(28 days)
Not Found
No
The device description and performance studies focus on material composition, compression levels, and equivalency testing against predicate devices, with no mention of AI or ML.
Option A: Yes
Explanation: The device is intended to "Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers," which are medical conditions, and it is a "Medical Support Stocking" with a specific compression range, indicating a therapeutic purpose.
No
The device description and intended use indicate it is a compression stocking for preventing edema, leg discomfort, and DVT, not for diagnosing medical conditions.
No
The device description explicitly states it is a "compression stocking" composed of "Polyamide / Elastane," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers." This describes a physical intervention (compression) applied externally to the body.
- Device Description: The device is a "compression stocking." This is a physical garment.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, disease, or condition based on the analysis of these samples.
- Any laboratory or diagnostic procedures.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a therapeutic/preventative device applied to the body.
N/A
Intended Use / Indications for 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.
Product codes
DWL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
SSL conducted equivalency testing against Futuro's stocking and found SSL's sock to be equivalent in composition and compression.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
2
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
3
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