The Cirona™ 6100 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™ 6100 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'''' 6100 system consists of a pump, a pair of single patient reusable soft compression garment(s) (sleeves), and the extension tubing set for calf and calf-thigh. 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 40mm Hg is used for both the calf and calf-thigh treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.

AI/ML Overview

The provided 510(k) summary describes a pneumatic compression device (Cirona™ 6100) for deep vein thrombosis prevention. The study conducted for this device is focused on showing its substantial equivalence to predicate devices through performance testing, rather than a clinical study evaluating its effectiveness in patients.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This device's performance testing is primarily based on functional standards and safety. The acceptance criteria are essentially that the device passes specific bench and laboratory tests, ensuring it meets its specifications and conforms to relevant safety standards.

Acceptance Criteria (Test)	Reported Device Performance
System Level Software Test	Passed
Pressure Accuracy	Passed
Cycle Time Test	Passed
Alarm Function Test	Passed
Pressure Sensor Calibration Test	Passed
Sleeve Bladder Burst Test	All sleeves tested maintained structural integrity at the highest pressure setting for anticipated maximum treatment time.
Compliance with IEC 60601-1 (2005)	Conforms
Compliance with IEC 60601-1-2 (2007)	Conforms
Compliance with AAMI ES 60601-1 (2012)	Conforms
Compliance with ISO 14971 (2007)	Conforms
Compliance with ISO 10993-5 (2009)	Conforms
Compliance with ISO 10993-10 (2012)	Conforms
Compliance with ISO 10993-12 (2007)	Conforms
Compliance with ANSI/ASQ Z1.9 (2008)	Conforms

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

The document does not explicitly state a specific "test set" in terms of patient data. The testing described is bench and laboratory testing of the device itself.

Sample Size for Test Set: Not specified for individual tests, but implies a sample sufficient to perform the listed performance tests (e.g., "all sleeves tested" for the bladder burst test).
Data Provenance: Not applicable as it's not a clinical study with patient data. The data is generated from engineering/performance testing of the device hardware and software.

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

Not applicable. The ground truth for engineering and performance tests is typically established by engineering specifications, regulatory standards, and established test protocols, not by clinical experts.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of expert opinions. The performance tests yield objective results (pass/fail, measurements against specifications).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of an MRMC comparative effectiveness study, nor would it be relevant for this type of device (a pneumatic compression system) seeking 510(k) clearance based on substantial equivalence to predicate devices through performance testing. The purpose of this submission is to show the device functions safely and effectively as intended, not to compare its efficacy against a control arm in a clinical setting or to evaluate human reader performance with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a hardware-based medical device, not an AI/algorithm-based diagnostic or assistive system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests is derived from:

Engineering Specifications: The design and operating parameters the device is intended to meet (e.g., 40mmHg pressure, 12-second inflation, 48-second relaxation).
Regulatory Standards: Conformance to recognized international and national standards for medical electrical equipment, risk management, and biological evaluation (e.g., IEC 60601-1, ISO 14971, ISO 10993 series).
Predicate Device Characteristics: Ensuring the Cirona™ 6100 has "very similar components" and "very similar principles of operation" to its predicates.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" in the context of an algorithm.

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

Not applicable, as there is no training set for an AI model.

Summary

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510(K) SUMMARY

APR 0 9 2013

Submitter:

Devon Medical Products.

Contact Person:

Ruth Wu, COO 1100 First Avenue, Suite 202

King of Prussia, PA 19406

Phone: 610.757.4103

610.930.4035 Fax:

Common Classification & Proprietary Names:

Intermittent Pneumatic Compression Device Common Names:

Cirona™ 6100 Proprietary Name:

Date Prepared:

December 6st, 2012

Classification

The classification name, 21 CFR Part and Paragraph number, product code and classification of the Cirona™ 6100.

ame	---------------.	.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1ressible limh Slopvo	270 5800

Predicate Devices:

The Cirona 6100 Deep Vein Thrombosis Prevention Therapy System is substantially equivalent to the following.

Predicate Device	Manufacturer	510(k)#
Flowtron Excel AC550	HNE HEALTHCARE, INC	K961166
VASO PRESS DVT SYSTEM, MODELS VP500, VP501	BRITT CORP., INC	K991038
RESTEP DVT SYSTEM, MODEL RSP-101	STORTFORD MEDICAL LLC	K090308
Flowtron Universal AC600	HNE HEALTHCARE, INC	K010744

Device Description

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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 40mm Hg is used for both the calf and calf-thigh treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.

Intended Use:

The Cironal " 6100 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.

Contraindications:

The Cirona™ 6100 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™ 6100 are substantially equivalent to those of the predicate devices.

The Cironal 10 6100 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. The pressure delivered is 40mmHg.

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Performance Testing

Various bench and laboratory testing were performed and they assure that the product meets its specifications. The sleeve bladder burst test was performed to ensure sleeves are structurally sound during treatment and all sleeves tested maintained structural integrity at the highest pressure setting for anticipated maximum treatment time. The device passed all the tests listed below. The manufacturer believes that the technological characteristics of the Cirona™ 6100 are substantially equivalent to those of the predicate devices. The performance testing includes the following tests:

	List of Performance Tests
Test 1	System Level Software Test
Test 2	Pressure Accuracy
Test 3	Cycle Time Test
Test 4	Alarm Function Test
Test 5	Pressure Sensor Calibration Test
Test 6	Sleeve Bladder Burst Test

Standards

The Cirona 10 6100 conforms to the following standards:

IEC 60601-1 2005 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:

AAMI ES 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

ISO 14971:2007 Medical devices - Application of risk management to medical devices

ISO 10993-5:2009 Biological evaluation of medical devices, Part 5: Tests for in vitro cytotoxicity

ISO 10993-10: 2012 Biological evaluation of medical devices, Part 10: Tests for irritation and skin sensitization

ISO 10993-12: 2007 Biological evaluation of medical devices, Part 12: Biological evaluation of medical devices, Part 12: Sample preparation and reference materials

ANSI/ASQ Z1.9-2008 American National Standard: Sampling procedures and Tables for inspection by variables for percent nonconforming

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Statement of Substantial Equivalence

The Cirona™ 6100 is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently 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™ 6100, is substantially equivalent to the predicate devices as described herein.

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

April 9, 2013

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

Re: K130571

Trade/Device Name: Devon Cirona 6100 DVT Prevention System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: February 28, 2013 Received: March 4, 2013

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.

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

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Page 2 - Mr. Mark Job -

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,

Matthew Gillillebrenner

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 STATEMENT

K130571 510(k) Number (if known):

Device Name: Cirona™ 6100 Deep Vein Thrombosis Prevention Therapy System

Indications for Use:

Prescription Use AND/OR (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)

Matthew G. Hillebrenner

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).