The Cirona 6300 disposable 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

Device Description

The Cirona™ 6300 disposable deep vein thrombosis prevention system (refer as Cirona 6300 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by simulating blood flow in the extremities (simulating muscle contractions). The Cirona 6300 system consists of a pair of pump 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 50mmHg pressure and followed by 50 seconds of deflation period once it reaches the desired pressure.

AI/ML Overview

The provided text describes the Cirona 6300 Disposable Deep Vein Thrombosis Prevention System and its 510(k) submission for substantial equivalence. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics in comparison to a ground truth as would be typical for an AI/ML device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Innovamed Vena Pro, K133274) through a comparison of technological characteristics and various engineering/performance tests.

Therefore, many of the requested items (acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable or not provided in this type of submission.

Here's a breakdown of the information that is available based on your request:

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy against a DVT diagnosis ground truth) nor does it report device performance in that manner. Instead, it lists several engineering and functional tests. The implied "acceptance criterion" for these tests is that the device performed as intended or demonstrated substantial equivalence to the predicate for those characteristics.

Function Performance Tests	Reported Outcome/Conclusion
TR36.0001 Pressure Accuracy Test Report	Performed as intended, substantially equivalent to predicate
TR36.0002 Pressure Switch Test Report	Performed as intended, substantially equivalent to predicate
TR36.0003 Cirona 6300 Cycle Time Test Report	Performed as intended, substantially equivalent to predicate
TR36.0004 Alarm Function Test Report	Performed as intended, substantially equivalent to predicate
TR36.0005 Battery Life Test Report	Performed as intended, substantially equivalent to predicate
TR36.0010 Cirona 6300 Garment Burst Testing Report	Performed as intended, substantially equivalent to predicate
Biocompatibility (Cytotoxicity, Sensitization, Irritation)	Evaluated according to FDA Good Laboratory Practice
Electrical Safety and EMC (IEC 60601-1, -1-2, -1-6, -1-11)	Conducted according to standards
Software Verification and Validation	Conducted; software considered "moderate" level of concern

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any performance tests; implied to be laboratory samples of the device undergoing engineering testing.
Data Provenance: Not applicable. These were engineering/bench tests, not clinical data.
Retrospective/Prospective: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document describes a physical medical device (intermittent pneumatic compression system) and its engineering validation, not an AI/ML diagnostic system that requires expert-established ground truth for a test set.

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

None. Not applicable to the type of device and testing described.

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

No. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. The "ground truth" for the engineering tests would be the established engineering specifications and performance characteristics of the device being tested (e.g., a pressure gauge accurately measuring 50mmHg, a timer accurately measuring 50 seconds).

8. The sample size for the training set

Not applicable. This device does not use machine learning, so there is no "training set."

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

Not applicable. As above, no machine learning training set involved.

In summary, this document is a 510(k) premarket notification for a physical medical device (DVT prevention system) based on substantial equivalence. It details engineering and functional tests to demonstrate the device meets its design requirements and is comparable to previously cleared devices. It does not involve AI/ML technology, clinical studies with human subjects, or the complex validation methodologies associated with AI systems described in your prompt.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

Devon Medical Products Steve Xu Regulatory Affairs Specialist 1100 First Avenue, Suite 202 King Of Prussia, Pennsylvania 19406

Re: K151189

Trade/Device Name: Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: August 7, 2015 Received: August 10, 2015

Dear Steve Xu,

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

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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 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 yours,

M.A. Hillebrenner

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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Indications for Use

510(k) Number (if known) K151189

Device Name

Cirona 6300 Disposable Deep Vein Thrombosis Prevention 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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Section 5

510K Summary

Submitter:

Devon Medical Products

1100 First Avenue, Suite 202

King of Prussia, PA 19406

Phone: 610.757.4127

610.930.4035 Fax:

Contact Person: John Siegel, COO

Date Prepared: September 18, 2015

Device:

Common Names: Intermittent Pneumatic Compression Device

Cirona™ 6300 Disposable Deep Vein Thrombosis Prevention System Proprietary Name:

Regulatory Class II

Product Code: JOW

Predicate Devices:

The Cirona 6300 Deep Vein Thrombosis Prevention System is equivalent to the following:

Predicate Device	Manufacturer	510(k)#
Vena Pro	Innovamed Health LLC	K133274

Device Description

Premarket notification device:

Cirona 6300 Disposable Deep Vein Thrombosis Prevention System

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Section 5 Intended Use:

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 .

Technological Characteristics:

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

Predicate	Innovamed Vena Pro
Indication for Use	S
Components	S
Material	SE
Biocompatibility	SE
Principle of Operation	SE
Pressure	S
User Interface	S

*SE - Substantial Equivalent *S - Same

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Section 5

The manufacturer believes that the technological characteristics of the Cirona 6300 Disposable Deep Vein Thrombosis Prevention System are substantially similar to those of the predicate device. Cirona 6300 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
TR36.0001	Pressure Accuracy Test Report
TR36.0002	Pressure Switch Test Report
TR36.0003	Cirona 6300 Cycle Time Test Report
TR36.0004	Alarm Function Test Report
TR36.0005	Battery Life Test Report
TR36.0010	Cirona 6300 Garment Burst Testing Report

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

Biocompatibility

Biocompatibility test evaluation for Cirona 6300 is done in according to 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 Cirona 6300.

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Electrical Safety and Electromagnetic Compatibility (EMC)

EMC tests were conducted according to the following standards:

IEC 60601-1: 2005+C1:2006+C2:2007 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
IEC 60601-1-2: 2007 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: 2010 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

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 Cirona 6300 Disposable Deep Vein Thrombosis Prevention 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).