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 Description

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 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.

AI/ML Overview

The provided document does not contain acceptance criteria or detailed study results with specific performance metrics. It is a 510(k) summary for the "Lifestyle Circulatory Enhancer (CE)" device, focusing on its substantial equivalence to predicate devices and its intended use.

However, based on the information provided, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., specific blood pressure increase, or reduction in orthostatic hypotension symptoms). The document focuses on "temporary circulatory enhancement" having a "positive effect on the symptoms of orthostatic hypotension."
Reported Device Performance: The document states that the "safety and effectiveness of use of the Lifestyle CE device was demonstrated by bench qualification, animal study and a review of investigator sponsored clinical studies." However, no specific performance data (e.g., blood pressure changes, symptom reduction rates) from these studies are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not provided. The document mentions "investigator sponsored clinical studies" but does not specify the number of participants.
Data Provenance: Not provided. It's unclear if the studies were prospective, retrospective, or where they were conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts & Qualifications: Not applicable as the provided document does not describe a study involving expert assessment or ground truth establishment in that context (e.g., image interpretation). The "ground truth" for this device would likely be physiological measurements or patient-reported outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This concept is typically relevant for studies where multiple readers or experts assess data and disagreements need resolution. The provided document doesn't detail such a process for the clinical studies mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: Not applicable. This device is a "Circulatory Enhancer," not an AI diagnostic tool. Therefore, a multi-reader multi-case study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a medical device for circulatory enhancement, not an algorithm, so "standalone performance" in the AI sense is not relevant. The device is used by a single user within the external airway channel.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Based on the device's function, the "ground truth" would likely involve objective physiological measurements (e.g., blood pressure, heart rate) and patient-reported outcomes (e.g., changes in lightheadedness, symptoms of orthostatic hypotension). However, the document does not specify how these were measured or confirmed in the mentioned studies.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. As per point 8, there's no training set for this type of device.

Summary

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APR - 7 2004

Advanced Circulatory Systems, Inc.

7615 Golden Triangle Drive (Suite A) Eden Prairie, MN 55344 (952) 947-9590 (telephone) (952) 942-8336 (facsimile)

510(k) Summary of Safety and Effectiveness

Company Name:	Advanced Circulatory Systems, Inc.7615 Golden Triangle Drive (Suite A)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 CirculatorySystems, Inc.	BWF, JOW	II	ResQPODTM CirculatoryEnhancer
K033401	Advanced CirculatorySystems, Inc.	BWF, JOW	II	Modification of theResQPODTM CirculatoryEnhancer
K032325,K951234	Jobst A Beiersdorf Co.	DWL	II	Medical Support Stockingsand other comunercial names

1.0 Description of Device

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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:

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 (301) 594-4648. 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 (800) 638-2041 or (301) 443-6597 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:

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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Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
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.(b)
Classification. Class II (performance standards).