(105 days)
Intended use for following codes: 9529(R), 9530(R), 9545(R), The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
Intended use for following codes: 9780(R), 9789(R), 9790(R), The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.
The Reprocessed Compression Garments are the compressible limb sleeve component of a pneumatic compression system intended to apply pressure to a patient's leg to aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The Reprocessed Compression Garments are compatible with the OEM pneumatic compression controller. The controller provides air to the sleeves through tubing connected to each bladder of the sleeve for the purposes of delivering pneumatic pressure to the limb. The controller software monitors the pressure in the bladders and releases the pressure by venting the air from the sleeve bladders through a valve system.
The proposed reprocessed device is for single-patient-use and will be available in knee and thigh configurations.
The provided document is a 510(k) summary for the Covidien Reprocessed Compression Garments. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this submission does not contain the type of acceptance criteria, study details, and performance metrics typically found for a medical device that uses an AI/ML algorithm or requires clinical performance evaluation against a specific ground truth.
This 510(k) is for a reprocessed medical device (compression garments) that is compared to its original predicate device based on functional equivalence, material equivalence, and cleaning validation. The performance data focuses on benchtop verification and process validation rather than human reader studies, AI algorithm performance, or ground truth-based evaluation.
Therefore, many of the requested categories in your prompt are not applicable to the information provided in this 510(k) summary. I will answer the applicable questions based on the text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Functional Characteristics | Demonstrated through benchtop verification and process validation. | This likely includes pressure delivery, leak testing, and reliability. Specific values are not provided. |
| Visual Inspection | Performed to validate the cleaning process and prior to release. | Indicates a quality control step. Specific criteria or defect rates are not provided. |
| Leak Testing | Performed as part of functional characteristics testing. | No specific pass/fail criteria or performance metrics provided. |
| Reliability Testing | Performed as part of functional characteristics testing. | No specific duration, cycles, or failure rates provided. |
| Biocompatibility | Performance data used to demonstrate device function. | No specific tests, results, or standards cited (beyond implied AAMI TIR 30:2011 for cleaning). |
| Cleaning Process Validation | Performed in line with AAMI TIR 30:2011 requirements. | This standard is for the "compatibility of materials with sterilization methods and the effects of reprocessing on medical devices." Implies successful validation against this standard. specific results are NOT reported in this document |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for performance testing (e.g., number of garments tested). The document says "Representative samples of the Reprocessed Compression Garments were tested."
- Data Provenance: Not specified. The testing was conducted by Covidien, a US-based company, so it's likely internal testing.
- Retrospective or Prospective: Not applicable; this was benchtop and process validation, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a reprocessed physical device, not an AI/ML diagnostic tool requiring expert-established ground truth from images or patient data. The "ground truth" here is the original predicate device's specifications and the ability of the reprocessed device to meet those.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process like that used for diagnostic studies was mentioned or implied.
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
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference standard for this submission is the performance and specifications of the original (predicate) compression garments and relevant engineering/material standards (e.g., AAMI TIR 30:2011 for cleaning). The reprocessed device is deemed substantially equivalent if it meets these established functional and safety criteria.
8. The sample size for the training set
Not applicable. This device does not involve an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI/ML algorithm.
§ 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).