The CirQlator™ Intrathoracic Pressure Regulator is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation, as prescribed by a physician, licensed practitioner, or qualified technician. Recommended duration of use is up to four hours.

Device Description

The CirQlator"M is an intrathoracic pressure regulator intended to interface with the airway of a patient and a ventilation source. A vacuum source is connected to the ITPR that provides continuous low-level vacuum except when a positive pressure breath is given by a ventilation source, e.g. manual resuscitator. The applied vacuum decreases the intrathoracic pressure. When interposed between positive pressure ventilations, a decrease in intrathoracic pressure has been shown to increase vital organ perfusion and decrease intracranial pressure during states of shock, cardiac arrest, and other low blood flow states in animal studies.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the "CirQlator™ Intrathoracic Pressure Regulator (ITPR)," rather than a performance study that establishes acceptance criteria for an AI/CADe device. Therefore, much of the requested information about AI performance, expert review, and ground truth is not applicable to this document.

However, I can extract information related to the device's intended performance as established for its 510(k) clearance based on substantial equivalence.

Here's a breakdown of what can be inferred and what cannot:

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

The document doesn't define explicit numerical acceptance criteria in the manner one would for an AI device's sensitivity, specificity, etc. Instead, the acceptance criterion for regulatory clearance via 510(k) is substantial equivalence to predicate devices.

Acceptance Criteria (Implied for 510(k) Clearance)	Reported Device Performance
Device performs as intended for its Indications for Use.	Demonstrated in animal testing.
Features and functionality are comparable to predicates.	Demonstrated in comparative bench testing.
No significant differences affecting safety or effectiveness compared to predicates.	Stated explicitly: "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices."

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

Test set sample size: Not specified. The document mentions "animal testing" but doesn't provide the number of animals or any details about their provenance.
Data provenance: "Animal testing" and "bench testing." No country of origin is mentioned for the data. The data appears to be prospective as it was conducted specifically to demonstrate the device's performance.

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)

Not applicable. This is not an AI/CADe study involving human image interpretation or clinical outcomes adjudicated by experts. The performance was assessed through bench and animal testing.

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

Not applicable. This is not an AI/CADe study requiring expert adjudication of results.

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

Not applicable. This is a standalone medical device, not an AI/CADe system designed to assist human readers.

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

Yes, in a sense. The "Performance testing" details "comparative bench testing" and "animal testing" which evaluate the device's function and performance intrinsically, without a human-in-the-loop interacting with an algorithm output. The device itself is a standalone piece of equipment.

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

The "ground truth" for the animal testing would involve physiological measurements and observations related to "increase vital organ perfusion and decrease intracranial pressure during states of shock, cardiac arrest, and other low blood flow states," as mentioned in the device description. For bench testing, the ground truth would be engineering specifications and expected physical performance. The document doesn't provide specifics on these "truths."

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that requires a training set.

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

Not applicable. No training set was used.

Summary

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	JUN 20 2007 Non-Confidential Summary of Safety and EffectivenessPage 1 of 214-Jun-07
Advanced Circulatory Systems, Inc.7615 Golden Triangle Drive, Suite AEden Prairie, MN 55344	Tel - 612-986-3917Fax -952-942-8336
Official Contact:	Keith Lurie, MD, Chief Medical Officer
Proprietary or Trade Name:	CirQlator™ Intrathoracic Pressure Regulator
Common/Usual Name:	Spirometer, therapeutic (incentive)
Classification Name:	Spirometer, therapeutic (incentive)
Device:	Intrathoracic Pressure Regulator (ITPR)
Predicate Devices:	ResQPOD® Circulatory Enhancer - K022906, K033401Bird Mark 8 ventilator – pre-amendment

11 188 9 11 2007 Non-Confidential Summary of Safety and Effectiveness

Device Description:

Indications for Use:
Indicated Use -	The CirQlator™ Intrathoracic Pressure Regulator is indicated for the temporarydecrease in intrathoracic pressure to increase blood circulation, as prescribed by aphysician, licensed practitioner, or qualified technician. Recommended duration ofuse is up to four hours.
Patient Population -	The CirQlator™ Intrathoracic Pressure Regulator may benefit people needingassisted ventilation that suffer from states of poor circulation, low blood pressure,or insufficient cardiac preload that may be reflected by low blood pressure. Thedevice is not intended for those patients who would not benefit from an increase incardiac preload.
Environment of Use -	Hospital, pre-hospital (including EMS)
Contraindications -	persons with pneumothorax;persons with hemothorax:persons who are hypertensive;persons with uncontrolled bleeding.

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 14-Jun-()7

Performance testing:

Comparative bench testing was performed for the proposed device and the predicates and the performance features and functionality where found to be comparable.

In addition, animal testing was performed to demonstrate the proposed device performed as intended.

Comparison to Legally Marketed Predicate Devices:

The ITPR is viewed as substantially equivalent to the following predicate devices -

ResQPOD Circulatory Enhancer (K022906, K033401) ●
. Bird Mark 8 respirator (pre-amendment)

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle-like emblem with three stylized legs or supports, symbolizing stability and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Circulatory Systems, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court # 102 Bonita Springs, Florida 34134-2015

JUN 2 U 2007

Re: K070490

Trade/Device Name: CirQlator" Intrathoracic Pressure Regulator (ITPR) Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: II Product Code: BWF, JOW Dated: June 14, 2007 Received: June 15, 2007

Dear Mr. Dryden:

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. Dryden

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 (OS) 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number:

KOJO 490 490 (To be assigned)

Device Name: CirQlator"M Intrathoracic Pressure Regulator (ITPR)

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D) 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)

Sion Sign Off) Culsion of Anesthesiology, General Hospital, Imaction Control, Dental Devices

K(k) Number. K070490

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).