(97 days)
Nonin's stand-alone non-invasive Model 7600 Regional Oximeter System is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
Nonin's® Model 7600 non-invasive Regional Oximeter System continuously monitors and records the mixed arterial/venous blood oxygen levels through non-invasive near-infrared spectroscopy sensors placed on the patient's forehead. The stand-alone system is comprised of three subsystems; sensor, patient oximetry device (Pod) and display unit. The sensor allows light absorption measurements at various wavelengths in the near infrared spectrum (approximately 700 to 900 nanometers). The sensor is approximately 1.5 by 3 inches. The sensors plug into the patient oximetry device (Pod) which controls the light emitted from the sensor LEDs and measures the light returning to the sensor photodiodes. From these measurements, the Pod determines specific absorption values and calculates the mixed arterial/venous oxygen saturation values. The Pods then communicate the cerebral oxygen saturation readings and other data to the display unit. The display unit displays real-time cerebral oximetry trend data. It is a battery-backed, mains powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module.
The provided text is a 510(k) summary for the Nonin Model 7600 Regional Oximeter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the format requested.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Here's an attempt to answer the questions based only on the provided text, indicating what information is missing:
Acceptance Criteria and Device Performance for Nonin Model 7600 Regional Oximeter System
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (INVOS® Model 5100 Cerebral Oximeter K001842) | "Nonin's Model 7600 Regional Oximeter System is substantially equivalent to the INVOS® Model 5100 Cerebral Oximeter manufactured by Somanetics Corporation and cleared by the FDA under K001842 on 9/15/00." "successfully undergone both laboratory and clinical testing in order to ensure that it has appropriate functional features and is substantially equivalent to the predicate device." |
| Appropriate functional features | "successfully undergone both laboratory and clinical testing in order to ensure that it has appropriate functional features..." |
| Safety | "successfully undergone both laboratory and clinical testing in order to ensure that it has appropriate functional features and is substantially equivalent to the predicate device." (Implied: safety is a component of 'appropriate functional features' and substantial equivalence). |
Note: The document primarily asserts substantial equivalence and successful testing, but does not provide quantitative performance metrics or specific, measurable acceptance criteria beyond this high-level claim.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document only mentions "clinical testing" without detailing the number of participants or cases.
- Data Provenance: Not specified. The text does not mention the country of origin or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document does not describe the establishment of ground truth or the involvement of experts for this purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. There is no mention of an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. The device described is a regional oximeter system, which is a standalone non-invasive physical measurement device, not an AI-based diagnostic image analysis tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself is a "stand-alone non-invasive Model 7600 Regional Oximeter System" that "continuously monitors and records the mixed arterial/venous blood oxygen levels." Its performance is inherent to its design and measurements. The 510(k) summary focuses on the device's functional integrity rather than an algorithm's performance in isolation from a human. The system calculates and displays oxygen saturation readings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. For physiological measurement devices like oximeters, ground truth typically involves comparison to a recognized gold-standard measurement (e.g., arterial blood gas analysis for oxygen saturation). However, this specific detail is not provided in the summary.
8. The sample size for the training set
- Not applicable/Not specified. The document describes a medical device, not a machine learning algorithm that requires a distinct "training set" in the conventional sense. The "training" for such a device would be part of its engineering and calibration, rather than a separate data set for an AI model.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as this is not an AI-based system with a training set.
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:
section 2. Summary and certification
1 ..
,
| 510(k) Summary | JUN 30 2009 |
|---|---|
| Submitter: | Nonin Medical, Inc. |
| Contact Person: | Lori M. RothClinical/Regulatory SpecialistNonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443 |
| Date Prepared: | March 24, 2009 |
| Trade Name: | Model 7600 Regional Oximeter System |
| Classification Name:and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | DQA |
| Predicate Device(s): | Nonin's Model 7600 Regional Oximeter System is substantiallyequivalent to the INVOS® Model 5100 Cerebral Oximetermanufactured by Somanetics Corporation that was cleared by theFDA under K001842 on 9/15/00. |
| Device Description: | Nonin's® Model 7600 non-invasive Regional Oximeter Systemcontinuously monitors and records the mixed arterial/venousblood oxygen levels through non-invasive near-infraredspectroscopy sensors placed on the patient's forehead. |
| The stand-alone system is comprised of three subsystems; sensor,patient oximetry device (Pod) and display unit. The sensor allowslight absorption measurements at various wavelengths in the nearinfrared spectrum (approximately 700 to 900 nanometers). Thesensor is approximately 1.5 by 3 inches. | |
| The sensors plug into the patient oximetry device (Pod) whichcontrols the light emitted from the sensor LEDs and measures thelight returning to the sensor photodiodes. From thesemeasurements, the Pod determines specific absorption valuesand calculates the mixed arterial/venous oxygen saturationvalues. The Pods then communicate the cerebral oxygen |
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saturation readings and other data to the display unit.
The display unit displays real-time cerebral oximetry trend data. It is a battery-backed, mains powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module.
Nonin's stand-alone non-invasive Model 7600 Regional Oximeter
System is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room,
Intended Use:
Functional and Safety Testing:
Conclusion:
long-term care and mobile environments. Nonin's Model 7600 Regional Oximeter System has successfully undergone both laboratory and clinical testing in order to ensure that it has appropriate functional features and is substantially
Nonin's Model 7600 Regional Oximeter System is substantially equivalent to the INVOS® Model 5100 Cerebral Oximeter manufactured by Somanetics Corporation and cleared by the FDA under K001842 on 9/15/00.
equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Public Health Service
JUN 3 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nonin Medical, Inc. c/o Lori Roth RN, BSN Clinical/Regulatory Specialist 13700 154 Avenue North Plymouth, MN 55441-5443
Re: K090807
Trade/Device Name: Model 7600 Regional Oximeter System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: MUD Dated: June 2, 2009 Received: June 3, 2009
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 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander for
Malvina B. Eydelman, M.B Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K090807
Device Name:
Nonin Medical, Inc. Model 7600 Regional Oximeter System
Indications for Use:
Nonin's stand-alone non-invasive Model 7600 Regional Oximeter System is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.R. Bicholas
(Division Sign-Off Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K090801
§ 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).