(90 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. Only the compression sleeves are reprocessed.
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 sterilization operations.
The provided text is for a 510(k) premarket notification for reprocessed compression sleeves. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, much of the typical information requested for AI/ML device studies (like sample sizes for test sets with ground truth, expert qualifications, adjudication methods, MRMC studies, and training set details) is not applicable in this context.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Cleaning | Adherent visible soil removed. |
| Decontamination | Decontamination performed. |
| Functionality | Each individual compression sleeve is tested for appropriate function of its components. Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. The design, materials, and intended use are identical to predicate devices. Mechanism of action is identical (standard mechanical design, materials, and sizes). No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
| Biocompatibility | Bench and laboratory testing was conducted to demonstrate biocompatibility. |
| Sterilization Validation | Bench and laboratory testing was conducted to demonstrate sterilization validation. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing is for a reprocessed medical device, where the focus is on maintaining the original device's performance through reprocessing steps. "Bench and laboratory testing" is mentioned, but specific sample sizes for these tests are not detailed. It's highly likely this was internal, retrospective testing, but the document does not specify.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable/not provided. For device reprocessing, the "ground truth" is typically the performance specifications of the original device. The testing conducted (biocompatibility, sterilization, function) are objective engineering and laboratory tests, not subjective expert assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments (e.g., image interpretation by multiple readers) to establish a consensus ground truth. The tests for reprocessed sleeves are objective performance measurements.
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
This information is not applicable. This is not an AI/ML device, and no MRMC study was conducted or required for this type of submission.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This information is not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reprocessed compression sleeves is based on:
- Original Device Specifications: The reprocessed devices are compared against the performance of the legally marketed predicate devices, ensuring "identical" design, materials, intended use, and mechanism of action. The implicitly accepted "ground truth" is that the original, new device performed safely and effectively.
- Objective Performance Metrics: For the specific tests mentioned (biocompatibility, sterilization validation, function tests), the ground truth would be established by validated test methods and predefined quantitative specifications inherent to those tests (e.g., sterility assurance levels, material integrity, pressure output ranges).
8. The sample size for the training set
This information is not applicable/not provided. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided. As there is no training set for an AI/ML model, this question is irrelevant to this device.
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MAR 11 2003
Image /page/0/Picture/1 description: The image shows a logo for Alliance Medical Corporation. The logo consists of three curved lines above the word "ALLIANCE". The lines are thick and black, and they are arranged in a slightly arched formation. The word "ALLIANCE" is in a simple, sans-serif font.
PART B: 510(k) SUMMARY
Submitter:
Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
- Contact: Moira Barton Regulatory Affairs Specialist (480) 763-5300 (o) (480) 763-5310 (f)
Phoenix, Arizona 85044
TEL 480.763.5300
10232 South 51st Street
FAX 480 763 5310 Toll Free 888,888,3433 v.alliance-medical.com
KC024087
- Date of preparation: December 10, 2002
Name of device: Trade/Proprietary Name: Reprocessed Compression Sleeves Common or Usual Name: Compression Sleeve Classification Name: Compressible Limb Sleeve
Predicate device(s):
as a comprehensive the control of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of
| K Number | Device Description |
|---|---|
| K944567 | PlexiPulse Acute Care Unit |
Device Compression sleeves are part of an external compression system, in description: 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.
- 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.
Indications Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein statement: thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.
Technological The design, materials, and intended use of Reprocessed Compression Sleeves are identical to the predicate devices. The characteristics: 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.
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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 sterilization operations.
Performance data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Compression Sleeves.
- Biocompatibilitv ●
- Sterilization Validation ●
- . Function Test(s)
Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended.
Conclusion:
Alliance Medical Corporation concludes that the modified 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that they appear to be connected or overlapping. The profiles are simple and abstract, with no distinct facial features. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 11 2003
Alliance Medical Corporation c/o Ms. Moira Barton 10232 South 51st Street Phoenix, AZ 85044
Re: K024087
Reprocessed Compression Sleeves. Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: December 10, 2002 Received: December 11, 2002
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 (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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
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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ll. Indications for Use Statement
510(k) Number (if known): KO24-087
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.
| Pump Model | Compression Sleeve Model |
|---|---|
| KCI 2110 | 112491, 112492, 112497 |
| KCI 2600 | 112453, 112452 |
| KCI PlexiPulse® | 235342, 235343, U40010 |
and Neurological Devices
510(k) Number_KO24087
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109) or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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).