The Cirona™ 6200 Series system is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

Device Description

The Cirona™ 6200 Series deep vein thrombosis prevention system is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition.

The Cirona™ 6200 Series system consists of a device and a pair of soft compression garment(s) (sleeves) and the extension tubing set for the calf, calf-thigh, and foot. The device will alternatively inflate the two garments and mimic the natural walking pace in order to enhance circulation. The device-supplied compression provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mmHg is used for the calf and calf-thigh treatments, where a pressure of 120mmHg is used for the foot treatment.

AI/ML Overview

The acceptance criteria and device performance for the Cirona™ 6200 Deep Vein Thrombosis Prevention Therapy System are summarized below based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes "Performance Testing" which consists primarily of bench and laboratory tests to assure the product meets its specifications. The specific acceptance criteria (target tolerances, passing thresholds) for each test are not explicitly detailed in the summary. However, the summary states that the product meets its specifications and that the manufacturer believes its technological characteristics are substantially equivalent to predicate devices. The "reported device performance" is essentially that the device passed these tests.

Test Name	Acceptance Criteria (Not Explicitly Stated, Implied as 'Meets Specifications')	Reported Device Performance
Cirona 6200 System Level Software Test	Implied: Software functions as designed, without critical errors.	Meets specifications
Cirona 6200 Pressure Accuracy	Implied: Delivers specified pressures (40mmHg for calf/thigh, 120mmHg for foot) with acceptable accuracy.	Meets specifications
Cirona 6200 Cycle, Time Test	Implied: Maintains specified inflation (12 seconds) and deflation (48 seconds) cycle times accurately.	Meets specifications
Cirona 6200 Alarm Function Test	Implied: All alarms (e.g., pressure faults, system errors) activate correctly under defined conditions.	Meets specifications
Cirona 6200 Foot Bladder Burst	Implied: Foot bladders withstand expected operational pressures and do not burst prematurely under stress.	Meets specifications
Cirona 6200 Battery Depreciation Test	Implied: Battery life/performance meets design specifications over time or usage cycles.	Meets specifications

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

The document describes "Bench and laboratory testing" for performance.

Sample Size for Test Set: Not explicitly stated. The testing listed ("Test 1" through "Test 6") appears to be a series of engineering/design verification tests on the device's components and system functionality, rather than a clinical study with a patient test set.
Data Provenance: The tests are described as "Bench and laboratory testing," suggesting they were conducted in a controlled lab environment by Devon Medical Products or a contracted testing facility. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as it does not appear to be human subject data.

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

This information is not applicable as the described testing does not involve human subject data or diagnostics requiring expert ground truth establishment. The "ground truth" for these engineering performance tests would be the device's design specifications.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The device is a therapeutic pneumatic compression device, not an imaging or diagnostic AI tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable in the typical AI sense. This device is a physical medical device (pneumatic compression system), not an algorithm-only diagnostic or predictive tool. Its "standalone" performance is assessed through the functional bench tests mentioned.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests is the device design specifications and relevant engineering standards. For example, for the "Pressure Accuracy" test, the ground truth is the specified pressure of 40mmHg or 120mmHg. For the "Cycle, Time Test," the ground truth is the 12-second inflation and 48-second deflation times.

8. Sample Size for the Training Set:

Not applicable. This device is hardware with embedded control logic, not a machine learning model that requires a "training set" in the context of AI/ML. Its operational parameters are designed and engineered, not learned from data.

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

Not applicable for the same reason as point 8. The device's functionality is based on engineering design and established physiological principles of pneumatic compression, not on ground truth established from a training dataset.

Summary

{0}------------------------------------------------

510(K) SUMMARY

Submitter:

Devon Medical Products

Contact Person:

Ruth Wu, CCO 1100 First Avenue, Suite 202 King of Prussia, PA 19406 Phone: 610.757.4103 Fax: 610.930.4035

Common Classification & Proprietary Names:

Common Names: Proprietary Name: Intermittent Pneumatic Compression Device Cirona™ 6200

Date Prepared:

Apr 16th, 2014

Classification

The classification name, 21 CFR Part and Paragraph number, product code and classification of the Cirona™ 6200.

Classification Name	21 CFRSection	ProductCode	Class
Compressible LimbSleeve	870.5800	JOW	II

Predicate Devices:

The Cirona 6200 Deep Vein Thrombosis Prevention Therapy System is substantially equivalent to the following.

Predicate Device	Manufacturer	510(k)#
Cirona 6100	Devon Medical Products	K130571
RESTEP DVT SYSTEM, MODELRSP-101	STORTFORD MEDICALLLC	K090308
Flowtron Universal AC600	HNE HEALTHCARE, INC	K010744

Device Description

JUN 2 7 2014

{1}------------------------------------------------

This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.

Intended Use:

Contraindications:

The Cirona™6200 system should NOT be used in the following conditions:

· Severe atherosclerosis or other ischemic vascular diseases
· Suspected or known acute deep vein thrombosis
· Severe congestive cardiac failure
· Existing pulmonary edema
· Existing pulmonary embolisms
· Extreme deformity of the limbs
· Any local skin or tissue condition in which the garments would interfere:
- · Gangrene
- Untreated or infected wounds
- · Recent skin graft
- · Dermatitis
· Known presence of malignancy in the legs
· Limb infections, including cellulitis, that have not received antibiotic coverage
Presence of lymphangiosarcoma

Technological Characteristics:

The manufacturer believes that the technological characteristics of the Cirona™ 6200 are substantially equivalent to those of the predicate devices.

The Cirona™ 6200 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 and, like the predicates. pressure is applied cyclically for 12 seconds inflated and 48 seconds deflated. A pressure of 40mmHg is used for the calf and calf-thigh treatments, where a pressure of 120mmHg is used for the foot treatment.

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 Cirona'™ 6200 are substantially equivalent to those of the predicate devices. The performance tests are included in section 18 Bench Test.

{2}------------------------------------------------

	List of Performance Tests
Test 1	Cirona 6200 System Level Software Test
Test 2	Cirona 6200 Pressure Accuracy
Test 3	Cirona 6200 Cycle, Time Test
Test 4	Cirona 6200 Alarm Function Test
Test 5	Cirona 6200 Foot Bladder Burst
Test 6	Cirona 6200 Battery Depreciation Test

Standards

The Cirona™ 6200 conforms to the following standards:

IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

EN 60601-1-2:2007 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard:

AAMI ES 60601-1: 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

EN ISO 14971:2012 Medical devices - Application of risk management to medical devices

Statement of Substantial Equivalence

The Cirona™ 6200 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 Cirona 6200, is substantially equivalent to the predicate devices as described herein.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO60-Cinn Silver Spring, MD 20993-0002

June 27, 2014

Devon Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K141578

Trade/Device Name: Cirona 6200 Deep Vein Thrombosis Prevention System Regulation Number: 21 CFR 870.5800 Regulation Name: Compression Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 11, 2014 Received: June 13, 2014

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 10 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 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

{4}------------------------------------------------

Page 2 - Mr. Mark Job

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" (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 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. Dallem

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

{5}------------------------------------------------

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)

K141578

Device Name

Cirona 6200 Deep Vein Thrombosis Prevention Therapy System

Indications for Use (Describe)

The Cirona 6200 Series system is a prescription device intented to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, urologic, obstetric conditions and treatments.

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.

THE CONTRACTOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR CONSTITUTION OF CONSECTION Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

M.A. Hillerman

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."

4.1

FORM FDA 3881 (1/14)

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).