(31 days)
Jobst Travel Socks are indicated for the following conditions: Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers.
Both products are manufactured on circular knit machines. Both products are made of nylon and spandex yarns and provide compression at the ankle of approximately 15-20mmHg. However, the JOBST Travel Socks also have cotton varns for added comfort. While both products are sized based on calf circumference, sizing information based on ankle circumference and shoe size will also be provided with the JOBST Travel Socks, for the convenience of the traveler. Compression is provided for these products by elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps reduce capillary leakage, prevent pooling of blood and improve blood flow. Consequently, they act prophylactically to help reduce the risk of developing deep vein thromboses (DVT) and superficial thromboembolisms.
This 510(k) summary (K032325) for the Jobst Travel Socks primarily establishes substantial equivalence to a predicate device, the Jobst Anti-Em/GP stocking (K955138), rather than presenting a detailed study that proves the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study design will not be directly derivable from this document.
The core argument for equivalence is based on:
- Materials: Both use nylon and spandex yarns, and Jobst Travel Socks also include cotton.
- Mode of Action: Both provide compression to reduce capillary leakage, prevent blood pooling, and improve blood flow, thereby prophylactically reducing DVT and superficial thromboembolism risk.
- Indications for Use: Both are indicated for individuals subjected to long periods of immobility, with the Travel Socks specifically mentioning "long distance travelers" and helping to "prevent edema and leg discomfort."
- Compression Level: Both provide approximately 15-20mmHg compression at the ankle.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, specific numerical acceptance criteria for a new clinical study are not provided. The "performance" is implicitly tied to being "substantially equivalent" to the predicate device in terms of materials, mode of action, compression, and intended use.
| Acceptance Criterion (Implied by Equivalence) | Reported Device Performance (Jobst Travel Socks) |
|---|---|
| Compression at Ankle (Equivalent to predicate) | Approximately 15-20mmHg |
| Materials Used (Equivalent to predicate) | Nylon and spandex yarns (with cotton yarns for added comfort, which is considered a non-critical difference) |
| Mode of Action (Equivalent to predicate) | Provide gradient compression, reduce capillary leakage, prevent pooling of blood, improve blood flow. |
| Indications for Use (Equivalent to predicate, with specific focus) | Help prevent deep vein thromboses (DVT); help prevent edema and leg discomfort and DVT for long distance travelers. |
| Manufacturing Method (Equivalent to predicate) | Manufactured on circular knit machines |
| Sizing Method (Equivalent to predicate, with additional convenience) | Sizing based on calf circumference (similar to predicate), with additional ankle circumference and shoe size information for convenience. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No new clinical test set is described or referenced in this 510(k) summary for the purpose of demonstrating performance against acceptance criteria. The submission relies on the established safety and effectiveness of the predicate device.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new test set requiring expert ground truth establishment is described.
4. Adjudication method for the test set
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a medical support stocking, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical support stocking.
7. The type of ground truth used
- Not applicable in the context of a new performance study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device (Jobst Anti-Em/GP stocking, K955138), which presumably underwent its own evaluation or was cleared based on prior substantial equivalence arguments.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
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AUG 2 8 2003
510(k) Summary Of Safety and Effectiveness
This submission covers the indication that compression stockings in the 15-20mmHg range and higher, such as the JOBST Travel Socks, help prevent deep vein thromboses (DVT). These products fall under the device classification of medical support stockings (21 CFR §880.5780). The Jobst Travel Socks are equivalent to the Jobst Anti-Em/GP stocking (K955138), which is indicated for use for the individuals subjected to long periods of immobility.
Both products are manufactured on circular knit machines. Both products are made of nylon and spandex yarns and provide compression at the ankle of approximately 15-20mmHg. However, the JOBST Travel Socks also have cotton varns for added comfort. While both products are sized based on calf circumference, sizing information based on ankle circumference and shoe size will also be provided with the JOBST Travel Socks, for the convenience of the traveler.
Compression is provided for these products by elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps reduce capillary leakage, prevent pooling of blood and improve blood flow. Consequently, they act prophylactically to help reduce the risk of developing deep vein thromboses (DVT) and superficial thromboembolisms.
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: August 27, 2003
Prepared by: Angelo R. Pereira BSN-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 features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.
Public Health Service
AUG 2 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Angelo Pereira Manager, Regulatory Affairs BEN-JOBST Incorporated 5825 Carnegie Boulevard Charlotte, North Carolina 28209-4633
Re: K032325
Trade/Device Name: Jobst Travel Socks Regulation Number: 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: July 25, 2003 Received: July 28, 2003
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.
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Page 2 -Mr. Pereira
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Raoser
Susan Runner, DDS. MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number
Page 1 of 1
Device name: Jobst Travel Socks
Indications For Use:
Over-the-Counter
Jobst Travel Socks are indicated for the following conditions:
Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers.
(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_________________
Patricia Cucurete
510(k) Number: K032325
§ 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.