(107 days)
Not Found
No
The device description focuses on the material, construction (circular knit), sizing based on physical measurements, and the mechanism of action (gradient compression) of a compression arm sleeve. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device description states that the product is a "compression arm sleeve" that provides "gradient compression" to "force fluid into the deep venous system and helps in the return of lymphatic fluid." These functions address the medical conditions listed under "Indications for Use," such as edema and lymphedema, indicating a therapeutic purpose.
No
Explanation: The device description states that the Jobst Ready-To-Wear Compression Arm Sleeves are medical support stockings that provide compression to the limb. Its intended use is to manage conditions like edema and lymphedema. There is no information suggesting it is used to diagnose any condition.
No
The device description clearly states it is a physical arm sleeve made of fabric (spandex and nylon yarns) and provides compression. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Jobst Ready-To-Use Arm Sleeve is a compression garment worn on the arm. It provides physical compression to manage conditions like edema and lymphedema.
- Intended Use: The intended use is to manage physical conditions affecting the arm, not to analyze biological samples.
The device falls under the classification of "medical support stockings" (21 CFR §880.5780), which are external support devices, not IVDs.
N/A
Intended Use / Indications for Use
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
Product codes
DWL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
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
1
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.
2
_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
3
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:
..............................................................................................................................................................................
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