(115 days)
The intended use of the Apieron INSIGHT™ eNO System is to quantitatively measure exhaled nitric oxide (eNO) in expired human breath as a marker of inflammation in persons with asthma. Measurement of eNO in expired human breath by the Apieron INSIGHT eNO System is a non-invasive, simple and safe method to measure a decrease in eNO in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of the therapeutic effects in patients with elevated eNO levels. The Apieron INSIGHT eNO System is suitable for use in children ages 8 to 17 years of age, and in adults 18 years of age and older. eNO measurements, as an adjunct to established clinical assessments, provide the physician an objective marker to evaluate the patient's response to anti-inflammatory therapy. The Apieron INSIGHT eNO System can be used by trained operators in a physician's office laboratory setting. The Apieron INSIGHT eNO System should not be used in critical care, emergency care or in anesthesiology.
The Apieron INSIGHT™ eNO System consists of a Monitor, a single-use disposable Sensor Cartridge and other disposable test supplies. The Monitor contains the measurement and breath sampling hardware and provides a user-friendly interface to guide the operator through the test sequence and guide the patient through the breath sampling maneuver. The disposable Sensor Cartridge contains a Biosensor that changes its optical transmission properties when it reacts with the nitric oxide in the breath sample. The Apieron INSIGHT eNO System is transportable, operated by an AC outlet and designed for use with the disposable Sensor Cartridge.
The provided text does not contain detailed information regarding specific acceptance criteria, performance metrics, or the study design with the level of detail requested for each point. The document is a 510(k) summary, which generally focuses on establishing substantial equivalence to a predicate device rather than providing exhaustive clinical study results.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "All necessary bench and clinical testing was conducted on the Apieron eNO System to support a determination of substantial equivalence to the predicate device." However, specific quantitative acceptance criteria (e.g., accuracy, precision limits) or the detailed reported performance values for these criteria are not provided in the given text.
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The text mentions "clinical testing" but does not specify the sample size, country of origin, or if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The device measures exhaled nitric oxide (eNO) as a marker of inflammation in asthma. Ground truth in this context would likely refer to a reference method for eNO measurement or clinical diagnosis of asthma/inflammation. The number and qualifications of experts for establishing such ground truth are not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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 device is not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting images. It is a system for quantitatively measuring exhaled nitric oxide. Therefore, an MRMC comparative effectiveness study in the context of human readers improving with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The Apieron INSIGHT™ eNO System is described as a "Breath Nitric Oxide Test System" that measures eNO. This implies a "standalone" performance in terms of the device's ability to accurately quantify eNO from a breath sample. However, specific standalone performance metrics (e.g., accuracy against a reference standard) and the study details for this are not provided. The text states it "quantitatively measure exhaled nitric oxide (eNO)," which implies a standalone function.
7. The type of ground truth used:
The ground truth for a device measuring eNO would typically be a reference method for nitric oxide measurement. While the text refers to the device measuring a "decrease in eNO...as an indication of the therapeutic effects," the specific ground truth used for validating the device's measurement accuracy is not explicitly stated. It can be inferred that the device's measurements would be compared against a recognized standard for eNO measurement.
8. The sample size for the training set:
As this is a 510(k) for a medical device that quantifies a biomarker, it is unlikely to involve a "training set" in the machine learning sense. The device has a "Biosensor that changes its optical transmission properties when it reacts with the nitric oxide." The performance evaluation would likely focus on the accuracy and precision of this sensor and the overall system. Therefore, a "training set" as commonly understood in AI/ML is not applicable and not mentioned.
9. How the ground truth for the training set was established:
Given that there is no mention of a training set in the AI/ML context, this question is not applicable.
{0}------------------------------------------------
Apieron, Inc.
SECTION 5 510(k) Summary (Cont.)
page 183
510(k) Notification K 00 326
GENERAL INFORMATION Applicant: Apieron, Inc. 155 Jefferson Drive Menlo Park, CA 94025 USA Phone: 650-454-8127 FAX: 650-454-8190
MAR 1 4 2008
Contact Person:
Richard Lotti President & CEO Apieron, Inc. 155 Jefferson Drive Menlo Park, CA 94025 USA Phone: 650-454-8127 FAX: 650-454-8190
Date Prepared: November 16, 2007
DEVICE INFORMATION
The Apieron INSIGHT™ eNO System consists of a Monitor, a single-use disposable Sensor Cartridge and other disposable test supplies. The Monitor contains the measurement and breath sampling hardware and provides a user-friendly interface to guide the operator through the test sequence and guide the patient through the breath sampling maneuver. The disposable Sensor Cartridge contains a Biosensor that changes its optical transmission properties when it reacts with the nitric oxide in the breath sample. The Apieron INSIGHT eNO System is transportable, operated by an AC outlet and designed for use with the disposable Sensor Cartridge.
