TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET

K121106 · Surgical Appliance Industries, Inc. · DWL · Apr 27, 2012 · General Hospital

Device Facts

• Record ID: K121106
• Device Name: TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET
• Applicant: Surgical Appliance Industries, Inc.
• Product Code: DWL · General Hospital
• Decision Date: Apr 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The TRUFORM® Ready-To-Wear Compression Arm Sleeve is intended to be used to apply pressure to the upper extremity and is indicated for use in the management of mild to moderate Lymphedema and other edema, phlebitis, post-thrombotic syndrome and vascular malformations. The TRUFORM® Ready-To-Wear Compression Gauntlet is intended to be used to apply pressure to the hand and wrist and is indicated for use in the management of Lymphedema and other edema.

Device Story

TRUFORM Ready-To-Wear Compression Arm Sleeve and Gauntlet; circular knit nylon and spandex compression garments. Sleeve applies pressure to upper extremity; gauntlet applies pressure to hand and wrist. Sizing based on circumferential measurements of wrist, arm, and palm. Available in multiple sizes and compression levels (15-30 mmHg). Used by patients in home or clinical settings for management of lymphedema, edema, phlebitis, post-thrombotic syndrome, and vascular malformations. Provides mechanical compression to assist in fluid management. Over-the-counter availability; user-applied.

Clinical Evidence

Bench testing only. Comparative compression bench tests demonstrated equivalent mmHg performance against predicate devices. Usability and label comprehension study conducted with OTC purchasers; 100% of respondents strongly agreed or agreed that they could understand instructions and properly use the device.

Technological Characteristics

Circular knit compression garments; materials: nylon and spandex yarns. Latex-free, air-permeable. Available in 3 sizes. Compression levels: 15-20 mmHg and 20-30 mmHg. Mechanical compression principle. No software or electronic components.

Indications for Use

Indicated for management of mild to moderate lymphedema, edema, phlebitis, post-thrombotic syndrome, and vascular malformations in the upper extremity, hand, and wrist.

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

• Jobst Ready-To-Wear Gauntlet (K013852)
• Jobst Ready-To-Wear Sleeve (K991570)

Submission Summary (Full Text)

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K121106

APR 2 7 2012

# 510(k) Summary 807.92(c)

# SPONSOR

Telephone:

Fax:

#### 807.92(a)(1)

Company Name:

Surgical Appliance Industries, Inc.

Company Address

3960 Rosslyn Drive Cincinnati, Ohio 45209-1195 800-888-0458 800-300-0055

Contact Person: Gary Parsons

Summary Preparation Date: December 13, 2011

DEVICE NAME 807.92(a)(2) Trade Name: TRUFORM® Ready-To-Wear Compression Arm Sleeve TRUFORM® Ready-To-Wear Compression Gauntlet Common/Usual Name: Compression Garment Classification Name: Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) Regulation Number: 880.5780 Product Code: DWL Device Class: Class II

#### PREDICATE DEVICE

807.92(a)(3) Legally Marketed Equivalent Device 510k # Manufacturer Product K013852 Jobst Ready-To-Wear Gauntlet BSN-Jobst, Inc. K991570 Jobst Ready-To-Wear Sleeve BSN-Jobst, Inc.

#### DEVICE DESCRIPTION

## 807.92(a)(4)

The TRUFORM® Ready-To-Wear Compression Arm Sleeve is circular knit with nylon and spandex yarns, is available in 3 sizes -- small, medium, and large, and is latex free, air-permeable and available in beige, black and brown.

The sizing of the TRUFORM® Ready-To-Wear Compression Arm Sleeve is based on circumferential measurements taken around the smallest part of the wrist, mid-lower arm, and around the mid-upper arm and is limited to individuals that fall within those specified ranges.

The TRUFORM® Ready-To-Wear Compression Gauntlet is circular knit with nylon and spandex yarns, is available in 3 sizes - small with compression of 15- 20 mmHg, medium with

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compression of 20-30 mmHg and large with compression of 20-30 mmHg. The thumb piece is sewn in place during a second operation. The Тклюям® Ready-To-Wear Compression Gauntlet is latex free, air-permeable and available in beige, black and brown.

