The Renfro Compression Socks are intended to help prevent pooling of blood in the legs by controlled pressure in the legs and help prevent deep vein thrombosis (DVT), edema and leg discomfort in individuals subjected to immobility

Device Description

The Renfro Compression Socks are devices intended to help prevent pooling of blood and fluid to the extremities by applying controlled pressure. The Renfro compression socks are knitted using yarns made of nylon, polyester, cotton and spandex.

AI/ML Overview

This is a 510(k) premarket notification for Renfro Compression Socks. This device is a Class II medical support stocking, and the submission establishes substantial equivalence to a predicate device rather than presenting a de novo performance study with acceptance criteria.

Therefore, the requested information elements related to standalone performance, MRMC studies, ground truth establishment, and test/training set details are not applicable in this context. The submission focuses on demonstrating that the new device has "similar physical and technical characteristics" to an already legally marketed device.

Here's the relevant information that can be extracted:

1. A table of acceptance criteria and the reported device performance

Characteristics	Acceptance Criteria (Predicate)	Reported Device Performance (Renfro Compression Socks)
Function	Prevent pooling of blood in legs	Prevent pooling of blood in legs
Principle of Operation	Application of controlled pressure	Application of controlled pressure
Anatomical Site	Foot/leg	Foot/leg
Prescription/over-the-counter use	Over-the-counter	Over-the-counter
Performance Testing (Specific Criteria)	Implied equivalence to predicate performance	"Comparative compression strength"

Note: The submission states that "All necessary performance testing has been conducted for the Renfro Compression Socks to assure substantial equivalence to the predicate devices and demonstrate the devices perform as intended." However, it does not explicitly list quantitative acceptance criteria for compression strength or provide detailed results beyond stating that it was tested comparatively. The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate.

2. Sample size used for the test set and the data provenance

Not Applicable: This submission is for a medical support stocking, not a diagnostic or AI-driven device requiring a "test set" in the conventional sense of clinical data. The performance section mentions "test units representative of finished devices" for comparative compression strength, but does not provide a specific sample size or provenance for a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: No clinical test set requiring expert ground truth was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: No clinical test set requiring adjudication was described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: No MRMC study was conducted as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This is not a standalone algorithm; it is a physical medical device (compression socks).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable: The evaluation is based on technical characteristics and comparative physical performance, not on diagnostic ground truth.

8. The sample size for the training set

Not Applicable: There is no training set mentioned, as this is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

Not Applicable: No training set described.

Summary

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K123398

Section 6

510(k) Summary

6. 510(k) Summary

DEC 1 8 2012

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Renfro Corporation
DATE PREPARED:	October 31, 2012
CONTACT PERSON:	Rebecca K PineRenfro CorporationPO Box 908611 Linville RoadMount Airy, NC 27030Phone: (760) 809.5178
TRADE NAME:	Dr. Scholl's Compression Socks
COMMON NAME:	Compression Socks
CLASSIFICATIONNAME:	Medical Support Stockings
DEVICECLASSIFICATION:	Class 2, per 21 CFR 880.5780
PRODUCT CODE	DWL

PREDICATE DEVICES: Elastic Therapy, Inc. Rx Fit Medical Socks (K925643)

Substantially Equivalent To:

The Renfro Compression Socks are substantially equivalent in intended use, principal of operation and technological characteristics to the Elastic Therapy, Inc. Rx Fit Medical Socks (K925643).

Description of the Device Subject to Premarket Notification:

Indication for Use:

Renfro Corporation Compression Socks

Page 11 of 63 Premarket Notification

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Section 6

Technical Characteristics:

The Renfro Compression Socks have similar physical and technical characteristics to the predicate devices. These characteristics are tabulated below:

Characteristics	Renfro Compression Socks	Elastic Therapy, Inc, Rx FitMedical Socks
Function	Prevent pooling of blood in legs	Prevent pooling of blood in legs
Principle of Operation	Application of controlledpressure	Application of controlledpressure
Anatomical Site	Foot/leg	Foot/leg
Prescription/over-the-counter use	Over-the-counter	- Over-the-counter

Performance Data:

All necessary performance testing has been conducted for the Renfro Compression Socks to assure substantial equivalence to the predicate devices and demonstrate the devices perform as intended. All testing was performed on test units representative of finished devices. Testing included:

. Comparative compression strength

Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Renfro Compression Socks are determined by Renfro Corporation, to be substantially equivalent to existing legally marketed devices.

Renfro Corporation Compression Socks Page 12 of 63 Premarket Notification

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2012

Ms. Rebecca K. Pine Renfro Corporation PO Box 908 661 Linville Road MOUNT AIRY NC 27030

Re: K123398

Trade/Device Name: Renfro Compression Socks Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: October 31, 2012 Received: November 5, 2012

Dear Ms. Pine:

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.

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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 Lo Russo

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): 123 398

Device Name: Renfro Compression Socks

Indications for Use:

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (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 (ODE)

Page of

Digitally signed by Richard C.

Chapman Date: 2012.12.12.18 13:15:58 -05'00'

(Division Sign-Off) (Division Sign-On)
Division of Anestheslology, General Hospital Infection Control, Dental Devices

K123398 510(k) Number;

Regulation Number and Section

§ 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.