to the patient's limbs. Its function is to provide therapy (prevention), not to diagnose a condition.
No
The device description explicitly states it is a "pneumatic pump that supplies compressed air to inflate compression garments," indicating it is a hardware device with software control, not a software-only device. The performance studies also include hardware validation and testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To help prevent Deep Vein Thrombosis (DVT)". This is a therapeutic or preventative purpose, not a diagnostic one.
- Device Description: The device is a pneumatic pump that applies external pressure to limbs. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.), which is the core characteristic of an IVD.
- Lack of IVD-related information: The description does not mention any analysis of biological samples, diagnostic markers, or any process related to determining a disease state or condition based on in vitro testing.
Therefore, the Flowtron ACS900 is a medical device used for physical therapy/prevention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To help prevent Deep Vein Thrombosis (DVT)
Product codes
JOW
Device Description
The Flowtron ACS900 is a pneumatic pump that supplies compressed air to inflate compression garments that are attached to patient's limbs. It is designed to work with the ArjoHuntleigh ranges of DVT calf/thigh compression garments, Foot compression garments and Tri Pulse calf/thigh compression garments. The pump automatically senses the type of compression garment connected and adjusts the pressure/time cycle accordingly. Each garment is compressed alternately, applying pressure to the patient's limb to help prevent deen vein thrombosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs, calf/thigh, Foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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:
- Full validation of pump software / hardware functionality, including Garment detection - Therapy delivery. Result: Passed
- Performance testing garments – Pressure cyclic test. with Tri Pulse garments, with Foot garments, with DVT garments. Result: Passed
- Electrical Testing to Standard AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012. Result: Complies with Standard
- EMC testing to Standard IEC 60601-1-2, 2007. Result: Complies with Standard
- Environmental Stability testing. -Storage / Distribution Test. -Operational Temperature /Humidity Test. Result: Passed
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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
No. 158 Fangzhou Road, Suzhou, 215024
Jiangsu
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
by ArjoHuntleigh AB.
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
air to inflate compression garments that are attached to patient's
limbs.
It is designed to work with the ArjoHuntleigh ranges of DVT calf/thigh
compression garments, Foot compression garments and Tri Pulse
calf/thigh compression garments.
The pump automatically senses the type of compression garment
connected and adjusts the pressure/time cycle accordingly.
Each garment is compressed alternately, applying pressure to the
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 |
| tubes |
4
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 | ||||
| functionality, including |
- Garment detection
- Therapy delivery | Passed | | |
| | Performance testing garments – Pressure cyclic
test.
with Tri Pulse garments
with Foot garments
with DVT garments | Passed | | |
| | Electrical Testing to Standard AAMI / ANSI
ES60601-1:2005/(R)2012 and A1:2012 | Complies with
Standard | | |
| | EMC testing to Standard IEC 60601-1-2, 2007 | Complies with
Standard | | |
| | Environmental Stability testing. | Passed | | |
| | -Storage / Distribution Test.
-Operational Temperature /Humidity Test. | | | |
| Technologies Summary: | The Flowtron ACS900 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
specific value inductor. The value inductor is built into the
compression garment hose connector. | | | |
| 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. | | | |