(49 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.
Here's an analysis of the provided 510(k) summary regarding the Reprocessed Compression Sleeves, focusing on acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a tabular format. Instead, it makes a general statement about the testing performed and the conclusion reached.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility | Testing conducted to demonstrate safety. |
| Effectiveness: Function as originally intended | Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. |
| Effectiveness: Equivalence to predicate device function | Identical design, materials, sizes, mechanism of action, and performance as predicate devices. |
| Processing Validation: Removal of soil & decontamination | Reprocessing includes removal of adherent visible soil and decontamination. |
| Processing Validation: Appropriate function of components | Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and E.O. exposure. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states that "Bench and laboratory testing was conducted," but no sample sizes for these tests are provided.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. This type of device (reprocessed compression sleeves) typically relies on objective physical, chemical, and functional testing rather than expert interpretation of images or clinical data for ground truth establishment in this context.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As noted above, the assessment of this device type does not typically involve human expert adjudication in the way medical imaging software might. The performance testing would likely involve standardized measurements and observations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. This type of study is not relevant for this device. MRMC studies are typically used to assess the impact of AI on human reader performance, especially in diagnostic imaging.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done? Not applicable. This device is not an algorithm or AI system. Its performance is assessed through physical and functional testing of the reprocessed sleeves.
7. Type of Ground Truth Used
The ground truth for this device's performance would be established through a combination of:
- Objective Measurements: Physical dimensions, material integrity tests, pressure characteristics, flow rates, etc.
- Chemical Analysis: To confirm cleanliness and absence of contaminants after reprocessing.
- Microbiological Testing: To confirm effective decontamination/sterilization.
- Functional Testing: To ensure the sleeve inflates and deflates correctly, holds pressure, and delivers compression as designed, mimicking original device performance.
- Comparison to Predicate Device Specifications: The reprocessed device is intended to perform identically to the original, so the "ground truth" implicitly references the established performance characteristics of a new, predicate device.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This product does not involve machine learning or AI, and therefore no "training set" in that sense. The manufacturing process itself could be seen as "trained" through process validation, but this term is not used in the context of device performance data for this product.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Established: Not applicable, as there is no "training set" for an AI algorithm. The methods used to validate the reprocessing procedure would involve standard engineering and quality control practices to ensure consistent and safe reprocessing outcomes.
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FEB 2 4 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: | October 25, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed Compression SleevesCommon or Usual Name: Compression SleeveClassification Name: Compressible Limb Sleeve |
| Predicate device: | |
| K NumberK040511 | Device DescriptionSCD Express Portable Compression System |
| 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 standard |
| mechanical design, materials and sizes are utilized. There areno changes to the claims, intended use, clinical applications,patient population, performance specifications, or method ofoperation. | |
| Alliance Medical Corporation's reprocessing of compressionsleeves includes removal of adherent visible soil anddecontamination. Each individual compression sleeve is testedfor appropriate function of its components prior to packaging,labeling, and EO exposure operations. | |
| Performance data: | Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of ReprocessedCompression Sleeves. |
| Biocompatibility Function Test(s) Validation of Processing | |
| Performance testing demonstrates that ReprocessedCompression Sleeves perform as originally intended. | |
| Conclusion: | Alliance Medical Corporation concludes that the modifieddevices (Reprocessed Compression Sleeves) are safe, effectiveand substantially equivalent to the predicate devices asdescribed herein. |
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2006
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs 10232 South 51st Street Phoenix, AZ 85044
Re: K060049
Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: December 28, 2005 Received: January 6, 2006
Dear Ms. Barton:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused in device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of to regists the Medical Device Amendments, or to conninered prior to May 20, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 devices that have been recuire in asse e approval of a premarket approval application (PMA). and Cosmetic (110) the (110) that the device, subject to the general controls provisions of the Act. The r ou may, arorerere, mans 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 may be subject to basil adable in 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 Please be advised that FDA s issualite of a substition with other requirements of the Act
that FDA has made a determination that your device also accomples . You must that FDA has made a determination that your arres by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21
comply with all the Act's requirements, including, but not manirements as set comply with all the Act s requirements, monamas manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if englicable, the electronic CFR Part 807); labeling (21 CFR Part 801); good manaxasing (2008); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 11 CFF) 1000, forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Scctions 31 device as described in your Section 510(k)
This letter will allow you to begin marketing your device to a leval This letter will allow you to begin harkemig your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalse and thus, p premarket notification. The FDA inding of substantial equivaliation wour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the regulation and 1100 m 11 comments on any more the regulation entitled If you desire specific advice for your de not on an a more the regulation entitled,
contact the Office of Compliance at (240) 276-0120. ↑ Also, please note the may obtain contact the Office of Complance at (210) 276-6100 (21CFR Part 807.97). You may obtain "Misbranding by relevence to premanse notificansity of the Act from the Division of Sm?!
other general information on your responsibilities under the Act from the 4800 638, 2 other general information on your responsionner Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Abolance area consideralindustry/support/index.html.
Sincerely yours,
Dmn R. Lachner
A 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): K060049
Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves
Indications For Use: When coupled with an appropriate inflation system, compressions in Indications I of OSE. Vinch outplou man an uppopramating deep very of healing time devices are intended for use in preventing doop for and reducing wound healing time.
Prescription Use _ × (per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Le Jones
Devices
510(K) Number K66(0044
CONFIDENTIAL
Alliance Medical Corporation Traditional 510(k)
13 of 374
§ 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).