(176 days)
Not Found
No
The summary describes a spectrophotometer and an auto sampler for analyzing breath samples using infrared spectroscopy. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section. The analysis is based on spectroscopic measurements, not AI/ML algorithms.
No
The device is an in vitro diagnostic device used to measure substances in breath CO2 gas for diagnostic purposes, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the POCone Infrared Spectrophotometer is an "in vitro diagnostic device" and is "intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection."
No
The device description clearly states it is an "Infrared Spectrophotometer" and an "Auto sampler," which are hardware components used for analyzing breath samples. The performance studies also mention electrical testing and system-level nonclinical testing of the hardware unit.
Yes, based on the provided text, the POCone Infrared Spectrophotometer is explicitly stated to be an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use / Indications for Use: The text clearly states, "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."
- Device Description: The text reiterates, "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 is described as an accessory to this IVD device, expanding its capabilities.
N/A
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.
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.
Product codes
MSQ, JJQ
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 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
point of care and clinical laboratory settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Iizuka
Operating 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 Infrared
Spectrophotometer) |
|----------------------|---------------------------------------------------------------------------|
| Common/Usual Name: | Infrared Spectrophotometer |
| Classification Name: | Colorimeter, Photometer, or Spectrophotometer for 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
3. PREDICATE DEVICES
POCone Infrared Spectrophotometer (parent device)
UBiT-IR300 Infrared Spectrometry System
1
4. 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.
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.
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
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.
2
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
4
K092817 510(k) Number (if known):
Device Name: POC-AS10 Auto sampler (Accessory to POCone Infrared Spectrophotometer)
Indications for Use:
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.
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