(428 days)
Not Found
No
The device description details a purely mechanical mechanism for pressure measurement and display. There is no mention of computational processing, algorithms, or learning from data. The performance studies are based on mechanical accuracy and responsiveness, not algorithmic performance.
No
The device is solely for monitoring airway pressure and does not provide any treatment or therapeutic function.
No
The device monitors patient airway pressure during ventilation, which is a measurement function. It does not provide a diagnosis of a condition.
No
The device description explicitly states it contains a diaphragm capsule and internal, interconnected movements, indicating it is a physical hardware device that measures pressure mechanically.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor directly measures pressure within the patient's airway during ventilation. This is a measurement taken in vivo (within the living body).
- Intended Use: The intended use is to monitor airway pressure during ventilation, not to analyze biological samples.
The device is a medical device used for monitoring a physiological parameter directly in the patient, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used to monitor patient airway pressure during ventilation with a manual resuscitation device or bag/mask unit. These devices are intended to be used by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
CAP
Device Description
The Instrumentation Industries, Inc. NS 120P-TRS airway pressure monitor measures positive pressures from 0-120cm H2O during manual ventilation. The device contains a diaphragm capsule which inflates when positive pressure is introduced and collapses when the pressure decreases. Through several internal, interconnected, movements caused by the inflating/deflating diaphragm, the pointer on the face of the gauge moves to indicate accurate pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by or on the order of a physician. Hospital, Physician Office, Emergency services.
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)
Study Type: Non-clinical testing, comparative accuracy and responsiveness testing.
Sample Size: Subject device (NS 120P-TRS): 50 samples for accuracy and responsiveness tests. Predicate device (NS 120-TRS): 10 samples for accuracy and responsiveness tests.
Key Results:
Accuracy Test Comparison:
- NS 120P-TRS (Subject): Average Accuracy Difference at 60 cm H2O Pressure was 0.6 cm H2O, and at 120 cm H2O Pressure was 0.9 cm H2O. Passed vendor's accuracy specification of +/- 1.9cm H2O.
- NS 120-TRS (Predicate): Average Accuracy Difference at 60 cm H2O Pressure was 0.8 cm H2O, and at 120 cm H2O Pressure was 1.8 cm H2O. Passed vendor's accuracy specification of +/- 3.8cm H2O.
Responsiveness Test Comparison: - Both NS 120P-TRS (Subject) and NS 120-TRS (Predicate) passed the responsiveness specification, responding instantly to pressure changes.
Conclusion: Validation testing shows that the NS 120P-TRS pressure gauge meets the manufacturer's and Instrumentation Industries Inc.'s accuracy specification and has needle movement that is responsive to pressure changes, and thus meets all of the pre-defined acceptance criteria, substantially equivalent to the predicate NS 120-TRS device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 1.6% full scale (1.92 cm H2O) for the subject device.
Accuracy: +/- 1.6% full scale (3.8 cm H2O) for the predicate device.
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.
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
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).
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May 1, 2019
Instrumentation Industries, Inc. Doris Walter RA/QA Manager 2990 Industrial Blvd. Bethel Park, Pennsylvania 15102
Re: K180510
Trade/Device Name: NS 120P-TRS Airway Pressure Gauge Regulation Number: 21 CFR 868.2600 Regulation Name: Monitor, Airway Pressure Regulatory Class: Class II Product Code: CAP Dated: April 1, 2019 Received: April 1, 2019
Dear Doris 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, fi applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180510
Device Name NS 120P-TRS Pressure Gauge
Indications for Use (Describe)
The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used to monitor patient arway pressure during ventilation with a manual resuscitation device or bag/mask unit.
These devices are intended to be used by or on the order of a physician.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Instrumentation Industries, Inc. The logo consists of a stylized icon on the left and the company name on the right. The icon is a rounded rectangle with a grid-like pattern inside, and the company name is written in a bold, sans-serif font.
