(90 days)
Not Found
No
The summary describes a reprocessed medical device (compression sleeve) and its performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The intended use explicitly states the device is "to be used by patients as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism."
No
The device is described as a "sequential compression sleeve" used as a "non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism." Its purpose is therapeutic prevention, not diagnosis.
No
The device description explicitly states it is a "compression sleeve component of a non-invasive external compression system," which is a physical hardware component. The summary focuses on the reprocessing of this physical sleeve.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a "compression sleeve component of a non-invasive external compression system." This describes a physical device used for external compression, not for analyzing samples from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis
- Reagents, calibrators, or controls used for in vitro testing
The device is clearly intended for external therapeutic use to prevent a medical condition, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
To be used for patients for whom external compression therapy is indicated for the prevention of deep vein thrombosis and resulting pulmonary embolism due to the present risk factors for thrombosis formation.
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.
Product codes
JOW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for University Health Care. The logo consists of a stylized "U" with a caduceus symbol on top, followed by the text "University Health Care" in a serif font. A line is present underneath the text. The right side of the image is blurry and contains a dark figure.
MAY 2 8 2008
Pre-Market Notification 510 (K) Summary
| Submitter Name: | University of Utah Hospitals and Clinics
50 North Medical Drive
Salt Lake City, UT 84132 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brent Alm
University of Utah Hospitals and Clinics
50 North Medical Drive
Salt Lake City, UT 84132
801-581-2847 |
| FDA Registration: | 3004595606 |
| Device Name: | Trade Proprietary Name - University Health Care Reprocessed Alternating
Leg Pressure (UHC APL) sleeve device |
| | Common or Usual Name - (ALP®) Alternating Leg Pressure Device |
| Classification: | Class II: Medical Device
Regulation: 21 CFR 870.5800
Panel Number: Panel 70
Product Code: JOW
Classification Name: Sleeve, Limb, Compression |
| Predicate Device: | Healthcare Service and Supply ALP® Alternating Leg Pressure Garment
K000303 |
| | 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-invasive
external compression system consisting of a pump/controller, connecting
tube and limb sleeve/garment device. |
| Intended Use: | To be used for patients for whom external compression therapy is
indicated for the prevention of deep vein thrombosis and resulting
pulmonary embolism due to the present risk factors for thrombosis
formation. |
University Health Care 510(k) Summary
1
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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Image /page/4/Picture/0 description: The image shows the logo for University Health Care. The logo consists of the letter U with a caduceus symbol inside of it. To the right of the U is the text "University Health Care" with a line underneath it.
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)
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