SSL's Medical Support Stocking is a compression stocking in the 14 -17mmHg range. It is composed of Polyamide / Elastane. A cotton feel Flight sock using air jet textured spun nylon.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical support stocking (Flight Sock), not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the study performed for this specific medical device.

Acceptance Criteria and Device Performance for SSL's Medical Support Stocking (Flight Sock)

The core "acceptance criteria" in this context is demonstrating substantial equivalence to legally marketed predicate devices, primarily through comparison of physical characteristics and intended use. The study performed focuses on this comparison.

| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
| :--------------------------- | :------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Compression Range | Equivalent compression in the 14-17 mmHg range to predicate devices. | The device is a compression stocking in the 14-17 mmHg range. Equivalent to predicate devices (Futuro's Venes Anti Embolism Stockings, K830696, and Jobst Travel Sock, K032325). |
| Composition | Equivalent materials to predicate devices. | Composed of Polyamide / Elastane (a cotton feel Flight sock using air jet textured spun nylon). Equivalent to predicate devices. |
| Intended Use | To help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers. | Same as the predicate devices. |

Study Information

Sample size used for the test set and the data provenance:
- The document implies a comparative equivalency study was performed against Futuro's Venes Anti Embolism Stockings (K830696).
- The specific number of samples (e.g., individual stockings or tests) for the equivalency testing is not specified in the provided text.
- Data Provenance: Not explicitly stated, but assumed to be internal testing by SSL Americas, Inc. (retrospective for the submission).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML study generating a diagnostic output. The "ground truth" here is the established characteristics and performance of the predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No human adjudication of results in the AI/ML sense. The equivalency was determined through direct comparison of physical properties (compression, composition).
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:
- No. This is not an AI/ML device, so no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the equivalency testing was the established characteristics and performance of the predicate devices (Futuro's Venes Anti Embolism Stockings and Jobst Travel Sock). This would involve physical measurements of compression and analysis of material composition.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

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K040553

MAR 1 1 2004

Image /page/0/Picture/2 description: The image shows the logo for SSL Americas, Inc. The letters "SSL" are in bold, and the words "Americas, Inc." are in a smaller font. A black swoosh design is above and below the text. The logo is simple and professional.

Office of Requlatory Affairs 3585 Engineering Drive, Suite 200 Norcross, GA 30092-9214 Tel: 770-582-222

SSL's Medical Support Stocking Premarket approval[510(k)] appliင်္မႈကိုလ်မှာ 2204

SSL Americas Premarket approval [510(k)] Summary

Section II Summary

II.A Submitter Information

SSL Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: 770 – 582 – 2222 Fax: 770 - 582 - 2233 Contact person: Chris Robinson, Date of Summary: February 2, 2004

II.B General Device Information

Device Trade Name: Flight Sock Device Common Name: Medical Support Stocking Classification: General Hospital and Personal Use Therapeutic Devices

II.C Predicate Devices

Venes Anti Embolism Stockings (K830696) Jobst Travel Sock (K032325)

II.D Device Description

SSL's Medical Support Stocking is a compression stocking in the 14 -17mmHg range. It is composed of Polyamide / Elastane. A cotton feel Flight sock using air jet textured spun nylon.

II.E Intended Use

SSL America's flight socks are intended to help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travellers.

II.F Substantial Equivalence

SSL America's flight socks are substantially equivalent in compression, purpose and composition to Futuro's Venes Anti Embolism Stockings (K830696) and Jobst Travel Sock (K032325). SSL conducted equivalency testing against Futuro's stocking and found SSL's sock to be equivalent in composition and compression.

Image /page/0/Picture/20 description: The image shows the word "durex" in a black box on the left side of the image. To the right of the word "durex" is the word "SILIPOS" in a sans-serif font. The word "durex" has a registered trademark symbol in the upper right corner of the box.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2004

Ms. Kathleen J. Harris Regulatory Manager SSL Americas 3585 Engineering Drive Suite 200 Norcross, Georgia 30092-9214

Re: K040353

Trade/Device Name: Medical Support Stockings (Flight Sock Regulation Number: 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: February 2, 2004 Received: February12, 2004

Dear Ms. Harris:

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 -Ms. Harris

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.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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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K040353

Indications for Use

510(k) Number (if known):

Device Name: Medical Support Stockings (brand name Flight Sock),

Indications For Use: Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers. Over the Counter

Prescription Use (Part 21 CFR B01 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Inere Moreau-Antrim Branch Chief
(Division Director)

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Page 1 of 1

510(k) Number: K040353

Regulation Number and Section

§ 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.