(79 days)
Not Found
No
The device description details a digitally controlled pneumatic compression system with programmable pressure and time settings, but there is no mention of AI or ML algorithms being used for decision-making, pattern recognition, or adaptive control based on patient data. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device description and intended use clearly state that it is designed to treat various medical conditions such as lymphedema, venous stasis ulcers, venous insufficiency, and peripheral edema, which are therapeutic applications.
No
The device description indicates that the CircuFlow 5208 is a treatment device that applies compression to a limb. It doesn't mention any diagnostic functions or capabilities.
No
The device description clearly details a physical pump and garments that apply pneumatic compression, indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the CircuFlow 5208 Sequential Compression Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The CircuFlow 5208 is a physical compression device that applies external pressure to a limb. Its function is to treat conditions like lymphedema and venous issues by physically manipulating the limb to improve circulation and reduce swelling.
- The description focuses on the mechanical operation of the device (pneumatic compression, pressure settings, inflation/deflation cycles) and its intended use for treating specific physical conditions. There is no mention of analyzing biological samples.
Therefore, the CircuFlow 5208 falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CircuFlow 5208 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 (comma separated list FDA assigned to the subject device)
JOW
Device Description
The CircuFlow 5208 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5208 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
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 5208 are substantially similar to those of the predicate devices. The performance testing includes the following 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K101523, K100677, K003909, K100446
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
FEB 1 4 2013
510(K) SUMMARY
Submitter:
Devon Medical Products, Inc.
Contact Person:
Ruth Wu, COO 1100 First Avenue, Suite 202 King of Prussia, PA 19406 Phone: 610.757.4103 610.930.4035 Fax:
Common Classification & Proprietary Names:
Sequential Compression Device Common Names: Proprietary Name: CircuFlow 5208
Date Prepared:
July 23'd, 2012
Classification
The classification name, 21 CFR Part and Paragraph number, product code and classification of the CircuFlow 5208.
| Classification Name | 21
Section | CFR Product
Code | Class |
|-----------------------------|---------------|---------------------|-------|
| Compressible Limb
Sleeve | 870.5800 | JOW | II |
Predicate Devices:
The CircuFlow 5208 Sequential Compression Device is substantially equivalent to the following.
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| CircuFlow 5200 | Devon Medical, Inc. | K101523 |
| Lymphapress Model 201MAX | Mego Afek Ltd | K100677 |
| Proact 1 | Proact Company | K003909 |
| CircuFlow 5100 | Devon Medical, Inc. | K100446 |
Device Description
The CircuFlow 5208 is a digitally controlled sequential pneumatic compression device designed to apply compression to a limb. The CircuFlow 5208 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).
Page 1 of 3
1
SECTION 5
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.
Intended Use:
The CircuFlow 5208 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 characteristics of the CircuFlow 5208 are substantially similar to those of the predicate devices.
The CircuFlow 5208 has very similar components to its predicate devices and has 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 5208 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 |
Page 2 of 3
2
SECTION 5
Standards
The CircuFlow 5208 conforms to the following standards:
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard:
AAMI ES 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 10993-5 Biological evaluation of medical devices - Part 1: Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices --Part 10:Tests for irritation and delayed-type hypersensitivity
ISO 14971 Medical devices - Application of risk management to medical devices
Statement of Substantial Eguivalence
The CircuFlow 5208 is substantially equivalent in technology, function, operating parameters, and 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 Products, believes that the CircuFlow 5208, is substantially equivalent to the predicate devices as described herein.
Page 3 of 3
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with three flowing lines representing the department's mission to promote health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 1 4 2013
Devon Medical Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K123647
Trade/Device Name: CircuFlow 5208 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: January 31, 2013 Received: February 1, 2013
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 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.
4
Page 2 -- Mr. Mark Job
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/AboutFDA/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 vours.
Matthew G. Hillebrenner
for
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
K1236
K12364 510(k) Number (if known):
Device Name: CircuFlow 5208 Sequential Compression Device
Indications for Use:
The CircuFlow 5208 Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
- Lymphedema 1
- Venous stasis ulcers -
- Venous insufficiency -
-
- Peripheral edema
The device is intended for home and hospital use.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
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)
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| 510/12 Number | 14
ﻟ |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |