(160 days)
Not Found
Not Found
No
The summary describes compression hosiery, a mechanical device, with no mention of AI, ML, image processing, or data-driven decision making.
Yes
The product's intended use clearly states that it helps prevent conditions such as leg discomfort, edema, and deep vein thrombosis (DVT), which are medical conditions, and therefore the device serves a therapeutic purpose.
No
Explanation: The device, Curad Compression Hosiery, is intended for prevention (of edema, leg discomfort, DVT) and applies pressure. It does not perform any diagnostic function such as identifying, measuring, or analyzing medical conditions or disease states.
No
The device is described as "Compression Hosiery," which is a physical garment and not software. The description focuses on the physical properties and intended use of the hosiery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Curad Compression Hosiery Function: The description clearly states that the Curad Compression Hosiery is a physical device applied externally to the legs. Its function is to apply pressure to the legs to help prevent edema, discomfort, and DVT. It does not involve testing samples from the body.
Therefore, based on the provided information, the Curad Compression Hosiery is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Curad Compression Hosiery is intended for use in helping prevent edema and leg discomfort, and helping prevent deep vein thrombosis (DVT) in individuals subjected to immobility.
15-20mmHg: Helps to prevent edema and leg discomfort, and helps to prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Especially for long distance travelers and those on their feet for extended periods of time.
20-30mmHg: Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
30-40mmHg: Helps to prevent edema and leg discomfort and helps to prevent deep vein thrombosis.
Product codes
DWL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5780 Medical support stocking.
(a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the three levels of government: federal, state, and local. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 1 2012
Mr. Matt Clausen Medline, Industries, Incorporated One Medline Place Mundelein, Illinois 60060
Re: K112769
Trade/Device Name: Curad® Compression Hosiery Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: January 19, 2012 Received: January 20, 2012
Dear Mr. Clausen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2- Mr. Clausen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, BS, MS, MBA Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K 11 3 7 6 9
Device Name:
Curad® Compression Hosiery
Indications For Use:
The Curad Compression Hosiery is intended for use in helping prevent edema and leg discomfort, and helping prevent deep vein thrombosis (DVT) in individuals subjected to immobility.
15-20mmHg: Helps to prevent edema and leg discomfort, and helps to prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Especially for long distance travelers and those on their feet for extended periods of time.
20-30mmHg: Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
30-40mmHg: Helps to prevent edema and leg discomfort and helps to prevent deep vein thrombosis.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Division of Anesthesiology, General Hospitalurrence of H, Office of Device Evaluation (ODE) Infection Control, Dental Devices
510(k) Number: K/12769