(36 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 medical device in question is Reprocessed Compression Sleeves by Alliance Medical Corporation. The provided document is a 510(k) summary, which indicates that the device has undergone a substantial equivalence review by the FDA. This specific document primarily focuses on establishing equivalence to predicate devices and describes general performance testing, not a detailed clinical study with specific acceptance criteria and performance metrics for the reprocessed sleeves that would be typical for an AI/ML device.
Therefore, the requested information, which is highly tailored to AI/ML device studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), cannot be fully extracted or accurately inferred from the provided 510(k) summary.
Here's an analysis based on what can be extracted and why other parts cannot be:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document states that "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended." The criteria are implicitly tied to the performance of the predicate devices. However, no specific quantitative or qualitative acceptance criteria (e.g., pressure output within X% of original, no leakage above Y, durability for Z cycles) are explicitly listed in this summary.
- Reported Device Performance:
- Bench and laboratory testing: Conducted to demonstrate "performance (safety and effectiveness)."
- Biocompatibility: No specific results or metrics are given, only that it was tested.
- Function Test(s): No specific results or metrics are given, only that it was tested.
- Validation of Processing: This implies that the reprocessing steps (cleaning, decontamination, individual sleeve testing) were validated, but no specific data or metrics are provided.
- Overall Conclusion: "Reprocessed Compression Sleeves perform as originally intended."
Without specific numerical or descriptive criteria, a table like the one requested cannot be constructed meaningfully. The document indicates that the reprocessed sleeves perform identically to the predicate devices in terms of "standard mechanical design, materials and sizes," and there are "no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." This implies the performance criteria are simply "meets the original specifications of the new device."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "individual compression sleeve is tested," but does not provide the number of sleeves tested.
- Data Provenance: Not applicable in the context of the provided information, as this refers to a reprocessed physical device, not an AI/ML algorithm's data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a reprocessed physical medical device, not an AI/ML diagnostic or assistive tool where human expert ground truth would be established for image or data interpretation. The "ground truth" for this device would be its physical and functional specifications.
4. Adjudication method for the test set:
- Not applicable. This refers to how discrepancies in expert opinions are resolved, which is relevant for AI/ML diagnostic studies, not for the functional testing of a physical device.
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:
- No. This type of study is specifically for AI/ML systems that assist human readers (e.g., radiologists interpreting images). The Reprocessed Compression Sleeves are physical items.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to the performance of an AI/ML algorithm without human intervention. The device is a physical compression sleeve.
7. The type of ground truth used:
- For this physical device, the "ground truth" would be the original specifications and performance characteristics of new, unadulterated compression sleeves (the predicate devices). Each reprocessed sleeve is tested against these established functional parameters.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary of what can be inferred for the Reprocessed Compression Sleeves:
The study proving the device meets its acceptance criteria involves bench and laboratory testing to demonstrate biocompatibility, function, and validation of processing. The inherent acceptance criterion is that the reprocessed sleeves perform identically to the new, predicate compression sleeves in all relevant aspects (design, materials, sizes, intended use, clinical applications, performance specifications, method of operation). The 510(k) summary indicates that these tests were sufficient to conclude "substantial equivalence." However, it does not provide the granular detail requested for AI/ML device studies.
{0}------------------------------------------------
Ko60091/
FEB 1 7 2006 1 1 1 2
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: | November 2, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed Compression SleevesCommon or Usual Name: Compression SleeveClassification Name: Compressible Limb Sleeve |
| Predicate device: | |
| K NumberK944567K915092 | Device DescriptionPlexiPulse Acute Care UnitTalley TM300 Sequential Multicom 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 Sleeves |
| Alliance Medical CorporationReprocessed Medline Compression SleevesTraditional 510(k) 9 of 200 | |
| is identical to the predicate devices in that the same standardmechanical 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. |
{1}------------------------------------------------
{2}------------------------------------------------
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 representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs 10232 South 51st Street Phoenix, AZ 85044
Re: K060091
Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: January 10, 2006 Received: January 12, 2006
Dear Ms. Barton:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section 9 ro(x) premaince is substantially equivalent (for the indications felerenced above and nave determined have and marketed predicate devices marketed in interstate for use stated in the enclosure) to regars and ment date of the Medical Device American proc commerce prior to May 26, 1776, the enastinent with the provisions of the Federal Food. Drug, devices that have been reclassince in accessaries was a premarket approval application (PMA). and Cosmetic Act (Act) market the device, subject to the general controls provisions of the Act. The You may, merclore, market the devices, boojes to annual registration, listing of general controls provisions of the line, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0070) als. Existing major regulations affecting your device can Inay be subject to suen additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous overning your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Ms. Moira Barton
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that 1 Dris and over device complies with other requirements of the Act that I Dri has made a doted regulations administered by other Federal agencies. You must or any I cut all the Act's requirements ancluding, but not limited to: registration and listing (21 Configity with an the 11et 3 requirements, as a manufacturing practice requirements as set CFN i art 607); adomig (21 OFR Part 820); and if applicable, the electronic forul in the quanty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (overiens (overies as described in your Section 510(k) This icter will anow you to ocgin mading of substantial equivalence of your device to a legally prematics notification. The PDF interest on 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 11 you desire specific acries ion your 240) 276-0120. Also, please note the regulation entitled, Connation of Collied of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
unma R. Jochner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications For Use Statement 1.
510(k) Number (if known): K060091
Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves
Indications For Use: When coupled with an appropriate inflation system, compression Indications For USe. When Coupleting deep vein thrombosis (DVT), diminishing postdevices are intended for use in preventing deep von thrombols ( = 1), 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 not write below this line – continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana R. Vochner
(Division Sign Off)
Cardiovascular Devices
(Division S
vision of Cardiovascular Devices
් ((x) Number_
CONFIDENTIAL
Alliance Medical Corporation Reprocessed Medline Compression Sleeves Traditional 510(k)
13 of 200
§ 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).