(14 days)
Not Found
No
The description details a pneumatic compression device with a fixed, automatically timed cycle and pressure settings, with no mention of adaptive learning, data analysis for personalized treatment, or any terms associated with AI/ML.
Yes
The device is intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis, which is a medical condition.
No
The device is described as a "pneumatic compression device" that "helps reduce the incidence of deep vein thrombosis" by enhancing circulation. Its purpose is preventative and therapeutic, not to diagnose a condition.
No
The device description explicitly states that the system consists of a "device" (which is a pneumatic compression device) and "soft compression garment(s) (sleeves)" and "extension tubing set," all of which are hardware components.
Based on the provided text, the Cirona™ 6200 Series system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a prescription device used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis. This is a therapeutic and preventative function, not a diagnostic one.
- Device Description: The description details a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis. It works by applying external pressure to the limbs. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on laboratory tests.
The Cirona™ 6200 Series system is a medical device used for physical therapy and prevention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
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. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs (calf, calf-thigh, and foot)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 CFR
Section | Product
Code | Class |
|-----------------------------|-------------------|-----------------|-------|
| Compressible Limb
Sleeve | 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, MODEL | ||
| RSP-101 | STORTFORD MEDICAL | |
| LLC | K090308 | |
| Flowtron Universal AC600 | HNE HEALTHCARE, INC | K010744 |
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.
JUN 2 7 2014
1
This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.
Intended Use:
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.
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.
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| 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
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)
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."
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4.1
FORM FDA 3881 (1/14)