(76 days)
Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.
When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.
Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections. Only the compression sleeves are reprocessed.
The provided text is a 510(k) summary for Reprocessed Compression Sleeves. It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific numerical acceptance criteria, detailed study designs, or expert qualifications for ground truth establishment.
Here's a breakdown of the available information and where details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary) | Numerical Acceptance Criteria (if available) |
|---|---|---|
| Biocompatibility | Demonstrated performance | Not specified |
| Function Test(s) | Demonstrated performance | Not specified |
| Validation of Processing | Demonstrated performance | Not specified |
Explanation of Device Performance: The document states, "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended." It also mentions, "Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and EO exposure operations." However, specific numerical targets or detailed metrics for "appropriate function" are not provided.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set in the performance studies (biocompatibility, function tests, validation of processing). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature). The studies appear to be bench and laboratory tests, implying they were conducted in a controlled environment rather than involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The studies described are bench and laboratory tests, not clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" here would likely be defined by engineering specifications and objective measurements of device function and material properties.
4. Adjudication Method for the Test Set
This information is not applicable and not provided as the tests are not observational studies requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating the performance of the reprocessed sleeves itself and its substantial equivalence to the predicate, not on human-in-the-loop performance or the effect of AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described are standalone performance tests of the device itself (biocompatibility, function, and processing validation). There is no "algorithm" in the context of this device; it is a physical medical device. The "standalone" performance refers to the device's inherent functional and material characteristics without human intervention during the test aside from operating the test equipment.
7. The Type of Ground Truth Used
For the performance studies (biocompatibility, function tests, validation of processing), the ground truth would be established based on:
- Engineering Specifications/Standards: Performance metrics likely compared against established design specifications for new compression sleeves and relevant industry standards.
- Material Science Properties: For biocompatibility, adherence to material safety standards.
- Functional Parameters: Objective measurements of pressure, inflation/deflation cycles, integrity of components, etc., compared against the predicate device's known performance or design criteria.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical medical device, not an AI/machine learning algorithm, so there is no "training set" in the computational sense. The studies focused on verifying the reprocessing methods and the resulting device's performance.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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K05 33/6
FEB 1 3 2006
SECTION B: 510(k) SUMMARY
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 |
|---|---|
| Contact: | Moira BartonRegulatory Affairs Manager(480) 763-5350 (o)(480) 763-5310 (f)mbarton@alliance-medical.com |
| Date of preparation: | July 25, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed Compression SleevesCommon or Usual Name: Compression SleeveClassification Name: Compressible Limb Sleeve |
| Predicate device: | |
| K NumberK012994 | Device DescriptionWizAir DVT™ Compressible Limb Sleeve |
| Device description: | Compression sleeves are part of an external compressionsystem, in which intermittent or sequential compression isprovided using a pump/controller and limb garment. The systemconsists of the following three main components: a control unit,inflatable limb sleeves and conduit tubing with detachableconnections. Only the compression sleeves are reprocessed. |
| Intended use: | Reprocessed Compression Sleeves are intended to helpprevent deep vein thrombosis and pulmonary embolism bysupplying a measured, intermittent pressure into thecompression sleeves worn on the lower extremities of arecumbent patient, resulting in a gradient, sequential, repetitivesqueezing and relaxing action, simulating normal musclecontractions. |
| Indicationsstatement: | When coupled with an appropriate inflation system,compression devices are intended for use in preventing deepvein thrombosis (DVT), diminishing post-operative pain andswelling, enhancing blood circulation, and reducing woundhealing time. |
| Technologicalcharacteristics: | The design, materials, and intended use of ReprocessedCompression Sleeves are identical to the predicate devices.The mechanism of action of Reprocessed Compression Sleevesis identical to the predicate devices in that the same standardAlliance Medical CorporationReprocessed Compression SleevesTraditional 510(k) |
.
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mechanical design, materials and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.
Alliance Medical Corporation's reprocessing of compression sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and EO exposure operations.
- Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Compression Sleeves.
- Biocompatibility .
- Function Test(s) .
- Validation of Processing .
Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended.
Alliance Medical Corporation concludes that the modified Conclusion: devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices as described herein.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Allance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs 10232 South 51st Street Phoenix, AZ 85044
Re: K053316
Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: November 15, 2005 Received: November 29, 2005
Dear Ms. Barton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Moira Barton
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dina R lochines
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use Statement 1.
510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves
Indications For Use: When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing postdovioo are intended log, enhancing blood circulation, and reducing wound healing time.
Prescription Use X (per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NONT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana R. McAnes
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K053316
Confidential
Alliance Medical Corporation Reprocessed ActiveCare™ Compression Sleeves Traditional 510(k)
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§ 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).