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 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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wright/Haloscale Respirometer:

This document is a 510(k) summary for a medical device that measures lung ventilation, and as such, it focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a novel clinical study to establish new acceptance criteria and prove its performance.

Therefore, many of the typical acceptance criteria and study elements you requested (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance with ground truth, etc.) are not applicable or not explicitly detailed in this type of submission. The "study" here is primarily a bench-testing and technical comparison to the predicate device and established technical standards.

Here's a breakdown based on the information provided:

Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) are typically derived from the performance specifications of the predicate device and relevant industry standards. The device's reported performance is then compared to these.

Acceptance Criteria (from Predicate/Standards)	Reported Device Performance (Wright/Haloscale Respirometer)
Accuracy
Tidal Volumes: $\pm$ 3% for minute volumes > 5 LPM	Achieved: $\pm$ 3% for minute volumes exceeding 5 LPM
Continuous Flow: $\pm$ 4% for minute volumes > 4 LPM	Achieved: $\pm$ 4% for minute volumes exceeding 4 LPM
Continuous Flow: $\pm$ 2% @ 16 LPM	Achieved: $\pm$ 2% @ 16 LPM
Continuous Flow: $\pm$ 5% to + 10% @ 60 LPM	Achieved: $\pm$ 5% to + 10% @ 60 LPM
Sensitivity
Starts volume registration at not more than 2.5 LPM	Achieved: Starts volume registration at not more than 2.5 LPM
Resistance
Proportional to square of flow rate, not more than 2cm H2O @ 100 LPM	Achieved: Proportional to square of the flow rate and not more than 2cm H2O @ 100 LPM
Dead Space
Not specified (implied to be similar to predicate if not mentioned)	Reported: 22 ml
Permissible Gases
Not specified (implied to be similar to predicate if not mentioned)	Reported: All respirable gases
Maximum Temperature
Not specified (implied to be similar to predicate if not mentioned)	Reported: 55°C (131°F)
Maximum internal to external pressure
Not specified (implied to be similar to predicate if not mentioned)	Reported: 30cm H2O
Maximum Leakage
60ml/min at 30cm H2O (to ASTM F1208-89)	Achieved: 60ml/min at 30cm H2O (to ASTM F1208-89)
Maximum Recommended Flow Rate
Not specified (implied to be similar to predicate if not mentioned)	Reported: 60 LPM (300 LPM continuous flow for short periods)

Note: "Not specified" for criteria where only the device's reported performance is given means the document doesn't explicitly state the predicate's equivalent spec, but the FDA's acceptance implies it met an unstated or inferred standard.

Sample size used for the test set and the data provenance
- Sample Size: Not specified. This would typically involve a series of bench tests using controlled gas flow measurements. The number of repetitions or specific test conditions is not detailed in this summary.
- Data Provenance: The data provenance is laboratory/bench testing conducted by nSpire Health, Inc. This is not clinical data from patients (retrospective or prospective). The location is implied to be at the manufacturer's facility (Longmont, CO).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a device of this type undergoing a 510(k) for substantial equivalence, clinical expert ground truth is typically not required for the technical characteristics comparison. The "ground truth" for the technical specifications is established by calibrated flow meters and pressure sensors used during bench testing.
Adjudication method for the test set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert opinions, typically in clinical studies or evaluations of subjective interpretations (e.g., image analysis). This is a technical performance assessment, not an expert review.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a mechanical respirometer, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was done, and there is no AI component.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The performance data presented (accuracy, sensitivity, resistance, etc.) are inherent characteristics of the device itself, determined through direct measurement during laboratory testing. It operates as a standalone mechanical device without human-in-the-loop performance in the sense of interpretative assistance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the technical characteristics is based on calibrated physical measurements from standard laboratory equipment (e.g., reference flow meters, pressure gauges) and adherence to established industry standards like ASTM F1208-89.
The sample size for the training set
- Not Applicable. This is a mechanical device, not a machine learning or AI model, so there is no concept of a "training set."
How the ground truth for the training set was established
- Not Applicable. Since there is no training set, this question is not relevant.

Summary

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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

Intended Use

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

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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 (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

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Indications for Use Statement

510(k) Number (if known):

Device Name: Wright/Haloscale Respirometer

Indications for Use:

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

Page 13

Regulation Number and Section

§ 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).