(82 days)
Not Found
No
The description focuses on data transfer, editing, archiving, searching, printing, comparing, and exporting data, which are standard data management functions and do not indicate the use of AI/ML. There are no mentions of AI, ML, or related concepts like DNNs, training sets, or performance metrics typically associated with AI/ML models.
No
The device is described as data management software intended to augment spirometer systems by transferring, managing, and reporting patient test data, not for direct therapeutic intervention.
No
The Puritan Bennett DataFlow™ Data Management Software is described as software that augments existing spirometer systems for data management purposes, allowing for transfer, editing, archiving, retrieval, printing, comparing, and exporting of patient test data. It does not perform diagnostic functions itself but facilitates the management of data collected by diagnostic spirometers.
Yes
The device is described as a "software program" that manages data from existing spirometer systems. It does not include any hardware components itself.
Based on the provided information, the Puritan Bennett DataFlow™ Data Management Software is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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." It focuses on managing data from a spirometer.
- Device Description: The description clearly states its function is to "transfer patient test data from the spirometer to an IBM compatible Personal Computer" and then allows for data manipulation, archiving, searching, printing, comparing, and exporting. It does not perform any diagnostic testing on a sample.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This software does not interact with biological specimens.
- Input: The input is data from a spirometer, not a biological sample.
- Output: The output is managed data, reports, and exported data, not a diagnostic result derived from analyzing a biological sample.
The software is a data management tool for a medical device (the spirometer), but it is not itself a diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
BZG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Corporation
2200 Faraday Avenue
Carlsbad, CA 92008 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Gina To
Senior Regulatory Affairs Project Manager
Nellcor Puritan Bennett, Inc.
4280 Hacienda Drive
Pleasanton, CA 94588
(925) 463-4427
(925) 463-4020 - FAX |
| Date Summary
Prepared: | December 10, 2002 |
| Trade Name: | Puritan Bennett DataFlow™ Data Management
Software |
| Common/Usual Name: | Diagnostic Spirometer |
| Classification Name: | Spirometer, Diagnostic
(BZG) per 21 CFR §868.1840 |
| Legally Marketed
Predicate Device: | Puritan-Bennett Renaissance Spirometry System
with the Optional Renaissance DB Data
Management Software, 510(k) #K944762 |
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.
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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:
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.
(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 ..