Classification:
Breath Nitric Oxide Test System, 21 CFR 862.3080, Class II (special controls). The special control is FDA's guidance entitled "Class II Special Controls Guidance Document: Breath Nitric Oxide Test System".
Product Code:
MXA
Trade Name: Apieron INSIGHT™ eNO System
Generic/Common Name:
Breath Nitric Oxide Test System
{1}------------------------------------------------
SECTION 5 510(k) SUMMARY (CONT.)
page 2 of 3
PREDICATE DEVICE
Aerocrine NIOX® System
INTENDED USE
The intended use of the Apieron INSIGHT™ eNO System is to quantitatively measure exhaled nitric oxide (eNO) in expired human breath as a marker of inflammation in persons with asthma. Measurement of eNO in expired human breath by the Apieron INSIGHT eNO System is a non-invasive, simple and safe method to measure a decrease in eNO in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of the therapeutic effects in patients with elevated eNO levels. The Apieron INSIGHT eNO System is suitable for use in children ages 8 to 17 years of age, and in adults 18 years of age and older. eNO measurements, as an adjunct to established clinical assessments, provide the physician an objective marker to evaluate the patient's response to anti-inflammatory therapy. The Apieron INSIGHT eNO System can be used by trained operators in a physician's office laboratory setting. The Apieron INSIGHT eNO System should not be used in critical care, emergency care or in anesthesiology.
PRODUCT DESCRIPTION
The Apieron INSIGHT™ eNO System consists of a Monitor, a single-use disposable Sensor Cartridge and other disposable test supplies. The Monitor contains the measurement and breath sampling hardware and provides a user-friendly interface to guide the operator through the test sequence and guide the patient through the breath sampling maneuver. The disposable Sensor Cartridge contains a Biosensor that changes its optical transmission properties when it reacts with the nitric oxide in the breath sample. The System is transportable, operated by an AC outlet and designed for use with the disposable Sensor Cartridge.
SUBSTANTIAL EQUIVALENCE
The indications for use for the predicate device is substantially equivalent to the proposed indications for use for the Apieron INSIGHT eNO System. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the Apieron INSIGHT eNO System is substantially equivalent to the predicate device.
{2}------------------------------------------------
SECTION 5 510(k) Summary (Cont.)
page 3 of 3
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench and clinical testing was conducted on the Apieron eNO System to support a determination of substantial equivalence to the predicate device.
SUMMARY
The Apieron INSIGHT eNO System is substantially equivalent to the predicate device.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 4 2008
Apieron Inc. c/o Mr. Richard Lotti President & CEO 155 Jefferson Drive Menlo Park, CA 94025
Re: K073265
Trade Name: Apieron INSIGHT™ eNO System Regulation Number: 21 CFR §862.3080 Regulation Name: Breath nitric oxide test system. Regulatory Class: Class II Product Code: MXA Dated: March 05, 2008 Received: March 06, 2008
Dear Mr. Lotti:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{4}------------------------------------------------
Page 2 -
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 offea mober (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Jean m. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
SECTION 4 INDICATIONS FOR USE STATEMENT
073245 510(k) Number (if known):
Device Name: Apieron INSIGHTTM eNO System
Indications For Use:
The intended use of the Apieron INSIGHT™ eNO System is to quantitatively measure exhaled nitric oxide (eNO) in expired human breath as a marker of inflammation in persons with asthma. Measurement of eNO in expired human breath by the Apieron INSIGHT eNO System is a non-invasive, simple and safe method to measure a decrease in eNO in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of the therapeutic effects in patients with elevated eNO levels. The Apieron INSIGHT eNO System is suitable for use in children ages 8 to 17 years of age, and in adults 18 years of age and older. eNO measurements, as an adjunct to established clinical assessments, provide the physician an objective marker to evaluate the patient's response to anti-inflammatory therapy. The Apieron INSIGHT eNO System can be used by trained operators in a physician's office laboratory setting. The Apieron INSIGHT eNO System should not be used in critical care, emergency care or in anesthesiology.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
§ 862.3080 Breath nitric oxide test system.
(a)
Identification. A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breath Nitric Oxide Test System.” See § 862.1(d) for the availability of this guidance document.