(177 days)
Not Found
Not Found
No
The device description focuses on mechanical compression and fabric components, with no mention of AI/ML terms or functionalities.
Yes
The device is intended to reduce the incidence of deep vein thrombosis, reduce pain and swelling, and increase arterial blood flow, all of which are therapeutic effects.
No
Explanation: The device is described as an accessory used for the prevention of deep vein thrombosis and pulmonary embolism by providing compression, not for diagnosing any condition.
No
The device description explicitly details physical components like inflatable bladders, fabric, tubing, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce the incidence of deep vein thrombosis, reduce pain and swelling, and increase arterial blood flow. These are therapeutic and preventative actions performed on the patient's body, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is described as an accessory to a system that provides compression to the legs. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is a therapeutic/preventative medical device used for physical compression.
N/A
Intended Use / Indications for Use
To reduce the incidence of deep vein thrombosis, reduce pain and swelling 10 rought or surgery and increase arterial blood flow.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The ClearMedical/Kendall SCDs are an accessory device to a SCD System which is used for the prevention of deep vein thrombosis and pulmonary embolism. The SCD Sleeve is designed with inflatable bladders that fill with air to provide compression to the legs. A connector tubing system attaches the SCD to the Controller svstem. The SCD Sleeves are latex-free, made of a polyester-cotton fabric. They are designed with velcro hook straps, three bladders and molded polyethylene tubing with a polypropylene snap-lock connector. Kendall has recently changed the device from the color blue to white. ClearMedical will designate the white SCDs with a "w" after the part number (i.e. 5330W).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
non-ambulatory patients in a hospital environment.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on an assessment of bench tests and non-clinical performance data, we believe that in all relevant safety and performance indicators the ClearMedical/ Kendall SCD Sleeves demonstrates substantial equivalence to the predicate devices, the Kendall SCD Sleeves.
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.
Not Found
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
K02606
Image /page/0/Picture/1 description: The image shows a logo with a water droplet inside a diamond shape. To the right of the logo, the text "FEB 6 2002" is printed in a bold, sans-serif font. The text likely represents a date, with "FEB" indicating February, "6" indicating the day, and "2002" indicating the year.
510(k) Summary
Image /page/0/Picture/3 description: The image shows the word "ClearMed" in a bold, sans-serif font. The letters are black against a white background. A small trademark symbol is located to the right of the word.
ClearMedical, Inc. Submitter's name and Address: 1776 - 13610 Place NE Bellevue, WA 98005 Ph (425) 401-1414 Fax (425) 401-1515 3017110 FDA Registration Number: Richard Radford Contact Person: Director of Research and Product Development August 8, 2001 Date Summary Prepared:
Trade or Proprietary Name:
Common Name:
Classification Name:
Sleeve, Limb, Compressible (per 21 CFR section 870.5800)/JOW
Sequential Compression Sleeves
ClearMedical/Kendall Sequential Compression
Equivalent Device
The ClearMedical/Kendall reprocessed Sequential Compression Device (SCD) Sleeves are substantially equivalent to the Kendall SCD Sleeves, Parts 5329, 5329W. 5330, 5330W. 5345, 5345W. 5480, and 5480W. This determination has been reached based on an evaluation and analysis of the predicate device's technical and promotional labeling and specific bench testing. For all established indicators of substantial equivalence, the ClearMedical devices demonstrated equality in safety and performance.
Device (SCD) Sleeves
Device Description:
The ClearMedical/Kendall SCDs are an accessory device to a SCD System which is used for the prevention of deep vein thrombosis and pulmonary embolism. The SCD Sleeve is designed with inflatable bladders that fill with air to
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1
510(k) Summary (Cont'd)
provide compression to the legs. A connector tubing system attaches the SCD to the Controller svstem.
The SCD Sleeves are latex-free, made of a polyester-cotton fabric. They are designed with velcro hook straps, three bladders and molded polyethylene tubing with a polypropylene snap-lock connector. Kendall has recently changed the device from the color blue to white. ClearMedical will designate the white SCDs with a "w" after the part number (i.e. 5330W).
Intended Use:
The ClearMedical/Kendall SCDs are intended as a single patient use accessory to a Kendall Controller System. The role of the SCD is to reduce the incidence of deep vein thrombosis, reduce pain and swelling after injurv and surgery, and increase arterial blood flow. The SCD Sleeves are used in conjunction with the Controller System for non-ambulatory patients in a hospital environment.
Technological Characteristics of ClearMedical and Predicate Devices:
The predicate device and the ClearMedical/Kendall SCDs contain bladders that inflate with air to control circulation of a limb. Attached to the Sleeve is a connector tubing system that connects to the Controller System. In form, the predicate device and the ClearMedical reprocessed SCD are the same.
Technological indicators of substantial equivalence were identified and included methods of infection control, fit/attachment, bladder function, velcro adhesion and connector function.
The predicate device is delivered to the customer labeled 'non-sterile' whereas the ClearMedical/Kendall SCDs are delivered to the customer labeled "High Level-Disinfected". ClearMedical's infection control methods meet or exceed the CDC standards ("Guideline for Handwashing and Hospital Environmental Control", 1985, "APIC Guideline for Selection and Use of Disinfectants") for this class of device.
Summary of ClearMedical/Kendall SCD Performance:
Based on an assessment of bench tests and non-clinical performance data, we believe that in all relevant safety and performance indicators the ClearMedical/ Kendall SCD Sleeves demonstrates substantial equivalence to the predicate devices, the Kendall SCD Sleeves.
2
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2002
Mr. Richard Radford Director of Research and Product Development ClearMedical, Inc. 1776 136th Place NE Belluvue, WA 98005-2328
Re: K012606
Trade Name: ClearMedical/Kendall Sequential Compression Device (SCD) Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: January 16, 2002 Received: January 17, 2002
Dear Mr. Radford:
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 deyice 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. Richard Radford
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso be actived that I Dr usean that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I 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 Of It 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) rms lotter will and will you to FDA finding of substantial equivalence of your device to a legally premation noticate 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 and 11 you docure bpoints art 809.10 for in vitro diagnostic devices), 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). Other general information on your responsibilities under the Act may be obtained from the Oiner general mironmation the mational 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,
cj
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
| 510(K) NUMBER (IF KNOWN): | K012606 |
|---|---|
| DEVICE NAME: | ClearMedical/Kendall Sequential Compression Devices (SCD) |
Part Numbers: 5329, 5330, 5345, 5480, 5329W, 5330W, 5345W, 5480W
INDICATIONS FOR USE:
To reduce the incidence of deep vein thrombosis, reduce pain and swelling 10 rought or surgery and increase arterial blood flow.
(Please do not write below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012606
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use _