(113 days)
The Nonin ® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO 2 ) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.
The Nonin® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The Model 7500 display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Model 7500 can be powered internally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack. The Model 7500 includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, sensor fault, user defined defaults, real-time data outputs, and patient security mode.
Nonin Medical, Inc. Model 7500 Digital Pulse Oximeter
Here's an analysis of the provided information regarding the acceptance criteria and study for the Nonin Medical, Inc. Model 7500 Digital Pulse Oximeter:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary is for the addition of the Model 8000Q2 Ear Clip Sensor to an existing device (Nonin's Model 7500 Digital Pulse Oximeter, cleared under K071285). The summary for K080255 primarily focuses on demonstrating that the new sensor, when used with the existing device, does not introduce new concerns regarding accuracy or risks. Therefore, specific numerical acceptance criteria and a detailed breakdown of device performance for this particular 510(k) are not explicitly listed in the typical format you might expect for a primary device clearance.
However, the summary states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data | Successfully undergone clinical testing to demonstrate meeting requirements |
| Meets requirements of ISO 9919:2005 Clause 102 section 102.2 Labeling | Successfully undergone bench and clinical testing to demonstrate meeting requirements |
| Meets requirements of IEC 60601-1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility | Successfully undergone bench and clinical testing to demonstrate meeting requirements |
| No new concerns regarding accuracy or risks when using 8000Q2 Ear Clip Sensor with Model 7500 | Conclusion: The addition of Model 8000Q2 Ear Clip Sensor when used with Nonin's Model 7500 does not raise any new concerns regarding accuracy or risks when used in combination. |
Important Note: The precise numerical accuracy (e.g., RMS difference between SpO2 readings and CO-Oximeter) for the Model 7500 itself would have been established during its original clearance (K071285) in alignment with ISO 9919, which specifies accuracy requirements for pulse oximeters. This current 510(k) relies on that prior demonstration and confirms that the new sensor maintains that performance.
2. Sample Size Used for the Test Set and Data Provenance
The provided document for K080255 does not explicitly state the sample size for the clinical testing conducted for the 8000Q2 Ear Clip Sensor. It only mentions "clinical testing."
- Data Provenance: Not specified, but generally, clinical studies for medical devices intended for the US market are expected to be conducted in a manner compliant with FDA regulations, often involving US-based patient populations or studies with robust ethical oversight. The summary does not specify if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide this information. For pulse oximetry, the ground truth for SpO2 accuracy is typically established using a reference CO-Oximeter, not primarily through human expert consensus on readings alone. If physician assessment of patient condition was part of the study (e.g., for perfusion), the qualifications of those physicians are not listed.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. In the context of pulse oximetry accuracy studies, adjudication is less about expert review of images/readings and more about the rigorous methodology of blood sampling and CO-Oximeter measurements to establish arterial oxygen saturation (SaO2) as the reference standard against which the device's SpO2 is compared.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging devices where human readers interpret images, and the AI's role is often assistive. For a pulse oximeter, the device provides a direct numerical measurement, and human interpretation of the measurement itself (as opposed to interpreting images from which the measurement is derived) is not the focus of such a study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the testing for the pulse oximeter's accuracy is inherently a standalone performance evaluation. The device generates SpO2 and pulse rate values directly. The "clinical testing" mentioned in the summary would involve comparing the device's readings against a gold standard (CO-Oximeter for SpO2) without human intervention in the device's calculation or display.
7. Type of Ground Truth Used
While not explicitly detailed in this summary, for pulse oximeters, the established ground truth for oxygen saturation (SpO2) accuracy studies is:
- Reference Oximetry (e.g., CO-Oximetry): Arterial blood samples are drawn and analyzed by a calibrated reference CO-Oximeter to determine the actual arterial oxygen saturation (SaO2). The pulse oximeter's SpO2 readings are then compared to these SaO2 values. This is the industry standard for establishing SpO2 accuracy.
8. Sample Size for the Training Set
The document does not provide information on the training set sample size. Pulse oximeters, particularly those from 2008, typically rely on physiological models and empirical calibration curves rather than "training sets" in the machine learning sense. While algorithms are involved, they are generally fixed based on extensive physiological research and empirical data collected during development, not necessarily a 'training set' in the modern AI iteration/re-training paradigm. Therefore, the concept of a training set as understood in current AI/ML might not directly apply or be documented in this type of 510(k).
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" with ground truth in the typical AI/ML sense is likely not applicable or detailed for this device. The underlying physiological models and calibration would have been developed based on extensive physiological research and empirical data (likely including human volunteer studies with reference CO-Oximetry), but this process isn't typically categorized as establishing "ground truth for a training set" in the context of a 510(k) for a pulse oximeter from this era.
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510(k) Summary
MAY 23 2008 Nonin Medical, Inc. Submitter: Lori M. Roth Contact Person: Clinical/Regulatory Specialist Nonin Medical, Inc. 13700 18t Ave. North Plymouth, MN 55441-5443 January 31, 2008 Date Prepared: Model 7500 Digital Pulse Oximeter Trade Name: Classification Name: Class II, 21 CFR 870.2700 and Number: 74 DQA Product Code: Nonin's Model 7500 Digital Pulse Oximeter Predicate Device(s): manufactured by Nonin Medical, Inc., cleared by the FDA under K071285 on 7/12/07. The Nonin® Model 7500 Digital Pulse Oximeter is Device Description: a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The Model 7500 display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Model 7500 can be powered internally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack. The Model 7500 includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, sensor fault, user defined defaults, real-time data outputs, and patient security mode.
Model 7500/8000Q2 Sensor Special 510(K): Premarket Notification Confidential
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| Intended Use: | The Nonin® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. |
|---|---|
| Functional and Safety Testing: | Nonin's Model 7500 Pulse Oximeter and 8000Q2 Ear Clip sensor have successfully undergone both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data, Clause 102 section 102.2 Labeling, and IEC 60601- 1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility. |
| Conclusion: | The addition of Model 8000Q2 Ear Clip Sensor when used with Nonin's Model 7500 does not raise any new concerns regarding accuracy or risks when used in combination. |
:
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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-like symbol with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2008
Ms. Lori M. Roth Clinical Regulatory Specialist Nonin Medical, Incorporated 13700 1st Avenue North Plymouth, Minnesota 55441-5443
Re: K080255
Trade/Device Name: Nonin Medical, Inc. Model 7500 Regulation Number: 21CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 23, 2008 Received: April 24, 2008
Dear Ms. Roth:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Roth
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Suzie Y. Michaels.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | Nonin Medical, Inc. Model 7500 |
| Indications for Use | The Nonin ® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO 2 ) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080255
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).