Search Results
Found 1 results
510(k) Data Aggregation
(98 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study information for the DVTCare CA5 device, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the DVTCare CA5 are primarily demonstrated through comparisons to predicate devices and extensive non-clinical bench testing. The key performance characteristics are outlined in the comparison table and further supported by test reports.
Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Feature | Acceptance Criteria (Implied by Predicate & Design) | Reported Device Performance (Subject Device DVTCare CA5) | Notes |
|---|---|---|---|
| Application | Non-invasive / external | Non-invasive / external | Consistent with predicate devices. |
| Portability | Portable, ambulant | Portable, ambulant | Consistent with predicate devices. |
| Basis of Operation | Aids venous return by cyclic, intermittent, pneumatic pressure application to compress lower limb(s). | Aids venous return by cyclic, intermittent, pneumatic pressure application to compress lower limb(s). | Consistent with predicate devices. |
| Location of Treatment Application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | Consistent with predicate devices. |
| System Management | Electronic, microprocessor controlled | Electronic, microprocessor controlled | Consistent with predicate devices. |
| Treatment Delivery | Uses electronic microprocessor and pneumatics to inflate and deflate bladder cuffs. | Uses electronic microprocessor and pneumatics to inflate and deflate bladder cuffs. | Consistent with predicate devices. |
| Pressure Source | Micropump controlled by electronic processor | Micropump controlled by electronic processor | Consistent with predicate devices. |
| Outlet Ports | Two (for K061125), Three (for K103187) | Two | Differs from one predicate (K103187) but within acceptable range as not raising new safety/effectiveness concerns. |
| Outlet Valves | One three-way valve with two vent valves (K061125); Three 3-way valves (K103187) | Two 2-way valves with one vent valve | Differs from both predicates but justified through non-clinical testing not to raise new safety/effectiveness concerns (Software Functions Verification Report highlighted, CA5 System Safety Testing Report). |
| Operating Modes | 'Single leg' mode, 'Double leg' mode, and potentially auxiliary modes (K103187). | 'Single leg' mode, 'Double leg' mode | Consistent with the core functionalities of predicates. |
| Working Pressure (User Adjustable) | 20-40mmHg (K061125), 20-65mmHg (K103187) | 20-50mmHg (user); 20-65mmHg (healthcare provider) | The default changed from 40mmHg (predicate K061125) to 50mmHg, and the upper limit for healthcare providers is consistent with predicate K103187. This change was validated (Software Functions Verification Report highlighted). |
| Inflation Time | 10 seconds (K061125) | 10 seconds | Consistent with at least one predicate. |
| Hold Time | 0 seconds (K061125); ~3.5 seconds (K103187) | 2 seconds | Differs from predicates (changed from 0s to 2s). This change was validated (Software Functional Requirements highlighted, Software Functions Verification Report highlighted, CA5 Predicate Testing). |
| Cycle Time | Preset 60 seconds, adjustable 60-75 seconds | Preset 60 seconds, adjustable 60-75 seconds | Consistent with predicate devices. Confirmed minimum cycle time of 60 seconds (fill, exhaust, relaxation). |
| System Diagnostics | Audible and visual alarms for system faults | Audible and visual alarms for system faults (and a self-diagnostic feature every half hour). | Consistent with predicates, with an added self-diagnostic feature (Software Functional Requirements highlighted, Software Functions Verification Report highlighted) to improve monitoring. |
| Battery Specifications | Ni-MH rechargeable battery | Li-Po rechargeable battery | Different type of battery than predicates, but validated not to raise new safety/effectiveness concerns (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). |
| Power Requirement | Rechargeable battery and/or 110VAC | Rechargeable battery and/or 110VAC | Consistent with predicate devices. External power supply changed but validated (UL REPORT GTM21089, Software Functions Verification Report highlighted, CA5 System Safety Testing Report, CA5 System EMC test report). |
| Air Delivery | Via flexible plastic (PVC) tube(s) terminated with quick disconnect CPC fittings | Via flexible plastic (PVC) tube(s) terminated with quick disconnect CPC fittings | Consistent with predicate devices. |
| Leg Cuffs Material | PVC bladder covered with brushed Nylon (K061125); PVC bladder encased in soft, non-woven medical fabric (K103187) | PVC bladder covered with brushed Nylon | Consistent with at least one predicate. |
