DR. SCHOLL'S COMPRESSION SOCKS

K123398 · Renfro Corporation · DWL · Dec 18, 2012 · General Hospital

Device Facts

• Record ID: K123398
• Device Name: DR. SCHOLL'S COMPRESSION SOCKS
• Applicant: Renfro Corporation
• Product Code: DWL · General Hospital
• Decision Date: Dec 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Renfro Compression Socks are medical support stockings designed to prevent blood and fluid pooling in the lower extremities. The device applies controlled pressure to the legs to mitigate risks associated with immobility, such as deep vein thrombosis (DVT), edema, and general leg discomfort. The socks are constructed from a knit blend of nylon, polyester, cotton, and spandex. They are intended for over-the-counter use by individuals experiencing immobility. The device functions through passive mechanical compression; no active power source or electronic components are involved. Clinical benefit is derived from the application of graduated or controlled pressure to support venous return.

Clinical Evidence

Bench testing only. Performance testing included comparative compression strength analysis to demonstrate that the device provides the intended pressure profile and is equivalent to the predicate device.

Technological Characteristics

Knitted compression stockings composed of nylon, polyester, cotton, and spandex. Principle of operation is passive mechanical application of controlled pressure to the foot and leg. Over-the-counter, non-powered, standalone device.

Indications for Use

Indicated for individuals subjected to immobility to help prevent blood pooling in the legs, deep vein thrombosis (DVT), edema, and leg discomfort.

Regulatory Classification

Identification

Medical support stocking to prevent the pooling of blood in the legs: 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. Medical support stocking for general medical purposes: 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.

Special Controls

*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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Predicate Devices

• Elastic Therapy, Inc. Rx Fit Medical Socks (K925643)

Submission Summary (Full Text)

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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 Pine<br>Renfro Corporation<br>PO Box 908<br>611 Linville Road<br>Mount Airy, NC 27030<br>Phone: [phone] |
| TRADE NAME: | Dr. Scholl's Compression Socks |
| COMMON NAME: | Compression Socks |
| CLASSIFICATION<br>NAME: | Medical Support Stockings |
| DEVICE<br>CLASSIFICATION: | 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:

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.

#### Indication for Use:

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.

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 Fit<br>Medical Socks |
|---------------------------------------|---------------------------------------|-----------------------------------------------|
| Function | Prevent pooling of blood in legs | Prevent pooling of blood in legs |
| Principle of Operation | Application of controlled<br>pressure | Application of controlled<br>pressure |
| Anatomical Site | Foot/leg | Foot/leg |
| Prescription/<br>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 [phone] or [phone] 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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5. Indications for Use Statement

#### INDICATIONS FOR USE STATEMENT

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

Device Name: Renfro Compression Socks

Indications for Use:

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

#### 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;