(95 days)
Not Found
No
The device description and other sections do not mention any AI or ML technology. The device is a compression sock, which is a mechanical device.
Yes
The intended use explicitly states the device helps prevent edema, leg discomfort, and deep vein thrombosis, which are therapeutic claims.
No
Explanation: The device description and intended use indicate that Therafirm Trouser Socks are used to help prevent edema, leg discomfort, and deep vein thrombosis. There is no mention of the device being used to diagnose any condition.
No
The device description clearly states it is a physical product (knit socks made of nylon and spandex) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly indicate that this device is a physical garment (socks) worn on the legs to provide compression. It does not involve the analysis of any biological specimens.
- Lack of IVD-related terms: The document does not mention any terms related to laboratory testing, specimen analysis, or diagnostic procedures.
Therefore, the Therafirm Trouser Socks are a medical device, but they fall under a different category than In Vitro Diagnostics. They are likely classified as a Class I or Class II medical device based on their intended use and mechanism of action (compression).
N/A
Intended Use / Indications for Use
Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers Over-The-Counter Use
The submission covers the indication for compression stockings in the 15-20 mmHg range, such as the Therafirm gradient compression trouser socks (including same products offered for OEM applications), help prevent edema and leg discomfort, and help prevent deep vein thrombosis, appecially for long distance travelers.
Help prevent edema and leg discomfort, and help prevent deep vein thrombosis in individuals subjected to immobility.
Product codes (comma separated list FDA assigned to the subject device)
DWL
Device Description
Therafirm Trouser Socks and their substantial equivalents are knit on circular knit machines. These products are made with nylon and spandex; however some Therafirm Trouser Socks contain Coolmax/Lycra for the wearer's comfort. Therafirm Trouser Socks and their substantial equivalents provide similar compression at the ankle, are sized based on ankle and calf circumferences, and include shoe sizes as a helpful reference.
The controlled gradient compression provided in both of these substantially equivalent products, starting with more compression circumferentially at the ankle and gradually decreases up to the surting will more capillary leakage, prevent pooling of blood, and improve blood, and improve blood flow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, calf, leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 - Bench and Exhibits on pages 40 - 43 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 Safety and Effectiveness Men's Trouser Socks and Women's Trouser Socks
KO91141
mended
9/01/11
510(K) Number K091141
Device Name: Therafirm Men's Trouser Socks and Women's Trouser Socks Indications for Use: Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers Over-The-Counter Use
Classification Name: Medical Support Stocking (21 CFR 880.5780, Product Code DWL
This submission covers the indication for compression stockings in the 15-20 mmHg range, such as the Therafirm gradient compression trouser socks (including same products offered for OEM applications), help prevent edema and leg discomfort, and help prevent deep vein thrombosis, appecially for long distance travelers. These products fall under the device classification of medical support stockings (21 CFR 880.5780), Class II medical device, Product Code DWL. Mother's Therafirm division manufactures Men's Trouser Socks and Women's Trouser Socks that fall in to this category, and they are substantially equivalent to Jobst Travel Socks (K032325) and SSL Americas Flight Sock (K040353).
Therafirm Trouser Socks and their substantial equivalents are knit on circular knit machines. These products are made with nylon and spandex; however some Therafirm Trouser Socks contain Coolmax/Lycra for the wearer's comfort. Therafirm Trouser Socks and their substantial equivalents provide similar compression at the ankle, are sized based on ankle and calf circumferences, and include shoe sizes as a helpful reference.
The controlled gradient compression provided in both of these substantially equivalent products, starting with more compression circumferentially at the ankle and gradually decreases up to the surting will more capillary leakage, prevent pooling of blood, and improve blood, and improve blood flow.
The 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 product.
This statement is to assure that Therafirm Trouser Socks are safe and effective when worn for their intended purpose and fit properly according to the guidelines.
See Section on Performance Testing - Bench and Exhibits on pages 40 - 43 for nonclinical testing that demonstrates that the device is safe, effective, and performs in comparison to predicate devices.
Contact Person: Jeffrey Dalbey
Therafirm Hosiery Company A Div. Of Knit-Rite, Inc. 126 Mill St. Ellerbe, NC 28338 Phone: 910-652-5541 800-462-4707 Fax:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 9 4 2009
Mr. Jeffrey C. Dalbey Director of R & D Knit-Rite, Incoporated Therafirm Hosiery Company 126 Mill Street Ellerbe, North Carolina 28338
Re: K091141
Trade/Device Name: Therafirm Anit-Embolism Stockings, Therafirm Men's Trouser Socks and Women's Trouser Socks
Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: · DWL Dated: July 2, 2009 Received: July 6, 2009
Dear Mr. Dalbey :
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 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. Dalbey
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony-U, On water fun
S. R. R. S. V. A.
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
U.S. Department.of Haulth & Hunba Services
Indications for Use Form
510(k) Number (if known): K091141
Device Name: Therafirm Anti-Embolism Stockings
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)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Page 9 (Amended 7-21-09)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Qtf) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091141
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)