(261 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.
Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.
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.
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 and labeling operations.
The provided document is a 510(k) summary for a reprocessed medical device, specifically compression sleeves, and does not contain the detailed information typically found in a study report for novel device performance or AI/software validation. Therefore, many of the requested elements for acceptance criteria and study details cannot be fully extracted.
Based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance (as stated) |
|---|---|---|
| Functional Equivalence | Perform "as originally intended" (of predicate devices) | "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended." |
| Safety | No adverse impact on patient safety from reprocessing | Implied by "demonstrate performance (safety and effectiveness)" and substantial equivalence conclusion |
| Effectiveness | Maintain original therapeutic effect from reprocessing | Implied by "demonstrate performance (safety and effectiveness)" and substantial equivalence conclusion |
| Material Integrity | Maintain design, materials, and mechanical characteristics | "The design, materials, and intended use of Reprocessed Compression Sleeves are identical to the predicate devices." |
| Component Function | Individual compression sleeve components function appropriately | "Each individual compression sleeve is tested for appropriate function of its components prior to packaging and labeling operations." |
| Cleanliness/Decontamination | Removal of adherent visible soil and decontamination | "Alliance Medical Corporation's reprocessing of compression sleeves includes removal of adherent visible soil and decontamination." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document only mentions "Bench and laboratory testing was conducted." It does not provide the number of reprocessed sleeves tested.
- Data Provenance: Not specified. It's bench and laboratory testing, so it's not patient data from a specific country, nor is it explicitly stated as retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was bench testing, not a study requiring expert clinical assessment for ground truth.
4. Adjudication method for the test set:
- Not applicable. This was bench testing, not a study requiring adjudication of expert opinions.
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 is a 510(k) for a reprocessed physical medical device (compression sleeves), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is not an algorithm.
7. The type of ground truth used:
- The ground truth for the performance claim appears to be the original intended performance of the predicate device. The testing confirms that the reprocessed device performs to these established specifications.
8. The sample size for the training set:
- Not applicable. This is a reprocessed physical device, not an AI/ML algorithm requiring a training set. The "reprocessing" procedure could be considered analogous to a "training" process for maintaining device specifications, but it's not a data-driven training set in the AI sense.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
{0}------------------------------------------------
FEB 0 5 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 |
|---|---|
| Contact: | Lorri ChavezRegulatory Affairs Manager(480) 763-5300 (o)(480) 763-5310 (f) |
| Date of preparation: May 16, 2002 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Compression SleeveCommon or Usual Name: Compression SleeveClassification Name: Compressible Limb Sleeve |
Predicate device(s):
| K Number | Device Description |
|---|---|
| K992454 | VenaFlow® System, Model 30A |
| K964238 | Aircast® Sterile VenaFlow® Disposable Cuff |
| K961676 | Aircast® VenaFlow® System (Modification) |
| K932900 | Aircast® VenaFlow® System |
| K011192 | Alliance Medical Corporation Reprocessed Compression Sleeves |
Compression sleeves are part of an external compression Device description: 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.
Intended use: 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.
{1}------------------------------------------------
| Indications statement: | Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation. |
|---|---|
| Technological characteristics: | The design, materials, and intended use of Reprocessed Compression Sleeves are identical to the predicate devices. The mechanism of action of Reprocessed Compression Sleeves is identical to the predicate devices in that the same standard 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 and labeling operations. |
| Performance data: | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Compression Sleeves. Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification, Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices as described herein. |
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with three flowing lines above it, possibly representing growth or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2003
Alliance Medical Corporation c/o Mr. Don Selvey Vice President, Regulatory Affairs and Quality Assurance 10232 South 51st Street Phoenix, AZ 85044
Re: K021654
Trade Name: Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: November 6, 2002 Received: November 7, 2002
Dear Mr. Selvey:
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.
{3}------------------------------------------------
Page 2 - Mr. Don Selvey
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 (OS) 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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
V. Oala Tule
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
II. Indications for Use Statement
510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves
Indications for Use: Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.
Concurrence of CDRH, Office of Device Evaluation (ODB
tion (ODE)
510(k) Number K021654
Prescription Use
(per 21 CFR 801.109)
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
CONFIDENTIAL
Alliance Medical Corporation Reprocessed Compression Sleeves Traditional 510(k)
§ 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).