The Instrumentation Industries, Inc. Negative Inspiratory Force (NIF) Meters are devices used to measure and monitor patient inspiratory effort. During use the NIF Meter is attached to the patient airway at a point that provides optimal readings of patient respiratory effort. Federal law restricts these devices to sale by or on the order of a physician.

Device Description

The NS Series NIF Meters are intended to measure inspiratory airway pressures of up to 30, 60 or 120 cm H2O , dependent upon the specific model used.

AI/ML Overview

This document is a 510(k) summary for the NS Series NIF (Negative Inspiratory Force) Meters, which are inspiratory airway pressure meters. It does not contain information about a study that proves the device meets specific acceptance criteria in the way described in the prompt.

The document focuses on demonstrating substantial equivalence to predicate devices (Instrumentation Industries, Inc. - BE 149 and Smiths Medical - NIF Kit) based on similar technological characteristics and intended use. The "acceptance criteria" discussed are implicit in the comparison of the new device's function, anticipated usage, and operation to the predicate devices.

Therefore, most of the requested information regarding detailed acceptance criteria and a study to prove them is not present in this 510(k) summary. I can only provide the information that is explicitly or implicitly present.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with reported device performance metrics in the sense of a clinical or performance study. Instead, the acceptance criteria are implied by the "Technological Characteristics" section, which highlights similarities and differences with predicate devices.

Acceptance Criteria (Implied by Predicate Comparison)	Reported NS Series NIF Meters Performance (from "Device Description" / "Technological Characteristics")
Functionality: To measure inspiratory pressure. (Similar to predicate devices)	Functionality: "NS Series NIF Meters are intended to measure inspiratory airway pressures..." and "The function of the NS Series NIF Meters... are the same. All are analog-faced manometers used to measure inspiratory pressure."
Anticipated Usage: Similar to predicate devices, including a memory indicator pointer (MIP) for maximum pressure.	Anticipated Usage: "The anticipated usage of all of the devices is the same. All versions of the NS NIF meters... include a memory indicator pointer (MIP) that records the maximum pressure reached during inspiration. The pointer can be re-set and the exercise repeated."
Operation: Analog manometer with a diaphragm that activates pressure and MIP via a spring when exposed to inhaled breath. (Technologically the same)	Operation: "The operation of the NIF meters is technologically the same: All have a diaphragm which, when exposed to a patient's inhaled breath, activates the pressure and MIP via a spring."
Measurement Range: Compatible with clinical needs for NIF measurement.	Measurement Range: The NS Series offers three pressure ranges: 0-30, 0-60, 0-120 cm H2O. (This is a difference from predicates which typically have 0-60 cm H2O, but is presented as an enhancement rather than a failure to meet criteria). The specific models are for "up to 30, 60 or 120 cm H2O."
Attachment Points: Provide suitable means for patient connection.	Attachment Points: The III NIF meters have three: ¼” NPT bottom fitting, ¼” NPT rear fitting, and a small-bore tubing fitting. (This is a difference from Smiths Medical NIF meter which has one type, but is presented as an enhancement).
Sold as: Device sold alone. (Different from Smiths Medical NIF kit)	Sold as: The NS Series NIF meters are sold alone; adapters and tubing are not included.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The 510(k) summary does not describe a test set, sample size, or data provenance from a specific study to evaluate the device's performance against detailed acceptance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. No test set or ground truth establishment process by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No adjudication method for a test set is described.

5. 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

This information is not applicable / not provided. This device is a manual inspiratory airway pressure meter, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable / not provided. This device is a manual, analog medical instrument. It does not involve algorithms or AI, so "standalone" algorithm performance is not relevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided in the document. No specific ground truth methodology is described, as the submission focuses on substantial equivalence to existing predicate devices based on design and intended use, rather than a clinical performance study with an established ground truth.

8. The sample size for the training set

This information is not provided in the document. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not provided in the document. No ground truth for a training set is mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Instrumentation Industries, Inc. The logo consists of a rounded rectangle with three vertical bars inside, followed by the company name in bold text. Below the company name is the tagline "We make Respiratory Care Work!" in a smaller, italicized font.

