(155 days)
Not Found
No
The description details a pneumatic compression device with a fixed, automatically timed cycle and pressure settings. There is no mention of adaptive learning, data analysis for decision-making, or any other characteristics typically associated with AI/ML. The performance studies focus on mechanical and functional testing, not algorithmic performance.
Yes
The device is described as a "DVT Prevention Therapy Device" and its intended use is to "increase venous blood flow in patients at risk of deep vein thrombosis," indicating it is used for treatment or prevention of a medical condition.
No
The device is described as a "DVT Prevention Therapy Device" that "noninvasively helps reduce the incidence of deep vein thrombosis" by "enhanc[ing] venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting." Its intended use is "preventatively to increase venous blood flow in patients at risk of deep vein thrombosis," which aligns with a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a "pneumatic compression device" and mentions "garments (sleeves)" and "extension tubing," which are physical hardware components. The performance studies also include "Pressure Accuracy Test," "Cycle Time Test," and "Battery Life Test," all indicative of a hardware device with integrated software for control.
No, the Devon 62 DVT Prevention Therapy Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. They perform tests on things like blood, urine, tissue, etc., to provide information about a person's health.
- The Devon 62 device is a therapeutic device. It applies pneumatic compression to the limbs to physically increase blood flow and prevent blood clots. It does not analyze any biological samples.
The description clearly states its function is to "increase venous blood flow" and "mimic the natural walking pace to enhance circulation" through "pneumatic compression." This is a physical intervention, not a diagnostic test performed on a specimen.
N/A
Intended Use / Indications for Use
The Devon 62 DVT Prevention Therapy Device 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, obstetric conditions and treatments.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life-threatening condition.
The Devon 62 DVT Prevention Therapy Device, with a pair of extension tubing, is for use with Cirona DVT calf-thigh and foot garments (sleeves). The device alternatively inflates the two garments and mimic the natural walking pace to enhance circulation. The compression supplied by the device 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, calfthigh and foot treatments. 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, legs
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)
To verify that the device design meet its function and performance requirements, samples of the device underwent function and mechanical testing.
The following tests were conducted:
Function Performance Tests:
TR68.J001 Devon 62 System Level Software Test Report
TR68.J002 Devon 62 Pressure Accuracy Test Report
TR68.J003 Devon 62 Cycle Time Test Report
TR68.J004 Devon 62 Alarm Function Test Report
TR68.J005 Devon 62 Pressure Sensor Calibration Test Report
TR68.J006 Devon 62 Battery Life Test Report
The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate.
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.
Cirona 6200 K141578
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).
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
February 21, 2019
Devon Medical Products (Jiangsu) Ltd % Ruth Wu Consultant Devon MD LLC 700 American Ave Ste 100 King of Prussia, Pennsylvania 19406
Re: K182578
Trade/Device Name: Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: December 20, 2018 Received: January 7, 2019
Dear Ruth Wu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando Aguel Fernando Aguel -S
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)
K182578
Device Name Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device
Indications for Use (Describe)
The Devon 62 DVT Prevention Therapy Device 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, obstetric conditions and treatments.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K Summary
Submitter:
Devon Medical Products (Jiangsu) Ltd.
East Half Of 1-2F, Appt D2,
- 1, Qingfeng Road
Nantong, Jiangsu, CHINA 226017
Phone: 011-86-513-51080927
Fax: 011-86-513-51080928
Contact Person: Neil Cheng
Date Prepared: August 29, 2018
Device:
| Common Names: | Intermittent Pneumatic Compression Device |
|---|---|
| Proprietary Name: | Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device |
| Regulation Number: | 21 CFR 870.5800 |
| Classification Name: | Compressive Limb Sleeve |
| Regulatory Class: | II |
| Product Code: | JOW |
Predicate Devices:
The Devon 62 DVT Prevention Therapy Device is equivalent to the following:
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| Cirona 6200 | Devon Medical Products | K141578 |
Device Description
The Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life-threatening condition.
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The Devon 62 DVT Prevention Therapy Device, with a pair of extension tubing, is for use with Cirona DVT calf-thigh and foot garments (sleeves). The device alternatively inflates the two garments and mimic the natural walking pace to enhance circulation. The compression supplied by the device 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, calfthigh and foot treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.
Indication for Use:
The Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device 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 Devon 62 DVT Prevention Therapy Device 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 Devon 62 DVT Prevention Therapy Device are substantially equivalent to those of the predicate devices.
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The Devon 62 DVT Prevention Therapy Device 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 40mmHq is used for the calf, calf-thigh and foot treatments.
Performance Tests
To verify that the device design meet its function and performance requirements, samples of the device underwent function and mechanical testing.
The following tests were conducted:
| Function Performance Tests | |
|---|---|
| TR68.J001 | Devon 62 System Level Software Test Report |
| TR68.J002 | Devon 62 Pressure Accuracy Test Report |
| TR68.J003 | Devon 62 Cycle Time Test Report |
| TR68.J004 | Devon 62 Alarm Function Test Report |
| TR68.J005 | Devon 62 Pressure Sensor Calibration Test Report |
| TR68.J006 | Devon 62 Battery Life Test Report |
The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate.
Biocompatibility
The Devon 62 DVT Prevention Therapy Device uses the same garments as its predicate and manufactured by the same manufacturer, so new biocompatibility testing was not run.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC tests were conducted according to the following standards:
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012(or IEC 60601-. 1:2012 reprint) Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
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- IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
Statement of Substantial Equivalence
The Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is substantially equivalent in technology, function, operating parameters, and indication for 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 (Jiangsu) Ltd believes that the Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is substantially equivalent to the predicate device Cirona 6200 (K141578) as described herein.