(261 days)
Not Found
No
The device description and intended use focus solely on the physical properties and mechanism of action of compression stockings, with no mention of AI or ML.
Yes
The stockings help to prevent edema, leg discomfort, and deep vein thrombosis (DVT), which are therapeutic effects.
No
Explanation: The device is described as "Anti-Embolism Stockings" which help prevent DVT and provide compression. Its function is therapeutic and preventative, not diagnostic. There is no mention of it analyzing, detecting, or measuring any physiological parameters to identify a condition.
No
The device description clearly states the device is a physical product (compression stockings made of nylon and spandex) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Anti-Embolism Stockings are compression stockings worn on the leg to prevent edema, discomfort, and DVT. Their mechanism of action is physical compression.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
- Physical Mechanism: The device works through a physical mechanism (graduated compression) applied externally to the body.
Therefore, the Anti-Embolism Stockings fall under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Anti-Embolism Stockings:
- . Help prevent edema and leg discomfort, and help prevent deep vein thrombosis (DVT) in individuals subjected to immobility.
- Over-the-Counter (OTC) Use .
Product codes (comma separated list FDA assigned to the subject device)
DWL
Device Description
The Anti-Embolism Stockings are compression stockings consisting of 90% nylon and 10% spandex. The thigh length stockings have a silicone band at the top. Knee length and thigh length models are each provided in three (3) different sizes.
The Anti-Embolism Stockings are designed for the post-operative patient. The knee and thigh length models of these anti-embolism stockings are produced on a circular knitting machine. Nylon varns are knit into the fabric structure while the nylon covered spandex yarns are in-laid into the fabric structure. The stockings are designed with the higher compression in the ankle region (18 mmHg) and lower, graduated compression in the calf (11 mmHg) and thigh regions (8 mmHg - thigh length model) of the leg. The mechanism of action is achieved via the graduated compression design.
The Anti-Embolism Stockings are not made with natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg, ankle, calf, thigh
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
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): 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.
K040353 Flight Sock, K032325 Jobst Travel Socks, K925643 RX FIT Medical Stockings, K830696 VENES Anti-Embolism Stocking, K091141 Therafirm Anti-Embolism Stockings and Therafirm Men's Trouser Socks and Women's Trouser Socks
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
Attachment 2 - 510(k) Summary
510(k) Summary
General Information:
Date of Summary Preparation: December 16, 2009
DEC 1 8 2009
BDF����
Beiersdorf
Beiersdort Inc 187 Danbury Road Willon, CT 2G897 Telephone (203) 503-5800
Name and Address of Manufacturer: Beiersdorf, Inc.
187 Danbury Road
Wilton, Connecticut 06897
Contact Person:
Rosemary Barvenik
Manager, Regulatory Affairs
Telephone: (203) 854-8040
Fax: (203) 563-5890
- Trade Name: Anti-Embolism Stockings Medical Support Stocking Common Name: 21 CFR 880.5780(a) Regulation Number: Classification Name: Medical Support Stocking II Regulatory Class: Classification Panel: General Hospital Product Code: DWL
Traditional 510(k) Premarket Notification December 16, 2009
Company Confidential Page 7 of 16
(203) 563-5890
1
Predicate Devices:
K040353 Flight Sock
K032325 Jobst Travel Socks
K925643 RX FIT Medical Stockings
K830696 VENES Anti-Embolism Stocking
K091141 Therafirm Anti-Embolism Stockings and Therafirm Men's Trouser Socks and Women's Trouser Socks
Kendall T.E.D. Anti-Embolism Stockings
(510(k) number unknown)
TRUFORM Anti-Embolism Stockings
(510(k) number unknown)
Indications for Use:
The Anti-Embolism Stockings:
- . Help prevent edema and leg discomfort, and help prevent deep vein thrombosis (DVT) in individuals subjected to immobility.
- Over-the-Counter (OTC) Use .
Device Description: The Anti-Embolism Stockings are compression stockings consisting of 90% nylon and 10% spandex. The thigh length stockings have a silicone band at the top. Knee length and thigh length models are each provided in three (3) different sizes.
The Anti-Embolism Stockings are designed for the post-operative patient. The knee and thigh length models of these anti-embolism stockings are produced on a circular knitting machine. Nylon varns are knit into the fabric structure while the nylon covered spandex yarns are in-laid into the fabric structure. The stockings are designed with the higher compression in the ankle region (18 mmHg) and lower, graduated compression in the calf (11 mmHg) and thigh regions (8 mmHg - thigh length model) of the leg. The mechanism of action is achieved via the graduated compression design.
The Anti-Embolism Stockings are not made with natural rubber latex.
Substantial Equivalence: The Anti-Embolism Stockings are substantially equivalent to predicates with respect to the intended use, indications for use, and the technological characteristics.
Traditional 510(k) Premarket Notification December 16, 2009
Company Confidential Page 8 of 16
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 1 8 2009
Ms. Rosemary Barvenik Regulatory Affairs Manager Beiersdorf, Incorporated 187 Danbury Road Wilton, Connecticut 06897
Re: K090921
Trade/Device Name: Anti-Embolism Stockings Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: December 3, 2009 Received: December 3, 2009
Dear Ms. Barvenik:
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 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.
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
3
Page 2- Ms. Barvenik
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely,
Svan Runow
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K090921
Device Name: Anti-Embolism Stockings -Models 71055-, 71057-, 71059-, 71064-, 71065-, 71068-00000-02
Indications for Use:
The Anti-Embolism Stockings:
Help prevent edema and leg discomfort, and help prevent deep vein thrombosis (DVT) in individuals subjected to immobility.
- Over-the-Counter (OTC) Use ●
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Austin For CIZ
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page __ of 1
KOG1999 510(k) Number:
Traditional 510(k) Premarket Notification December 16, 2009
Company Confidential Page 6 of 16