(330 days)
K031559, 031559
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description and intended use point to a physical compression device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "non-invasive therapeutic method" for preventing deep vein thrombosis and pulmonary embolism, and for intra-operative compression therapy.
No
The device is described as a "non-invasive therapeutic method" to prevent deep vein thrombosis and for intra-operative compression therapy. It focuses on treatment/prevention rather than diagnosis.
No
The device description and intended use clearly indicate a physical device (reprocessed ALP®1 for calf compression) and bench testing related to its performance, not a software-only product.
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 provide intra-operative compression therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description mentions a "Reprocessed (up to 18" calf circumference)" device, which aligns with a physical compression device used on the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Focus on Therapy: The entire description points towards a device used for treatment and prevention, not for diagnosing a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Prevent deep vein thrombosis and resulting pulmonary embolism.
- Intra-operative compression therapy.
The ReNu Medical Reprocessed ALP®1 is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to: - Prevent deep vein thrombosis and resulting pulmonary embolism.
Product codes
JOW
Device Description
The ReNu Medical Reprocessed (up to 18" calf circumference)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Calf
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients in both the home and institutional settings
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)
Bench testing was conducted to ensure that reprocessing did not compromise the performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031559, 031559
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
Ko5/227
510 (k) Summary
Submitters Name and Address: ReNu Medical 9800 Evergreen Way Everett, WA 98024 Phone: 425-353-1110 Fax: 425-353-1110
FDA Registration Number: 3034520
Contact Person: L. Bruce Pierson Chief Operating Officer
Date Summary Prepared: 3-12-05
Trade or Proprietary Name(s): ReNu Medical Reprocessed ALP®1 Calf Garment (up to 18" calf circumference)
APR
6 2006
Common Name:
Sleeve, Limb, Compression
Product Code:
JOW
Panel
Cardiovascular 870.5800
Classification:
Class II
Equivalent Device(s)
Re Nu Medical Reprocessed Kendall Impad - 510(k) # K031559 Re Nu Medical Reprocessed Huntleigh Flowtron - 510(k) # 031559
Device Description:
The ReNu Medical Reprocessed (up to 18" calf circumference)
CONFIDENTIAL
1
Intended Use
- · Prevent deep vein thrombosis and resulting pulmonary embolism.
- Intra-operative compression therapy. .
Technological Characteristics of the ReNu Medical Reprocessed Healthcare Service and Supply ALP™ 1 Calf Garment.
The predicate devices and the ReNu Medical ALP®1 Sequential Compression Sleeve are identical in overall design, materials, energy source, mode of operation, performance techniques, and reprocessing methodology.
Summary of Comparison Tests
Bench testing was conducted to ensure that reprocessing did not compromise the performance of the device.
Biocompatability
Reprocessing does not affect the biocompatibility of the device.
Process Validation:
Validation information has been provided as part of this submission to demonstrate that the device safety and. performance is not impacted by subsequent reprocessing
Image /page/1/Picture/11 description: The image shows the word "CONFIDENTIAL" in bold, uppercase letters. The word is slightly tilted, with the left side appearing lower than the right. The text is dark against a lighter background, making it stand out.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2006 APR
ReNú Medical c/o Mr. L. Bruce Pierson Chief Operating Officer 9800 Evergreen Way Everett, WA 98204-2780
Re: K051227
ReNu Reprocessed ALP®1 Calf Garment (up to 18" calf circumference) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: December 23, 2005 Received: January 11, 2006
Dear Mr. Pierson:
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. L. Bruce Pierson
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 vours,
Bhimmarfor
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: ReNu Reprocessed ALP®1 Calf Garment (up to 18" calf circumference)
Indications for Use:
The ReNu Medical Reprocessed ALP®1 is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:
- Prevent deep vein thrombosis and resulting pulmonary embolism. .
Precautions and Contraindications:
Sleeves may not be recommended for patients with the following:
- Any local leg condition in which sleeves would interfere: dermatitis, gangrene, . recent skin graft, untreated infected wounds.
- Congestive heart failure. .
- Severe arteriosclerosis or other ischemic vascular disease. .
- . Pulmonary edema.
- Known or suspected deep vein thrombosis or phlebitis. .
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Btmuna
Page 1 of
Division Slan-Offi Division of Cardlovascular Devices 510(k) Number
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