POCONE INFRARED SPECTROPHOTOMETER

K041148 · Otsuka Pharmaceutical Co., Ltd. · MSQ · Jul 15, 2004 · Microbiology

Device Facts

• Record ID: K041148
• Device Name: POCONE INFRARED SPECTROPHOTOMETER
• Applicant: Otsuka Pharmaceutical Co., Ltd.
• Product Code: MSQ · Microbiology
• Decision Date: Jul 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis. The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori infection, and Otsuka Breath Collection Bags. The POCone is suitable for use in both clinical laboratory and point-of-care settings.

Device Story

POCone Infrared Spectrophotometer performs quantitative infrared spectroscopic analysis of breath samples to detect H. pylori. Patient provides baseline and post-dose breath samples into collection bags; bags attach to device ports. Device automatically injects samples, removes moisture, and measures 13CO2/12CO2 ratios via infrared light source and cooled detector. Operation is automatic; user interface via keypad/LCD; results printed internally. Used in clinical labs or point-of-care settings by healthcare personnel. Output is Delta over baseline (DOB) value; DOB ≥ 2.4 indicates positive H. pylori infection. Benefits include rapid, on-site diagnostic testing for dyspepsia or asymptomatic patients.

Clinical Evidence

Multi-center, prospective clinical study (n=220) comparing POCone to UBiT-IR300. Primary endpoint: percent agreement using 2.4 DOB cutoff. Results: 99.55% overall agreement (95% CI: 97.67, 99.98), 100% positive agreement, 99.25% negative agreement. Secondary endpoint: paired DOB values showed high correlation (r > 0.99) and linear relationship. Bench testing confirmed compliance with IEC 60601-1 and IEC 60601-1-2, with negligible carryover and inter-device variability.

Technological Characteristics

Infrared spectrophotometer; measures 13CO2/12CO2 ratios via infrared absorption. Compact form factor for portability. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Uses breath collection bags. Standalone operation.

Indications for Use

Indicated for patients undergoing 13C-urea breath testing for the detection of Helicobacter pylori (H. pylori) infection. Suitable for use in point-of-care and clinical laboratory settings.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Predicate Devices

• UBiT-IR300 Infrared Spectrophotometer (K013371)

Submission Summary (Full Text)

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# 510(k) Summary for POCone Infrared Spectrophotometer

#### 1. SPONSOR

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

Contact Person:

| Japan: | Hideji Nonomura |
|------------|-----------------|
| Telephone: | 81-88-665-2126 |
| U.S.: | Kyoko Tsuchiya |
| Telephone: | 720-479-6449 |

Date Prepared: April 30, 2004

#### 2. DEVICE NAME

| Proprietary Name: | POCone Infrared Spectrophotometer |
|----------------------|-------------------------------------------------------------------|
| Common/Usual Name: | Infrared Spectrophotometer |
| Classification Name: | Colorimeter, Photometer, or Spectrophotometer for<br>Clinical Use |

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

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

#### PREDICATE DEVICE 3.

- · · UBiT-IR300 Infrared Spectrophotometer Otsuka Pharmaceutical Co., Ltd. K013371

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#### 4. DEVICE DESCRIPTION

The POCone Infrared Spectrophotometer is a compact analyzer designed for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori. The POCone 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 A13CO2, and expressed as delta per mil (%) or Delta Over Baseline (DOB).

#### ട. INTENDED USE

The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO, gas by infrared spectroscopic analysis.

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

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Both the POCone Infrared Spectrophotometer and the UBiT-IR300 Infrared Spectrophotometer are general purpose instruments that are intended to measure changes in 1302 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 13C-urea breath tests can be used in conjunction with either instrument and the required breath samples collected for analysis. The POCone and UBiT-IR300 use the same breath collection bags that subjects blow into for collection of the breath samples.

The POCone and UBiT-IR300 are both infrared spectrophotometers and utilize the same principle of measurement to analyze 13CO2 enrichment in breath samples. Both instruments are intended for use in point of care and clinical laboratory settings. The major differences between the POCone Infrared Spectrophotometer and the UBiT-IR300 Infrared Spectrophotometer are that the POCone offers increased portability and decreased sample measurement times.

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#### 7. PERFORMANCE TESTING

#### 7.1 Nonclinical Testing

The POCone Infrared Spectrophotometer was tested to and complies with applicable requirements of IEC 60601-1 and IEC 60601-1-2.

Reproducibility and carryover studies were conducted using the POCone. These studies demonstrated that the POCone performs according to its specifications and that there is negligible carryover and inter-device variability.

#### 7.2 Clinical Testing

A clinical study was conducted to evaluate the performance of the POCone Infrared Spectrophotometer to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis. The multi-center, prospective study was designed to compare the POCone Infrared Spectrophotometer for measuring 13CO2 enrichment in breath with the UBiT-IR300 Infrared Spectrophotometer. Subjects were recruited from five Physician Office Laboratory (POL)/Point of Care (POC) settings. 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 POCone and UBiT-IR300 methods. The number of evaluable subjects was 220 across all participating sites.

The primary endpoint was the percent agreement of the POCone results as compared to the UBiT-IR300 results using a cut-off value of 2.4 Delta Over Baseline (DOB). The percent agreement for all subjects is as follows:

| % Overall Agreement: | 99.55% | [95% CI: (97.67, 99.98)] |
|-----------------------|---------|---------------------------|
| % Positive Agreement: | 100.00% | [95% CI: (95.90, 100.00)] |
| % Negative Agreement: | 99.25% | [95% CI: (96.27, 99.96)] |

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.

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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 with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 5 2004

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

k041148 Re:

> Trade/Device Name: POCone Infrared Spectrophotometer Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I Product Code: MSO, JJO Dated: April 30, 2004 Received: May 3, 2004

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 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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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Salartys

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): KOH 1148

Device Name: POCone Infrared Spectrophotometer

Indications for Use:

The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO, content in breath CO2 gas by infrared spectroscopic analysis.

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie h. Poole

ision Sign

Office of In Vitro Diagnostla Device Evaluation and Safety

510(k) 1