(231 days)
SureTek Compression Sleeves are intended for use with a compatible pump controller for intermittent compression of the lower extremities so as to increase venous return as a prophylaxis to Deep Vein Thrombosis.
Compression Sleeves are inflatable cuffs designed to apply intermittent pressure to the foot, calf or thigh in order to increase venous return and prevent pooling of blood associated with the formation of Deep Vein Thrombosis (DVT). The devices consist of inflatable vinyl bladder(s) lined with an outer non-woven fabric; the bladder is connected to pneumatic tubing for connection with a compatible pump system that controls the sleeve's pressure cycle. Hook-and-loop fasteners sewn into the fabric are used to secure the sleeve to the foot or leg. Models are available in a range of dimensions in order to fit varying foot, calf and thigh circumferences. Reprocessed sleeves have identical technological characteristics as the predicate devices, i.e. device materials, dimensions, operating principle and system compatibility are unchanged during reprocessing. SureTek sleeves are provided as sterile, while the manufacturer product is provided non-sterile.
The SureTek Reprocessed Compression Sleeve is a medical device intended to increase venous return as a prophylaxis to Deep Vein Thrombosis (DVT) by applying intermittent pressure to the lower extremities. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The device is a reprocessed compression sleeve, and as such, its performance criteria are primarily focused on demonstrating equivalence to new, unused devices and compliance with relevant reprocessing and sterility standards.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Performance substantially equivalent to new, unused devices | Bench testing following the maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices. |
| Cleaning Efficacy | Effective decontamination of grossly contaminated instruments | SureTek cleaning process is validated to be effective for decontamination of grossly contaminated instruments under worst-case operational conditions. |
| Packaging Integrity & Sterility Maintenance | Conforms to ISO 11607 (packaging for terminally sterilized medical devices) and relevant EN868-1, ASTM standards. Maintenance of product sterility. | Product packaging conforms to all relevant requirements of ISO 11607, with performance qualifications tested according to EN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02. Product sterility and process validation conform to the relevant requirements of ISO 11135 Medical Devices – Validation and routine control of ethylene oxide sterilization. |
| Biocompatibility & Safety | Conforms to ISO 10993 (biological evaluation of medical devices for ethylene oxide residuals and biocompatibility) | Products conform to the relevant requirements of ISO 10993 Biological Evaluation of Medical Devices for ethylene oxide residuals and biocompatibility of device materials. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Bench Testing: The document states "maximum number of use and reprocessing cycles." A specific number of devices or cycles is not provided in the summary.
- Data Provenance: The studies described (bench testing, cleaning validation, packaging, sterility, and biocompatibility testing) are all prospective tests performed on the reprocessed devices themselves. The country of origin of the data is not specified, but it can be inferred that the testing was conducted to meet US regulatory requirements.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of device (a reprocessed compression sleeve) does not typically involve human expert interpretation for "ground truth" establishment in the same way an AI diagnostic algorithm would. The listed studies are technical validations against established standards. Therefore, information about the number or qualifications of "experts" to establish a diagnostic ground truth is not applicable or provided. The "truth" is determined by measurements against engineering and biological standards.
4. Adjudication Method for the Test Set
Not applicable. The studies conducted are not based on expert adjudication of cases, but rather on direct measurements and validations against standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a reprocessed medical device, not an AI-assisted diagnostic tool. Therefore, a MRMC comparative effectiveness study involving human readers improving with AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical device (a reprocessed compression sleeve), not a standalone algorithm.
7. Type of Ground Truth Used
The ground truth used for proving acceptance was based on a combination of:
- Performance Standards: Comparisons to the performance characteristics of new, unused predicate devices.
- Validated Test Methods and Industry Standards: Compliance with international standards such as ISO 11607, EN868-1, ASTM F88-00, F2906-04, D4169-04a, F1980-02, ISO 11135, and ISO 10993.
- Worst-Case Scenario Validation: Specific validation of cleaning efficacy under "worst case operational conditions."
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI algorithm, there is no training set or associated ground truth establishment process in that context.
§ 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).