Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard electromechanical operation and software control for pressure and timing, with no mention of AI or ML.

Therapeutic

Yes.
The device's intended uses include aiding in the prevention of DVT, enhancing blood circulation, diminishing post-operative pain and swelling, reducing wound healing time, and aiding in the treatment and healing of various medical conditions, which are all therapeutic claims.

Diagnostic

No

The device is intended to prevent DVT by stimulating blood flow and aiding in treatment; it does not collect information to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a pump unit, leg cuffs, tubing, pressure transducer, plastic shell, membrane switch, quick disconnects, external power supply input jack, and a non-serviceable battery. While it mentions integrated system software, the device's primary function relies on the interaction of these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, the DVTCare CA5 is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly describes a device that physically interacts with the patient's body (applying compression to the legs) to stimulate blood flow and prevent DVT. This is a therapeutic and preventative function, not a diagnostic one.
Device Description: The description details a mechanical system involving a pump, air, and cuffs to apply external pressure. It does not involve the analysis of biological samples (like blood, urine, or tissue) which is the hallmark of IVD devices.
Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro testing.

In summary, the DVTCare CA5 is a medical device used for physical therapy and prevention, not for diagnosing a disease or condition through the examination of specimens taken from the human body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DVTcare CA5 is intended to be a portable system that is prescribed by healthcare professionals to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.

Product codes

JOW

Device Description

The subject 'DVTCare CA5' is a light weight, portable, prescriptive device intended to aid in prevention of Deep Vein Thrombosis (DVT) by helping to stimulate blood flow in the legs. This functionality is accomplished through the use of electronically controlled pump unit delivering a set amount of air to the leg cuffs that, in turn, compresses the calf(s) to aid blood flow out of the lower extremities. The pump control unit components are protectively housed in a plastic shell except the outer membrane switch (needed for user interface), 2 locking, plastic quick disconnects for air tube connection, and an external power supply input jack. The device is provided with non-serviceable battery to allow user portability, and an external power supply for mains connection.

During device operation, the pump unit provides air to the cuff through flexible plastic tubing, inflating it to a specified pressure (set by user or healthcare provider), to compress the lower limb, thus aiding venous return. Air pressure and delivery are monitored by a pressure transducer and integrated system software contained in the plastic control unit. Immediately after the pressure transducer detects that the cuff has achieved the set pressure, the cuff deflates to ambient pressure. This allows the blood flow to return to the limb. The device software ensures the cycle time is a minimum of 60 seconds (the is the length of time for one complete cycle on one cuff including fill time, exhaust, and relaxation time). This is done to prevent excessive stimulation of the limb.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

legs (calf)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals

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)

The 'DVTCare CA5' has been subjected to extensive in-house bench testing for design. software and performance validation. Moreover, the device was also evaluated by third party test laboratories for compliance to Electrical safety (IEC/UL/CAN60601-1) and Electromagnetic Compatibility (IEC 60601-1-2) and Environmental testing. Being a portable unit, the DVTCare CA5 was also tested to standard MIL-STD 810D, section 514.3-1 for Vibration integrity. The results from these non-clinical tests demonstrated that the proposed DVTCare CA5 meets design. safety and performance requirements; and does not raise any new concerns of safety and effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K061125, K103187

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Section VIII

VIII.A 510(k) Summary

MAY 0 2 2013

510(k) Number K130174

Date: Mar 11 2013

Submitter:

Ossur Americas Inc. 27051 Towne Centre Drive Foothill Ranch, CA 92610 Phone: 949-268-3185 Establishment Registration Number: 3003764610

Contact Person:

Ubaldo Anaya Quality Assurance Manager

Device name and classification:

Trade Name / Model: DVTCare CA5 Common or usual name: Compressible Limb Sleeve Device Classification Name: Compressible Limb Sleeve Class: II Product Code: JOW Regulation Number: 21 CFR 870.5800

Predicate Devices:

i. DVTCare CA5, Doctors Orders (K061125), Acquired by Ossur Americas
TriplePlay-VT Vascular Therapy System TPVT-01, Wildcat Medical Inc (K103187) ii.

