(90 days)
The University Health Care Reprocessed Alternating Leg Pressure (UHC APL) sleeve device reprocessing methods do not change the intended use of the original manufacturer Healthcare Service and Supply ALP® (K000303) alternating leg pressure sleeve device. Both are sequential compression sleeves to be used by patients as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism.
UHC APL is the compression sleeve component of a non-invasive external compression system consisting of a pump/controller, connecting tube and limb sleeve/garment device.
The provided text describes the 510(k) premarket notification for the University Health Care Reprocessed Alternating Leg Pressure (UHC APL) sleeve device. The focus of the submission is to demonstrate that the reprocessed device is substantially equivalent to legally marketed predicate devices, specifically the Healthcare Service and Supply ALP® Alternating Leg Pressure Garment (K000303), after being reprocessed multiple times.
Here's an analysis of the acceptance criteria and the study as per the request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material/Design Equivalence | Overall design, materials, energy source, mode of operation, performance technique, and reprocessing methods are substantially equivalent to predicate devices. | "The UHC APL reprocessed sleeve device is substantially equivalent in overall design, materials, energy source, mode of operation, performance technique, and reprocessing methods as the predicate devices." |
| Bladder Function | Bladder function of the UHC APL reprocessed compression sleeve after reprocessing six (6) times demonstrates substantial equivalence to new original ALP® Sleeves. | "Test results... demonstrate that the bladder function of the UHC APL reprocessed compression sleeve after reprocessing six (6) times were substantially equivalent to the new original ALP® Sleeves." |
| Safety and Efficacy | No adverse effects or complications resulting from reprocessing the UHC APL sleeve device six (6) times. The device is safe and effective and performs substantially equivalent to legally marketed new original ALP® sleeve device. | "Testing indicated no adverse effects or complications resulting from reprocessing the UHC APL sleeve device six (6) times. The tests conclude that the UHC APL reprocessed sleeve device is safe and effective, and performs substantially equivalent to legally marketed new original ALP® sleeve device." |
| Biocompatibility | The UHC APL reprocessed sleeve device meets ISO 10993-1 test Matrix requirements for biocompatibility, indicating substantial equivalence to the predicate device in all required categories. | "The UHC APL reprocessed sleeve device was tested for biocompatibility according to the ISO 10993-1 test Matrix. The results indicate substantial equivalence in all required categories to the predicate device." |
| Intermediate Disinfection and Cleaning Efficacy | The UHC APL reprocessed sleeve device passes intermediate level of disinfection testing. | "Tests conclude that UHC APL reprocessed sleeve device passed the intermediate level of disinfection testing." |
| Cleaning Efficacy (TOC) | The UHC APL reprocessed sleeve device, after contamination and cleaning using the Kendall K031189 cleaning process, demonstrates Total Organic Carbons (TOC) ppb equal to or less than the PBB (presumably initial level or acceptable limit for particulate burden) of the new sleeve. | "Nelson Labs' TOC Procedure SOP/CHM/0411.1 was used to test Total Organic Carbons (TOC) ppb of the reprocessed sleeves that have been contaminated on 44 in 2 and cleaned using the Kendall K031189 cleaning process. UHC APL reprocessed sleeve device passed having scored equal to or less than the PBB of TOC on the new sleeve." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "reprocessed sleeve device six (6) times" for bladder function and safety/efficacy testing. This implies at least one device was reprocessed six times and tested after each reprocessing cycle, or multiple devices were tested after six reprocesses. However, the exact number of individual sleeve devices tested is not specified.
The data provenance is retrospective in the sense that it's comparing a reprocessed device to an already marketed new device. The testing itself would have been prospective to generate the new data for the reprocessed device. However, the origin of the data (e.g., country) is not specified beyond being submitted by the University of Utah Hospitals and Clinics in Salt Lake City, UT, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study focuses on technical performance testing (e.g., bladder function, biocompatibility, cleaning efficacy) rather than diagnostic accuracy involving expert interpretation. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., for image interpretation) does not apply here.
4. Adjudication Method for the Test Set
This information is not applicable for this type of technical performance testing. Adjudication methods like "2+1" or "3+1" are typically used in studies where human readers provide interpretations (e.g., diagnostic image reading), and disagreements need to be resolved. This study involves objective laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable. This submission is for a medical device (compression sleeve) and its reprocessing, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as this is not an algorithm or AI-based device.
