(71 days)
Not Found
No
The device description and other sections do not mention any AI or ML technology. The device is a simple compression sock.
Yes
The device is intended to help prevent edema, leg discomfort, and deep vein thrombosis, which are therapeutic effects aimed at preventing and alleviating medical conditions.
No
The device description focuses on its mechanism of action (compression) to prevent conditions like edema and DVT, not to identify or diagnose existing conditions. There are no mentions of diagnostic capabilities, imaging, or AI/ML for detection.
No
The device description clearly states it is a physical product (compression socks) made of nylon and spandex, not software.
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.
- Device Description: The provided description clearly states that the device is a physical product (compression socks) worn externally on the body.
- Intended Use: The intended use is to physically apply compression to the legs to prevent edema and DVT, not to analyze biological samples.
The information provided describes a medical device that provides physical therapy/support, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Help prevent edema and leg discomfort, and help prevent deep vein thrombosis in individuals subjected to immobility. This submission covers the indication that Shape to Fit Compression Socks(including same products offered for OEM applications) help encourage circulatory wellness and prevent, ankles and feet, and alleviate swelling in legs and help prevent deep varicose veins.
Product codes (comma separated list FDA assigned to the subject device)
DWL
Device Description
Shape to Fit Compression Socks and their substantial equivalents, mentioned above, are compression socks knitted by circular knit machines with nylon and spandex. They all include knee-high which are sized based on ankle and calf circumference fit. Shape to Fit Compression Socks provide controlled, uniform graduated compression, as is provided in all of these substantially equivalent products, starting with more compression circumferentially at the ankle at approximately 15 mmHg to 20 mmHg / 20 mmHg to 30 mmHg (based on average ankle size) then gradually decreases up to the proximal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Legs, ankles and feet
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
See Section on Performance Testing -for nonclinical testing that demonstrates that the device is safe, effective, and performs in comparison to predicate devices.
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
§ 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
ः
510(k) SUMMARY
510(K) SUMMARY
510 (K) Number K101906 Device Name: Shape to Fit Compression Socks
Indications for Use: Help prevent edema and leg discomfort, and help prevent deep vein thrombosis in individuals subjected to immobility.
Over-The-Counter Use
Classification Name: Medical Support Stocking (21 CFR 880.5780, Product Code DWL. This submission covers the indication that Shape to Fit Compression Socks(including same products offered for OEM applications) help encourage circulatory wellness and prevent, ankles and feet, and alleviate swelling in legs and help prevent deep varicose veins. These products fall under the device classification of medical support stockings (21 CFR 880.5780), Class II medical device, Product Code DWL. Shape to Fit Compression Socks (including same products offered for OEM applications) that belong to this category, and they are substantially equivalent to (K062873) Medical Support Stocking(Brand Name Supolar Netex Stockings), Therafirm anti-embolism stockings, Knit-Rite Inc ( K091141) and Jobst Institute Inc. (K032325).
Shape to Fit Compression Socks and their substantial equivalents, mentioned above, are compression socks knitted by circular knit machines with nylon and spandex. They all include knee-high which are sized based on ankle and calf circumference fit. Shape to Fit Compression Socks provide controlled, uniform graduated compression, as is provided in all of these substantially equivalent products, starting with more compression circumferentially at the ankle at approximately 15 mmHg to 20 mmHg / 20 mmHg to 30 mmHg (based on average ankle size) then gradually decreases up to the proximal end.
The Shape to Fit products being submitted are substantially equivalent to the predicate product in material content, function and indication and as such can be considered as safe and effective as the referenced, predicate products. This statement is to assure that Shape to Fit Compression Socks is safe and effective when worn for their intended purpose and fit properly according to the guidelines. See Section on Performance Testing -for nonclinical testing that demonstrates that the device is safe, effective, and performs in comparison to predicate devices.
1
Image /page/1/Picture/0 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 symbol that resembles three overlapping human figures or abstract shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Peggy Kuo Overseas Manager Tsung Hau Technology Company, Limited 3F Building A, No. 248-21, Sinsheng Road Taiwan, R.O.C. China (Taiwan) 806 KH
SEP 1 7 2010
Re: K101906
Trade/Device Name: Shape to Fit Compression Socks Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: August 26, 2010 Received: August 26, 2010
Dear Ms. Kuo:
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.
2
Page 2- Ms. Kuo
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.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
3
SEP 1 7 2010
INDICATION FOR USE
Indications for Use
510(k) Number (if known):K 101906
Device Name: Shape to Fit Compression Socks
Indications for Use:
Help prevent edema and leg discomfort, and help prevent deep vein thrombosis in individuals subjected to immobility
Prescription Use _____________________________________________________________________________________________________________________________________________________________ ( Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODB
C. Office of Device Evaluation (ODE)
Al C. A
9/7/10
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devises Division of Amorol, Dental Devices
510(k) Number: K/01906