BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS

K123820 · Bossong Hosiery Mills, Inc. · DWL · Apr 2, 2013 · General Hospital

Device Facts

• Record ID: K123820
• Device Name: BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS
• Applicant: Bossong Hosiery Mills, Inc.
• Product Code: DWL · General Hospital
• Decision Date: Apr 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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

Device Story

Bossong Hosiery Medical Support Stockings; graduated compression hosiery. Applies external mechanical pressure to lower extremities; promotes venous blood return; reduces edema; prevents venous stasis. Used by patients for symptom relief or DVT prophylaxis; available OTC or prescription depending on compression level. Non-invasive; passive mechanical device.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use.

Technological Characteristics

Graduated compression hosiery; various compression levels (8-15, 10-20, 15-20, 20-30, 30-40 mmHg). Mechanical compression principle; textile construction.

Indications for Use

Indicated for patients requiring compression therapy for tired/aching legs, minor to severe leg swelling, leg pain, poor circulation, varicose veins, venous insufficiency, post-surgical recovery (vein stripping, sclerotherapy, phlebectomy), post-phlebitic syndrome, leg ulcers, phlebitis, reversible lymphedema, and DVT prevention in immobile or long-distance travel patients. Available in 8-15, 10-20, 15-20, 20-30, and 30-40 mmHg compression levels.

Regulatory Classification

Identification

Medical support stocking to prevent the pooling of blood in the legs: 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. Medical support stocking for general medical purposes: 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.

Special Controls

*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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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 [phone] or [phone] 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

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# 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)

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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

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KI23820 510(k) Number: