The Devon 24 deep vein thrombosis prevention system is intended to be an easy to use portable by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

· Aid in the prevention of DVT
· Enhance blood circulation
· Diminish post-operative pain and swelling
· Reduce wound healing time

· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Device Description

The Devon 24 deep vein thrombosis prevention therapy system (referred as Devon 24 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The Devon 24 system consists of a pair of pumps and sleeve assemblies.

The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 40mmHg pressure and followed by a deflation period once it reaches the desired pressure, each cycle time is 50 seconds.

AI/ML Overview

This document, a 510(k) Premarket Notification for the Devon 24 Deep Vein Thrombosis Prevention Therapy System, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, many of the requested sections regarding the study design and results cannot be fully addressed from the provided text.

Based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests conducted, but it does not explicitly state quantitative acceptance criteria or the specific numerical results for each test. Instead, it offers a general conclusion that "The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate."

Test Name	Acceptance Criteria (Not explicitly stated with values)	Reported Device Performance (General Conclusion)
Pressure Accuracy Test	Would typically involve a target pressure range and tolerance (e.g., ±X mmHg)	"Device is performing as intended"
Pressure Sensor Calibration Test	Would involve accuracy and linearity requirements for the sensor	"Device is performing as intended"
Cycle Time Test	Specific duration for inflation/deflation cycle (e.g., 50 seconds ±Y seconds)	"Device is performing as intended" (document states 50-second cycle time)
Alarm Function Test	Alarms activate under specified fault conditions	"Device is performing as intended"
Battery Life Test	Specific duration of operation on a full charge	"Device is performing as intended"
Garment Burst Testing	Withstand a certain pressure without bursting (e.g., >X mmHg)	"Device is performing as intended"
Biocompatibility	Pass cytotoxicity, sensitization, irritation tests	Passed; uses same material as predicate, which previously passed these tests.
Electrical Safety & EMC	Conformity to IEC 60601 series standards	Conforms to IEC 60601-1, -1-2, -1-6, -1-11.
Software Verification & Validation	Meet "moderate" level of concern V&V requirements	Documentation provided, considered adequate for "moderate" level of concern.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated. The document mentions "samples of the device" for performance and mechanical testing, but the number of units tested is not provided.
Data Provenance: The tests were conducted internally by Devon Medical Products (Jiangsu) Ltd. in China. The document does not specify if the data involved human subjects or was entirely bench-top testing. Given the type of tests listed, they appear to be primarily bench-top (in-vitro) engineering and functional tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not Applicable. For the engineering and functional tests performed (pressure, cycle time, alarms, battery, burst, electrical safety, software V&V), ground truth is established through measurement instruments and compliance with technical standards and specifications, not through expert human interpretation as would be the case for diagnostic imaging or clinical outcomes.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, typically in clinical studies or when human interpretation of data is required to establish a consensus ground truth. The tests described are objective engineering and functional measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "No animal study or clinical study was conducted." MRMC studies are clinical studies involving human readers/observers.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

Not Applicable. This device is a physical medical device (intermittent pneumatic compression system), not an algorithm or AI software for diagnosis or image analysis. Its "standalone" performance refers to its functional operation as demonstrated by the engineering tests for pressure, cycle time, etc., which were reported as "performing as intended."

7. The Type of Ground Truth Used:

Engineering Specifications and Standard Compliance. For the performance tests, the "ground truth" is defined by the device's design specifications (e.g., target pressure, cycle time) and adherence to recognized international standards for electrical safety and electromagnetic compatibility (IEC 60601 series). For biocompatibility, the ground truth was the results of previously conducted biocompatibility tests on the predicate device's materials, per FDA Good Laboratory Practice.

8. The Sample Size for the Training Set:

Not Applicable. This information pertains to machine learning algorithms. The Devon 24 is a mechanical/electronic device, not an AI or imaging device that uses a "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/2 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 a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2017

Devon Medical Products (Jiangsu) Ltd. Julian Chu Plant Manager East Half of 1-2f, Appt D2, 1, Qingfeng Road. Nantong。 226017 China

Re: K170814

Trade/Device Name: Devon 24 Deep Vein Thrombosis Prevention Therapy System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 11, 2017 Received: April 12, 2017

Dear Julian Chu:

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Nicole G. Ibrahim -S

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170814

Device Name

Devon 24 Deep Vein Thrombosis Prevention Therapy System

Indications for Use (Describe)

This device can be used in the home or clinical settings to:

· Aid in the prevention of DVT
· Enhance blood circulation
· Diminish post-operative pain and swelling
· Reduce wound healing time

· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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Section 5

510K Summary

Submitter:

Devon Medical Products (Jiangsu) Ltd.

East Half Of 1-2F, Appt D2,

1, Qingfeng Road

Nantong, Jiangsu, CHINA 226017

Phone: 011-86-531-51080927

011-86-531-51080928 Fax:

Contact Person: Julian Chu

Date Prepared: June 13, 2017

Device:

Common Names:	Intermittent Pneumatic Compression Device
Proprietary Name:	Devon 24 Deep Vein Thrombosis Prevention Therapy System
Regulation Number:	21 CFR 870.5800
Classification Name:	Compressive Limb Sleeve
Regulatory Class:	II
Product Code:	JOW

Predicate Devices:

The Devon 24 Deep Vein Thrombosis Prevention Therapy System is equivalent to the following:

Predicate Device	Manufacturer	510(k)#
Cirona 6300	Devon Medical Products	K151189

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Device Description

Premarket notification device:

Devon 24 Deep Vein Thrombosis Prevention Therapy System

Intended Use:

The Devon 24 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

. Aid in the prevention of DVT
. Enhance blood circulation
Diminish post-operative pain and swelling
Reduce wound healing time

. Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

As a prophylaxis for DVT by persons expecting to be stationary for long periods of time .

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Technological Characteristics:

Below is a table of comparison for the technological characteristics against the predicate device:

Predicate	Cirona 6300
Indication for Use	S
Components	S
Material	S
Biocompatibility	S
Principle of Operation	SE
Pressure	D
User Interface	S

The manufacturer believes that the technological characteristics of the Devon 24 Disposable Deep Vein Thrombosis Prevention System are substantially similar to those of the predicate device. Devon 24 has very similar components to its predicate devices and very similar principles of operation.

Performance Tests

To verify that the device design met its function and performance requirements, samples of the device underwent function and mechanical testing.

The following tests were conducted:

Function Performance Tests
TR63.J001	Pressure Accuracy Test Report
TR63.J002	Pressure Sensor Calibration Test Report
TR63.J003	Devon 24 Cycle Time Test Report
TR63.J004	Alarm Function Test Report
TR63.J005	Battery Life Test Report
TR63.J006	Devon 24 Garment Burst Testing Report

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Section 5

The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate.

Biocompatibility

The Devon 24 uses the exact same sleeve material as its predicate, in the same direct body contact method, and manufactured by the same manufacturer, so new biocompatibility testing was not run. The predicate device underwent the biocompatibility test evaluation in accordance with the FDA Good Laboratory Practice. The following tests were done:

. Cytotoxicity
Sensitization
Irritation

Sterilization and Shelf Life

Sterilization and shelf life is not applicable to Devon 24.

Electrical Safety and Electromagnetic Compatibility (EMC)

EMC tests were conducted according to the following standards:

IEC 60601-1: 2005+C1:2006+C2:2007+A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
. IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for safety -Collateral Standard: Usability including IEC 62366: Application of usability engineering to medical devices
IEC 60601-1-11: 2015 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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Software Verification and Validation

Software verification and validation was conducted and documentation is provided. The software was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in serious injury to the patient or operator.

Animal Study and Clinical Study

No animal study or clinical study was conducted.

Statement of Substantial Equivalence

The Devon 24 Disposable Deep Vein Thrombosis Prevention Therapy System 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.

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).