(98 days)
The Bio Compression Systems Sequential Circulator SC-2008-OC/Sequential Circulator SC-2004-OC with associated garments are sequential, pneumatic compression devices intended for the primary or adjunctive treatment of primary or secondary lymphedema. The devices are 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 devices are intended for home or hospital use.
The Bio Compression Systems, Inc. SC-2004-OC Sequential Circulator and SC-2008-OC Sequential Circulator, are pneumatic compression devices ('pumps') with associated compressible garment sleeves. The pumps are 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 pumps can operate unilaterally and bilaterally as needed.
This document is a 510(k) premarket notification for the Sequential Circulator SC-2008-OC and SC-2004-OC. The purpose of this notification is to demonstrate that the new devices are substantially equivalent to previously legally marketed predicate devices.
Here's an analysis of the provided text in relation to the requested acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a tabulated format with specific pass/fail thresholds. Instead, it describes general performance specifications and testing that is conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet all performance specifications. | "Before being released to market, every device is tested and must meet all performance specifications." |
| Satisfy aesthetic acceptance criteria. | Functional testing includes electrical leakage, pressure adjustment, inflation pressure in each chamber, air pressure display accuracy, and inflation/deflation cycle times. (Implicitly met if devices are released to market.) |
| Comparable inflation cycle profiles to predicate devices. | "The results demonstrate comparable inflation cycle profiles (rise times, inflation pressures, deflation times, and cycle times) between the applicant and predicate devices." |
| No new potential safety risks compared to predicate devices. | "The modified devices do not introduce any new potential safety risks and are substantially equivalent to the predicate devices." (Based on risk management, safety & performance testing, compliance with voluntary standards, and comparison to predicate devices.) |
| Electrical leakage within acceptable limits. | Functional testing includes "electrical leakage." (Implicitly met.) |
| Accurate pressure adjustment. | Functional testing includes "pressure adjustment." (Implicitly met.) |
| Accurate inflation pressure in each chamber. | Functional testing includes "inflation pressure in each chamber." (Implicitly met.) |
| Accurate air pressure display (despite its removal in new model). | Functional testing includes "air pressure display accuracy." (This refers to testing of the predicate or ensures that the new device's knob setting corresponds accurately to the pressure, effectively replacing the visual display with a reliable mechanical setting). The text notes the display was removed for "ease of use," implying its function is now integrated or superseded by the knob's reliability. |
| Correct inflation/deflation cycle times. | Functional testing includes "inflation/deflation cycle times." (Implicitly met.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the performance testing. It states: "Before being released to market, every device is tested and must meet all performance specifications." This suggests that 100% of manufactured units undergo testing, which could be considered the "test set" in this context for manufacturing quality control, rather than a specific clinical or validation test set.
The provenance of the data is implied to be from the manufacturer's internal testing processes ("Bio Compression Systems, Inc."). No information is given regarding the country of origin of the data beyond the company's location in Moonachie, NJ, USA. The study appears to be an internal engineering validation and manufacturing quality control study, not a clinical trial; thus, it is a retrospective analysis of product performance against specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No external experts are mentioned as being involved in establishing the "ground truth" for the performance specifications or test results. The performance data seems to be based on engineering measurements and comparisons to the established specifications of the predicate devices. The "ground truth" for basic device function (like pressure, cycle times) is typically based on validated measurement equipment and engineering standards, not expert clinical interpretation.
4. Adjudication Method for the Test Set
No adjudication method is described. This type of engineering validation study generally relies on objective measurements against pre-defined engineering specifications, rather than subjective interpretation requiring adjudication among multiple parties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No MRMC study was conducted or is mentioned. This device is a pneumatic compression device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no AI component, and the concept of human readers improving with AI assistance is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a physical medical device (pneumatic compressor) and does not involve an algorithm with standalone performance in the context of AI/software. Its performance is its direct mechanical and electrical function.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications and direct measurements. For example, pressure measurements, electrical leakage tests, and timing of inflation/deflation cycles against pre-defined, acceptable ranges. It's a technical ground truth rather than a clinical one like pathology, expert consensus on images, or outcomes data. The comparability to predicate devices also serves as a ground truth for "substantial equivalence."
8. The Sample Size for the Training Set
This question is not applicable. There is no AI or machine learning component, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set.
§ 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).