(90 days)
Not Found
Not Found
No
The device description clearly states it is a mechanically driven dial powered by kinetic energy, with no mention of computational processing or AI/ML terms.
No
The device is described as a measurement and monitoring tool that indicates the level of lung ventilation. It does not actively treat or modify a physiological function.
Yes
The device measures and monitors lung ventilation to indicate whether adequate ventilation is being achieved, which is a diagnostic function to assess a patient's physiological state.
No
The device description explicitly states it is a "mechanically driven dial" and "driven by the kinetic energy in the flowing gas," indicating it is a hardware device, not software.
Based on the provided information, the Wright/Haloscale Respirometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Wright/Haloscale Respirometer directly measures the volume of expired gas from a patient's lungs. It does not analyze a specimen derived from the body.
- Intended Use: The intended use is to measure and monitor lung ventilation by measuring expired volumes, which is a direct physiological measurement, not an analysis of a biological sample.
Therefore, this device falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post operative recovery.
It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.
Product codes (comma separated list FDA assigned to the subject device)
BZK
Device Description
The Respirometer is a mechanically driven dial, where the dial indicates gas volume passed, and the mechanism is driven by the kinetic energy in the flowing gas. The device measures expirate gas flow and measurements are unaffected by inspirate gas flow. It has an on/off button to lock the pointer and a reset button to return the pointer to zero when it approaches full scale
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
intensive care 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)
Not Found
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.
Not Found
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
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).
0
510(K) Summarv
6091853
Submitter Information
Submitter Name:
| Telephone Number: | |
|---|---|
| Fax Number: | |
| Contact Person: | |
| Email: | |
| Date Prepared: |
nSpire Health. Inc. 1830 Lefthand Circle Longmont, CO 80501 303.666.5555 x3406 729.890.6607 Kimberly Stark kstark@nspirehealth.com April 2009
Device Category
Regulation No .: Product Code: Regulatory Class: Trade Name: Common Name: Classification name:
21 CFR 868.1850 BZK II Wright/Haloscale Respirometer Respirometer Spirometer, monitoring (w/wo alarm)
Equivalent legally-marketed devices.
Boehringer Laboratories Adult Spirometer #8800
Description
The Respirometer is a mechanically driven dial, where the dial indicates gas volume passed, and the mechanism is driven by the kinetic energy in the flowing gas. The device measures expirate gas flow and measurements are unaffected by inspirate gas flow. It has an on/off button to lock the pointer and a reset button to return the pointer to zero when it approaches full scale
Intended Use
The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post operative recovery.
It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.
Technological Characteristics
| Accuracy | Tidal Volumes:
Continuous Flow: | $\pm$ 3% for minute volumes exceeding 5 LPM
$\pm$ 4% for minute volumes exceeding 4 LPM
$\pm$ 2% @ 16 LPM
$\pm$ 5% to + 10% @ 60 LPM |
|-------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity | Starts volume registration at not more than 2.5 LPM | |
| Resistance | Proportional to square of the flow rate and not more than 2cm H2O @ 100 LPM | |
| Dead Space | 22 ml | |
510(k) - Wright/Haloscale Respirometer
CONFIDENTIAL and PROPRIETARY
Page
1
| Permissible Gases | All respirable gases |
|---|---|
| Maximum Temperature | 55°C (131°F) |
| Maximum internal to external pressure | 30cm H2O |
| Maximum Leakage | 60ml/min at 30cm H2O (to ASTM F1208-89) |
| Maximum Recommended Flow Rate | 60 LPM (300 LPM continuous flow for short periods) |
Conclusion
:
The nSpire Respirometer has the same intended use and indications, principle of operation, technological characteristics, and is substantially equivalent in safety and effectiveness to the marketed predicate device with respect to its intended use.
Parties And Comments of Children Comments of Children Comments of Children Comments of Children
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe.
SEP 2 1 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kimberly Stark Director of Global Quality and Regulatory Affairs
NSpire Health, Incorporated
1830 Lefthand Circle Longmont, Colorado 80501
Re: K091853
Trade/Device Name: Wright/Haloscale Respirometer Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: II Product Code: BZK Dated: June 22, 2009 Received: June 23, 2009
Dear Ms. Stark:
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 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. Stark
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification", (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
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 vours.
ph for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: Wright/Haloscale Respirometer
Indications for Use:
The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post operative recovery.
It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.
L. Schultze
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 4091853
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
CONFIDENTIAL and PROPRIETARY 510(k) - Wright/Haloscale Respirometer
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