| Leg Cuff Sterility | Clean / non sterile | Clean / non sterile | Consistent with predicate devices. |
| Leg Cuff Usage | Single patient use | Single patient use | Consistent with predicate devices. |
| Software Control for Battery | N/A (for older battery types) | Modified to provide control for Lithium Ion battery | New feature due to battery change, validated (Software Functional Requirements highlighted). |
| Resettable Compliance Counter | N/A | Added for provider use to record hours of use | New feature, validated (Software Functional Requirements highlighted, Software Functions Verification Report highlighted). |
| Electrical Safety | Compliance to IEC/UL/CAN60601-1 | Compliant (verified by third-party labs) | Demonstrated through non-clinical testing. |
| Electromagnetic Compatibility (EMC) | Compliance to IEC 60601-1-2 | Compliant (verified by third-party labs) | Demonstrated through non-clinical testing. |
| Environmental Testing | (Implied by device type) | Performed (by third-party labs) | Demonstrated through non-clinical testing. |
| Vibration Integrity | Compliance to MIL-STD 810D, section 514.3-1 | Compliant (verified by third-party labs) | Demonstrated through non-clinical testing specifically for portable units. |
| Case Material | ABS (predicate K061125) | ASA-PC | Changed from ABS, but validated not to raise new safety/effectiveness concerns (CA5 System Safety Testing Report, V0 material trans test 110512, CA5 Crush Test). |
Study that Proves the Device Meets Acceptance Criteria
The document describes non-clinical bench testing as the primary method to prove the device meets acceptance criteria and demonstrates substantial equivalence to predicate devices. There is no mention of clinical studies involving human subjects.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of devices. The "test set" refers to the DVTCare CA5 device itself, which underwent a series of validation tests. It's implied that typical design verification and validation testing for a medical device involves one or more units of the final device.
- Data Provenance: The testing was "in-house bench testing for design, software and performance validation" by the manufacturer (Ossur Americas Inc.), and "evaluated by third-party test laboratories" for specific standards (Electrical safety, EMC, Environmental, Vibration). This indicates a combination of internal and external validation. The country of origin for the data (beyond the company's location in Foothill Ranch, CA) is not specified further. The studies are by nature prospective as they are conducted on a manufactured device to verify its performance against design specifications and regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The testing was performed by "third-party test laboratories" for compliance standards and by internal "design, software and performance validation" teams. The qualifications of these individuals are not detailed, but it's implied they are experts in electrical safety, EMC, environmental testing, vibration testing, and device design/software validation.
4. Adjudication Method for the Test Set
Not applicable. The tests mentioned are objective compliance tests against established standards (e.g., IEC, UL, MIL-STD) and internal design specifications. There's no subjective assessment requiring adjudication in the context described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study typically assesses human interpretation of medical images or data, which is not relevant for this device (a DVT prevention pump).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the testing described is primarily standalone performance of the device's hardware and software. The device itself (the pump unit) functions autonomously based on its programming to deliver pneumatic compression. Its performance is evaluated based on its ability to meet specified pressure, cycle time, hold time, safety, and operational parameters, without human intervention during the functional tests.
7. The type of ground truth used
The "ground truth" for the non-clinical testing consists of:
- Regulatory Standards: IEC/UL/CAN60601-1 (Electrical safety), IEC 60601-1-2 (EMC), MIL-STD 810D, section 514.3-1 (Vibration integrity).
- Design Specifications: Internal design requirements for working pressure, cycle time, hold time, battery performance, software functions, etc.
- Predicate Device Characteristics: The performance parameters of the legally marketed predicate devices served as a benchmark for demonstrating substantial equivalence.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI models that require a "training set" of data.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
Ask a specific question about this device
Page 1 of 1