(143 days)
The Synecare 1000 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
The SyneCare 1000 deep vein thrombosis prevention therapy system (referred as SyneCare 1000 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The SyneCare 1000 system consists of a pair of pumps 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 a deflation period once it reaches the desired pressure, each cycle time is 60 seconds
The provided document describes the SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System and its substantial equivalence to a predicate device (VenaPro, K133274). The acceptance criteria and the study conducted are primarily focused on engineering performance, biocompatibility, electrical safety, and software verification rather than clinical effectiveness per se.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a non-AI medical device (Deep Vein Thrombosis Prevention Therapy System), the "acceptance criteria" are related to its engineering performance and safety, rather than diagnostic accuracy or clinical outcomes as might be seen for devices using AI or for drug approvals. The device's performance is demonstrated through various engineering tests to show substantial equivalence to the predicate device.
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance | Justification/Reference |
|---|---|---|---|
| Functional Performance | Pressure Accuracy | Met requirements (implied) | RDTR-IP-001.01: Pressure Accuracy Test Report. Device provides 50mmHg pressure. |
| Cycle Time | Met requirements (implied) | RDTR-IP-002.01: Cycle Time Test Report. Preset at 60 seconds (inflation and deflation). | |
| Alarm Function | Met requirements (implied) | RDTR-IP-003.01: Alarm Function Test Report. Audible and visual alarms for system faults. | |
| Battery Life | Met requirements (implied) | RDTR-IP-004.01: Battery Life Test Report. Ensures functionality despite different battery from predicate. | |
| Air Tightness | Met requirements (implied) | RDTR-IP-005.01: Air Tightness Test Report. | |
| Operational Parameters (Pressure, Cycle time, GUI, UI) | Same as predicate (50mmHg, 60s cycle, no GUI, one-button UI) | Technological Characteristics comparison table. | |
| Biocompatibility | Contact with human skin (sleeve material) | Met requirements (Cytotoxicity, Sensitization, Irritation) | Biocompatibility testing at CCIC Huatongwei International Inspection (Suzhou) Co.,Ltd. PVC bladder with brushed Nylon. |
| Sterilization & Shelf Life | Sterility and Shelf Life (3 years) | Sterilization not applicable; Shelf life verified | SyneCare 1000 Accelerated Aging Test Report. |
| Electrical Safety & EMC | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-11 | Met relevant standards (EMC tests conducted) | EMC tests conducted according to specified IEC standards. |
| Software V&V | Software Verification and Validation | Documentation provided; considered "moderate" level of concern | Software verification and validation conducted. |
| Clinical Equivalence | Indications for Use, Contraindications | Substantially equivalent to predicate (K133274) | Technological Characteristics comparison table. |
Summary of Device Performance: The device's performance is reported as meeting all tested functional and operational requirements, demonstrating substantial equivalence to the predicate device (VenaPro, K133274) across all comparable features. The differences (e.g., battery voltage) were specifically tested to ensure they do not negatively impact effectiveness.
2. Sample size used for the test set and the data provenance
The document specifies that "samples of the device underwent function and mechanical testing." However, the exact sample size (N) for these performance tests (e.g., how many devices were tested for pressure accuracy, battery life, etc.) is not explicitly stated in the provided text.
The data provenance is implicit: the tests were conducted by Jiangsu Synecoun Medical Technology Co., Ltd. and by CCIC Huatongwei International Inspection (Suzhou) Co.,Ltd. The device manufacturer is based in China. The data is retrospective in the sense that the tests were performed on finished product samples for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device and submission. This device is a mechanical/pneumatic system, not an AI or diagnostic imaging device that requires expert interpretation to establish ground truth for a test set. The "ground truth" here is objective physical measurements and adherence to engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., images) by multiple experts. For this device, the tests are primarily objective engineering measurements and compliance checks against established standards, which do not involve expert adjudication in that sense.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. A Multi-Reader Multi-Case (MRMC) study is relevant for AI-powered diagnostic or screening devices that assist human readers (e.g., radiologists interpreting images). The SyneCare 1000 is a physical compression therapy system and does not involve human "readers" or AI assistance in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical therapy system and does not have a "standalone algorithm" in the context of AI or diagnostic interpretation. Its performance is evaluated as an integrated system (pump and sleeve).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the engineering and safety tests, the "ground truth" used is:
- Established engineering specifications and standards: For pressure accuracy, cycle time, alarm function, air tightness, electrical safety (IEC standards), and software validation.
- Defined biological response endpoints: For biocompatibility tests (cytotoxicity, sensitization, irritation).
- Defined performance over time: For shelf life/accelerated aging tests.
There is no expert consensus, pathology, or outcomes data used as "ground truth" in the manner typically seen for diagnostic devices, as this is a therapeutic device whose safety and performance are assessed through objective engineering and biocompatibility evaluations.
8. The sample size for the training set
This question is not applicable. Since the device is not an AI/machine learning system, there is no "training set" in the computational learning sense.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this device.
§ 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).