The Puritan Bennett DataFlow™ Data Management Software is intended to augment the Puritan Bennett PB-700 Renaissance® II Spirometer System and the Nellcor Puritan Bennett NPB-500 Simplicity™ Spirometer System's data management capability.

Device Description

Puritan Bennett DataFlow™ Data Management Software is a software program used in conjunction with the Puritan Bennett PB-700 Renaissance® II Spirometer System and the Nellcor Puritan Bennett NPB-500 Simplicity™ Spirometer System to transfer patient test data from the spirometer to an IBM compatible Personal Computer. Once transferred, the DataFlow software allows the operator to perform any or all of the following: edit or add patient demographic information, archive the test, search for and retrieve archived test(s), print test reports, compare archived tests, and export test data for use by other application software.

AI/ML Overview

The Puritan Bennett DataFlow™ Data Management Software is a data management program for spirometers. The provided text outlines its intended use and summarizes how the manufacturer demonstrated substantial equivalence to a predicate device. However, it does not contain detailed information regarding specific acceptance criteria or a comprehensive study report with quantitative performance metrics.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on verifying that the software performs as intended according to its specifications and that its technological characteristics are the same as the predicate device. It does not provide a table of specific acceptance criteria (e.g., "data transfer accuracy > 99%") or quantitative performance metrics for the device itself.

Acceptance Criteria	Reported Device Performance
Adheres to specifications for functions (edit, add patient info, archive, search, retrieve, print, compare, export)	"All functions as defined in the specifications were completely verified and validated." (No specific quantitative performance metrics provided).
Compatibility with specified spirometers (PB-700 and NPB-500)	"The performance of the DataFlow software program was comprehensively tested with the PB-700 and NPB-500 spirometers." (No specific quantitative compatibility test results are presented).
Adherence to FDA CDRH guidances	"DataFlow adheres to the following FDA CDRH guidances: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 29, 1998; Off-The-Shelf Software Use in Medical Devices, September 9, 1999." (Compliance is stated, but no direct performance metric).
Substantial equivalence to predicate device	"The DataFlow software program performs as intended according to its performance specification. DataFlow is substantially equivalent to its predicate device." (This is a conclusion, not a performance metric against specific criteria.)

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "The performance of the DataFlow software program was comprehensively tested," but it does not specify a sample size for any test set or provide details about data provenance (e.g., country of origin, retrospective/prospective). This likely indicates that the testing was function-based verification and validation rather than a clinical study with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document describes software verification and validation, not a study involving human experts to establish ground truth for a test set. Therefore, this information is not applicable and not provided.

4. Adjudication Method:

Given that the testing described is software verification and validation, an adjudication method in the context of expert review for a test set is not applicable and not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study is relevant for diagnostic devices that involve human interpretation. This device is data management software. Therefore, an MRMC comparative effectiveness study is not applicable and not mentioned.

6. Standalone Performance:

The software is described as a "PC-based standalone software program." The testing mentioned ("The performance of the DataFlow software program was comprehensively tested") refers to its standalone functional performance in conjunction with the spirometers. However, it's not a "standalone" in the sense of an AI algorithm performing a diagnostic task without human input; it's a data management tool. The document does not provide quantitative standalone performance metrics for specific tasks (e.g., "data transfer success rate").

7. Type of Ground Truth Used:

The ground truth for this type of software (data management) would be its adherence to its own specifications and correct execution of its defined functions. It would not typically involve pathology, outcomes data, or expert consensus in the way a diagnostic AI algorithm would. The document implies that the ground truth was the functional specifications and the correct operation of the software.

8. Sample Size for the Training Set:

This software is not an AI/ML algorithm that requires a training set in the conventional sense. It's a data management program. Therefore, information about a "training set" sample size is not applicable and not provided.

9. How the Ground Truth for the Training Set Was Established:

As there is no training set for this type of software, this information is not applicable and not provided.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through functional verification and validation, confirming that the data management software performs as intended according to its specifications and is technologically similar to a predicate device. It does not contain the detailed quantitative performance metrics or study designs typically associated with clinical studies for diagnostic devices or AI algorithms.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Puritan-Bennett, a medical equipment manufacturer. Above the logo is the text "K023225" in a handwritten style. The Puritan-Bennett logo is displayed in a rectangular box with a dark background and white text.

4280 Hacienda Drive Pleasanton, CA 94588

Tele: 925-463-4427 Fax: 925-463-4020

DEC 1 8 2002

510(k) Summary

Submitted by:	Puritan-Bennett Corporation2200 Faraday AvenueCarlsbad, CA 92008
Company Contact:	Gina ToSenior Regulatory Affairs Project ManagerNellcor Puritan Bennett, Inc.4280 Hacienda DrivePleasanton, CA 94588(925) 463-4427(925) 463-4020 - FAX
Date SummaryPrepared:	December 10, 2002
Trade Name:	Puritan Bennett DataFlow™ Data ManagementSoftware
Common/Usual Name:	Diagnostic Spirometer
Classification Name:	Spirometer, Diagnostic(BZG) per 21 CFR §868.1840
Legally MarketedPredicate Device:	Puritan-Bennett Renaissance Spirometry Systemwith the Optional Renaissance DB DataManagement Software, 510(k) #K944762

Device Description

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Intended Use

The DataFlow software program is intended to augment the data management capability of the Puritan Bennett PB-700 Renaissance® II Spirometer System and the Nellcor Puritan Bennett NPB-500 Simplicity™ Spirometer System. The DataFlow software program is for use by healthcare professionals (e.g., technicians, nurses and/or physicians) in hospitals, physicians' offices, alternate care and occupational health environments under the direction of a physician. DataFlow is not intended for use by patients.

Summary of Technological Characteristics of the Device Compared to the Legally Marketed Device

The Puritan Bennett DataFlow™ Data Management Software has the same technological characteristics as the above referenced predicate device. The intended use of the DataFlow software is the same as the predicate device inasmuch as the function of DataFlow is to augment the spirometer's data management capability. The DataFlow software has the same technological characteristics as the predicate device, where both are PC-based standalone software programs and offer similar basic features.

Tests Performed to Support Determination of Substantial Equivalence

The performance of the DataFlow software program was comprehensively tested with the PB-700 and NPB-500 spirometers. All functions as defined in the specifications were completely verified and validated.

DataFlow adheres to the following FDA CDRH guidances:

CDRH Guidance for the Content of Premarket Submissions for Software Contained . in Medical Devices, May 29, 1998
. CDRH Off-The-Shelf Software Use in Medical Devices, September 9, 1999

Conclusions

The DataFlow software program performs as intended according to its performance specification. DataFlow is substantially equivalent to its predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is displayed in a simple, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Ms. Gina To Senior Regulatory Affairs Project Manager Puritan Bennett Corporation 4280 Hacienda Drive Pleasanton, California 94588-2719

Re: K023225

Trade Name: Puritan Bennett DataFlow™ Data Management Software Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: 73 BZG Dated: September 26, 2002 Received: September 27, 2002

Dear Ms. To:

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 - Ms. Gina To

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) 594-4646. 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,

Susa Ruam

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Puritan Bennett DataFlow™ Data Management Software 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)

Prescription
use

Over-the-counter
use

R. H. Austin

sion Sign-Off) ion of Anesthesiology, General Hospital, tion Control, Dental Devices

510(k) Number ..

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).