(151 days)
No
The description mentions automatic garment sensing and pressure/time cycle adjustment, which is likely rule-based logic or simple sensor interpretation, not AI/ML. There are no mentions of AI, ML, or related concepts in the summary.
Yes
The device is intended to prevent deep vein thrombosis (DVT), which is a medical condition, making it a therapeutic device as it provides therapy to prevent a condition.
No
Explanation: The device is described as a pneumatic pump designed to prevent Deep Vein Thrombosis by inflating compression garments. Its function is to apply pressure to limbs, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly states it is a "pneumatic pump" that supplies compressed air to inflate compression garments. This indicates a significant hardware component, not a software-only device. The performance studies also include hardware testing like "Full validation of pump software / hardware functionality" and "Electrical Testing".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Flowtron ACS800 pump is a mechanical device that applies external pressure to a patient's limbs using inflatable garments. It does not analyze any biological specimens.
- Intended Use: The intended use is to help prevent Deep Vein Thrombosis (DVT) by physically compressing the limbs, not by analyzing biological markers.
Therefore, the device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
To help prevent Deep Vein Thrombosis (DVT)
Product codes
JOW
Device Description
The Flowtron ACS800 pump 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 deep vein thrombosis.
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 specific value inductor built into the 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.
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
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing to demonstrate equivalence included:
- Full validation of pump software / hardware functionality, including Garment detection and Therapy delivery. Result: Passed.
- Performance testing garments - Pressure cyclic test with Tri Pulse garments, Foot garments, and DVT garments. Result: Passed.
- Real Time - life testing - pump. Result: Confirms specification.
- Vibration testing - pump. Result: Passed.
- Electrical Testing to Standard IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007). Result: Complies with Standard.
- EMC testing to Standard EN 60601-1-2, 2007. Result: Complies with Standard.
- Tri Pulse garment biocompatibility testing to standards ISO10993-1, ISO10993-5 & ISO10993-10. Result: Complies with Standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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.
Ul. Ks Wawrsyniaka 2
62052 Komorniki
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
manufactured by Huntleigh Healthcare Ltd.
and
STS garments (K012008) cleared 21 Sept 2001 originally manufactured
by Huntleigh Healthcare Ltd.
Huntleigh Healthcare was acquired by the ArjoHuntleigh AB group and
all rights to properties and registrations assigned to Huntleigh
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
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 deep vein thrombosis. | | |
1
ARIOHUNTLEIGH GETINGE GROUP
Models:
| Model REF | Device | Features |
|---|---|---|
| 513003 | Flowtron ACS800 | AC powered pump |
| 513003OR | Flowtron ACS800 | AC powered pump with longer length connection |
| tubes | ||
| TRP10, TRP20, | ||
| TRP30, TRP40 & | ||
| 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 |
- Garment detection
- Therapy delivery | Passed |
| Performance testing garments - Pressure cyclic test.
with Tri Pulse garments
with Foot garments
with DVT garments | Passed |
| Real Time - life testing - pump. | Confirms
specification |
| Vibration testing - pump. | Passed |
| Electrical Testing to Standard IEC 60601-1: 2005.
- CORR. 1 (2006) + CORR. 2 (2007) | Complies with
Standard |
..
2
ARJOHUNTLEI GETINGE GROUP
| EMC testing to Standard EN 60601-1-2, 2007 | Complies with
Standard |
|----------------------------------------------------------------------------------------------------|----------------------------|
| Tri Pulse garment biocompatibility testing to
standardsISO10993-1, ISO10993-5 & ISO10993-
10 | Complies with
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.
3
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
4
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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
5
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))