(41 days)
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K/DEN number: Not found in the text.
No
The description focuses on material composition, manufacturing process (cut and sewn, flat knit), and the application of the LaPlace formula for calculating dimensions based on patient measurements. There is no mention of AI or ML algorithms for analysis, prediction, or decision-making.
Yes
The device is indicated for conditions like CVI, edema, and lymphedema, and provides compression to force fluid into the venous system and return lymphatic fluid, which are therapeutic functions.
No
The device description outlines garments designed for compression therapy to manage conditions like edema and lymphedema. It describes how the garments are made and how they provide compression, but it does not mention any function for identifying, analyzing, or monitoring medical conditions. The stated "Intended Use" clearly lists conditions the device is used for, not conditions it diagnoses.
No
The device description clearly describes physical garments made of fabric and yarns, which are hardware components. The mention of calculations using the LaPlace formula relates to the design process of the physical garment, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (CVI, edema, lymphedema, phlebitis, vascular malformations) are all conditions related to the circulatory and lymphatic systems within the body.
- Device Description: The device is a garment (compression stocking/garment) that applies external pressure to a limb. It is described as being made of fabric and applying compression.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are typically tests or devices used outside the body to analyze biological samples. This device is applied to the body to provide therapeutic compression.
N/A
Intended Use / Indications for Use
The Elvarex garments are equivalent to the preamendment Jobst-Custom garments which are used for the same indications.
Consequently, they can be used to treat the same indications, i.e. CVI, edema, lymphedema, phlebitis and vascular malformations. The contraindications for the two 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.
Product codes
21 CFR §880.5780
Device Description
While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon varns, the Elvarex garments are flat knit using yarns made of nylon, natural rubber latex, cotton and spandex and then sewn together.
Both products use the specific measurements for a patient and calculate the final garment dimensions using the LaPlace formula. Compression is provided for both products by large elastic yarns that act circumferentially on the limb. The gradient compression present with both products helps to force fluid into the deep venous system and in the return of Ivmphatic fluid.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
OCT 16 1996
Beiersdorf-Jobst, Inc.
5825 Carnegie Blvd.
Charlotte, NC 28209-4633 Phone: 704-554-9933
510(k) Summary of Safety and Effectiveness
This submission covers Elvarex compression garments which are classified as medical support stockings (21 CFR §880.5780). The Elvarex garments are equivalent to the preamendment Jobst-Custom garments which are used for the same indications.
While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon varns, the Elvarex garments are flat knit using yarns made of nylon, natural rubber latex, cotton and spandex and then sewn together.
Both products use the specific measurements for a patient and calculate the final garment dimensions using the LaPlace formula. Compression is provided for both products by large elastic yarns that act circumferentially on the limb. The gradient compression present with both products helps to force fluid into the deep venous system and in the return of Ivmphatic fluid. Consequently, they can be used to treat the same indications, i.e. CVI, edema, lymphedema, phlebitis and vascular malformations. The contraindications for the two 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.
Elvarex has been on the market for several years in Europe and has an established track record. There have also been no reports of serious injury resulting from its use during the three year period assessed.
The product being submitted is substantially equivalent to the predicate product in the materials used, mode of action, and indications of use. It also has a long history of use and has proven to be as safe and effective as the predicate product.
Date: August 2, 1996
Prepared by: Angelo R. Pereira Beiersdorf-Jobst, Inc. 5825 Camegie Boulevard Charlotte, NC 28209 Phone: (704) 551-7178