(15 days)
Not Found
No
The description details a digitally controlled pneumatic compression device with programmable settings, but there is no mention of AI or ML algorithms for decision-making, pattern recognition, or adaptive control beyond pre-programmed parameters.
Yes
This device is intended for the treatment of various medical conditions such as Lymphedema, Venous stasis ulcers, Venous insufficiency, and Peripheral edema, which directly indicates a therapeutic purpose.
No
The device is described as a "compression device" intended for "treatment" of various conditions, not for diagnosis. Its operation involves applying pressure to a limb according to physician prescription, consistent with a therapeutic device.
No
The device description clearly outlines a physical, digitally controlled pneumatic compression device that applies pressure to a limb using air flow and garments. This involves hardware components like a pump, chambers, and sensors, which are not characteristic of a software-only medical device. The performance studies also focus on hardware-related tests like dielectric strength, leakage current, and pressure calibration.
Based on the provided information, the CircuFlow 5200 Sequential Compression Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CircuFlow 5200 Function: The CircuFlow 5200 is a physical compression device that applies external pressure to a limb. It does not analyze biological samples or perform any diagnostic tests on bodily fluids or tissues.
- Intended Use: The intended use clearly states it's for the treatment of conditions like lymphedema, venous stasis ulcers, venous insufficiency, and peripheral edema. It is a therapeutic device, not a diagnostic one.
- Device Description: The description details a pneumatic compression system that inflates garments on a limb. This aligns with a physical therapy or treatment device, not an IVD.
Therefore, the CircuFlow 5200 falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CircuFlow 5200 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
Lymphedema
Venous stasis ulcers
Venous insufficiency
Peripheral edema
The device is intended for home and hospital use.
Product codes
JOW
Device Description
The CircuFlow 5200 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5200 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into garments chambers, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones).
After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within each chamber can be programmed and individual chambers can be skipped or the pressure decreased in the case of a wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use, home and hospital 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)
Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the CircuFlow 5200 are substantially similar to those of the predicate devices. The performance testing includes the following tests: Dielectric Strength Test, Leakage Current Test, Pressure Calibration for Pressure Sensor, Pressure Gradient Performance, Inflation & Deflation Time Performance, Treatment Time Performance.
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
510(K) SUMMARY
Submitter:
Devon Medical, Inc.
JUN 1 7 2010
Contact Person:
Ruth Wu, COO
1100 First Avenue, Suit 100
King of Prussia, PA 19406
800.571.3135 Phone:
Fax: 484.636.3380 ·
Common Classification & Proprietary Names:
Common Names: Sequential Compression Device Proprietary Name: CircuFlow 5200
Date Prepared:
March 10, 2010
Classification
The classification name, 21 CFR Part and Paragraph number, product code and classification of the CircuFlow 5200.
| Classification Name | 21 CFR Section | Product Code | Class |
|---|---|---|---|
| Compressible Limb Sleeve | 870.5800 | JOW | II |
Predicate Devices:
The CircuFlow 5200 Sequential Compression Device is substantially equivalent to the following.
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| CircuFlow 5100 | Devon Medical, Inc. | K100446 |
| GS-128 Sequential Compression System | MedMark Technologies | K050584 |
Device Description
The CircuFlow 5200 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5200 enables different treatment pressures and treatment times that should be used according to physician prescription. When activated, air flows into garments chambers, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones).
After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within each chamber can be programmed and individual chambers can be skipped or the pressure decreased in the case of a wound.
1
SECTION 5
Intended Use:
The CircuFlow 5200 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
- Lymphedema -
- -Venous stasis ulcers
- Venous insufficiency -
-
- Peripheral edema
The device is intended for home and hospital use.
Technological Characteristics:
The manufacturer believes that the technological characteristic of the CircuFlow 5200 are substantially similar to those of the predicate devices.
The CircuFlow 5200 has very similar components to its predicate devices and very similar principles of operation. The device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, like the predicates, pressure is applied cyclically for a specified period of time, according to the physician's prescription.
Performance Testing
Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the CircuFlow 5200 are substantially similar to those of the predicate devices. The performance testing includes the following tests:
| List of Performance Tests | |
|---|---|
| Test 1 | Dielectric Strength Test |
| Test 2 | Leakage Current Test |
| Test 3 | Pressure Calibration for Pressure Sensor |
| Test 4 | Pressure Gradient Performance |
| Test 5 | Inflation & Deflation Time Performance |
| Test 6 | Treatment Time Performance |
Standards
The CircuFlow 5200 conforms to the following standards: IEC 60601-1-1 IEC 60601-1-2 UL 60601-1 ISO 10993 ISO 14971
Statement of Substantial Equivalence
The CircuFlow 5200 is substantially equivalent in technology, function, operating parameters, and
2
SECTION 5
intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Inc, believes that the CircuFlow 5200, is safe and effective and substantially equivalent to the predicate devices as described herein.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUN 1 7 2010
Devon Medical Inc. c/o Mr. Mark Job Regulatory Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K101523
Circuflow 5200 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: June 1, 2010 Received: June 2, 2010
Dear Mr. Job:
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
4
Page 2 - Mr. Mark Job
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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutfiDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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,
Dma R. Vi. Auner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4
INDICATIONS FOR USE STATEMENT
K181523 510(k) Number (if known):
Device Name: CircuFlow 5200 Sequential Compression Device
Indications for Use:
The CircuFlow 5200 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
- Lymphedema -
- Venous stasis ulcers -
- Venous insufficiency -
- Peripheral edema -
The device is intended for home and hospital use.
Prescription Use X ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
AND/OR
R. V. Jones
on Sian-O Division of Cardiovascular Devices
510/k) Number KIO (5 2