(107 days)
Jobst Ready-To-Use Arm Sleeve may be used under the direction of a healthcare professional to manage the flowing conditions: Edema Mild to moderate lymphedema Phlebitis Post-thrombotic syndrome Vascular Malformations Hypertrophic scars
This submission covers JOBST Ready-To-Wear Compression Arm Sleeves, which fall under the device classification of medical support stockings (21 CFR §880.5780). They are equivalent to the preamendment Jobst-Custom garments, and the SIGVARIS 902/503 Arm Sleeves, which are used for the same indications. While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon varns, the SIGVARIS 902 and JOBST Ready-To-Wear Arm Sleeves are circular knit with spandex and nylon yarns. The sizing of the Ready-To-Wear Arm Sleeves is based on circumferential measurements of the wrist, forearm and mid-upper arm and is limited to people whose arm dimensions fall within the specified ranges. The Jobst-Custom garments are sized based on measurements taken every inch and a half. They can be made to fit a wider range of limb dimensions and a wider range of compression as needed by the individual patient. 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 to force fluid into the deep venous system and helps in the return of lymphatic fluid.
The provided text is a 510(k) summary for a medical device (compression arm sleeves) and an FDA clearance letter. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment for an AI/ML device.
This document pertains to a traditional medical device (compression garments) that gained market clearance through the "substantial equivalence" pathway, meaning it was deemed as safe and effective as existing legally marketed predicate devices. This type of submission relies on comparisons to established devices and typically does not involve the rigorous testing and validation studies outlined in your request, which are more applicable to novel diagnostic or AI/ML-driven devices.
Therefore, I cannot extract the requested information from the provided text.
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510(k) Summary of Safety and Effectiveness
This submission covers JOBST Ready-To-Wear Compression Arm Sleeves, which fall under the device classification of medical support stockings (21 CFR §880.5780). They are equivalent to the preamendment Jobst-Custom garments, and the SIGVARIS 902/503 Arm Sleeves, which are used for the same indications.
While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon varns, the SIGVARIS 902 and JOBST Ready-To-Wear Arm Sleeves are circular knit with spandex and nylon yarns.
The sizing of the Ready-To-Wear Arm Sleeves is based on circumferential measurements of the wrist, forearm and mid-upper arm and is limited to people whose arm dimensions fall within the specified ranges. The Jobst-Custom garments are sized based on measurements taken every inch and a half. They can be made to fit a wider range of limb dimensions and a wider range of compression as needed by the individual patient.
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 to force fluid into the deep venous system and helps in the return of lymphatic fluid. Consequently, they can be used to manage the same indications. i.e. CVI, edema, lymphedema, phlebitis, post-thrombotic syndrome and vascular malformations. These products can also be used to manage hypertrophic scars and post liposuction for the arms. The contraindications for these products are also the same, i.e. significant arterial insufficiency, cutaneous infections, dermatitis in the acute phase, wet dermatosis and conditions in which venous and lymphatic return is not desired.
The product being submitted is substantially equivalent to the predicate products in the materials used, mode of action, and indications for use and can be considered as safe and effective as the predicate products.
Date: May 4, 1999
Prepared by: Angelo R. Pereira Beiersdorf-Jobst. Inc. 5825 Carnegie Boulevard Charlotte, NC 28209 Phone: (704) 551-7178
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1999
Mr. Angelo Pereira Manager, Requlatory Affairs Beiersdorf-Jobt, Incorporated 5825 Carnegie Boulevard Charlotte, North Carolina 28209-4633
Re : K991570 Jobst Ready-To-Wear Arm Sleeves Trade Name: Regulatory Class: II Product Code: DWL Dated: July 30, 1999 Received: August 02, 1999
Dear Mr. Pereira:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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_Page 2 - Mr. Pereira
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed or babbuance device 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro reguration (broces), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small ander the maj be obertisits toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:
Prescription Use
(Per 21 CFR 801.109)
K991570
Device name: Jobst Ready-To-Wear Arm Sleeve
Indications For Use.
Over-the-Counter
Jobst Ready-To-Use Arm Sleeve may be used under the direction of a healthcare professional to manage the flowing conditions:
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Edema Mild to moderate lymphedema Phlebitis Post-thrombotic syndrome Vascular Malformations Hypertrophic scars
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over The Counter Use
Patricio Rucetti
(Division Sign-Off) Division of Dental, and General Hosp 5 1 0(k) Number
§ 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.