(50 days)
No
The document explicitly states that the only software changes are related to counting sensor uses and adding air purges, and there is no mention of AI, ML, or related concepts.
No
The device is intended to measure exhaled nitric oxide as a marker of inflammation and to evaluate a patient's response to anti-inflammatory therapy. It does not provide therapy itself.
Yes
The device is described as quantitatively measuring exhaled nitric oxide (eNO) as a marker of inflammation in persons with asthma, and these measurements "as an adjunct to established clinical assessments, provide the physician an objective marker to evaluate the patient's response to anti-inflammatory therapy." This indicates its role in providing objective data for clinical assessment and monitoring, which is a diagnostic function.
No
The device description explicitly states that the system consists of a Monitor and a multi-use disposable Sensor Cartridge, which are hardware components. While there are software modifications, the core device includes physical hardware for measurement and breath sampling.
Based on the provided information, the Apieron INSIGHT™ eNO System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to "quantitatively measure exhaled nitric oxide (eNO) in expired human breath". This involves analyzing a biological sample (breath) outside of the body to provide information about a patient's health status (inflammation in persons with asthma).
- Device Description: The device utilizes a "Biosensor" that reacts with nitric oxide in the breath sample, indicating a chemical reaction and analysis of a biological specimen.
- Care Setting: It is intended for use in a "physician's office laboratory setting", which is a common environment for IVD testing.
The core function of analyzing a biological sample (exhaled breath) to provide diagnostic information (marker of inflammation in asthma) firmly places this device within the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
MXA
Device Description
The proposed Apieron INSIGHT™ eNO System consists of a Monitor, a multi-use disposable Sensor Cartridge and the same disposable test supplies as the cleared device. The only difference between the proposed devices and the cleared device is that the single-use disposable eNO Sensor Cartridge of the INSIGHT System has been tested and proven to support up to 10 patient uses and 5 QC tests. A modification has been made to the software which will allow for counting the uses of the Sensor Cartridge and prevention of uses beyond the specified limits. Two sensors are being proposed for clearance one for 10 patient uses and 5 QC tests and one for 5 patient uses and 5 QC tests. The Monitor functions the same and contains the same measurement and breath sampling hardware to provide for a user-friendly interface guiding the operator through the test sequence and the patient through the breath sampling maneuver. The 10-use and the 5-use disposable Sensor Cartridges contain the same Biosensor as in the cleared device which changes its optical transmission properties when it reacts with the nitric oxide in the breath sample. Apart for some software changes to deal with the number of sensor uses, and the addition of more air purges between tests to clear the sensor of nitric oxide from the previous test, the proposed Apieron INSIGHT eNO System is unchanged. It is transportable, operated by an AC outlet and designed for use with the Sensor Cartridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human breath
Indicated Patient Age Range
children ages 8 to 17 years of age, and in adults 18 years of age and older.
Intended User / Care Setting
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.
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)
All necessary bench testing was conducted on the proposed Apieron INSIGHT eNO System to support a determination of substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Apieron INSIGHT™ eNO System (K073265)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
APIERON, INC.
SECTION 6 510(k) SUMMARY (CONT.)
| 510(k) Notification K | 083617 |
|---|---|
| ----------------------- | -------- |
GENERAL INFORMATION
Applicant:
Apieron, Inc. 155 Jefferson Drive Menlo Park, CA 94025 U.S.A. Phone: 650-454-0322 FAX: 650-838-8290
JAN 2 7 2009
Contact Person:
Nina Peled, Ph.D., MBA Vice President, Global Head of Regulatory and Clinical Affairs Apieron, Inc. Menlo Park, CA 94025 U.S.A. Phone: 650-454-0322 650-838-8290 FAX: Email: nina.peled@apieron.com
Date Prepared: December 6, 2008
Classification: Breath Nitric Oxide Test System, 21 CFR 8862.3080, Class II
Product Code: MXA
Trade Name: Apieron INSIGHT™ eNO System
Generic/Common Name: Breath Nitric Oxide Test System
PREDICATE DEVICE Apieron INSIGHT™ eNO System (K073265)
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
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1
SECTION 6 510(k) SUMMARY (CONT.)
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 proposed Apieron INSIGHT eNO System consists of a Monitor, a multi-use disposable Sensor Cartridge and the same disposable test supplies as the cleared device. The only difference between the proposed devices and the cleared device is that the single-use disposable eNO Sensor Cartridge of the INSIGHT System has been tested and proven to support up to 10 patient uses and 5 QC tests. A modification has been made to the software which will allow for counting the uses of the Sensor Cartridge and prevention of uses beyond the specified limits. Two sensors are being proposed for clearance one for 10 patient uses and 5 QC tests and one for 5 patient uses and 5 QC tests. The Monitor functions the same and contains the same measurement and breath sampling hardware to provide for a user-friendly interface guiding the operator through the test sequence and the patient through the breath sampling maneuver. The 10-use and the 5-use disposable Sensor Cartridges contain the same Biosensor as in the cleared device which changes its optical transmission properties when it reacts with the nitric oxide in the breath sample. Apart for some software changes to deal with the number of sensor uses, and the addition of more air purges between tests to clear the sensor of nitric oxide from the previous test, the proposed Apieron INSIGHT eNO System is unchanged. It is transportable, operated by an AC outlet and designed for use with the Sensor Cartridge. The proposed Apieron INSIGHT eNO System has the same indication for use as the predicate device, the Apieron INSIGHT eNO System (K073265).
SUBSTANTIAL EQUIVALENCE
The Apieron INSIGHT eNO System is substantially equivalent to the predicate device with regard to function, intended use, and physical characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the proposed Apieron INSIGHT eNO System is substantially equivalent to the predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench testing was conducted on the proposed Apieron INSIGHT 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 7 2009
Apieron, Inc. c/o Nina Peled, Ph.D., MBA Vice President, Global Head of Regulatory and Clinical Affairs 155 Jefferson Drive Menlo Park, CA 94025
Re: K083617
Trade/Device Name: Apieron INSIGHTTM eNO System Regulation Number: 21 CFR 862.3080 Regulation Name: Breath nitric oxide test system Regulatory Class: Class II Product Code: MXA Dated: December 24, 2008 Received: December 29, 2008
Dear Dr. Peled:
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).
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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 (301) 594-3084. 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known): K083617
Device Name: Apieron INSIGHT™ eNO System
Indication 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 (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety -
510(k): K083617