(15 days)
No
The device description and performance studies focus on the physical properties and sizing of compression garments, with no mention of AI or ML technologies.
Yes
The device is intended for the management and treatment of medical conditions such as Lymphedema, other edema, phlebitis, post-thrombotic syndrome, and vascular malformations, making it a therapeutic device.
No
The device is a compression garment intended for management of conditions like lymphedema, not for diagnosing them.
No
The device description clearly states it is a physical product made of nylon and spandex yarns, available in different sizes and colors, and its performance is evaluated through bench tests measuring compression in mmHg. This indicates a hardware-based medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TRUFORM® Ready-To-Wear Compression Arm Sleeve and Gauntlet are external devices applied to the body to provide physical pressure. They do not analyze any biological samples.
- Intended Use: The intended use is to apply pressure to the upper extremity and hand/wrist for the management of conditions like lymphedema and edema. This is a physical therapy/supportive function, not a diagnostic one based on analyzing biological samples.
The information provided clearly describes a medical device used for external physical support and management of conditions, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
DWL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity, hand and wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
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 TRUFORM® 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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.
2
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.
3
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.
4
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
5
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
Page 1 of 1
510(k) Number: K121106