The UBiT-IR300 Infrared Spectrometry System is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The system consists of the UBiT-IR300 Infrared Spectrophotometer, the UBiT-AS10 Autosampler, and Otsuka Breath Collection Bags.

The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The UBiT-IR300 System is suitable for use in both clinical laboratory and point-of-care settings.

Device Description

The UBiT-IR300 Infrared Spectrometry System is a compact analyzer designed for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori. The UBiT-IR300 measures absorption of breath gas by calculating the ratios of 13CO2/12CO2 for a reference breath gas and a sample breath gas. The difference between the ratios for the reference and sample breath gases is calculated to obtain the final measurement result, which is reported as △'3CO2 and expressed as delta per mil (%) or Delta Over Baseline (DOB).

The System consists of the following components:

UBiT-IR300 Infrared Spectrophotometer -
UBiT-AS10 Autosampler -
Otsuka Breath Collection Bags -

AI/ML Overview

The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The device was compared against the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method.

Here's the breakdown of the acceptance criteria and study details:

Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Overall Agreement	Not explicitly stated, but high agreement with GIRMS is expected for substantial equivalence.	99.06% [95% CI: (97.35, 99.74)]
Positive Agreement	Not explicitly stated.	98.29% [95% CI: (94.26, 99.70)]
Negative Agreement	Not explicitly stated.	99.51% [95% CI: (97.49, 99.97)]
Correlation (r)	Not explicitly stated, but high correlation is expected.	r > 0.99 with GIRMS method
Linear Relationship	Not explicitly stated, but a strong linear relationship with GIRMS is expected.	Regression lines pass through the origin with a slope very near one.

Note: The acceptance criteria are not explicitly stated as numerical thresholds in the provided text. However, for a device seeking 510(k) clearance by demonstrating substantial equivalence, the expectation is that its performance is comparable to or non-inferior to the predicate device. The presented results clearly indicate a very high level of agreement and correlation, suggesting these metrics met the implicit requirements for substantial equivalence.

Study Details

Sample Size used for the Test Set and Data Provenance:
- Sample Size: 320 evaluable subjects.
  - 257 subjects from combined Physician Office Laboratory (POL) sites.
  - 63 subjects from one clinical laboratory site.
- Data Provenance: The study was a multi-center, prospective study. The country of origin is not explicitly stated, but given the sponsor (Otsuka Pharmaceutical Co., Ltd., Japan) and the contact person's US number, it's likely a US-based or international study with US participant sites. The data is prospective as subjects were recruited and underwent the urea breath test for the study.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- The ground truth in this study was established using the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method. The study design directly compares the UBiT-IR300's results to the GIRMS method.
- Therefore, the "experts" in this context are the established and recognized methodology of GIRMS for 13CO2 enrichment measurement. There's no mention of a separate panel of human experts in the traditional sense (e.g., radiologists) establishing ground truth, as it's a direct analytical comparison.
Adjudication Method for the Test Set:
- Not applicable in the conventional sense. The "adjudication" is inherent in the comparison of the UBiT-IR300 results against the GIRMS method, which serves as the reference standard. Agreement and correlation were calculated based on this direct comparison.
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:
- No, this was not an MRMC study. This study evaluated the performance of an analytical device (UBiT-IR300) directly against a reference analytical method (GIRMS) for measuring 13CO2 enrichment, not human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the UBiT-IR300 Infrared Spectrometry System. It measures the device's ability to accurately measure 13CO2 enrichment independently, with its results then compared to the established GIRMS method.
The type of ground truth used:
- The ground truth was established by the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method. This is an established and accepted analytical method for measuring 13CO2 enrichment in breath.
The sample size for the training set:
- The provided summary does not explicitly mention a separate "training set" for the device's development. This is typical for an analytical instrument where performance is often based on the device's physical and algorithmic design, rather than a machine learning model that requires a distinct training phase on clinical data. The clinical study described served as a validation/test set.
How the ground truth for the training set was established:
- As no explicit training set is mentioned in the summary, this question is not directly applicable. If a training phase existed during device development, the ground truth would likely have been established through controlled experiments and calibrations using known standards for 13CO2 enrichment, analogous to the GIRMS method used for the clinical validation.

Summary

{0}------------------------------------------------

510(k) Summary

K01337/

for UBiT-IR300 Infrared Spectrometry System

SPONSOR 1.

Otsuka Pharmaceutical Co., Ltd. 2-9, Kanda Tsukasa-cho, Chiyoda-ku Tokyo 101-8535 Japan

Contact Person: Hideji Nonomura Japan: 81-88-665-2126 Telephone:

Mr. Yasuo Irie U.S .: 978-749-8000 Telephone:

December 17, 2001 Date Prepared:

DEVICE NAME 2.

Proprietary Name:	UBIT-IR300 Infrared Spectrometry System
Common/Usual Name:	Infrared Spectrometry System
Classification Name:	Colorimeter, Photometer, or Spectrophotometer for Clinical Use

For use of the UBiT-IR300 System in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection, the following are also applicable:

Analysis System for Use with 13C-Urea Breath Test Common/Usual Name: Classification Name: Urea Breath Test

Predicate Devices 3.

