The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The POC-AS10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.

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.

Device Description

The POC-AS10 Auto sampler is an optional accessory to the POCone Infrared Spectrophotometer. The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The POC-AS10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer. By connecting the POC-AS10 Auto sampler to the POCone Infrared Spectrophotometer, up to ten pairs of breath collection bags (20 bags total) can be set up at one time.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the POC-AS10 Auto sampler, an accessory to the POCone Infrared Spectrophotometer. It focuses on device description, intended use, and substantial equivalence to a predicate device. However, it does not contain detailed information regarding acceptance criteria or a comprehensive study report with specific performance metrics for the device itself.

The "Performance Testing" section states: "The nonclinical testing consisted of reproducibility and carry-over studies using standard gas samples. The testing demonstrated that the POC-AS10 Auto sampler accessory to the POCone Infrared Spectrophotometer successfully fulfilled prospectively defined verification and validation activities."

This statement confirms that testing was done and deemed successful against "prospectively defined verification and validation activities," but it does not explicitly list those acceptance criteria or the quantitative results of the studies. Therefore, I cannot populate the table or provide detailed answers to many of your questions based solely on the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The document mentions "prospectively defined verification and validation activities."	"successfully fulfilled prospectively defined verification and validation activities." (Specific quantitative results for reproducibility and carry-over are not provided.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not specified. The document only mentions "reproducibility and carry-over studies using standard gas samples."
Data Provenance: Not specified.
Retrospective/Prospective: The verification and validation activities were "prospectively defined," implying the studies themselves were likely prospective in nature, but this is not explicitly stated for the data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. The testing involved "standard gas samples," implying a technical or engineering validation rather than clinical ground truth established by medical experts for patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. Adjudication methods are typically relevant for human interpretation of data, which is not the primary focus of the performance testing described for this auto sampler accessory.

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

No, an MRMC comparative effectiveness study was not done. This device is an auto sampler accessory for an infrared spectrophotometer, not an AI diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The "nonclinical testing consisted of reproducibility and carry-over studies using standard gas samples" which can be considered a form of standalone performance testing for the accessory's mechanical and analytical function. However, it's not an "algorithm-only" test in the AI sense, but rather a system performance test.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the reproducibility and carry-over studies, the "ground truth" would be the known concentration/composition of the "standard gas samples" used. This is a technical standard, not a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable/Not specified. This document describes an accessory to a spectrophotometer, not a system that is "trained" in the machine learning sense.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML system requiring a training set with established ground truth.

Summary

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K092817

MAR - 9 2010

510(k) Summary POC-AS10 Auto sampler (Modification of POCone Infrared Spectrophotometer)

1. SPONSOR

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

Contact Person:	Mr. Shinji IizukaOperating Officer, General Manager
Telephone:	81 3 6361 7311
E-mail:	iizukas@otsuka.jp
Date Prepared:	September 11, 2009

2. DEVICE NAME

Proprietary Name:	POC-AS10 Auto sampler (Accessory to POCone InfraredSpectrophotometer)
Common/Usual Name:	Infrared Spectrophotometer
Classification Name:	Colorimeter, Photometer, or Spectrophotometer for ClinicalUse

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

3. PREDICATE DEVICES

POCone Infrared Spectrophotometer (parent device)

UBiT-IR300 Infrared Spectrometry System

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4. DEVICE DESCRIPTION

5. INTENDED USE/INDICATIONS FOR 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 POC-AS10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The POC-AS10 Auto sampler is an optional accessory to the POCone Infrared Spectrophotometer. The POC-AS10 Auto sampler, connected to the POCone Infrared Spectrophotometer, is substantially equivalent to the parent device based on the intended use and technological characteristics.

7. PERFORMANCE TESTING

Testing activities for the POC-AS10 Auto sampler consisted of electrical testing of the POC-AS10 Auto sampler unit and system level nonclinical testing with the POC-AS10 Auto sampler connected to the POCone Infrared Spectrophotometer. The nonclinical testing consisted of reproducibility and carry-over studies using standard gas samples. The testing demonstrated that the POC-AS10 Auto sampler accessory to the POCone Infrared Spectrophotometer successfully fulfilled prospectively defined verification and validation activities.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

HAR 0 9 2010

Cynthia A. Sinclair Medical Device Consultants On behalf of: Otsuka Pharmaceutical Co., Ltd. 49 Plain Street North Attleboro, MA 02760

Re: K092817

Trade/Device Name: POCone Infrared Spectrophotometer, POC-AS10 Auto sampler Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: MSQ, JJQ Dated: February 5, 2010 Received: February 12, 2010

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 class II (Special Controls), 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); medical device reporting (reporting of

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Page 2 - Cynthia A. Sinclair

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jau, austria

Sally Hojvat, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics Center for Devices and Radiological Health

Enclosure

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K092817 510(k) Number (if known):

Device Name: POC-AS10 Auto sampler (Accessory to POCone Infrared Spectrophotometer)

Indications for Use:

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 In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Freddie M. Poole
Vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

5109(4) KD 922817

Regulation Number and Section

§ 866.3110

Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter 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.(b)
Classification. Class I (general controls).