(91 days)
Not Found
No
The document describes a standard spirometry system and does not mention any AI or ML components or capabilities.
No
The device is described as a "diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs" and is "designed for use in the diagnosis, assessment, and monitoring of certain lung diseases," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The PB700 Renaissance II Spirometry System is a diagnostic tool..." and the "Device Description" section reiterates, "The Renaissance II Spirometry System is designed for use in the diagnosis, assessment, and monitoring of certain lung diseases."
No
The device description explicitly lists multiple hardware components including the spirometer, base station, AC adapter, flow sensor, syringe adapter, and optional accessories like a calibration syringe and printer. This indicates it is a system with both hardware and software, not a software-only device.
Based on the provided information, the PB700 Renaissance II Spirometry System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The PB700 Spirometry System measures the volume and flow of air moved in and out of a patient's lungs. This is a direct measurement of a physiological function, not an analysis of a sample taken from the body.
- Intended Use: The intended use describes it as a "diagnostic tool to measure the maximal volume and flow of air...". This aligns with a device that measures a physical parameter, not one that analyzes a biological sample.
Therefore, the PB700 Renaissance II Spirometry System is a diagnostic device, but it falls under the category of in vivo diagnostic devices (measuring parameters within the living body) rather than in vitro diagnostic devices.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BZG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
4 to 99 years
Intended User / Care Setting
hospitals, physicians' offices, laboratories, and occupational health testing environments.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PB100 Renaissance Spirometry System, K944762
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 2 7 2002
510(k) Summary
| Submitted by: | Puritan Bennett Incorporated
2200 Faraday Avenue
Carlsbad, CA 92008 |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Company Contact: | James R. Bonds
Senior 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 Marketed
Predicate Device
(Unmodified): | PB100 Renaissance Spirometry System, K944762 |
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.
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.
1
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.
2
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.
3
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
4
510(k) Number (if known):
PB700 Renaissance II Spirometry System Device Name:
Indications For Use:
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.
(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)
OR