(86 days)
BE 149
Not Found
No
The summary describes a mechanical device for measuring inspiratory pressure and does not mention any AI or ML components or capabilities.
No
The device is used to measure and monitor inspiratory effort, not to treat a condition. It is a diagnostic/monitoring device.
No
The device measures inspiratory effort, which is a physiological parameter, but the documentation does not state that it is used to diagnose a disease or condition. It is used to "measure and monitor" patient effort. The "Intended Use / Indications for Use" section does not mention diagnosis.
No
The device description explicitly states it measures inspiratory airway pressures up to a certain cm H2O, which implies a physical pressure sensor and gauge, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device measures and monitors patient inspiratory effort by being attached to the patient airway. This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: It measures inspiratory airway pressures. This is a physical measurement, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic assays, which are hallmarks of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures a physical force directly from the patient's respiratory system.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BXR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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.
Instrumentation Industries, Inc. - BE 149 - Preamendment device, Smiths Medical - NIF Kit
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
§ 868.1780 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).
0
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.
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 device |
- Smiths Medical - NIF Kit |
| Device Description | The NS Series NIF Meters are intended to measure inspiratory airway
pressures of up to 30, 60 or 120 cm $H_2O$ , dependent upon the specific model
used. |
| Intended Use of the Device | 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.
NS 30-PBR
NS 60-PBR
NS 60-TRR
NS 30-TRR
NS 60-TBR
NS 120-TRR
Federal law restricts these devices to sale by or on the order of a physician. |
| Technological Characteristics | Similarities: - The function of the NS Series NIF Meters, the BE 149 and the Smiths
Medical NIF kit are the same. All are analog-faced manometers used to
measure inspiratory pressure |
1
.
:
:
:
| 2. The anticipated usage of all of the devices is the same. All versions of the
NS NIF meters, the BE 149 and the Smiths Medical NIF Kit include a memory
indicator pointer (MIP) that records the maximum pressure reached during
| 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 |
| diaphragm which, when exposed to a patient's inhaled breath, activates the |
| pressure and MIP via a spring. |
| Differences: |
- The capacity varies among them:
The BE 149 range = 0-60 cm H20
The Smiths Medical NIF Kit range = 0-60 cm H20
The NS Series offers three pressure ranges: 0-30, 0-60, 0-120 cm H20 - The Smiths Medical NIF meter is sold in an inclusive kit; The NS Series
NIF meters are sold alone; adapters and tubing are not included. - The Smiths Medical NIF meter is offered with only one type of attachment
point 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. |
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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.
3
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
4
Indications for Use
510(k) Number (if known):
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