(16 days)
Not Found
No
The device description details a manual pneumatic compression system with adjustable pressure and time settings, controlled by a user-adjusted regulator and factory default settings. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as being intended for the "primary or adjunctive treatment of primary or secondary lymphedema," and "additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities," which are all therapeutic uses.
No
The device is a therapeutic device designed for primary or adjunctive treatment of lymphedema, venous insufficiency, and chronic venous stasis ulcers, and general treatment of swelling of the extremities, not for diagnosis.
No
The device description explicitly states it is composed of a pneumatic manual pump and a limb sleeve/garment, which are hardware components.
Based on the provided information, the CircuFlow 5100 Sequential Compression Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies physical compression to a limb for therapeutic purposes (treating lymphedema, venous insufficiency, etc.). This is a physical therapy or medical device function, not a diagnostic test performed on samples taken from the body (in vitro).
- Device Description: The description details a pneumatic pump and limb sleeves that apply pressure. This aligns with a physical therapy or medical device, not a device that analyzes biological samples.
- No mention of diagnostic testing: There is no mention of analyzing blood, urine, tissue, or any other biological sample.
- Performance Studies: The performance studies listed are related to the physical and electrical performance of the device and the materials used, not the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CircuFlow 5100 does not perform this function.
N/A
Intended Use / Indications for Use
The CircuFlow 5100 is a sequential gradient compression pneumatic device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous static ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities. The device is intended for home or hospital use.
The CircuFlow 5100 Sequential Compression Device is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The CircuFlow 5100 is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components:
- Pneumatic manual pump
- · Limb sleeve or garment composes of 4 chambers
The CircuFlow 5100 enables different treatment pressures (0-120mmHg) and treatment times (30 minutes to continue) that should be used according to physician prescription. When activated, air flows into chamber, 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 chambers are adjustable -pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chambers 2, 3 & 4 are individually lowered according to the default factory settings.
A calibrated dial gauge displays pressure in the range of 0-200 mmHg.
Garments are available in 8 sizes, and custom garments are available in variations from standard sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb, extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home or 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 5100 are substantially similar to those of the predicate devices. The performance testing includes the following tests:
Electrical Safety Tests
Dielectric Strength Test
Leakage Current Test
Gradient Performance Test
Garment Tests
Pressure Performance Test
Tensile Strength Test
Material Biocompatibility Tests
Cytotoxicity Test
Sensitization Test
Irritation and Intracutaneous Reactivity Test
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.
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
SECTION 5
MAR - 5 2010
510(K) SUMMARY
Submitter:
Devon Medical, Inc.
Contact Person:
Ruth Wu, COO 1100 First Avenue, Suit 100
King of Prussia, PA 19406
Phone: 800.571.3135
Fax: 484.636.3380
Common Classification & Proprietary Names:
Common Names: Sequential Compression Device Proprietary Name: CircuFlow 5100
Date Prepared:
December 31st 2009
Classification
The classification name, 21 CFR Part and Paragraph number, product code and classification of the CircuFlow 5100.
| Classification Name | 21 CFR Section | Product Code | Class |
|---|---|---|---|
| Compressible Limb Sleeve | 870.5800 | JOW | II |
Predicate Devices:
The CircuFlow 5100 Sequential Compression Device is substantially equivalent to the following.
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| SC-3008 Sequential Circulator | Bio Compression Systems Inc. | K043423 |
| GS-128 Sequential Compression | ||
| System | MedMark Technologies | K050584 |
Device Description
The CircuFlow 5100 is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components:
- Pneumatic manual pump
- · Limb sleeve or garment composes of 4 chambers
The CircuFlow 5100 enables different treatment pressures (0-120mmHg) and treatment times (30 minutes to continue) that should be used according to physician prescription. When activated, air flows into chamber, 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
1
SECTION 5
order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within chambers are adjustable -pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chambers 2, 3 & 4 are individually lowered according to the default factory settings.
A calibrated dial gauge displays pressure in the range of 0-200 mmHg.
Garments are available in 8 sizes, and custom garments are available in variations from standard sizes.
Intended Use:
The CircuFlow 5100 is a sequential gradient compression pneumatic device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous static ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities. The device is intended for home or hospital use.
Technological Characteristics:
The manufacturer believes that the technological characteristic of the CircuFlow 5100 are substantially similar to those of the predicate devices.
The CircuFlow 5100 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 5100 are substantially similar to those of the predicate devices. The performance testing includes the following tests:
| Electrical Safety Tests |
|---|
| Dielectric Strength Test |
| Leakage Current Test |
| Gradient Performance Test |
| Garment Tests |
| Pressure Performance Test |
| Tensile Strength Test |
| Material Biocompatibility Tests |
| Cytotoxicity Test |
| Sensitization Test |
| Irritation and Intracutaneous Reactivity Test |
2
SECTION 5
Standards
The CircuFlow 5100 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 5100 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 Inc, believes that the CircuFlow 5100, is safe and effective and substantially equivalent to the predicate devices as described herein.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an eagle or other bird with its wings spread, rendered in a simple, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MAR - 5 2010
Devon Medical Inc. c/o Mr. Mark Job Regulatory Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K100446 Circuflow 5100 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: February 16, 2010 Received: February 17, 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 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/CDRHQffices/ucm115809.html 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Duna R. Ladner
Image /page/4/Picture/7 description: The image shows a signature next to the letters 'Br' and 'Di'. The signature is illegible, but it appears to be a cursive signature. The letters 'Br' and 'Di' are in a simple font and are aligned vertically. The image is black and white and has a simple composition.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
K100446 510(k) Number (if known):
Device Name: the Devon CircuFlow 5100 Sequential Compression Device
Indications for Use:
The CircuFlow 5100 Sequential Compression Device is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities.
The device is intended for home or 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)
sumer D. Vcliner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ki 00446