NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS

K081693 · Instrumentation Industries, Inc. · BXR · Sep 11, 2008 · Anesthesiology

Device Facts

• Record ID: K081693
• Device Name: NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
• Applicant: Instrumentation Industries, Inc.
• Product Code: BXR · Anesthesiology
• Decision Date: Sep 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1780
• Device Class: Class 2

Indications for Use

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 Story

NS Series NIF Meters are analog-faced manometers designed to measure and monitor patient inspiratory airway pressure. The device features a diaphragm mechanism that, when exposed to a patient's inhaled breath, activates a pressure gauge and a memory indicator pointer (MIP) via a spring. The MIP records the maximum pressure reached during inspiration and can be manually reset for repeated exercises. The device is attached to the patient's airway at a point providing optimal readings. It is intended for use by healthcare professionals in clinical settings. By providing a quantitative measurement of inspiratory effort, the device assists clinicians in assessing respiratory function and making informed clinical decisions regarding patient care. Available in pressure ranges of 0-30, 0-60, or 120 cm H2O, with various fitting options (1/4” NPT bottom, 1/4” NPT rear, or small-bore tubing).

Clinical Evidence

Bench testing only.

Technological Characteristics

Analog-faced manometer; diaphragm-spring sensing mechanism; memory indicator pointer (MIP) for peak pressure recording; pressure ranges 0-30, 0-60, 120 cm H2O; mechanical device; no software or electronic components.

Indications for Use

Indicated for patients requiring measurement and monitoring of inspiratory effort. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• Instrumentation Industries, Inc. - BE 149
• Smiths Medical - NIF Kit

Submission Summary (Full Text)

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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

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2990 Industrial Boulevard • Bethel Park, PA 15102-2536 Phone: [phone] US Toll-Free: 1-800-633-8577 Fax: [phone] 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 device<br>2. Smiths Medical - NIF Kit |
| Device Description | The NS Series NIF Meters are intended to measure inspiratory airway<br>pressures of up to 30, 60 or 120 cm $H_2O$ , dependent upon the specific model<br>used. |
| Intended Use of the Device | The Instrumentation Industries, Inc. Negative Inspiratory Force (NIF) Meters<br>are devices used to measure and monitor patient inspiratory effort. During use<br>the NIF Meter is attached to the patient airway at a point that provides optimal<br>readings of patient respiratory effort.<br>NS 30-PBR<br>NS 60-PBR<br>NS 60-TRR<br>NS 30-TRR<br>NS 60-TBR<br>NS 120-TRR<br>Federal law restricts these devices to sale by or on the order of a physician. |
| Technological Characteristics | Similarities:<br>1. The function of the NS Series NIF Meters, the BE 149 and the Smiths<br>Medical NIF kit are the same. All are analog-faced manometers used to<br>measure inspiratory pressure |

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| 2. The anticipated usage of all of the devices is the same. All versions of the<br>NS NIF meters, the BE 149 and the Smiths Medical NIF Kit include a memory<br>indicator pointer (MIP) that records the maximum pressure reached during<br>inspiration. The pointer can be re-set and the exercise repeated. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3. The operation of the NIF meters is technologically the same: All have a<br>diaphragm which, when exposed to a patient's inhaled breath, activates the<br>pressure and MIP via a spring. |
| Differences:<br>1. The capacity varies among them:<br>The BE 149 range = 0-60 cm H20<br>The Smiths Medical NIF Kit range = 0-60 cm H20<br>The NS Series offers three pressure ranges: 0-30, 0-60, 0-120 cm H20<br>2. The Smiths Medical NIF meter is sold in an inclusive kit; The NS Series<br>NIF meters are sold alone; adapters and tubing are not included.<br>3. The Smiths Medical NIF meter is offered with only one type of attachment<br>point which is a small-bore tubing port. The III NIF meters have three: ¼”<br>NPT bottom fitting, ¼” NPT rear fitting, and a small-bore tubing fitting. |

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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 [phone]. 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 [phone] or [phone] 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:

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.

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