(111 days)
None
Not Found
No
The provided text describes compression stockings with different pressure levels and indications for use. There is no mention of any computational or analytical capabilities, let alone AI or ML.
Yes
The intended uses/indications for use describe medical conditions such as "poor blood circulation," "deep vein thrombosis (DVT)," "varicose veins," "venous insufficiency," "edema," and "leg ulcers," and the device is described as helping to prevent or manage these conditions. These are clearly therapeutic applications.
No.
The intended use describes the device as providing compression for symptoms related to leg issues (e.g., tired, aching legs, poor blood circulation, swelling, varicose veins), and helping to prevent conditions like deep vein thrombosis. It does not mention diagnosing any conditions.
No
The provided text only describes the intended use and indications for use of a medical device, which appears to be compression stockings based on the pressure ranges and conditions listed. There is no information about the device's description, particularly whether it is software-only or includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The intended use describes the device as providing compression to the legs for various conditions like tired legs, swelling, varicose veins, and DVT prevention. This is a physical intervention applied externally to the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, using reagents, or performing any kind of laboratory test.
The device described is a compression stocking or garment intended for therapeutic or preventative use on the legs.
N/A
Intended Use / Indications for Use
- 8-15 mmHg: Mild For tired, aching legs, minor leg swelling, leg pain, poor blood circulation.
- 10-20 mmHg: Anti-Embolism Stocking - Helps prevent edema and leg discomfort, and helps prevent deep vein thrombosis (DVT) in patients subjected to immobility.
- 15-20 mmHg: Moderate - For mild varicose veins, post surgery, poor blood circulation, leg discomfort, mild to moderate swelling, tired and aching legs; Helps prevent deep vein thrombosis for long distance travelers and edema.
- 20-30 mmHg: Firm - For varicose veins, post surgery, venous insufficiency, moderate to severe varicosis, moderate swelling; Helps prevent deep vein thrombosis for long distance travelers and edema.
- 30-40 mmHg: Extra Firm - For edema, after healing of leg ulcers, severe chronic venous insufficiency, postphlebitic syndrome, post deep vein thrombosis (DVT), advanced varicose veins, phlebitis and reversible lymphedema; Post varicose vein surgery, vein stripping, sclerotherapy, plebectomy.
Product codes
DWL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Legs
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)
Not Found
Reference Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus symbol.
Public Health Service
April 2, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
Bossong Hosiery Mills, Incorporated C/O Mr. Roger Rand Roger Rand Medical Device Consulting 3855 8" Street Place North West Hickory, North Carolina 28601
Re: K123820
Trade/Device Name: Bossong Hosiery Medical Support Stockings Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: January 4, 2013 Received: January 18, 2013
Dear Mr. Rand:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
1
Page 2 - Mr. Rand
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set fòrth 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.
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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
with
-uioht-m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Bossong Hosiery Medical Support Stockings
Indications for Use:
8-15 mmHg
Mild For tired, aching legs, minor leg swelling, leg pain, poor blood circulation 8
10-20 mmHg_ Anti-Embolism Stocking
- Helps prevent edema and leg discomfort, and helps prevent deep vein thrombosis (DVT) in patients 基 subjected to immobility.
15-20 mmHg
Moderate
Firm
- For mild varicose veins, post surgery, poor blood circulation, leg discomfort, mild to moderate . swelling, tired and aching legs
- Helps prevent deep vein thrombosis for long distance travelers and edema #
20-30 mmHg
- For varicose veins, post surgery, venous insufficiency, moderate to severe varicosis, moderate swelling 에
-
Helps prevent deep vein thrombosis for long distance travelers and edema
- 30-40 mmHg Extra Firm
- For edema, after healing of leg ulcers, severe chronic venous insufficiency, postphlebitic syndrome, 하 post deep vein thrombosis (DVT), advanced varicose veins, phlebitis and reversible lymphedema
- 해 Post varicose vein surgery, vein stripping, sclerotherapy, plebectomy
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)
Image /page/2/Picture/24 description: The image shows the FDA logo. The letters "FDA" are stylized with multiple parallel lines, creating a three-dimensional effect. The logo is simple and recognizable, representing the Food and Drug Administration.
Richard C. Chapman 2013.03.26 10:07:26 -04'00'
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Powises Division of Ancol, Dental Devices
2 189 2
KI23820 510(k) Number: