(29 days)
The Stat Profile pHOx Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of pH, pCO2, pO2, Hct, Hb, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea/BUN, Creatinine, SO2%, and expired (exhaled) gases.
Stat Profile pHOx Blood Gas Analyzer
The provided text is an FDA 510(k) clearance letter for the "Stat Profile pHOx Blood Gas Analyzer." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information required to fulfill the request regarding acceptance criteria and a study proving those criteria were met for a device algorithm.
The letter explicitly states:
- "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the device's clearance was based on demonstrating substantial equivalence to a predicate device, rather than explicit performance against pre-defined acceptance criteria in a standalone clinical study as might be conducted for novel AI/ML devices.
Therefore, I cannot provide the requested information for the following reasons based on the provided text:
- Acceptance Criteria and Reported Device Performance: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present reported device performance metrics against such criteria.
- Sample Size and Data Provenance (Test Set): This information is not present.
- Number and Qualifications of Experts for Ground Truth (Test Set): This information is not present.
- Adjudication Method (Test Set): This information is not present.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not describe such a study or any effect sizes related to human readers improving with AI assistance.
- Standalone Performance Study: The letter does not detail a standalone performance study with specific metrics. Its clearance is based on substantial equivalence.
- Type of Ground Truth Used: This information is not present.
- Training Set Sample Size: This information is not present, as the document relates to regulatory clearance rather than explicit algorithm development.
- Ground Truth for Training Set: This information is not present.
The document primarily focuses on the regulatory clearance process, specifically 510(k) approval based on substantial equivalence, and not on the scientific study details of algorithm development and performance validation.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 5 1998
Paul W. MacDonald . Faul W. MacDonala
Director of Quality Assurance /Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham, Massachusetts 02254-9141
Re : K980991 Stat Profile pHOx Analyzer Requlatory Class: II Product Code: CHL, GKF Dated: March 16, 1998 March 17, 1998 Received:
Dear Mr. MacDonald:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification™ (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Bitman
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
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510(k) Number: K980991
Device Name: Stat Profile pHOx Blood Gas Analyzer
Indications for Use:
Intended Use
The Stat Profile pHOx Analyzer is intended for in vitro diagnostic use by health care The Stat Profile pHOX Analyzer is intended for in vill Claudiosco arous as and annon in and and on the management on (SO2%) and professionals in the quantiative detonimation of expired (exhaled) gases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cimcer Laboratory vices | |
| 510(k) Number | 2480991 |
Prescription Use_K (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.