(101 days)
Model 8203CA
The Model 8203CA single-patient use, non-sterile, disposable sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8203CA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.
Model 8204CA
The Model 8204CA single-patient use, non-sterile, disposable sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8204CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.
The SenSmart Model 8203CA Regional Oximetry Sensor (Model 8203CA) and SenSmart Model 8204CA Regional Oximetry Sensor (Model 8204CA) are single-patient use, non-sterile disposable regional (tissue saturation) sensors intended for use with the Nonin Medical Model X-100 SenSmart Regional Oximetry System (Model X-100). The proposed devices are also compatible with the Nonin Model 7600 Regional Oximeter (Model 7600).
Here's an analysis of the acceptance criteria and study information based on the provided text, using the requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria for typical performance metrics like sensitivity and specificity. The testing performed is more about compliance with general safety, functional, and performance standards.
| Test / Criterion | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Pass |
| Temperature and Humidity | Compliance with IEC 60601-1, EN 1789 | Pass |
| Atmospheric Pressure (Altitude) | Compliance with IEC 60601-1 | Pass |
| Electromagnetic Immunity and Emissions | Compliance with IEC 60601-1-2 | Pass |
| Performance | Compliance with ISO 80601-2-61, IEC 60601-1, IEC 60601-1-6; IEC 60601-1-12; IEC 62304; ANSI/AAMI EC13; ISO 14155-1; ISO 14155-2 | Pass |
| Ingress Protection | Compliance with ISO 80601-2-61 | Pass |
| Diaphoretic related ingress | Internal performance characterization | Pass |
| Mechanical Durability | Compliance with IEC 60601-1, ISO 80601-2-61, ISTA 2A, ASTM D-4169 | Pass |
| Biocompatibility | Compliance with ISO 10993-1 | Biocompatible |
| rSO2 Accuracy | Critical sensor optics technology unchanged from predicate devices; accuracy demonstrated through detailed device comparison, analysis, and testing. | Demonstrated |
| Clinical Performance | Critical sensor optics technology unchanged from predicate devices; prior clinical testing from predicate (K102715) is applicable. | Applicable (from predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of efficacy for the new devices. Instead, it relies on the fact that "the critical sensor optics technology of the proposed devices remains unchanged from the predicate devices." Therefore, the clinical data proving efficacy is derived from the predicate devices (Nonin SenSmart Model 8003CA and Model 8004CA Regional Oximetry Sensors cleared under K102715).
- Sample Size: Not specified for the current submission, as it defers to the predicate device's clinical testing. The sample size for the predicate's clinical testing would be in K102715.
- Data Provenance: Not explicitly stated for the predicate's clinical data from K102715, but it would have been part of that prior submission. The current submission relies on this existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The current submission does not involve new clinical trials requiring expert-established ground truth for a test set. It relies on the clinical performance previously established for the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. As no new clinical test set with human interpretation is presented in this submission, there's no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned for these specific devices. The submission focuses on substantial equivalence based on unchanged critical sensor optics technology and functional performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The device is a regional oximetry sensor, which measures physiological parameters. Its performance is inherent in its measurement accuracy and compliance with physical and electrical standards, not in an "algorithm only" sense like an AI diagnostic tool. The "rSO2 Accuracy testing" mentioned is a standalone assessment of the sensor's measurement capability, concluding it is demonstrated due to the unchanged optics from the predicate.
7. The Type of Ground Truth Used
For the functional and safety testing, the ground truth is established by compliance with recognized international and national standards (e.g., IEC 60601-1, ISO 80601-2-61, ISO 10993-1).
For the rSO2 accuracy and clinical performance, the ground truth is implicitly based on the clinical validation data and reference methods used during the clearance of the predicate devices (K102715). Without access to K102715, the precise nature of that ground truth (e.g., arterial blood gas analysis for oxygen saturation) isn't specified in this document.
8. The Sample Size for the Training Set
Not applicable. This device is a medical sensor, not an AI/ML algorithm that requires a "training set" in the typical machine learning sense. Its design and calibration are based on established engineering principles and physiological models, rather than learned patterns from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set for an AI/ML algorithm is not relevant here.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Nonin Medical Inc. Laura Lind Sr. Regulatory Affairs Specialist 13700 1st Avenue North Plymouth, Minnesota 55441
Re: K151305
Trade/Device Name: SenSmart Model 8203CA Regional Oximetry Sensor, SenSmart Model 8204CA Regional Oximetry Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: July 30, 2015 Received: July 31, 2015
Dear Laura Lind:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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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 of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151305 - Page 1 of 1
Device Name
SenSmart™ Model 8203CA Regional Oximetry Sensor SenSmart™ Model 8204CA Regional Oximetry Sensor
Indications for Use (Describe)
Model 8203CA
The Model 8203CA single-patient use, non-sterile, disposable sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8203CA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.
Model 8204CA
The Model 8204CA single-patient use, non-sterile, disposable sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8204CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "NONIN" in blue, with a small diamond above the "I". To the left of the word is an orange geometric shape. The word "NONIN" is written in a stylized font, with the letters slightly slanted to the right. The overall impression is of a logo or brand name.
