(76 days)
Not Found
No
The document describes a mechanical compression device and its reprocessing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time, all of which are therapeutic effects.
No.
The device is a compression sleeve intended to prevent deep vein thrombosis and pulmonary embolism by applying pressure. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease.
No
The device description explicitly states that the system consists of a control unit, inflatable limb sleeves, and conduit tubing, and that only the compression sleeves are reprocessed. This indicates the device includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies external pressure to the lower extremities to prevent DVT and other circulatory issues. This is a physical intervention, not a test performed on biological samples in vitro (outside the body).
- Device Description: The description details a system of a control unit, inflatable sleeves, and tubing. This aligns with a physical compression device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
- 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 for Use: "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."
Product codes
JOW
Device Description
"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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study type: Bench and laboratory testing
- Sample size: Not Found
- AUC: Not Found
- MRMC: Not Found
- Standalone performance: Not Found
- Key results: "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K05 33/6
FEB 1 3 2006
SECTION B: 510(k) SUMMARY
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Moira Barton
Regulatory Affairs Manager
(480) 763-5350 (o)
(480) 763-5310 (f)
mbarton@alliance-medical.com |
| Date of preparation: | July 25, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed Compression Sleeves
Common or Usual Name: Compression Sleeve
Classification Name: Compressible Limb Sleeve |
| Predicate device: | |
| K Number
K012994 | Device Description
WizAir DVT™ Compressible Limb Sleeve |
| Device description: | 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. |
| 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
statement: | 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. |
| 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
Alliance Medical Corporation
Reprocessed Compression Sleeves
Traditional 510(k) |
.
1
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, labeling, and EO exposure operations.
- Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Compression Sleeves.
- Biocompatibility .
- Function Test(s) .
- Validation of Processing .
Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended.
Alliance Medical Corporation concludes that the modified Conclusion: devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices as described herein.
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 forming its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Allance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs 10232 South 51st Street Phoenix, AZ 85044
Re: K053316
Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: November 15, 2005 Received: November 29, 2005
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.
3
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dina R lochines
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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Indications For Use Statement 1.
510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves
Indications For Use: When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing postdovioo are intended log, enhancing blood circulation, 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 NONT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana R. McAnes
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K053316
Confidential
Alliance Medical Corporation Reprocessed ActiveCare™ Compression Sleeves Traditional 510(k)
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