(63 days)
Not Found
No
The summary describes an expansion of intended use for a pH electrode on existing analyzers and does not mention AI or ML.
No
The device is described as an analyzer used for the measurement of pH in pleural fluid, which is a diagnostic function, not a therapeutic one. The "Intended Use" explicitly states its function as a "clinically useful tool in the management of patients," implying a role in diagnosis or monitoring rather than direct treatment.
Yes
The device is described as "used for the measurement of ph in pleural fluid," and this measurement is stated to be a "clinically useful tool in the management of patients with parapneumonic effusions." This directly indicates the device provides information used for diagnosis or management of a medical condition. Furthermore, the mention of predicate devices in the K895317 and K872888 range (blood gas analyzers) also indicates a diagnostic purpose.
No
The device description explicitly states it is an "expansion of the intended use for the pH electrode on the OMNI Modular, OMNI C and OMNI S analyzers," indicating it is a hardware-based analyzer with a software component, not a standalone software-only device.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the measurement of pH in pleural fluid for clinical management of patients. This involves analyzing a biological specimen (pleural fluid) outside of the body to provide information for diagnosis or treatment.
- Device Description: The device is an analyzer designed to perform this measurement.
- Predicate Devices: The predicate devices listed are blood gas analyzers, which are classic examples of IVD devices used for in vitro analysis of biological fluids.
The key characteristic of an IVD is that it is used to examine specimens derived from the human body to provide information for clinical purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
We have expanded the claim for the pH electrode to include the following text:
Pleural Fluid:
The Omni (Modular, C and S) can be used for the measurement of ph in pleural fluid, as long as care is taken to ensure that the specimen to be analyzed is clear of fibrin clots or other debris which may block the sample transport system.
The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.
Product codes (comma separated list FDA assigned to the subject device)
CHL
Device Description
Expansion of the intended use for the pH electrode on the OMNI Modular, OMNI C and OMNI S analyzers to allow for the measurement of pH in pleural fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pleural fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.
0
APR % 2 2005
| 510(k) Summary | |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information |
| provides sufficient detail to understand the basis for a determination of | |
| substantial equivalence. | |
| 1) Submitter | |
| name, address, | |
| contact | Roche Diagnostics |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 521-7688 |
Contact Person: Dimitris Demirtzoglou
Date Prepared: February 17, 2005 |
| 2) Device name | Proprietary name: Roche Diagnostics pH electrode on the OMNI Modular, C
and S Analyzers
Common name: Electrode, Blood Gases (PCO2, PO2) and pH
Classification name: Electrode, Blood Gases (PCO2, PO2) and pH |
| 3) Predicate
device | The OMNI Analyzers (OMNI Modular, OMNI C and OMNI S) are
substantially equivalent to the AVL model 995-Hb pH/blood gas analyzer
(K895317) and the CIBA-Corning Model 288 blood gas system (K872888).
The AVL 995-Hb and CIBA-Corning 288 were the analyzers used in the
studies described in the peer reviewed literature articles. |
| 4) Device
Description | Expansion of the intended use for the pH electrode on the OMNI Modular,
OMNI C and OMNI S analyzers to allow for the measurement of pH in
pleural fluid. |
| | Continued on next page |
1
510k Summary, Continued
| 5.) Intended
Use | We have expanded the claim for the pH electrode to include the following
text: | | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|---------------------------|
| | Pleural Fluid: | | |
| | The Omni (Modular, C and S) can be used for the measurement of ph in
pleural fluid, as long as care is taken to ensure that the specimen to be
analyzed is clear of fibrin clots or other debris which may block the sample
transport system.
The pH measurement of pleural fluid can be a clinically useful tool in the
management of patients with parapneumonic effusions. | | |
| 6.) Similarities
and Differences | The table on the next page indicates the similarities and differences between
the pH electrodes in the OMNI Analyzers, the AVL model 995-Hb pH/blood
gas analyzer (literature article #1) and the CIBA-Corning Model 288 blood
gas analyzer (literature article #2). | | |
| Feature/Claim | OMNI Analyzers
(Modular, C and S) | AVL Model 995-Hb | CIBA-Corning
Model 288 |
| pH Measuring
Principle | OMNI uses the Sorensen 1909
principle which is based on
the measurement of hydrogen
ion (H⁺) concentration. | SAME | SAME |
| Electrode Membrane
Reference Electrode | H⁺ sensitive glass membrane
Ag/AgCl | SAME
Colomel | SAME
Ag/AgCl |
| Concentration of the
KCl Reference
Solution | 1.2 M | 0.6 M | 4 M |
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 2 2005
Mr. Dimitris Demirtzoglou Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250
Re: K050423
K050423
Trade/Device Name: OMNI Modular, OMNI C and OMNI S Analyzer (pH Electrode) Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (Pco2, Po2) and blood pH test system Regulatory Class: Class II Product Code: CHL Dated: February 17, 2005 Received: February 18, 2005
Dear Mr. Demirtzoglou:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section - ro{x} premaince is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to legally maneted povice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Editor For Area France commerce prior to May 20, 1770, the encenters with the provisions of the Federal Food. Drug, devices that have been reclassified in acceracited in a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval incr and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, merelote, market me device, basjovite in the more ments for annual registration, listing of general controls of the Fiel Herenes of the Herelies against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (See acove) inro s. Existing major regulations affecting your device it may be subject to such additional controllar Childing (CFR), Parts 800 to 895. In addition, FDA call be found in Thic 21, Coub of I concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issualies of a bassuitate with other requirements of the Act that FDA has made a decerminations administered by other Federal agencies. You must of any Federal statutes and regulations asimilations of the registration and listing (21 comply with an the Ace 3 requirements and and 809); and good manufacturing practice CFR Fall 807), labeling (21 CFR 710 in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
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 premarket notification: "The I DTP Intember of 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 of questions on the promotion and Safety at (240)276-0484. Also, please note the P in o Diagnostic Dolly by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the Tou may other belief general meetines and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sean M. Cooper MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: OMNI Modular, OMNI C and OMNI S Analyzer (pH Electrode)
Indications For Use:
We have expanded the claim for the pH electrode to include the following text:
Pleural Fluid:
The Omni (Modular, C and S) can be used for the measurement of ph in pleural fluid, as a I he Onlin (Modular, C and by can oo be analyzed is clear of fibrin clots of fibrin clots or fong as care is which may block the sample transport system.
The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.
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 Devices (OIVD)
La Keating
Division Sign-Off
Division Sign-On
Office of In Vitro Diagnostic Device Evaluation and
K0504803
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