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5. "510(k) Summary" as required by section 807.92(c)
| Submitter: | Nonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443 |
|---|---|
| Phone:Fax: | 763-553-9968763-553-7807 |
| Contact Person: | Laura LindSenior Regulatory Affairs Specialist |
| Date Prepared: | May 15, 2015 |
| Trade Names: | SenSmart™ Model 8203CA Regional Oximetry SensorSenSmart™ Model 8204CA Regional Oximetry Sensor |
| Common Name:Classification Name:Regulation Number: | Regional oximetry sensorOximeter, Tissue SaturationClass II, 21 CFR 870.2700 (Oximeter) |
| Product Code, Panel: | MUD, Cardiovascular |
| Predicate Device(s): | The Nonin SenSmart Model 8203CA and Model 8204CA RegionalOximetry Sensors are predicated on the Nonin SenSmart Model8003CA and Model 8004CA Regional Oximetry Sensors clearedunder K102715 (December 17, 2010.) |
| Device Description: | The SenSmart Model 8203CA Regional Oximetry Sensor (Model8203CA) and SenSmart Model 8204CA Regional OximetrySensor (Model 8204CA) are single-patient use, non-steriledisposable regional (tissue saturation) sensors intended for usewith the Nonin Medical Model X-100 SenSmart Regional OximetrySystem (Model X-100). The proposed devices are also compatiblewith the Nonin Model 7600 Regional Oximeter (Model 7600). |
| Intended Use: | Model 8203CAThe Model 8203CA single-patient use, non-sterile, disposablesensor is intended for use as an adjunct monitor of trends inregional hemoglobin oxygen saturation of blood underneath thesensor of adult or pediatric patients weighing greater than 88pounds (40 kilograms). The sensor may be repositioned orreplaced with another 8203CA sensor without baseline re-establishment. It is intended for use in environments including theoperating room, surgical recovery, critical care, emergency room,long-term care, and mobile environments. |
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Image /page/4/Picture/0 description: The image shows the logo for Nonin. The logo consists of an orange geometric shape on the left and the word "NONIN" in blue on the right. The geometric shape is made up of several squares that are nested inside each other. The word "NONIN" is written in a sans-serif font, and the letters are all capitalized.
Image /page/4/Picture/1 description: The image shows three parallelograms of different colors. The first parallelogram is orange, the second is blue, and the third is gray. The parallelograms are arranged side by side.
Model 8204CA
The Model 8204CA single-patient use, non-sterile, disposable sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8204CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care. emergency room, long-term care, and mobile environments.
Testing: The Nonin Model 8203CA and Model 8204CA sensors are supported by safety, electromagnetic compatibility, device performance, and clinical testing to ensure appropriate functionality and to demonstrate substantial equivalence to the predicate devices. The devices were tested with the Model X-100 system.
Functional and Safety Testing:
The results of the testing demonstrate equivalency with the predicate devices and compliance to recognized standards. Table 1 summarizes test results for the proposed devices, which met the relevant requirements of the applicable recognized standards.
Table 1
| Test | Reference | Result |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Pass |
| Temperature and Humidity | IEC 60601-1EN 1789 | Pass |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Electromagnetic Immunity andEmissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61IEC 60601-1IEC 60601-1-6; IEC 60601-1-12IEC 62304ANSI/AAMI EC13ISO 14155-1; ISO 14155-2 | Pass |
| Ingress Protection | ISO 80601-2-61 | Pass |
| Diaphoretic related ingress | Internal performancecharacterization | Pass |
| Mechanical Durability | IEC 60601-1ISO 80601-2-61ISTA 2AASTM D-4169 | Pass |
| Biocompatibility | ISO 10993-1 | Biocompatible |
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Image /page/5/Picture/0 description: The image shows the word "NONIN" in blue, with a stylized square logo in orange to the left of the word. The word "NONIN" is written in a sans-serif font, with the "O" in the word having a small white square inside of it. The stylized square logo is made up of two squares, one inside the other, with the inner square being slightly offset from the outer square.
| rSO2 Accuracy testing: the critical sensor optics technology ofthe proposed devices remains unchanged from the predicatedevices. rSO2 accuracy is demonstrated through detailed devicecomparison, analysis and testing. | |
|---|---|
| Clinical testing: the critical sensor optics technology of theproposed devices remains unchanged from the predicate devices.Thus prior clinical testing provided in K102715 is applicable for theproposed Model 8203CA and Model 8204CA sensors. | |
| Testing conclusion: the proposed Model 8203CA and Model8204CA sensors meet all acceptance criteria. Based on testresults, analysis and comparison to the legally marketedpredicates, the Model 8203CA and Model 8204CA sensorsperform equivalently to the predicate sensors for their intendeduse. | |
| Summary ofSubstantialEquivalence: | The Model 8203CA and Model 8204CA sensors have thefollowing similarities to the predicate devices:Identical indications for use Identical intended use environments Identical patient population Same primary mode of operation Identical critical sensor optics technology Used with the same systems in same manner Perform equivalently to the same specifications Similar construction and materials |
| Conclusion: | No new questions of safety and effectiveness were raised. Basedon the results of the above referenced testing, the same criticaloptics technology, results from safety and performance testingand analysis, and risk management assessment, Nonin Medicalhas determined that the proposed SenSmart Model 8203CARegional Oximetry Sensor and SenSmart Model 8204CARegional Oximetry Sensor are substantially equivalent to thepredicate Nonin SenSmart Model 8003CA Regional OximetrySensor and SenSmart Model 8004CA Regional Oximetry Sensor |
and the proposed devices are safe for their intended use.
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§ 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).