WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014

K091853 · Nspire Health, Inc. · BZK · Sep 21, 2009 · Anesthesiology

Device Facts

• Record ID: K091853
• Device Name: WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
• Applicant: Nspire Health, Inc.
• Product Code: BZK · Anesthesiology
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1850
• Device Class: Class 2

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.

Device Story

The Wright/Haloscale Respirometer is a mechanical device used to monitor lung ventilation in intensive care, anesthesia, and post-operative settings. It functions as a respirometer, measuring expired gas volumes to assess ventilation adequacy. The device operates via a mechanically driven dial mechanism powered by the kinetic energy of flowing gas; it measures expirate flow while remaining unaffected by inspirate flow. It features an on/off button to lock the pointer and a reset button to return the dial to zero. The device is intended for use by healthcare professionals to monitor patients in open or closed circuits. By providing real-time volume measurements, it assists clinicians in determining if adequate ventilation is being achieved, thereby supporting clinical decision-making regarding patient respiratory status.

Clinical Evidence

Bench testing only. Performance metrics include accuracy of ±3% for minute volumes >5 LPM, ±4% for >4 LPM, ±2% at 16 LPM, and +5% to +10% at 60 LPM. Sensitivity starts at ≤2.5 LPM. Resistance is ≤2cm H2O at 100 LPM. Leakage is ≤60ml/min at 30cm H2O per ASTM F1208-89.

Technological Characteristics

Mechanical respirometer; kinetic energy-driven dial mechanism. Dead space: 22 ml. Max flow rate: 60 LPM (300 LPM short-term). Max internal/external pressure: 30cm H2O. Max temperature: 55°C. Compatible with all respirable gases. Leakage tested to ASTM F1208-89.

Indications for Use

Indicated for intensive care patients, including those undergoing anesthesia or post-operative recovery, who are spontaneously breathing or mechanically ventilated, to monitor lung ventilation via expired volume measurement.

Regulatory Classification

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.

Predicate Devices

• Boehringer Laboratories Adult Spirometer #8800

Submission Summary (Full Text)

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# 510(K) Summarv

6091853

## Submitter Information

Submitter Name:

| Telephone Number: | |
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| 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 [e-mail] 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:<br>Continuous Flow: | $\pm$ 3% for minute volumes exceeding 5 LPM<br>$\pm$ 4% for minute volumes exceeding 4 LPM<br>$\pm$ 2% @ 16 LPM<br>$\pm$ 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

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| 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 [phone] or [phone] 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

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## 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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