(66 days)
Not Found
No
The description focuses on standard pulse oximetry technology and does not mention AI, ML, or related concepts.
No.
The device is indicated for measuring, displaying, and recording physiological parameters (SpO2 and pulse rate), which falls under diagnostic or monitoring functions, not therapeutic intervention.
Yes
The device measures and displays physiological parameters (SpO2 and pulse rate) which are used by healthcare professionals to assess a patient's condition, thereby aiding in diagnosis.
No
The device description explicitly states it is a "portable, tabletop device" and mentions hardware components like LEDs, an AC adapter, and a rechargeable battery pack.
Based on the provided information, the Nonin® Model 7500 Digital Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the Nonin Model 7500 clearly states it measures functional oxygen saturation and pulse rate directly from the patient using a sensor (implied by the mention of "sensor fault detection"). It does not involve the analysis of blood, urine, tissue, or other bodily fluids or substances in a laboratory setting.
- The intended use and device description focus on direct patient monitoring. The device is described as 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." This is a direct physiological measurement, not an in vitro test.
Therefore, the Nonin® Model 7500 Digital Pulse Oximeter falls under the category of a medical device used for patient monitoring, but not an IVD.
N/A
Intended Use / 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 (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.
Product codes
DQA
Device Description
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 detection (SPIM), user defined defaults, real-time data outputs, and patient security mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, infant, and neonatal patients.
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)
Nonin's Model 7500 Digital Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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).
0
510(k) Summary
| Submitter:
Contact Person: | Nonin Medical, Inc.
Lori M. Roth
Clinical/Regulatory Specialist
Nonin Medical, Inc.
13700 1st Ave. N.
Plymouth, MN 55441-5443
JUL 12 2007 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 4, 2007 |
| Trade Name: | Model 7500 Digital Pulse Oximeter |
| Classification Name:
and Number:
Product Code: | Oximeter
Class II, 21 CFR 870.2700
DQA |
| Predicate Device(s): | The predicate device is the Model 2500A Digital Pulse
Oximeter, K050056 cleared on June 21, 2005. |
| Device Description: | 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
detection (SPIM), user defined defaults, real-time data
outputs, and patient security mode. |
:
Confidential
1
| 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 (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 Digital Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications. |
| Conclusion: | Nonin's Model 7500 Digital Pulse Oximeter is substantially equivalent to the predicate device in terms of accuracy, functional design and principles of operation. Performance test results do not raise new questions of safety and effectiveness when compared to the legally marketed device. |
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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 with three overlapping wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lori M. Roth Clinical/ Regulatory Specialist Nonin Medical, Incorporated 13700 1st Avenue North Plymouth, Minnesota 55441-5443
JUL 1 2 2007
Re: K071285
Trade/Device Name: Model 7500 Digital Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 12, 2007 Received: June 13, 2007
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.
3
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 (QS) 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) 276-0120. 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 yours.
Sybilte Y. Michie Omd.
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
4
Indications for Use Statement
510(K) Number:
Device Name:
Model 7500 Digital Pulse Oximeter
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 (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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Senyte Y. Michaelons.
(Division Sign-Off) Division of Anesthesic Infection Control, D
510(k) Number: K071285