BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES

K020538 · Boehringer Laboratories · DWL · May 15, 2002 · General Hospital

Device Facts

• Record ID: K020538
• Device Name: BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
• Applicant: Boehringer Laboratories
• Product Code: DWL · General Hospital
• Decision Date: May 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Boehringer Laboratories, Inc. Pneumatic Ambulatory Compression System (PACS™) is indicated for the application of controlled pressure to the lower extremities in order to prevent blood pooling in the lower Pooling of blood in the legs is associated with: venous leg. insufficiency, edema, lymphedema, active venous ulcers, healed venous ulcers, pronounced varicosities and post-thrombotic syndrome. The PACS™ is to be used on the order of a Physician.

Device Story

Pneumatic Ambulatory Compression System (PACS) provides controlled pressure to lower extremities to prevent blood pooling. Device operates via pneumatic compression to manage conditions including venous insufficiency, edema, lymphedema, and venous ulcers. Used under physician order. System applies mechanical pressure to legs to improve venous return and reduce symptoms associated with venous stasis. Benefits include reduction of edema and support for ulcer healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatic compression system for lower extremities. Operates via controlled pneumatic pressure application. Class II device (21 CFR 880.5780).

Indications for Use

Indicated for patients requiring controlled lower extremity compression to prevent blood pooling associated with venous insufficiency, edema, lymphedema, active/healed venous ulcers, pronounced varicosities, and post-thrombotic syndrome. Prescription use only.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2002

Mr. Christopher Radl Project Engineer Boehringer Laboratories, Inc. 500 E. Washington St. Norristown, PA 19401

Re: K020538

Trade Name: Boehringer Laboratories Pneumatic Ambulatory Compression System (PACS) Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: Class II (two) Product Code: DWL Dated: February 15, 2002 Received: February 19, 2002

Dear Mr. Radl:

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 - Mr. Christopher Radl

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Nola Tull

onna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): K020538

Device Name: Boehringer Laboratories Pneumatic Ambulatory Compression System

Indications for use:

The Boehringer Laboratories, Inc. Pneumatic Ambulatory Compression System (PACS™) is indicated for the application of controlled pressure to the lower extremities in order to prevent blood pooling in the lower Pooling of blood in the legs is associated with: venous leg. insufficiency, edema, lymphedema, active venous ulcers, healed venous ulcers, pronounced varicosities and post-thrombotic syndrome. The PACS™ is to be used on the order of a Physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K020538 |
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Prescription Use/ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)