(127 days)
Not Found
No
The description focuses on a pneumatic pump and garment system for cyclic compression, with no mention of AI/ML technologies or related concepts like data analysis, algorithms, or learning.
Yes
The device is described as a "therapeutic device" implicitly through its intended uses, which include "Prevention of Deep Vein Thrombosis (DVT)", "Enhancement of venous & arterial circulation", and "Assist healing of cutaneous ulcers", all of which are treatment or prevention-oriented functions.
No
Explanation: The device description and intended use focus on therapeutic actions like preventing DVT, enhancing circulation, and reducing edema and pain through cyclic compression. There is no mention of diagnosing conditions, processing diagnostic data, or providing diagnostic information.
No
The device description clearly states it is a "wrap around foot garment comprising of a bladder and surrounding material" and is connected to a "pneumatic pump," indicating it is a hardware device with physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Flowtron Foot Garment is a mechanical device that applies external compression to the foot. It works by physically manipulating blood flow within the body.
- Intended Use: The intended uses listed are all related to physical therapy and circulatory support, not the analysis of biological samples.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
- Prevention of Deep Vein Thrombosis (DVT) ●
- Enhancement of venous & arterial circulation ●
- . Prevention of venous stasis
- Assist healing of cutaneous ulcers .
- Reduction of acute or chronic edema .
- Reduction of lower limb pain due to surgery or trauma .
- Reduction of compartmental pressures ●
Product codes
JOW
Device Description
The Flowtron Foot Garment is a wrap around foot garment comprising of a bladder and surrounding material intended to apply cyclic compression to the foot to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT).
The Flowtron Foot Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Foot Garment in a cyclic manner.
Flowtron Foot Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot, lower limb
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K965153, Huntleigh FP5000 System, Model FP5000
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 GETINGE GROUP
510(k) Summary
Flowtron Foot Garments – Sterile
DEC
| Name & Address: | ArioHuntleigh AB
Verkstadsvägen 5
241 38 Eslöv, SWEDEN | | | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------|--|--|
| Telephone: | +(44) 29 2044 7084 | | | | |
| Fax: | +(44) 29 2049 2520 | | | | |
| Prepared: | 6 December 2012 | | | | |
| Contact: | David Moynham – Regulatory Affairs Engineer | | | | |
| Device Name: | Flowtron Foot Garments - Sterile | | | | |
| Common Name | Sleeve, Limb, Compressible | | | | |
| Classification | Class | Product Code | Classification Regulation | | |
| | ll | JOW | 21 CFR 870.5800 | | |
| Classification Name: | Sleeve, Limb, Compressible | | | | |
| Predicate Device: | K965153, Huntleigh FP5000 System, Model FP5000 | | | | |
| Indications for Use: | Prevention of Deep Vein Thrombosis (DVT)
�
Enhancement of venous & arterial circulation
Prevention of venous stasis
Assist healing of cutaneous ulcers
●
Reduction of acute or chronic edema
●
Reduction of lower limb pain due to surgery or trauma
�
Reduction of compartmental pressures | | | | |
| | | | | | |
Description :
The Flowtron Foot Garment is a wrap around foot garment comprising of a bladder and surrounding material intended to apply cyclic compression to the foot to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT).
The Flowtron Foot Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Foot Garment in a cyclic manner.
Flowtron Foot Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps .
1
GETINGE GROUP
Models
| Model REF | Device | Feature |
|---|---|---|
| FG100S | Flowtron Foot Garment Regular - FG100S | Sterile |
| FG200S | Flowtron Foot Garment Large- FG200S | Sterile |
Substantial Equivalence:
The Flowtron Foot Garments - Sterile and the Foot Garments included in the predicate device clearance are identical in all respects including materials, construction, performance and indications for use. The only difference being the sterility of the Flowtron Foot Garments.
Full details of the validation of sterility processing and shelf life stability have been submitted for sterile garments.
Technologies Summary:
The Flowtron Foot Garments – Sterile and the Foot Garments included as part of the predicate device clearance are identical in all respects including materials, construction, performance and indications for use. The only difference in technology being the sterility aspect. Sterile garments being processed using Ethylene Oxide in accordance with ISO 11135.
Conclusion:
The Flowtron Foot Garments - Sterile and the Foot Garments of the predicate device are substantially equivalent. Issues raised by the sterilisation process have been addressed in the validation process and these demonstrate that the sterile Foot Garments remain safe and.effective.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 7 2012
Arjohuntleigh C/O Mr. David Moynham 35 Portmanmoor Road Cardiff, S. Glamorgan, CF24 5HN, United Kingdom
Re: K122330
Trade/Device Name: Flowtron Foot Garment - Regular - Sterile, FG 100S and Flowtron Foot Garment - Large- Sterile, FG 200S Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: November 2, 2012 Received: November 7, 2012
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.
3
Page 2 - Mr. David Moynham
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease of advised that 1 Dris tosaantes over device complies with other requirements of the Act that I DIT has intates and regulations administered by other Federal agencies. You must or any 1 edelar suttates and regulations, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Clice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-related adverse ovents) (2) 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 11 you desire specific advice 10: your a microsoffices/CDRH/CDRHOffices/ucm115809.htm for go to hep. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation online 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 Tou may ocain 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,
Kenneth J. Cavanaugh
for
Bram D. Zuckerman, MD Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number:
Device Name:
Flowtron Foot Garments-Sterile
Indications for Use:
- Prevention of Deep Vein Thrombosis (DVT) ●
- Enhancement of venous & arterial circulation ●
- . Prevention of venous stasis
- Assist healing of cutaneous ulcers .
- Reduction of acute or chronic edema .
- Reduction of lower limb pain due to surgery or trauma .
- Reduction of compartmental pressures ●
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)
lc
of Cardiovascular Devices
510(k) Number K122330