ABCA-NT Gas Isotope Ratio Mass Spectrometer (GIRMS) System . Europa Scientific Limited K974322

{1}------------------------------------------------

DEVICE DESCRIPTION 4.

The System consists of the following components:

UBiT-IR300 Infrared Spectrophotometer -
UBiT-AS10 Autosampler -
Otsuka Breath Collection Bags -

INTENDED USE న్.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Both the UBiT-IR300 System and the ABCA-NT are general purpose instrument systems that are intended to measure changes in 13CO2 content in breath CO2 and have many potential applications. One of the applications for these systems is for use with commercially available 13C-urea breath tests (13C-UBT) for H. pylori. Meretek Urea Breath Test Collection Kits can be used in conjunction with either system and the required breath samples collected for analysis.

{2}------------------------------------------------

The UBiT-IR300 System includes specially designed breath collection bags that subjects blow into for collection of the breath samples. The ABCA-NT uses standard commercially available evacuated tubes for collection of breath samples.

The UBiT-IR300 and the ABCA-NT systems are similar in functional design but use different methods of gas measurement. The UBiT-IR300 uses an infrared spectrophotometer to analyze the gas samples, while the ABCA-NT uses a Gas Isotope Ratio Mass Spectrometer (GIRMS). The UBiT-IR300 is smaller and more compact than the ABCA-NT, and is specifically designed for on-site use. Both systems include an autosampler and a computer for data analysis and storage. The UBiT-IR300 computer is built into the analyzer, while the ABCA-NT has an external computer system.

PERFORMANCE TESTING 7.

Nonclinical Testing 7.1

The UBiT-IR300 and UBiT-AS10 were tested to and comply with IEC 60601-1 and IEC 60601-1-2.

Reproducibility and carry-over studies were conducted on the UBiT-IR300 alone and with the UBiT-IR300 connected to the UBiT-AS10 Autosampler. These studies demonstrate that the UBiT-IR300 performs according to its specifications and there is negligible carryover.

7.2 Clinical Testing

A clinical study was conducted to evaluate the performance of the UBiT-IR300 Infrared Spectrometry System to measure changes in '3CO2 content in breath CO2 gas by infrared spectroscopic analysis. The multi-center, prospective study was designed to compare the UBiT-IR300 Infrared Spectrophotometer for measuring 13CO2 enrichment in breath with the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method. Subjects were recruited from four Physician Office Laboratory (POL) settings and one clinical laboratory setting. Subjects underwent a standard urea breath test (UBT) which is used for the detection of Helicobacter pylori (H. pylori) infection. Analyses of breath samples were performed using both the UBiT-IR300 Infrared Spectrophotometer and GIRMS methods. The number of evaluable subjects was 257 for the combined POL sites and 63 for the clinical laboratory site with a total of 320 evaluable subjects across all participating sites.

{3}------------------------------------------------

The primary endpoint was the percent agreement of the UBiT-IR300 results as compared to the result generated by the GIRMS method using a cut-off value of 2.4 Delta Over Baseline (DOB). Results for all POLs plus the clinical laboratory are as follows:

% Overall Agreement:	99.06% [95% CI: (97.35, 99.74)]
% Positive Agreement:	98.29% [95% CI: (94.26, 99.70)]
% Negative Agreement:	99.51% [95% CI: (97.49, 99.97)]

As a secondary endpoint, paired Delta Over Baseline (DOB) values were analyzed directly in order to determine the extent to which the methods were linearly related and the degree to which they were correlated. Comparison of the paired DOB values demonstrates that the two methods give results which are very highly correlated (r>.99) and appear to be linearly related to one another. The data suggest that the regression lines pass through the origin with a slope very near one.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Otsuka Pharmaceutical Co., Limited c/o Ms. Cynthia A. Sinclair, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Received: October 11, 2001

DEC 2 1 2001

Re: K013371

Trade/Device Name: UBiT-IR300 Infrared Spectrometry System Regulation Number: 21 CFR 862.2300, 866.3110 Regulation Name: Colorimeter, Photometer, Spectrophotometer for Clinical Use, Urea Breath Tests Regulatory Class: Class I Product Code: JJQ, MSQ Dated: October 9, 2001

Dear Ms. Sinclair:

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 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and 1 II you desire specific dayse for your astic devices), please contact the Office of Compliance at additionally 607.10 for in The carguestions on the promotion and advertising of your device, (301) 594-4566. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monthation on your responsiver Assistance at its toll-free number (800) 638-2041 or 1401) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ UBiT-IR300 Infrared Spectrometry System

Indications For Use:

The UBiT-IR300 Infrared Spectrometry System is an in vitro diagnostic device The UDIT 11000 mm changes in 18CO2 content in breath CO2 gas by infrared The system consists of the UBiT-IR300 Infrared spectroscopic analysis. Spections of the UBiT-AS10 Autosampler, and Otsuka Breath Collection Bags.

The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with The OB1 - 11000 and Meretek 13C-urea breath tests for the detection of Helicobacter evlari (H. pylori) infection. The UBiT-IR300 System is suitable for use in both clinical laboratory and point-of-care settings.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Luddi lu. Poole

boratory Devices

510(k) Number K013371

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.

(a)
Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.