K081693

Section 5 Page 1 of 2

2990 Industrial Boulevard • Bethel Park, PA 15102-2536 Phone: 412-854-1133 US Toll-Free: 1-800-633-8577 Fax: 412-854-5668 www.iiimedical.com

Date Prepared: June 13, 2008 Revised: August 7, 2008 Contact Person for this Submission: Doris F. Walter Submitter: Doris F. Walter Official Correspondent for Instrumentation Industries, Inc.: Edward C. Horey

510(k) SUMMARY

For

NS Series NIF Meters

Trade Name	NS Series NIF (Negative Inspiratory Force) Meters
Common Name	NIF Meter
Classification Name	Inspiratory Airway Pressure Meter
Regulation	21 CFR 868.1780
Predicate Devices	1. Instrumentation Industries, Inc. - BE 149 - Preamendment device2. Smiths Medical - NIF Kit
Device Description	The NS Series NIF Meters are intended to measure inspiratory airwaypressures of up to 30, 60 or 120 cm $H_2O$ , dependent upon the specific modelused.
Intended Use of the Device	The Instrumentation Industries, Inc. Negative Inspiratory Force (NIF) Metersare devices used to measure and monitor patient inspiratory effort. During usethe NIF Meter is attached to the patient airway at a point that provides optimalreadings of patient respiratory effort.NS 30-PBRNS 60-PBRNS 60-TRRNS 30-TRRNS 60-TBRNS 120-TRRFederal law restricts these devices to sale by or on the order of a physician.
Technological Characteristics	Similarities:1. The function of the NS Series NIF Meters, the BE 149 and the SmithsMedical NIF kit are the same. All are analog-faced manometers used tomeasure inspiratory pressure

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2. The anticipated usage of all of the devices is the same. All versions of theNS NIF meters, the BE 149 and the Smiths Medical NIF Kit include a memoryindicator pointer (MIP) that records the maximum pressure reached duringinspiration. The pointer can be re-set and the exercise repeated.
3. The operation of the NIF meters is technologically the same: All have adiaphragm which, when exposed to a patient's inhaled breath, activates thepressure and MIP via a spring.
Differences:1. The capacity varies among them:The BE 149 range = 0-60 cm H20The Smiths Medical NIF Kit range = 0-60 cm H20The NS Series offers three pressure ranges: 0-30, 0-60, 0-120 cm H202. The Smiths Medical NIF meter is sold in an inclusive kit; The NS SeriesNIF meters are sold alone; adapters and tubing are not included.3. The Smiths Medical NIF meter is offered with only one type of attachmentpoint which is a small-bore tubing port. The III NIF meters have three: ¼”NPT bottom fitting, ¼” NPT rear fitting, and a small-bore tubing fitting.

2. The anticipated usage of all of the devices is the same. All versions of theNS NIF meters, the BE 149 and the Smiths Medical NIF Kit include a memoryindicator pointer (MIP) that records the maximum pressure reached duringinspiration. The pointer can be re-set and the exercise repeated.

3. The operation of the NIF meters is technologically the same: All have adiaphragm which, when exposed to a patient's inhaled breath, activates thepressure and MIP via a spring.

Differences:1. The capacity varies among them:The BE 149 range = 0-60 cm H20The Smiths Medical NIF Kit range = 0-60 cm H20The NS Series offers three pressure ranges: 0-30, 0-60, 0-120 cm H202. The Smiths Medical NIF meter is sold in an inclusive kit; The NS SeriesNIF meters are sold alone; adapters and tubing are not included.3. The Smiths Medical NIF meter is offered with only one type of attachmentpoint which is a small-bore tubing port. The III NIF meters have three: ¼”NPT bottom fitting, ¼” NPT rear fitting, and a small-bore tubing fitting.

and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the fir

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2008

Ms. Doris F. Walter Regulatory Affairs/Quality Assurance Manager Instrumentation Industries, Incorporated 2990 Industrial Boulevard Bethel Park, Pennsylvania 15102-2536

Re: K081693

Trade/Device Name: NS Series NIF (Negative Inspiratory Force) Meters Regulation Number: 21 CFR 868.1780 Regulation Name: Inspiratory Airway Pressure Meter Regulatory Class: II Product Code: BXR Dated: September 3, 2008 Received: September 4, 2008

Dear Ms. Walter:

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. Walter

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Muhammad Karim forey

Chiu Lin, Ph.D. 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

510(k) Number (if known):

K081693

Device Name: NS series NIF (Negative Inspiratory Force) Meters

Statement of Indications for Use:

Federal law restricts these devices to sale by or on the order of a physician.

Prescription Use V (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)

(Division Sign

Division of Anesthesiology, General Hospital Infection Control, Dental Devicess

510(k) Number: 93

Regulation Number and Section

§ 868.1780 Inspiratory airway pressure meter.

(a)
Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.(b)
Classification. Class II (performance standards).