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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CircuFlow 5200 Sequential Compression Device. This submission focuses on establishing substantial equivalence to existing predicate devices through bench and laboratory testing. It does not present a clinical study or performance data in the way typically seen for AI/ML-driven medical devices.

Therefore, many of the requested categories for AI/ML study details (e.g., sample size for test sets, expert consensus, MRMC studies, ground truth for training data) are not applicable to this submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission defines "Performance Testing" as a set of bench and laboratory tests to assure the product meets its specifications and is substantially similar to predicate devices. Specific acceptance criteria values are not explicitly stated in the provided text, nor are specific quantitative performance results for each test. The document generally states that "Bench and laboratory testing was performed and assures that the product meets its specifications."

Acceptance Criteria Category	Specific Acceptance Criteria (Not Explicitly Stated - Inferred as "Meets Specifications")	Reported Device Performance (Not Explicitly Stated - Inferred as "Met Specifications")
Dielectric Strength Test	Must meet relevant safety standards and specifications.	Stated to meet specifications.
Leakage Current Test	Must meet relevant safety standards and specifications.	Stated to meet specifications.
Pressure Calibration for Pressure Sensor	Must accurately calibrate and maintain specified pressure levels.	Stated to meet specifications.
Pressure Gradient Performance	Must deliver sequential inflation with appropriate pressure gradients as designed.	Stated to meet specifications.
Inflation & Deflation Time Performance	Must inflate and deflate within specified timeframes.	Stated to meet specifications.
Treatment Time Performance	Must accurately maintain prescribed treatment durations.	Stated to meet specifications.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. This was bench and laboratory testing, not a clinical study with patient data.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth for clinical cases was not established as this was not a clinical study.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is a sequential compression device, not an AI/ML diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This device is a physical medical device (pneumatic compression) and does not involve an AI algorithm with standalone performance metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the "Performance Testing" section, the "ground truth" would be the engineering specifications and recognized electrical/mechanical safety standards (e.g., IEC 60601-1-1, IEC 60601-1-2, UL 60601-1). The device's performance was measured against these predefined engineering and safety requirements.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not use machine learning, therefore, there is no "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable.

Summary Explanation:

The K101523 submission for the CircuFlow 5200 is a 510(k) premarket notification for a physical medical device. The focus is on demonstrating substantial equivalence to already legally marketed predicate devices, primarily through bench and laboratory performance testing against engineering specifications and relevant safety standards. It is not an AI/ML device submission, and therefore, the structured questions regarding clinical studies, data provenance, expert labeling, and AI performance metrics are not relevant to this document. The "study" proving the device meets acceptance criteria consists of the listed "Performance Tests" performed in a "bench and laboratory" setting, ensuring the device functions according to its design specifications and electrical safety standards.

Summary

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K101523

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

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.

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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

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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.

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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

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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

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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

Regulation Number and Section

§ 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).