(176 days)
Not Found
No
The description focuses on the physical properties and intended use of compression stockings, with no mention of AI or ML.
Yes
The device is described as "Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs," which describes a therapeutic effect. Additionally, it is classified as "medical support stockings (21 CFR 880.5780)".
No
Explanation: The device, SunPolar Netex Medical Stockings, is described as providing compression to prevent blood pooling and apply controlled pressure. Its classification is "medical support stockings." There is no indication that it diagnoses any condition; rather, it is a therapeutic or preventative device.
No
The device description explicitly states it is a physical product (medical support stockings made of nylon and spandex yarns) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prevent the pooling of blood in the legs and apply controlled pressure to the legs." This is a physical action on the body, not a test performed on a sample taken from the body.
- Device Description: The device is described as "medical support stockings" made of "nylon and spandex yarns" that provide "compression." This aligns with a physical medical device, not a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or performing any kind of laboratory test.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and external.
N/A
Intended Use / Indications for Use
Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
Product codes
DWL
Device Description
The SunPolar Netex Medical stockings which fall under the device classification of medical support stockings (21 CFR 880.5780). Both products are produced on circular knit machines and are made of nylon and spandex yarns. They provide similar compression at the ankle. This submission covers the indication that compression stockings in the 20-40mmHg range can help to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
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
Over the Counter
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
MAR 2 0 2007
510 (k) Summary of Safety and Effectiveness
This submission covers the SunPolar Netex Medical stockings which fall under the device classification of medical support stockings (21 CFR 880.5780). The SunPolar Netex Medical Stockings are equivalent to the Jobst Travel Sock (K032325).
Both products are produced on circular knit machines and are made of nylon and spandex yarns. They provide similar compression at the ankle. This submission covers the indication that compression stockings in the 20-40mmHg range can help to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
The product being submitted is substantially equivalent to the predicate product in the materials used, mode of action, and indications for use, and can therefore be considered as safe and effective as the predicate product.
Date: January 22, 2007
Prepared by: James Wang E.C.I. (USA) Corporation 544 Fairways Circle St. Louis, MO 63141-7521 Phone: (314) 432-5656
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its head turned to the right, and its wings forming a protective shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2007
Mr. James Wang Director E.C.I (USA) Corporation 544 Fairways Circle Saint. Louis, Missouri 63141
Re: K062873
Trade/Device Name: Medical Support Stocking (Brand Name SunPolar Netex Stockings) Regulation Number: 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: January 30, 2007 Received: February 12, 2007
Dear Mr. Wang:
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.
2
Page 2 - Mr. Wang
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 vour 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) 276-0115. 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.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): 662873
Device Name: Medical Support Stocking (brand name SunPolar Netex Stockings)
Indications for Use:
Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
Over the Counter
Prescription Use (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)
Ald C. Ibyon for 3/20/07
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