The PB700 Renaissance II Spirometry System is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician's offices, laboratories, and occupational health testing environments.

Device Description

The PB700 Spirometry System consists of the Renaissance II Spirometer, the PB710 Base Station, AC Adapter, the disposable FSII Flow Sensor, a syringe adapter (for calibration), and nose clips. Optional accessories include calibration syringe, printer and serial communications cables, and a compatible printer. The Renaissance II Spirometry System is designed for use in the diagnosis, assessment, and monitoring of certain lung diseases.

AI/ML Overview

The provided document is a 510(k) summary for the PB700 Renaissance II Spirometry System. It primarily focuses on demonstrating substantial equivalence to a predicate device (PB100 Renaissance Spirometry System) rather than detailing specific acceptance criteria and a comprehensive study report with the requested metrics.

Here's an analysis based on the provided text, addressing each point to the best of its ability or explaining why the information is not available:

A table of acceptance criteria and the reported device performance

The document explicitly states: "The modified PB700 Renaissance II Spirometry System has been tested and found to meet all design criteria." However, it does not provide a table outlining specific acceptance criteria (e.g., flow measurement accuracy, volume measurement accuracy, specific ranges of operation) nor the quantitative reported performance for these criteria. The submission relies on establishing substantial equivalence to the predicate device, implying that if the device meets its design criteria, and those designs are equivalent to a legally marketed device, then it is acceptable.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text. The document states "The modified PB700 Renaissance II Spirometry System has been tested..." but does not detail the nature of this testing, the sample size of any test sets (patient or otherwise), or the provenance of any data.
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)

This information is not available in the provided text. As the submission focuses on functional equivalence of a diagnostic spirometer, the concept of "ground truth" derived from expert review (as in image analysis) is not directly applicable in the same way. Performance would typically be assessed against calibrated reference instruments.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of this type of device submission.
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

This information is not applicable and not available in the provided text. The PB700 Renaissance II Spirometry System is a diagnostic spirometer measuring physiological parameters (volume and flow); it is not an AI-assisted diagnostic tool that would involve "human readers" interpreting outputs in the sense of image analysis or similar diagnostic aids. Therefore, an MRMC study with AI assistance is not relevant to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a standalone diagnostic tool in the sense that it measures and calculates spirometry parameters. Its performance is inherent in its measurements. The document implies performance was assessed in a "standalone" fashion as it states "has been tested and found to meet all design criteria." However, specific details of how this "standalone" performance was measured (e.g., tests against known flow/volume standards, clinical trials) are not provided. The comparison is primarily against the predicate device's technological characteristics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a spirometer, "ground truth" would typically be established using calibrated reference instruments (e.g., highly accurate flow/volume simulators or calibration syringes with known volumes). The document mentions a "syringe adapter (for calibration)" as part of the system, suggesting calibration against known standards. However, the specific type of ground truth used during the validation testing is not detailed.
The sample size for the training set

This information is not applicable and not available in the provided text. Spirometers like the PB700 Renaissance II are typically based on established physical principles (e.g., pressure differential across a pneumotachograph) and calibration, not machine learning algorithms that require "training sets" in the conventional sense. The "calculations to express the volume in clinically relevant terms" refer to standard physiological equations and comparisons to published reference values, not a trained model.
How the ground truth for the training set was established

This information is not applicable and not available due to the reasons stated in point 8.

Summary

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K022103

SEP 2 7 2002

510(k) Summary

Submitted by:	Puritan Bennett Incorporated2200 Faraday AvenueCarlsbad, CA 92008
Company Contact:	James R. BondsSenior Director, Regulatory and Clinical Affairs(925) 463-4371(925) 463-4020 - FAX
Date Summary Prepared:	June 28, 2002
Trade Name:	PB700 Renaissance II Spirometry System
Common/Usual Name:	Diagnostic Spirometer
Classification Name:	Spirometer, Diagnostic per 21 CFR §868.1840
Product Code:	BZG
Legally MarketedPredicate Device(Unmodified):	PB100 Renaissance Spirometry System, K944762

Device Description

Intended Use

The Renaissance II Spirometry System is a diagnostic tool used to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. This testing can be used in the detection and monitoring of certain lung diseases. The system is intended for use with pediatric and adult patients (4 to 99 years) in hospitals, physicians' offices, laboratories, and occupational health testing environments.

Summary of Substantial Equivalence

The Renaissance II Spirometry System has the same technological characteristics as the above referenced predicate device. In both devices, air flow is directly measured via a sensor and connecting pressure tube, then electronically integrated to obtain volume. Both the modified and unmodified devices then perform calculations to express the volume in clinically relevant terms, including comparisons to predicted normal values from published literature. The intended use of the modified and predicate device is the same.

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The modified PB700 Renaissance II Spirometry System has been tested and found to meet all design criteria. The modifications to the predicate device have been carried out with appropriate design control procedures.

Conclusion

The modified PB700 Renaissance II Spirometry System does not raise new questions of safety or effectiveness when compared to the legally marketed predicate device, and the modified device is substantially equivalent to the predicate device.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

SEP 2 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Bonds Senior Director, Regulatory Affairs Puritan-Bennett Corporation 2200 Faraday Avenue Carlsbad, California 92008

Re: K022103

Trade/Device Name: PB700 Renaissance II Spirometry System Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: September 6, 2002 Received: September 9, 2002

Dear Mr. Bonds

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.

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.

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Page 2 - Mr. Bonds

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatow 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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510(k) Number (if known):

PB700 Renaissance II Spirometry System Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JHW. Hatcher

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K022103

Prescription Use /

Over-the-Counter Use

(Per 21 CFR 801.109)

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).