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 Description

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 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 TRUFORM® 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.

AI/ML Overview

This document describes the TRUFORM® Ready-To-Wear Compression Arm Sleeve and TRUFORM® Ready-To-Wear Compression Gauntlet. The acceptance criteria and study detailed below focus on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics for a novel technology.

1. Table of Acceptance Criteria and Reported Device Performance

For the TRUFORM® Compression Arm Sleeve and Gauntlet, the primary acceptance criterion was substantial equivalence to their respective legally marketed predicate devices. This equivalence was assessed in terms of compression (mmHg) and user understanding/usability.

Acceptance Criterion	Reported Device Performance	Study Type
Compression (e.g., mmHg) Substantially equivalent to predicate devices in measuring mmHg of compression.	TRUFORM® sleeves and gauntlets were found to be substantially equivalent to Jobst predicate sleeves and gauntlets in measuring mmHg of compression.	Comparative Compression Bench Test
Usability and Label Comprehension Over-the-counter purchaser can read and understand instructions and properly use the device.	User studies demonstrated that 100% of responses to questions were "strongly agree" or "agree", indicating successful comprehension and usability.	Usability and Label Comprehension Study

2. Sample Size Used for the Test Set and the Data Provenance

Comparative Compression Bench Test: The sample size for this test is not explicitly stated in the provided document. It refers to comparing "Jobst predicate sleeves and TRUFORM® sleeves" and "Jobst predicate gauntlets and ТЯυFоям® gauntlets," implying multiple units were tested from each.
- Provenance: The provenance of the data is not specified (e.g., country of origin). It appears to be an internal bench test conducted by Surgical Appliance Industries, Inc.
- Retrospective/Prospective: As a bench test, it is inherently prospective in its data collection from the manufactured devices.
Usability and Label Comprehension Study: The sample size for this study is not explicitly stated. It refers to "User studies conducted," but does not give a number of participants.
- Provenance: The provenance of the data is not specified. It implies a general user study, likely conducted within the US given the FDA submission.
- Retrospective/Prospective: This was a prospective study, directly involving users interacting with the device and its labeling.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to the studies performed for this device.

For the comparative compression bench test, the "ground truth" was established by objective compression measurements (mmHg) using standard methods, not expert interpretation.
For the usability and label comprehension study, the "ground truth" was established by direct user responses and their ability to successfully use the product. Experts were not used for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable to the studies performed.

The comparative compression test relied on quantitative measurements, not subjective interpretation requiring adjudication.
The usability study relied on direct user feedback; any inconsistencies in responses would typically be analyzed rather than adjudicated by experts.

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

There was no MRMC comparative effectiveness study done. This device is a medical compression garment, not an AI-assisted diagnostic tool.

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

There was no standalone (algorithm only) performance study done. This device is a physical compression garment.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Comparative Compression Bench Test: The ground truth was objective physical measurement of compression (mmHg). This is a direct physical property of the device, not based on expert consensus, pathology, or outcomes data.
Usability and Label Comprehension Study: The ground truth was direct user feedback and observed user behavior demonstrating comprehension and proper usage.

8. The Sample Size for the Training Set

There was no "training set" in the context of an AI/machine learning model, as this device is a physical product and not an AI-driven system.

9. How the Ground Truth for the Training Set was Established

As there was no training set for an AI/machine learning model, this question is not applicable.

Summary

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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 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.

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 (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 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 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

Page 1 of 1

510(k) Number: K121106

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.