LIFESTYLE CIRCULATORY ENHANCER

K040084 · Advanced Circulatory Systems, Inc. · BWF · Apr 7, 2004 · Anesthesiology

Device Facts

• Record ID: K040084
• Device Name: LIFESTYLE CIRCULATORY ENHANCER
• Applicant: Advanced Circulatory Systems, Inc.
• Product Code: BWF · Anesthesiology
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lifestyle Circulatory Enhancer (CE) is indicated for the temporary increase in blood circulation as prescribed by a physician or licensed practitioner. The Lifestyle CE may benefit people who suffer from states of poor circulation and low blood flow, including those individuals who suffer from orthostatic hypotension symptoms, such as lightheadedness, when moving from a sitting or reclining position to a standing position.

Device Story

Lifestyle Circulatory Enhancer (CE) is a non-sterile, single-user device used within the external airway channel. Device provides temporary circulatory enhancement by increasing blood pressure to mitigate symptoms of orthostatic hypotension. Operation involves patient inspiration through the device; mechanism is identical to predicate ResQPOD CE devices. Used by patients under physician/practitioner prescription to improve blood flow during postural changes. Clinical benefit includes reduction of lightheadedness associated with orthostatic hypotension.

Clinical Evidence

Evidence includes bench qualification, animal study, and review of investigator-sponsored clinical studies. No specific performance metrics (e.g., sensitivity, specificity) provided in the summary.

Technological Characteristics

Non-sterile, single-user device for external airway use. Technology is identical to ResQPOD CE devices. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for patients suffering from poor circulation and low blood flow, specifically those experiencing orthostatic hypotension symptoms (e.g., lightheadedness) upon transitioning from sitting/reclining to standing. Requires prescription by a physician or licensed practitioner.

Regulatory Classification

Identification

An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.

Predicate Devices

• ResQPOD Circulatory Enhancer (K022906)
• Modification of the ResQPOD Circulatory Enhancer (K033401)
• Medical Support Stockings (K032325, K951234)

Submission Summary (Full Text)

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## APR - 7 2004

### Advanced Circulatory Systems, Inc.

7615 Golden Triangle Drive (Suite A) Eden Prairie, MN 55344 [phone] (telephone) [phone] (facsimile)

### 510(k) Summary of Safety and Effectiveness

| Company Name: | Advanced Circulatory Systems, Inc.<br>7615 Golden Triangle Drive (Suite A)<br>Eden Prairie, MN 55344 |
|---------------|------------------------------------------------------------------------------------------------------|
| Contact: | Robert Cohen, Chief Executive Officer |
| Phone: | 952 947-9615 |
| Fax: | 952 942-8336 |
| Summary Date: | April 5, 2004 |
| Trade Name: | Lifestyle Circulatory Enhancer (CE) |
| Common Name: | Circulatory Enhancer |

Classification Name: The predicate devices were found substantially equivalent to: 21 CFR 868.5690 Incentive Spirometer, Product Code: BWF 21 CFR 870.5800 Compressible Limb Slecve, Product Code: JOW 21 CFR 880.5780 Medical Support Stocking, Product Code: DWL

Predicate Devices:

| 510(k) | Manufacturer | Product Code | Class | Trade Name |
|---------------------|---------------------------------------|--------------|-------|----------------------------------------------------------|
| K022906 | Advanced Circulatory<br>Systems, Inc. | BWF, JOW | II | ResQPODTM Circulatory<br>Enhancer |
| K033401 | Advanced Circulatory<br>Systems, Inc. | BWF, JOW | II | Modification of the<br>ResQPODTM Circulatory<br>Enhancer |
| K032325,<br>K951234 | Jobst A Beiersdorf Co. | DWL | II | Medical Support Stockings<br>and other comunercial names |

#### 1.0 Description of Device

The Lifestyle Circulatory Enhancer (CE) device is a non-sterile, single user device that is used within the external airway channel. Inspiration through the Lifestyle CE device provides temporary circulatory enhancement. Temporary circulation enhancement increases

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blood pressure, which has a positive effect on the symptoms of orthostatic hypotension. The technology providing temporary circulatory enhancement is the same as in the predicate ResQPOD CE devices.

#### 2.0 Intended Use

The Lifestyle CE device indication for use is:

The Lifestyle Circulatory Enhancer (CE) is indicated for the temporary increase in blood circulation as prescribed by a physician or licensed practitioner. The Lifestyle CE may benefit people who suffer from states of poor circulation and low blood flow, including those individuals who suffer from orthostatic hypotension symptoms, such as lightheadedness, when moving from a sitting or reclining position to a standing position.

#### 3.0 Technology

The technology of the Lifestyle CE device for the temporary increase in circulation is the same as the technology of the predicate ResQPOD CE devices; reference 510(k) K022906 and K033401.

#### 4.0 Conclusions

The safety and effectivencss of use of the Lifestyle CE device was demonstrated by bench qualification, animal study and a review of investigator sponsored clinical studies. The intended use and technology of the Lifestyle CE device are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized, parallel lines that resemble an abstract representation of a bird or a symbol of forward movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2004

Advanced Circulatory Systems, Inc c/o Mr. Gary Syring Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589

Re: K040084 Lifestyle Circulatory Enhancer Regulation Number: 21 CFR 868.5690, 870.5800, and 880.5780 Regulation Name: Incentive Spirometer, Compressible Limb Sleeve, and Medical Support Stocking Regulatory Class: Class II (two) Product Code: BWF, JOW, and DWL Dated: January 12, 2004 Received: January 15, 2004

Dear Mr. Syring:

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. Gary Syring

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Dennis R. Holmes

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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K040084

Device Name: Lifestyle Circulatory Enhancer

Indications for Use:

The Lifestyle Circulatory Enhancer (CE) is indicated for the temporary increase in blood circulation as prescribed by a physician or licensed practitioner. The Lifestyle CE may benefit people who suffer from states of poor circulation and low blood flow, including those individuals who suffer from orthostatic hypotension symptoms, such as lightheadedness, when moving from a sitting or reclining position to a standing position.

Prescription Use X (Part 21 CFR 801 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)

Dama R. Vochmer
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_K046084

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