(69 days)
Not Found
No
The device description and performance studies focus on material properties and compression, with no mention of AI/ML.
Yes.
The device is used to manage medical conditions such as Edema, Lymphedema, and Hypertrophic scars, indicating a therapeutic purpose.
No
The device description indicates it is a compression gauntlet used for managing conditions like edema and lymphedema, which are therapeutic rather than diagnostic. It does not perform any measurements or analyses to determine the presence or nature of a medical condition.
No
The device description clearly states the device is a physical garment made of fabric (spandex, viscose, nylon yarns) and is a circular knit product with a sewn-in thumb piece. It provides compression through elastic yarns. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage conditions like Edema, Lymphedema, and Hypertrophic scars. This involves applying compression to the body externally.
- Device Description: The device is a gauntlet (a type of garment) made of fabric with elastic properties. It provides compression to the limb.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with or analyze any biological specimens.
The description clearly indicates a physical garment used for therapeutic purposes on the body, not a diagnostic tool used on samples in a lab.
N/A
Intended Use / Indications for Use
Jobst Ready-To-Wear Gauntlet may be used under the direction of a Healthcare professional to manage the flowing conditions:
Edema Lymphedema Hypertrophic scars
Product codes
DWL
Device Description
While the JUZO Gauntlet is flat knit and sewn together from fabric made of spandex, viscose and nylon yarns, the JOBST Ready-To-Wear Gauntlet is circular knit with spandex and nylon yarns. The thumb piece is then sewn in place in a second operation.
Both products are available in two compression ranges, 20-30 mmHg and 30-40 mmHq. the compression ranges most often prescribed by physicians for the indications involved. Both products are sized based on the palm and wrist measurements.
Compression is provided for all of these products by large elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps reduce capillary leakage and improve capillary and lymphatic absorption. Consequently, they can be used to manage the same indications, i.e. edema and lymphedema. These products can also be used to manage hypertrophic scars.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the direction of a Healthcare professional
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
The Fastox test is performed by NAMSA in Northwood, OH using three rabbits per test. The test area is observed at 24, 48 and 72-hour intervals.
Conclusion: Based on the above data it appears unlikely that use of the Jobst RTW Gauntlet will result in any significant skin irritation to the patient.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
510(k) Summary of Safety and Effectiveness
This submission covers the JOBST Ready-To-Wear Gauntlet, which falls under the device classification of medical support stockings (21 CFR §880.5780). It is equivalent to the JUZO Gauntlet, which is used for the same indications.
While the JUZO Gauntlet is flat knit and sewn together from fabric made of spandex, viscose and nylon yarns, the JOBST Ready-To-Wear Gauntlet is circular knit with spandex and nylon yarns. The thumb piece is then sewn in place in a second operation.
Both products are available in two compression ranges, 20-30 mmHg and 30-40 mmHq. the compression ranges most often prescribed by physicians for the indications involved. Both products are sized based on the palm and wrist measurements.
Compression is provided for all of these products by large elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps reduce capillary leakage and improve capillary and lymphatic absorption. Consequently, they can be used to manage the same indications, i.e. edema and lymphedema. These products can also be used to manage hypertrophic scars.
The product being submitted is substantially equivalent to the predicate product in the materials used, mode of action, and indications for use and can be considered as safe and effective as the predicate product.
Date: November 16, 2001
Prepared by: Angelo R. Pereira BSN-JOBST, Inc. 5825 Carnegie Boulevard Charlotte, NC 28209 Phone: (704) 551-7178
1
BIOCOMPATIBILITY Jobst Ready-To-Wear Gauntlet
The Jobst Ready-To-Wear (RTW) Gauntlet is made of spandex and nylon. These are the same fibers as used in the Jobst Custom garments (K925154) as well as in UltraSheer (Ultimate Stockings -- K920444) and the Ready-To-Wear Arm Sleeve (K991570).
The RTW Gauntlets are dyed in the same dye loads as the UltraSheer stockings and so are exposed to the same dyes and dye chemicals.
Samples of UltraSheer stockings have previously been tested using the Fastox Primary Skin Irritation test. There was no evidence of any skin irritation.
The Fastox test is performed by NAMSA in Northwood, OH using three rabbits per test. The test area is observed at 24, 48 and 72-hour intervals.
Conclusion: Based on the above data it appears unlikely that use of the Jobst RTW Gauntlet will result in any significant skin irritation to the patient.
Angelo Pereira Manager, Regulatory Affairs BSN-JOBST, Inc.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Ms. Angelo R. Pereira Manager of Regulatory Affairs BSN-Jobst, Incorporated 5825 Carnegie Boulevard Charlotte, North Carolina 28209-4633
Re: K013852
Trade/Device Name: Jobst Ready-To-Wear Gauntlet Regulation Number: 880.5780 Regulation Name: Compression Garments -- Gauntlet Regulatory Class: II Product Code: DWL Dated: November 16, 2001 Received: November 20, 2001
Dear Mr.Pereira:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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.
3
Page 2 - Mr. Pereira
You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must comply with and are labeling (21 CFR Part 801); good manufacturing practice allo listing (21 OF RT at 807), abolity 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.
This letter will allow you to begin marketing your device as described in your Section I hils icter will and w you to cogin manas finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 11 you doser app 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and Office of Confightance wee, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timotly A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number
Page 1 of 1
Device name: Jobst Ready-To-Wear Gauntlet
Indications For Use:
Over-the-Counter
Jobst Ready-To-Wear Gauntlet may be used under the direction of a Healthcare professional to manage the flowing conditions:
Edema Lymphedema Hypertrophic scars
Patricia Cicerale
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number 10/385
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR Over The Counter Use