Device Description:

The subject 'DVTCare CA5' is a light weight, portable, prescriptive device intended to aid in prevention of Deep Vein Thrombosis (DVT) by helping to stimulate blood flow in the legs. This functionality is accomplished through the use of electronically controlled pump unit delivering a set amount of air to the leg cuffs that, in turn, compresses the calf(s) to aid blood flow out of the lower extremities. The pump control unit components are protectively housed in a plastic shell except the outer membrane switch (needed for user interface), 2 locking, plastic quick disconnects for air tube connection, and an external power supply input jack. The device is provided with non-serviceable battery to allow user portability, and an external power supply for mains connection.

1

During device operation, the pump unit provides air to the cuff through flexible plastic tubing, inflating it to a specified pressure (set by user or healthcare provider), to compress the lower limb, thus aiding venous return. Air pressure and delivery are monitored by a pressure transducer and integrated system software contained in the plastic control unit. Immediately after the pressure transducer detects that the cuff has achieved the set pressure, the cuff deflates to ambient pressure. This allows the blood flow to return to the limb. The device software ensures the cycle time is a minimum of 60 seconds (the is the length of time for one complete cycle on one cuff including fill time, exhaust, and relaxation time). This is done to prevent excessive stimulation of the limb.

Intended Use / Indications for Use:

The subject DVTcare CA5 is intended to be a portable system that is prescribed by healthcare professionals to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.

Technological Characteristics and comparison with predicates:

The intended use of the subject 'DVTCare CA5' is same as the intended use of the predicates DVTCare CA5 (K061125) and TriplePlay-VT (K103187). The fundamental technology of the proposed device is also same as that of the predicates. A comparison of the main characteristics and features of these devices is provided as follows:

| | DVTCare CA5 | DVTCare CA5 | TriplePlay-VT Vascular
Therapy System, TPVT-
01 | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device
(Ossur Americas, Inc.) | Predicate K061125
(Össur Americas) | Predicate K103187
(Wildcat Medical Inc.) | |
| Characteristics
/ Features | | | | |
| Application | Non-invasive / external | Non-invasive / external | Non-invasive / external | |
| Portability | Portable, ambulant | Portable, ambulant | Portable, ambulant | |
| Basis of
operation | Aids venous return by
using cyclic, intermittent,
pneumatic pressure
application (inflation
followed by deflation) to
compress the lower
limb(s). | Aids venous return by
using cyclic, intermittent,
pneumatic pressure
application (inflation
followed by deflation) to
compress the lower
limb(s). | Aids venous return by
using cyclic, intermittent,
pneumatic pressure
application (inflation
followed by deflation) to
compress the lower
limb(s). | |
| | DVTCare CA5 | DVTCare CA5 | TriplePlay-VT Vascular
Therapy System, TPVT-
01 | |
| Characteristics
/ Features | Subject Device
(Ossur Americas, Inc.) | Predicate K061125
(Össur Americas) | Predicate K103187
(Wildcat Medical Inc.) | |
| Location of
treatment
application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | Lower limb(s) (Calf) | |
| System
management | Electronic,
microprocessor controlled | Electronic,
microprocessor controlled | Electronic,
microprocessor controlled | |
| Treatment
delivery | Uses electronic
microprocessor and
pneumatics to inflate and
deflate bladder cuffs to
achieve compression
therapy | Uses electronic
microprocessor and
pneumatics to inflate and
deflate bladder cuffs to
achieve compression
therapy | Uses electronic
microprocessor and
pneumatics to inflate and
deflate bladder cuffs to
achieve compression
therapy | |
| Pressure Source | Micropump controlled by
electronic processor | Micropump controlled by
electronic processor | Micropump controlled by
electronic processor | |
| Outlet ports | Two | Two | Three | |
| Outlet valves | Two 2-way valves with
one vent valve | One three-way valve with
two vent valves | Three 3-way valves | |
| Operating
Modes | • 'Single leg' mode
• 'Double leg' mode | • 'Single leg' mode
• 'Double leg' mode | • Leg 1
• Leg 2
• Auxiliary
• Leg 1+auxiliary
• Leg 2+auxiliary | |
| Working
Pressure | Single and double leg
modes are preset at
50mmHg; and adjustable
by user between 20-
50mmHg, | Single and double leg
modes are preset at
40mmHg; and adjustable
by user between 20-
40mmHg. | Leg 1 and Leg 2 modes
are preset at 50mmHg;
and adjustable between
20-65mmHg

