(79 days)
When coupled with an appropriate inflation system, compression garments are intended to increase venous return from the legs and feet as a prophylaxis for the formation of deep vein thrombosis (DVT) or subsequent pulmonary embolism (PE) in high risk and/or non-ambulatory patients. The compression garments are prescription devices intended for a single patient use only.
Compressible limb sleeves are devices that are used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb and increasing venous flow. Compression therapy is generally prescribed as a prophylaxis for deep vein thrombosis (DVT). The compression system consists of two primary pieces: an air compression pump and a soft, flexible sleeve in which the patient's extremity is placed. A hose to the pump connects to the sleeve, and when the pump is turned on, the air inflates the sleeve, applying a gentle pressure to the patient's extremity. Compression garments consist of a non-woven fabric with “hook and loop” fasteners for attaching around the foot or leg. Air cells within the garment are molded to plastic hoses with connectors for attachment to the pump. The hoses and connectors are non-detachable and are reprocessed as part of the garment. Depending upon the original equipment manufacturer (OEM), garments may contain a single bladder and hose or multiple compartments and hoses that are sequentially pressurized. Vanguard receives previously used compression garments from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the garments; and returns them to the healthcare facility.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Vanguard Reprocessed Compression Garments":
Overall Assessment:
The provided document (K012403) is a 510(k) Summary of Safety & Effectiveness for reprocessed compression garments. As such, the primary focus is on establishing substantial equivalence to existing legally marketed predicate devices, not on a traditional clinical trial proving novel device performance against specific clinical acceptance criteria. Therefore, many of the typical questions regarding acceptance criteria and studies (like sample size for test sets, expert ground truth, MRMC studies, standalone performance with metrics like sensitivity/specificity, or training set details) are not applicable in this context.
Instead, the "acceptance criteria" are implied by the demonstration that the reprocessed devices are "essentially identical" in technological characteristics and perform "as intended" after reprocessing, through various validation tests.
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a reprocessing 510(k), explicit, quantitative acceptance criteria for clinical performance are not stated in the way they would be for a novel device. The "acceptance criteria" are implicitly met by demonstrating that the reprocessed devices retain the original device's performance, sterility, and biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL): 10⁻⁶ (for sterilized devices) | Achieved to a 10⁻⁶ assurance level. Ethylene oxide gas sterilization was utilized, and validation demonstrates sterility. (Technological Characteristics section) |
| Biocompatibility: Continued safety after reprocessing | Post-sterilization biocompatibility testing demonstrates that the devices continue to be safe. (Technological Characteristics section) |
| Functional/Performance: Perform as intended | Post-sterilization performance/functional testing demonstrates that the devices continue to be effective for their intended use. "Functional/performance testing demonstrates that the reprocessed devices perform as intended." (Technological Characteristics & Test Data sections) |
| Cleaning/Decontamination Efficacy | "Decontamination and cleaning... validations" performed. (Test Data section) |
| Packaging Integrity | "Packaging... validations" performed. (Test Data section) |
| Technological Characteristics Equivalence | "The Vanguard reprocessed compression garments are essentially identical to the currently marketed OEM compression garments. No changes are made to the currently marketed devices' specifications (with the exception of sterility)." (Technological Characteristics section) |
| Safety and Effectiveness | "…demonstrates that the devices continue to be safe and effective for their intended use." and "…are safe and effective." (Technological Characteristics & Test Data sections) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the various validation tests (decontamination, cleaning, packaging, sterilization, functional/performance, biocompatibility). It simply states that "validations" and "testing" were performed.
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given the context of a 510(k) for reprocessed medical devices, these would typically be lab-based or engineering studies conducted by the reprocessor (Vanguard Medical Concepts, Inc.) to validate their specific processes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This concept is not directly applicable to this type of submission. The "ground truth" for these tests would be established by validated scientific methods and industry standards for sterilization, biocompatibility, and functional performance, rather than expert clinical consensus on a patient test set. The design of the studies and interpretation of results would be by qualified engineers, microbiologists, and other technical specialists.
4. Adjudication Method for the Test Set
- Not applicable. The tests are laboratory and engineering validations, not studies requiring human rater adjudication for clinical outcomes or image interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a reprocessed physical medical garment, not an AI or imaging diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a reprocessed physical medical garment, not an algorithm. The "standalone" performance would be equivalent to the performance of the reprocessed device itself in functional tests.
7. The Type of Ground Truth Used
The "ground truth" for the various tests would be:
- Sterility: Achieved by demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶, as per industry standards for sterile medical devices. This is a quantifiable measure.
- Biocompatibility: Established through standardized biocompatibility testing (e.g., cytotoxicity, irritation, sensitization as per ISO 10993 series), comparing the reprocessed device's biological response to accepted safety thresholds.
- Functional/Performance: Established by comparing the performance characteristics (e.g., inflation pressure, cycle times, structural integrity) of the reprocessed garment to the original OEM specifications and performance of new OEM garments.
- Cleaning/Decontamination: Established by demonstrating the removal of biological and chemical contaminants to predetermined, safe levels.
- Packaging: Established by demonstrating the integrity of the sterile barrier and protection of the device.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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).