APIERON INSIGHT ENO SYSTEM

K083617 · Apieron, Inc. · MXA · Jan 27, 2009 · Clinical Toxicology

Device Facts

• Record ID: K083617
• Device Name: APIERON INSIGHT ENO SYSTEM
• Applicant: Apieron, Inc.
• Product Code: MXA · Clinical Toxicology
• Decision Date: Jan 27, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3080
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

The Apieron INSIGHT eNO System measures exhaled nitric oxide (eNO) in human breath as an asthma inflammation marker. The system comprises a monitor and a multi-use disposable sensor cartridge. The patient performs a breath sampling maneuver guided by the monitor interface. The biosensor within the cartridge reacts with nitric oxide in the breath sample, altering its optical transmission properties. The monitor processes this optical signal to quantify eNO levels. Used in physician office laboratories by trained operators, the device provides an objective marker to assess patient response to anti-inflammatory therapy. The system includes software to track sensor usage (limiting to 5 or 10 uses) and performs air purges between tests to clear residual nitric oxide. Benefits include non-invasive monitoring of therapeutic efficacy.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements to confirm performance after increasing cartridge usage limit to ten uses and implementing additional QC tests.

Technological Characteristics

System includes a monitor and disposable sensor cartridge containing a biosensor. Sensing principle: optical transmission change upon reaction with nitric oxide. Connectivity: AC-powered, transportable. Software: includes usage-tracking and automated air-purge cycles. Sterilization: not specified.

Indications for Use

Indicated for use with the Apieron INSIGHT eNO System to measure fractional exhaled nitric oxide (FeNO) in human breath.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Apieron INSIGHT™ eNO System (K073265)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K083617

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k073265 Apieron INSIGHT eNO System
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for increasing the number of uses of the eNO Sensor Cartridge from one to ten with additional QC tests. The eNO system software has been modified to track number of uses of the cartridge.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use, physical characteristics, test steps, performance characteristics and software validation and verification.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.