(100 days)
The SCD RESPONSE Compression System is designed to apply sequential compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.
The SCD Response™ Compression System is a microprocessor controlled pneumatic compression device which provides intermittent, sequentially graduated pressure to compressible limb sleeves. When the sleeves compress the legs, the veins collapse, forcing the blood to move toward the heart. After compression, the sleeves deflate, allowing the veins to take shape again and fill with blood. The full cycle then repeats again.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Kendall Model 7325 SCD Response™ Compression System.
Key Finding: The provided document states that no clinical test results were submitted in support of this premarket notification submission. Therefore, detailed information on acceptance criteria and a study proving the device meets those criteria from a clinical perspective is not available within this document. The submission relies solely on non-clinical comparative testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study demonstrating meeting acceptance criteria was performed, this table will reflect the non-clinical comparative testing conclusions.
| Acceptance Criteria Category | Specific Criteria (Inferred from Non-Clinical Tests) | Reported Device Performance (Summary of Non-Clinical Test Conclusions) |
|---|---|---|
| Functional Performance | Similar compression characteristics to predicate device | Similar |
| Similar pressure control to predicate device | Similar | |
| Similar timing sequence (default cycle) to predicate device | Similar | |
| Operational Performance | Similar operating alarms to predicate device | Similar |
| Similar sleeve compatibility to predicate device | Similar | |
| Similar safety characteristics to predicate device | Similar | |
| Software Performance | Software testing indicated similar performance to predicate device | Similar |
Note: The primary acceptance criterion for this 510(k) submission was "substantial equivalence" to the predicate Kendall SCD Sequel™ Compression System based on these non-clinical performance characteristics. The new feature of detecting venous refill time and adjusting the decompression cycle was considered a "significant change" but its clinical efficacy in reducing DVT was not (or not yet) proven through clinical trials for this submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable for a clinical test set, as no clinical tests were performed. For non-clinical bench testing, the sample size is not specified in the document.
- Data Provenance: Not applicable for clinical data. For non-clinical bench testing, the data origin would be the Kendall Company's testing facilities, likely in the USA. The document does not specify a country of origin for the data.
- Retrospective or Prospective: Not applicable, as no clinical tests were performed. Non-clinical bench testing would be considered prospective for the specific tests conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable, as no clinical tests were performed and thus no "ground truth" for patient outcomes was established by experts in the context of this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no clinical tests were performed requiring adjudication of patient outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is relevant for imaging devices where multiple readers interpret cases. The Kendall SCD Response™ Compression System is a therapeutic medical device, not an imaging device, and no clinical studies were performed.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Standalone Study Done: Yes, in a sense, as the non-clinical bench testing evaluated the device's intrinsic mechanical and software performance characteristics in isolation (i.e., without a human patient or a human operator actively "in the loop" making diagnostic/treatment decisions based on its output in a clinical setting). The device's new adaptive feature (detecting venous refill time) was part of this standalone evaluation to demonstrate its functionality and comparability to the predicate device.
7. Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the "ground truth" was established by comparing the device's performance to the known specifications and performance characteristics of the legally marketed predicate device (Kendall SCD Sequel™ Compression System), and against internal engineering and safety standards. This is a form of design verification and validation against a predicate's performance.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML-based diagnostic system that typically requires a "training set" in the conventional sense. Its function is based on pre-programmed algorithms and mechanical processes. If the "venous refill time detection" uses an algorithm that was developed based on data, that development process is not detailed here, and it would be more akin to algorithm development data rather than a "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there was no specified training set for an AI/ML model. The device's operational parameters would have been developed and validated through engineering design, prototyping, and bench testing, with the "ground truth" being the desired mechanical and functional specifications.
§ 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).