(137 days)
Not Found
No
The device description details a pneumatic compression system with fixed pressure and cycle time settings, with no mention of adaptive or learning capabilities. The performance studies focus on mechanical and functional testing, not AI/ML performance metrics.
Yes
Explanation: The intended use explicitly states that the device is for "prevention of DVT," "enhanc[ing] blood circulation," "diminish[ing] post-operative pain and swelling," "reduc[ing] wound healing time," and "aid[ing] 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." These are all therapeutic applications.
No
The device is intended for the prevention of DVT and stimulating blood flow by simulating muscle contractions through pneumatic compression; it does not collect or analyze any data to diagnose a medical condition.
No
The device description explicitly states it is a "pneumatic compression system" consisting of "a pair of pump and sleeve assemblies" that "alternatively inflate and deflate the garment (sleeve)". This clearly indicates the presence of hardware components (pumps, sleeves) and is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Cirona 6300 Function: The Cirona 6300 is a pneumatic compression system that physically stimulates blood flow in the extremities. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly describes a physical intervention (stimulating blood flow) to prevent DVT and aid in the treatment of various conditions related to circulation. It does not involve diagnostic testing.
Therefore, the Cirona 6300 falls under the category of a therapeutic or preventative medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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
Product codes
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescribed by a physician.
This device can be used in the home or clinical settings.
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
Function and mechanical testing were performed to verify device design met function and performance requirements. Tests conducted included: Pressure Accuracy Test Report, Pressure Switch Test Report, Cirona 6300 Cycle Time Test Report, Alarm Function Test Report, Battery Life Test Report, Cirona 6300 Garment Burst Testing Report. Biocompatibility tests (Cytotoxicity, Sensitization, Irritation) were performed. EMC tests were conducted according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-1-11. Software verification and validation was performed for software considered a "moderate" level of concern. No animal or clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
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
1
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
2
Indications for Use
510(k) Number (if known) K151189
Device Name
Cirona 6300 Disposable Deep Vein Thrombosis Prevention System
Indications for Use (Describe)
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
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)
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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
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.
4
Section 5
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.
Intended Use:
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 .
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
5
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.