NS 120P-TRS Airway Pressure Gauge

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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<br>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<br>K081778<br>Distributed by Instrumentation Industries, Inc. | | | Device<br>Description | The Instrumentation Industries, Inc. NS 120P-TRS airway pressure monitor measures<br>positive pressures from 0-120cm H2O during manual ventilation. The device contains a<br>diaphragm capsule which inflates when positive pressure is introduced and collapses when<br>the pressure decreases. Through several internal, interconnected, movements caused by the<br>inflating/deflating diaphragm, the pointer on the face of the gauge moves to indicate accurate<br>pressure. | | | Indications for<br>Use | The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used<br>to monitor patient airway pressure during ventilation with a manual resuscitation device or<br>bag/mask unit.<br>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:<br>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.<br><br>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.<br><br>The technological modification: Adjusting the tab at different heights controls the movement of an internal lever:<br>- 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 $H_2O$ .<br>- 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) - 2. 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. - 3) 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<br>Samples | Vendor's<br>Accuracy<br>Specification | Average Accuracy<br>Difference at 60 cm<br>H20 Pressure | Average Accuracy<br>Difference at 120 cm<br>H20 Pressure | Pass<br>or<br>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<br>Samples | Instrumentation<br>Industries Inc.'s<br>Response<br>Specification | Pass/Fail | Notes | |------------------------|----------------------|-------------------------------------------------------------------|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | NS 120P-TRS (Subject) | 50 | Must respond<br>instantly to<br>pressure | Pass | | | NS 120-TRS (Predicate) | 10 | Must respond<br>instantly to<br>pressure and<br>vacuum | Pass | The vacuumreadings for the<br>predicate gauge are not really<br>relevant for this comparison as<br>the subject gauge has no<br>vacuumcapability, but are<br>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<br>determination of substantial equivalency when used for monitoring positive pressure. The<br>NS 120P-TRS has been found to be substantially equivalent to the NS 120-TRS. | |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|