(62 days)
The Bio Compression Systems Sequential Circulator SC-2004FC-OC with associated garments is a sequential, pneumatic compression device intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency and chronic venous stasis ulcers associated with venous insufficiency, as well as, general treatment for swelling of the extremities. The device is intended for home or hospital use.
The Bio Compression Systems, Inc. SC-2004FC-OC Sequential Circulator is a pneumatic compression device ('pump') with associated compressible garment sleeves. The pump is manually adjusted by the user to produce air pressure to inflate and deflate segmented inflatable chambers of garment sleeves. The garment sleeves are externally applied over affected extremities. The pumps consist of compressors capable of producing a maximum pressure of 80 mmHg and provide graduated or gradient pressurization to the chambers of the garments. The sequential inflation is applied distally to proximally with distal chambers inflated to a greater pressure than proximal ones. As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all of the chambers are inflated, they are then simultaneously released and the cycle repeats. The user can adjust the Pressure Knob on the front of the device for desired pressure. Associated garments are available in a variety of standard sizes.
The provided document is a 510(k) summary for the Bio Compression Systems Sequential Circulator SC-2004FC-OC. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance through clinical studies with defined acceptance criteria for a new, innovative device. Therefore, the information requested in the prompt, which is typical for studies validating AI/ML algorithms or novel medical devices, is largely not applicable or not present in this document.
However, I can extract what is relevant to "acceptance criteria" and "study that proves the device meets the acceptance criteria" within the context of a 510(k) for a pneumatic compression device with a minor modification.
Summary of Acceptance Criteria and Device Performance (within the context of this 510(k) submission):
The "acceptance criteria" in this context are primarily related to the functional specifications and safety of the device, ensuring the modified device performs comparably to the predicate and does not introduce new risks. The "study" for this type of device modification is typically internal engineering and performance testing.
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Maintain core function of sequential pneumatic compression. | The device is a pneumatic compression device ('pump') that inflates and deflates segmented chambers, applied distally to proximally, with graduated pressure. The fundamental technology has not been altered. |
| Pressure Output | Capable of producing a maximum pressure of 80 mmHg. Provide graduated or gradient pressurization. | The pumps consist of compressors capable of producing a maximum pressure of 80 mmHg. They provide graduated or gradient pressurization to the chambers. There are "no maximum pressure changes, as they identically match those of the predicate devices." |
| Inflation/Deflation Cycle | Maintain sequential inflation (distal to proximal), constant pressure hold, simultaneous release. | Identical to predicate: Sequential inflation is applied distally to proximally with distal chambers inflated to a greater pressure than proximal ones. Pressure is held constant until all chambers are inflated, then simultaneously released. "Comparable inflation cycle profiles (rise times, inflation pressures, deflation times, and cycle times) between the applicant and predicate devices." |
| User Adjustment | User can adjust pressure. | The user can adjust the Pressure Knob on the front of the device for desired pressure. |
| Safety - Electrical | Electrical leakage within acceptable limits. | Tested for electrical leakage. (Specific results not detailed in the summary, but implied to meet standards). |
| Safety - Risks Introduced by Modification | The modification (motor change) should not introduce additional safety risks. | "There is no additional risk introduced by this change." "The modified device does not introduce any new potential safety risks and is substantially equivalent to the predicate devices." |
| Performance - General | Meet all performance specifications (e.g., pressure adjustment accuracy, air pressure display accuracy). | "Before being released to market, every device is tested and must meet all performance specifications." "Functional testing includes electrical leakage, pressure adjustment, inflation pressure in each chamber, air pressure display accuracy, and inflation/deflation cycle times." (Specific quantitative results not detailed in the summary, but implied to meet standards). |
| Aesthetic Acceptance | Meet aesthetic acceptance criteria. | "In addition to aesthetic acceptance criteria..." (No details provided on what these are, but implied to be met). |
| Substantial Equivalence | Overall device remains substantially equivalent to predicate devices. | "Based upon risk management, safety & performance testing, compliance with voluntary standards, and comparison to predicate devices, the Sequential Circulator SC-2004FC-OC is substantially equivalent to the predicate devices Sequential Circulators SC-2004-OC and SC-2008-OC." |
Detailed Information as Requested (with caveats for this type of submission):
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A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" here are defined by the required functional specifications and safety benchmarks for a pneumatic compression device, particularly in demonstrating equivalence to a predicate. The "reported device performance" indicates that the device met these criteria through internal testing.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. For this type of engineering and performance testing, it would typically be a fixed number of manufactured units from a production run, often a small sample or even just the modified prototype, to verify specifications.
- Data Provenance: This would be internal engineering test data generated by Bio Compression Systems, Inc. The document does not specify country of origin or whether it's retrospective/prospective. As it's testing of a newly modified device, it would be prospective for the modification.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is an engineering modification to a physical device, not an AI/ML algorithm or diagnostic imaging device where expert consensus for ground truth is typically required. The "ground truth" for pressure, cycle times, and electrical safety is established by engineering standards, calibrated measurement equipment, and regulatory requirements (e.g., maximum pressure limits, electrical safety standards).
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Adjudication method for the test set:
- Not Applicable. See point 3. Testing of physical device specifications doesn't involve adjudication in the way clinical studies or expert review for AI algorithms do. Results are typically pass/fail against predetermined engineering specifications.
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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:
- Not Applicable. This is a pneumatic compression device, not a diagnostic imaging system or an AI-enabled device requiring human interpretation. Therefore, MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance testing is established by engineering specifications, calibrated measurement standards, and compliance with recognized voluntary standards (e.g., for electrical safety, pressure accuracy).
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The sample size for the training set:
- Not Applicable. This is a physical device modification, not an AI/ML system requiring a training set.
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How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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).