The sizing of the TRUFORM® Ready-To-Wear Compression Gauntlet is based on circumferential measurements taken around the palm and around the smallest part of the wrist, and is limited to individuals that fall within those specified ranges in sizing chart.

#### DEVICE INTENDED USE

#### 807.92(a){5)

The TRUFORM® Ready-To-Wear Compression Arm Sleeve is Intended to be used to apply pressure to the upper extremity and is indicated for use in the management of mild to moderate Lymphedema and other edema, phlebitis, post-thrombotic syndrome and vascular malformations.

The TRUFORM® Ready-To-Wear Compression Gauntlet is Intended to be used to apply pressure to the hand and wrist and is indicated for use in the management of Lymphedema and other edema.

### COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

The TRUFORM® Ready-To-Wear Compression Arm Sleeve and TRUFORM® Ready-To-Wear Compression Gauntlet are similar to the predicate devices in material used, mode of action and indications for use and can be considered as safe and effective as the predicate products.

#### NONCLINICAL TEST

#### 807.92(b)

## SAFETY and EFFECTIVENESS

Comparative compression bench test

A comparative compression bench test was conducted to determine the substantial equivalence of the TRUFORM® Ready-To-Wear Arm Sleeve compared to the Jobst Ready-To-Wear Arm Sleeve (K991570). Comparative testing reveals that Jobst predicate sleeves and TRUFORM® sleeves are substantially equivalent in measuring mmHg of compression.

A comparative compression bench test was conducted to determine the substantial equivalence of the TRUFORM® Ready-To-Wear Gauntlet compared to the Jobst Ready-To-Wear Gauntlet (K013852). Comparative testing reveals that Jobst predicate gauntlets and Тяυғоям® gauntlets are substantially equivalent in measuring mmHg of compression.

#### Usability and Label Comprehension Study

User studies conducted for usability and label comprehension showed that the over the counter purchaser of this device could read and understand the instructions, and could properly use the device.

The results demonstrated that 100% of the responses to the questions were strongly agree or agree.

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# CONCLUSION

# 807.92(b)(3)

The Ткогокм® Ready-To-Wear Compression Gauntlet and Тяυғоям® Arm Sleeve are substantially equivalent to the predicate device in:

- Intended Use .
- Material Characteristics and .
- Performance Characteristics .

After analyzing comparative compression bench test and user testing data, it is the conclusion of Surgical Appliance Industries that the Тюговм® Ready-To-Wear Compression Arm Sleeve and TRUFORM® Ready-To-Wear Compression Gauntlet are as safe and effective as the predicate device. User studies showed that the over the counter purchaser of this device could read and understand the instructions and could properly use the product.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is in all caps. The text is likely part of a document or form from the Department of Health and Human Services.

Public Health Service

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

Surgical Appliance Industries, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K121106

Trade/Device Name: TruForm® Ready-To-Wear Arm Sleeve and Gauntlet Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: April 11, 2012 Received: April 12, 2012

Dear Mr. Devine:

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.

APR 2 7 2012

Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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## Page 2 - Ms. Devine

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.html 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 D. Watson, B.S., M.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

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# Indications for Use Form

# Indications for Use

K121106 510(k) Number (if known):

Device Name: TruForm® Ready-To-Wear Arm Sleeve and Gauntlet

Indications for Use:

The TRUFORM® Ready-To-Wear Compression Arm Sleeve is intended to be used to apply pressure to the upper extremity and is indicated for use in the management of mild to moderate Lymphedema and other edema, phlebitis, post-thrombotic syndrome and vascular malformations.

The TRUFORM® Ready-To-Wear Compression Gauntlet is intended to be used to apply pressure to the hand and wrist and is indicated for use in the management of Lymphedema and other edema.

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)

Ali C. Ay. 4/27/12

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

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510(k) Number: K121106