2

3

Like the predicates, the subject device uses intermittent, pneumatic compression to simulate muscle contractions in the legs aiding the return of venous flow. The compression is achieved by air delivery, through flexible plastic tubing that are terminated with CPC quick lock connectors, to inflatable cuffs/bladders that are wrapped around the limb(s) to transmit the pneumatic force to the leg. The air delivery is controlled by a microprocessor controlled pump and valve system. The specifications of the proposed device (such as working pressure, cycle

4

time and hold-time) are also comparable to the identified predicates. Like the predicates, the proposed 'DVTCare CA5' includes audible and visual alarms for system monitoring and fault recognition. Like the predicates, the proposed device also incorporates rechargeable batteries enabling the unit to be portable; and is offered with an external power supply for connection to mains supply (for normal operation and battery recharging). The difference in type of battery between the subject device (Li-PO battery) and the predicate devices (Ni-MH battery), different configuration of outlet valves and slight difference in appearance do not raise any new concerns of safety or effectiveness.

Non-Clinical Testing

The 'DVTCare CA5' has been subjected to extensive in-house bench testing for design. software and performance validation. Moreover, the device was also evaluated by third party test laboratories for compliance to Electrical safety (IEC/UL/CAN60601-1) and Electromagnetic Compatibility (IEC 60601-1-2) and Environmental testing. Being a portable unit, the DVTCare CA5 was also tested to standard MIL-STD 810D, section 514.3-1 for Vibration integrity. The results from these non-clinical tests demonstrated that the proposed DVTCare CA5 meets design. safety and performance requirements; and does not raise any new concerns of safety and effectiveness.

Design Change	Validation Document
Upgrade from NiMH batteries to Lithium Ion batteries.	DVT Charge Parameters and Verification Report
Globtek battery UN38 3 TEST REPORT
EC DECLARATION EN62133 battery
Software Functions Verification Report highlighted
CA5 System Safety Testing Report
CA5 System EMC test report
CA5 Shelf Life Test
CA5 PCB Verification Report
Changes in the external power supply.	UL REPORT GTM21089
Software Functions Verification Report highlighted
CA5 System Safety Testing Report
CA5 System EMC test report
The single 3-way outlet valve with two vent valves has been replaced by two 2-way fill valves with one common vent valve.	Software Functions Verification Report highlighted
CA5 System Safety Testing Report
Case material changed from ABS to ASA-PC.	CA5 System Safety Testing Report
V0 material trans test 110512
CA5 Crush Test
Software has been modified to provide control for the Lithium Ion battery.	Software Functional Requirements highlighted

The list of Design Changes and the corresponding Validation Documents are listed below. The location of each Test Report can be found in this in the Cover Letter, Section IV.B.

5

| Default pressure setting for both 'single-
leg' and 'double-leg' modes has changed
from 40mmHg to 50mmHg. | Software Functions Verification Report
highlighted |
|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| The hold-time specification for both
modes has changed from 0 seconds to 2
seconds before deflation. | Software Functional Requirements highlighted
Software Functions Verification Report
highlighted
CA5 Predicate Testing |
| Self-diagnostic feature added to verify
proper operation every half hour during
use. | Software Functional Requirements highlighted
Software Functions Verification Report
highlighted |
| Resettable Compliance Counter added for
provider use to record number of hours
use by each patient. | Software Functional Requirements highlighted
Software Functions Verification Report
highlighted |

Conclusion:

Based on validation testing, compliance to voluntary standards and non-clinical bench testing information provided in the submission; the proposed 'DVTCare CA5' is substantially equivalent to the predicate devices, and does not raise any new concerns of safety of effectiveness. Therefore, the proposed device is substantially equivalent to the referenced predicate devices.

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

May 2, 2013

Ossur Americas Inc. c/o Mr. Ubaldo Anaya Quality Assurance Manager 27051 Towne Center Drive Foothill Ranch, CA 92610

Re: K130174

Trade/Device Name: DVTCare CA5 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: March 14, 2013 Received: March 15, 2013

Dear Mr. Anaya:

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.

7

Page 2 - Mr. Mark Job

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.

Bram D. Zuckerman

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

8

Section VII

VII.C Indications for Use

510(k) Number (if known): K130174

Device Name: DVTCare CA5

Indications for Use:

The DVTCare CA5 is intended to be a portable system that is prescribed by healthcare professionals to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bram D. Zuckerman 2013.05.02 16:33

VII.C - 1