7. The Type of Ground Truth Used
The ground truth used for comparison is the performance and characteristics of the new, original ALP® sleeve device (K000303), which is the predicate device. This is a form of "predicate performance" or "established equivalent performance." For instance:
- For bladder function: The performance of new ALP® sleeves.
- For biocompatibility: The known biocompatibility profile of the predicate device.
- For cleaning efficacy: The cleanliness/TOC levels of new sleeves or an established acceptable limit.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context would refer to the development and validation of the reprocessing protocol itself, but a "training set" in the computational sense is not relevant.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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MAY 2 8 2008
Pre-Market Notification 510 (K) Summary
| Submitter Name: | University of Utah Hospitals and Clinics50 North Medical DriveSalt Lake City, UT 84132 |
|---|---|
| Contact: | Brent AlmUniversity of Utah Hospitals and Clinics50 North Medical DriveSalt Lake City, UT 84132801-581-2847 |
| FDA Registration: | 3004595606 |
| Device Name: | Trade Proprietary Name - University Health Care Reprocessed AlternatingLeg Pressure (UHC APL) sleeve device |
| Common or Usual Name - (ALP®) Alternating Leg Pressure Device | |
| Classification: | Class II: Medical DeviceRegulation: 21 CFR 870.5800Panel Number: Panel 70Product Code: JOWClassification Name: Sleeve, Limb, Compression |
| Predicate Device: | Healthcare Service and Supply ALP® Alternating Leg Pressure GarmentK000303 |
| ReNu Medical Reprocessed ALP® Calf Garment K051227 | |
| UUHC's Reprocessed Compression Sleeve Device K031189 | |
| Device Description: | UHC APL is the compression sleeve component of a non-invasiveexternal compression system consisting of a pump/controller, connectingtube and limb sleeve/garment device. |
| Intended Use: | To be used for patients for whom external compression therapy isindicated for the prevention of deep vein thrombosis and resultingpulmonary embolism due to the present risk factors for thrombosisformation. |
University Health Care 510(k) Summary
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Technical Characteristics: The UHC APL reprocessed sleeve device is substantially equivalent in overall design, materials, energy source, mode of operation, performance technique, and reprocessing methods as the predicate devices.
Testing and Standards: Performance Test: Test results in the report demonstrate that the bladder function of the UHC APL reprocessed compression sleeve after reprocessing six (6) times were substantially equivalent to the new original ALP® Sleeves.
Safety Efficacy: Testing indicated no adverse effects or complications resulting from reprocessing the UHC APL sleeve device six (6) times. The tests conclude that the UHC APL reprocessed sleeve device is safe and effective, and performs substantially equivalent to legally marketed new original ALP® sleeve device.
Biocompatibility: The UHC APL reprocessed sleeve device was tested for biocompatibility according to the ISO 10993-1 test Matrix. The results indicate substantial equivalence in all required categories to the predicate device.
Intermediate Disinfection and Cleaning Efficacy: Tests conclude that UHC APL reprocessed sleeve device passed the intermediate level of disinfection testing. The new original ALP® sleeve predicate has the technological advantage over the reprocessed device, having never been reprocessed.
Cleaning Efficacy: Nelson Labs' TOC Procedure SOP/CHM/0411.1 was used to test Total Organic Carbons (TOC) ppb of the reprocessed sleeves that have been contaminated on 44 in 2 and cleaned using the Kendall K031189 cleaning process. UHC APL reprocessed sleeve device passed having scored equal to or less than the PBB of TOC on the new sleeve.
Conclusion: Device testing and comparisons of specification determined that UHC APL reprocessed sleeve devices are substantially equivalent to the predicate devices with respect to device intended use and performance, as well as product disinfection, packaging, labeling and safety and efficacy.
University Health Care 510(k) Summary
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a wave or ribbon.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2008
University of Utah Hospitals and Clinics c/o Mr. Brent Alm 50 North Medical Drive Salt Lake City, UT 84132
Re: K080551
University Health Care Processed Alternating Leg Pressure Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: February 28, 2008 Received: February 28, 2008
Dear Mr. Alm:
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 - Mr. Brent Alm
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. vc Mner
ABram 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
510(k) Number (if known): K080551
Device Name: UHC APL
Indications for Use: The University Health Care Reprocessed Alternating Leg Pressure (UHC APL) sleeve device reprocessing methods do not change the intended use of the original manufacturer Healthcare Service and Supply ALP® (K000303) alternating leg pressure sleeve device. Both are sequential compression sleeves to be used by patients as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism.
Prescription Use X (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Lo Jones
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K08055)
Page 1 of 1
§ 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).