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: 9/5/2018; Contact Person/Submitter: Doris F. Walter Official Correspondent for Instrumentation Industries, Inc.: Edward C. Horey
510(k) SUMMARY NS 120P-TRS Pressure Gauge K180510
| Trade Name of
| Subject Device | NS 120P-TRS Pressure Gauge | |
|---|---|---|
| Common Name | Monitor, Airway Pressure | |
| Classification | Class II | |
| Regulation | 21 CFR 868.2600 | |
| Product Code | CAP | |
| Predicate Device | NS 120-TRS Vacuum/Pressure Gauge | |
| K081778 | ||
| Distributed by Instrumentation Industries, Inc. | ||
| Device | ||
| Description | The Instrumentation Industries, Inc. NS 120P-TRS airway pressure monitor measures | |
| positive pressures from 0-120cm H2O during manual ventilation. The device contains a | ||
| diaphragm capsule which inflates when positive pressure is introduced and collapses when | ||
| the pressure decreases. Through several internal, interconnected, movements caused by the | ||
| inflating/deflating diaphragm, the pointer on the face of the gauge moves to indicate accurate | ||
| pressure. | ||
| Indications for | ||
| Use | The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used | |
| to monitor patient airway pressure during ventilation with a manual resuscitation device or | ||
| bag/mask unit. | ||
| These devices are intended to be used by or on the order of a physician. | ||
| Intended Use of the Device | The NS 120P-TRS would be used in-line with a Resuscitation Bag Mask Unit to monitor positive pressures when manually ventilating a patient, to assure that safe prescribed pressures are not exceeded. | |
| Where Used | Hospital, Physician Office, Emergency services. | |
| Material and Physical Characteristics | ||
| NS 120P-TRS Subject Device | NS 120-TRS Predicate Device | |
| Pressure Range: $0-120cm H_2O$ | $-120cm H_2O - 0 - +120cm H_2O$ | |
| Accuracy: +/- 1.6% full scale (1.92 cm $H_2O$ ) | Accuracy: +/- 1.6% full scale (3.8 cm $H_2O$ ) | |
| Measuring element: Copper alloy diaphragm capsule | Same | |
| Connection: ¼" NPT, brass | Same | |
| Case: Black ABS | Same | |
| Assembly Screws: Steel | Same | |
| Lens: Acrylic | Same | |
| Pointer: Black finished aluminum | Same | |
| Dial: Aluminum, white background with black scale. | Same | |
| UV-resistant Movement: Brass and nickel-silver with highly-polished bearing surfaces. | Same | |
| Biocompatibility: No new biocompatibility testing has been performed. Biocompatibility information is leveraged from the predicate device. All of the materials and processing of the final finished form of the subject device are identical to those of the predicate device. In accordance with the FDA 2016 Biocompatibility Guidance Document, Attachment F, the general example statement for Comparison to the previously marketed device is utilized as follows: | ||
| The materials used in the NS 120P-TRS, manufactured by NoShok, are identical to the materials used in the NS 120-TRS, also manufactured by NoShok, as approved in K081778 in formulation, processing, and sterilization, and no other chemicals have been added. | ||
| Technological Characteristics | Both the subject and predicate device contain the exact same components but the technological characteristics of the subject and predicate devices are different due to an adjustable tab. |
One technological modification, the physical adjustment of the abovementioned tab, dictates whether the gauge will read both negative and positive pressure, or whether it will read only positive pressure.
The technological modification: Adjusting the tab at different heights controls the movement of an internal lever:
- For the predicate device, the tab is bent higher, allowing greater movement of the upper lever so that both positive and negative pressure can be introduced for the full range of -120cm $H_2O$ to +120cm $H_2O$ .
- For the Subject device, the tab is bent lower to permit the upper lever to move in the positive direction only, within the range of 0cm $H_2O$ to +120cm $H_2O$ . | |
| Performance Testing: Summary of non-clinical testing data | | |
4
The objectives of the validation testing were to:
5
- Ensure that the new NS 120P-TRS pressure gauges (subject device) met the accuracy tolerance of 1. 1.6% of full scale (+1.9cm H20)
-
- Compare the accuracy testing results of the new NS 120P-TRS pressure gauge against a similar, currently-marketed vacuum/pressure gauge already in our product line, the NS 120-TRS vacuum/pressure gauge (predicate device). Accuracy tolerance of the predicate device is also 1.6% of full scale (+3.8cm H20). Please note that the tolerance is doubled for the predicate device because its scale is twice the range of the NS 120P-TRS (subject) device as the predicate device measures both positive and negative pressure.
-
- Compare needle responsiveness of subject and predicate device. The acceptance criteria for responsiveness of the needle movement is that both gauges must respond instantly to pressurization changes.
The following tables summarize the comparative results of non-clinical testing performed for the subject NS 120P-TRS and NS 120-TRS predicate devices.
Accuracy Test Comparison for NS 120P-TRS and NS 120-TRS
| Device | Number of
Samples | Vendor's
Accuracy
Specification | Average Accuracy
Difference at 60 cm
H20 Pressure | Average Accuracy
Difference at 120 cm
H20 Pressure | Pass
or
Fail |
|------------------------|----------------------|---------------------------------------|---------------------------------------------------------|----------------------------------------------------------|--------------------|
| NS 120P-TRS (Subject) | 50 | $\pm$ 1.9cm H20 | 0.6 cm H20 | 0.9 cm H20 | Pass |
| NS 120-TRS (Predicate) | 10 | $\pm$ 3.8cm H20 | 0.8 cm H20 | 1.8 cm H20 | Pass |
Responsiveness Test Comparison for NS 120P-TRS and NS 120-TRS
| Device | Number of
Samples | Instrumentation
Industries Inc.'s
Response
Specification | Pass/Fail | Notes |
|------------------------|----------------------|-------------------------------------------------------------------|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NS 120P-TRS (Subject) | 50 | Must respond
instantly to
pressure | Pass | |
| NS 120-TRS (Predicate) | 10 | Must respond
instantly to
pressure and
vacuum | Pass | The vacuumreadings for the
predicate gauge are not really
relevant for this comparison as
the subject gauge has no
vacuumcapability, but are
included for completeness. |
Summary of testing:
Validation testing shows that the NS 120P-TRS pressure gauge meets the manufacturer's and Instrumentation Industries Inc.'s accuracy specification and has needle movement that is responsive to pressure changes, and thus meets all of the pre-defined acceptance criteria, substantially equivalent to the predicate NS 120-TRS device.
Based upon these testing results, the subject device. NS 120P-TRS Pressure Gauge has been found to be substantially equivalent when measuring pressure to the predicate NS 120-TRS Vacuum/Pressure gauge.
| Conclusion: | The NS 120P-TRS has been compared against a currently marketed device for the
determination of substantial equivalency when used for monitoring positive pressure. The
NS 120P-TRS has been found to be substantially equivalent to the NS 120-TRS. |
| ------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|