(99 days)
Nonin's Model 8000SX Reusable Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused. It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.
The 8000SX is a fingertip transmittance sensor comprised of a molded silicone boot that contains identical sensor optics and cable as the currently marketed Model 8000AA. The 8000SX sensor comes in three sizes, Model 8000SL (Large) for finger heights between 0.5 inches and 1.0 inch, Model 8000SM (Medium) for finger heights between 0.4 inches and 0.75 inches, and Model 8000SS (Small) for finger heights between 0.3 inches and 0.5 inch The sensors are compatible with all Nonin branded pulse oximeters.
The provided text describes a 510(k) summary for the Nonin Model 8000SX Oximeter Sensor. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance data in the typical format of a clinical trial report.
Therefore, much of the requested information cannot be directly extracted from the provided text. The document refers to "bench and clinical testing" to demonstrate compliance with ISO 9919:2005 Clause 50 (Accuracy of Operating Data), but it does not provide the specific acceptance criteria or the study results in detail.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully provided. The document states that the device "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." However, it does not specify the quantitative acceptance criteria for "Accuracy of Operating Data" or present a table of the device's measured performance against those criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The text mentions "clinical testing" but does not detail the sample size, patient demographics, data provenance (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 applicable/Cannot be provided. For oximetry accuracy studies, the "ground truth" for SpO2 is typically established using a co-oximeter measuring arterial blood gas samples (SaO2), not by expert readers. The text does not describe how ground truth was established, but it would not involve experts in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Cannot be provided. As the ground truth for oximeters is typically based on objective blood gas analysis, an adjudication method for conflicting expert opinions would not be relevant.
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, this was not done. The device is an oximeter sensor, which directly measures physiological parameters. It is not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Yes (implicitly). The device itself, an oximeter sensor, operates as a standalone measurement tool. Its performance (accuracy of SpO2 measurement) would be evaluated inherently without human intervention in the primary measurement task. The clinical testing mentioned typically assesses the device's ability to accurately measure SpO2 without human interpretation influencing the measurement itself, though human clinicians would use the readings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be directly stated, but typically for oximetry, the ground truth is SaO2. While not explicitly stated in the document, for oximetry accuracy according to ISO 9919, the ground truth for arterial oxygen saturation (SpO2) is typically established by simultaneously measuring arterial blood gas samples (SaO2) using a laboratory co-oximeter.
8. The sample size for the training set
- Not applicable. The Nonin Model 8000SX Oximeter Sensor is a hardware device that measures physiological parameters. It does not employ machine learning algorithms that would require a "training set" in the conventional sense. Its design and calibration are based on established optical principles and physiological models.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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Kosziciol.
510(k) Summary
Submitter:
Contact Person:
Nonin Medical, Inc.
July 9, 2009
74 DQA
Oximeter Sensor
Lori M. Roth Clinical/Regulatory Specialist Nonin Medical, Inc. 13700 1st Ave. North Plymouth, MN 55441-5443
OCT 2 1 2009
Date Prepared:
Trade Name:
Product Code:
Classification Name: and Number:
Class II, 21 CFR 870.2700
Predicate Device(s):
Device Description:
Nonin's 8000AA sensor as cleared in the following 510(K) submissions: Model 7500 (K080255 cleared on May 23, 2008), Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model 9600 (K040589 cleared on June 3, 2004), Model 4000 (K052669 cleared on December 23, 2005), Model 2500A (K050056 cleared on June 21, 2005), Model 2500 (K002690 cleared on October 11, 2000), Model 2120 (K031487 cleared on March 22, 2004).
Envitec's SoftTip Reusable Sensor (Small, Medium and Large), cleared under K992215, 29 March 2000.
The 8000SX is a fingertip transmittance sensor comprised of a molded silicone boot that contains identical sensor optics and cable as the currently marketed Model 8000AA. The 8000SX sensor comes in three sizes, Model 8000SL (Large) for finger heights between 0.5 inches and 1.0 inch, Model 8000SM (Medium) for finger heights between 0.4 inches and 0.75 inches, and Model 8000SS (Small) for finger heights between 0.3 inches and 0.5 inch The sensors are compatible with all Nonin branded pulse oximeters.
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Nonin's Model 8000SX Reusable Sensors are indicated for Intended Use: non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused. lt is intended for use in environments including operating room, surgical recovery, critical care, emergency room, longterm care, home use and mobile environments Functional and Nonin's Model 8000SX sensor have successfully undergone Safety Testing: 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 Model 8000SX sensor is substantially equivalent to Nonin's Model 8000AA and Envitec's SoftTip sensors when
used with Nonin branded Pulse Oximeters monitors.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the agency's mission to protect the health of all Americans. The eagle is a stylized design with three lines representing its wings and a simple outline for its body.
Food and Drig Administration 10903 New Hampshire Avenne Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lori Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 1st Avenue North Plymouth, Minnesota 55441
OCT 2 1 2009
Re: K092101
Trade/Device Name: Nonin Medical, Inc. Model 8000SX Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 18, 2009 Received: September 21, 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.
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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); 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.
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/CDRH/CDRHOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours
1 for
Susan Runner, D.D.S., M.A. Acting 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) | K092101 |
|---|---|
| Device Name | Nonin Medical, Inc. Model 8000SX Sensor Series |
| Indications for Use | Nonin's Model 8000SX Reusable Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused. It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments. |
Prescription Use X (Part 21 CFR 801 Subpart D)
사용 제품 : 10 :
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schullte
(Division Sign-Off)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
¯1º(½) Numher:
§ 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).