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510(k) Data Aggregation
(28 days)
Reprocessed SCD™ Express Compression Sleeves (Large and X-Large Sizes) & Reprocessed SCD™ Comfort Compression Sleeves (All Sizes)
The Kendall SCD Compression System is designed 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.
Reprocessed SCD™ Express Compression Sleeves (Small and Medium Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
The Reprocessed Compression Sleeves are the sleeve component of the pneumatic compression system intended to apply circumferential pressure to a patient's leg. This pressure will aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The Reprocessed Compression Sleeves are compatible with the OEM pneumatic compression controller. The controller generates air pressure which is transferred through tubing to individual bladders within the sleeve. The controller delivers and monitors the pressure within the bladders. Once predetermined time and pressure criteria are met, the pressure is released by venting air through a valve system.
The Reprocessed Compression Sleeves are for single-patient-use and are available in knee length (both Express and Comfort Sleeves) and thigh length (Express Sleeves only) configurations.
This document describes the reprocessing of Kendall SCD Express Compression Sleeves and Kendall SCD Comfort Compression Sleeves. The information provided heavily focuses on the equivalence of the reprocessed devices to previously reprocessed devices and the original equipment manufacturer (OEM) devices, rather than a study proving the device meets specific performance acceptance criteria for a new medical device.
Therefore, many of the specific questions about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of a diagnostic or AI device, for example, are not directly applicable to this submission. The "study" mentioned here is primarily bench-top verification and cleaning validation to demonstrate that the reprocessed sleeves maintain appropriate functional characteristics and are substantially equivalent.
Here's an attempt to answer the questions based on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of discrete acceptance criteria with specific numerical thresholds for performance (e.g., sensitivity, specificity, accuracy) like one would expect for a diagnostic device. Instead, the acceptance criteria are implicitly met by demonstrating "appropriate functional characteristics" and "substantial equivalence" through the following:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual Inspection | Passed (part of internal manufacturing process prior to release) |
| Simulated Use Testing | Passed (demonstrates appropriate functional characteristics) |
| Leak Testing | Passed (demonstrates appropriate functional characteristics) |
| System Compatibility Verification | Passed (demonstrates appropriate functional characteristics with OEM controller) |
| Cleaning Validation | Passed (demonstrates safety and cleanliness after reprocessing) |
| Functional Testing (post-reprocessing) | Passed (demonstrates all reprocessed products meet functional requirements prior to release) |
| Substantial Equivalence to Predicate Device (K161105) | Achieved (based on cleaning validation and functional testing) |
| Maintenance of Intended Use | Confirmed (no changes to clinical applications, patient population, performance specifications, or method of operation) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Representative samples of the Reprocessed Compression Sleeves were tested." However, it does not specify the exact sample size used for the bench-top verification, simulated use, leak testing, system compatibility verification, or cleaning validation.
- Data Provenance: The document implies the testing was conducted by Covidien, a US-based company (Mansfield, MA). The data would be prospective in that the tests were carried out specifically for this 510(k) submission on samples.
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)
This question is not applicable to this submission. "Ground truth" in the context of expert consensus (like for AI or diagnostic devices) is not relevant here. The ground truth for this device lies in its physical functionality, safety (cleaning), and equivalence to the predicate, which would be assessed by engineers/technicians and regulatory review against established standards and internal specifications, not expert diagnostic interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective interpretation (e.g., by multiple readers) to resolve discrepancies and establish a robust ground truth. Here, the tests are objective bench-top measurements and validations.
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. The device is a reprocessed compression sleeve, not a diagnostic or AI-powered system that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on:
- Engineering specifications and standards: The performance metrics (e.g., pressure output, leak integrity, compatibility) are compared against pre-defined engineering requirements for the device type.
- Predicate device performance: The reprocessed device's performance is expected to be identical to the predicate device in functional characteristics.
- Cleaning validation standards: To ensure the device is safe and effectively reprocessed.
8. The sample size for the training set
This question is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this type of device.
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(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.
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