(58 days)
The Model 8006CA reusable, non-sterile, regional oximetry sensor is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation (rSO2) of blood underneath the sensor of adult and pediatric patients weighing ≥ 88 pounds (≥ 40 kilograms). The sensor and/or the patient interface may be repositioned or replaced with another 8006CA sensor without baseline re-establishment.
Nonin's Model 8006PI single patient use, non-sterile disposable patient interface is designed for use with Nonin's Model 8006CA sensor.
The sensor and patient interface is in hospitals, long-term care, medical facilities, sleep laboratories, and subacute environments.
The Model 8006CA Reusable Regional Oximetry Sensor and Model 8006PI Disposable Patient Interface work together for use with the Nonin Medical SenSmart Model X-100 Universal Oximetry System (Model X-100).
The Nonin Medical, Inc. Model 8006CA Reusable Regional Oximetry Sensor and Model 8006PI Disposable Patient Interface have undergone testing to establish substantial equivalence to predicate devices (Model 8004CA and Model 8204CA Regional Oximetry Sensors).
Here is a summary of the acceptance criteria and performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Predicate Device) | Reported Device Performance (Model 8006CA/8006PI) |
|---|---|---|
| Functional and Safety Testing | ||
| Electrical Safety | Complies with IEC 60601-1 | Pass |
| Temperature and Humidity | Complies with IEC 60601-1, EN 1789, IEC 60601-1-12 | Pass |
| Atmospheric Pressure (Altitude) | Complies with IEC 60601-1, IEC 60601-1-12 | Pass |
| Electromagnetic Immunity and Emissions | Complies with IEC 60601-1-2 | Pass |
| Performance | Complies with ISO 80601-2-61, IEC 60601-1, IEC 60601-1-6, IEC 60601-1-12, IEC 62304, ANSI/AAMI EC13, ISO 14155 | Pass |
| Ingress Protection | Complies with IEC 60601-1, ISO 80601-2-61 | Pass |
| Mechanical Durability | Complies with IEC 60601-1, ISO 80601-2-61 | Pass |
| Biocompatibility | Complies with ISO 10993-1 | Biocompatible |
| Regional (rSO2) Accuracy | ||
| rSO2 Accuracy (Arms) | Absolute: Right 4.1, Left 3.8, Both 3.9, Hypercapnia 5.1, Hypocapnia 3.3 (from K102715) | Not explicitly re-tested, but "critical sensor optics technology... remains unchanged" and "prior clinical testing... is applicable." It "performs equivalently to the same specifications." |
| Declared range | 50 - 100% (from K102715) | "Performs equivalently to the same specifications." |
| Inter-/Intra-sensor repeatability | ± 2 digits (from K102715) | "Performs equivalently to the same specifications." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "prior clinical testing provided in K102715 is applicable for the proposed Model 8006CA sensor and Model 8006PI patient interface" because "The critical sensor optics technology of the proposed devices remains unchanged from the predicate devices." Therefore, the clinical test set data for Regional (rSO2) Accuracy testing is from the K102715 submission for the predicate Model 8004CA Sensor. The specific details of the sample size, data provenance (country of origin, retrospective/prospective), etc., for that original clinical study are not provided in this document (K190560).
The current submission (K190560) relies on "detailed device comparison, analysis and testing" and the equivalency of the critical sensor optics.
For the Functional and Safety Testing, the tests were performed on the proposed devices (Model 8006CA and Model 8006PI) and are likely prospective tests conducted specifically for this submission. The sample sizes for these engineering tests are not specified but are typically small (e.g., a few units) sufficient to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The regional oximetry accuracy is derived from clinical testing, but the specifics of expert involvement in establishing ground truth (e.g., from an arterial blood gas reference for SpO2) are not detailed within this 510(k) summary. It refers back to a previous submission (K102715).
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is an oximeter, which provides a direct measurement, not an interpretative tool that requires human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the functional, safety, and performance tests assess the standalone performance of the device (Model 8006CA/8006PI) in conjunction with the Nonin Medical SenSmart Model X-100 Universal Oximetry System. The regional oximetry accuracy cited from the predicate device's clinical testing also represents standalone algorithm performance in measuring rSO2.
7. The Type of Ground Truth Used
For the regional oximetry accuracy (rSO2), the ground truth typically involves a reference method for measuring regional oxygen saturation, often arterial blood gas analysis or other established physiological measurements, in a controlled hypoxemic study. However, the specific type of ground truth used for the predicate device's clinical testing (K102715) is not explicitly stated in this document. Given the nature of oximetry, it would likely be a direct physiological measurement.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. Since the validation relies on the "critical sensor optics technology... remains unchanged" from predicate devices and the device is a measurement sensor rather than an AI/machine learning algorithm that requires extensive training data, the concept of a "training set" in the context of machine learning is not directly applicable here.
9. How the Ground Truth for the Training Set was Established
As no training set is discussed or implied for an AI/ML model, this information is not applicable here. The device's performance is based on its physical and optical design, not on learned patterns from a dataset.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name is "U.S. Food & Drug Administration".
Nonin Medical, Inc. Nancy DeAngelo Sr. Regulatory Affairs Specialist 13700 1st Avenue North Plymouth, Minnesota 55441
May 2, 2019
Re: K190560
Trade/Device Name: SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: February 28, 2019 Received: March 7, 2019
Dear Nancy Deangelo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Stevenson, For Acting Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K190560
Device Name
Model 8006CA Reusable. Regional Oximetry Sensor and Model 8006PJ Single Patient Use. Disposable Patient Interface
Indications for Use (Describe)
The Model 8006CA reusable, non-sterile, regional oximetry sensor is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation (rSO2) of blood underneath the sensor of adult and pediatric patients weighing ≥ 88 pounds (≥ 40 kilograms). The sensor and/or the patient interface may be repositioned or replaced with another 8006CA sensor without baseline re-establishment.
Nonin's Model 8006PI single patient use, non-sterile disposable patient interface is designed for use with Nonin's Model 8006CA sensor.
The sensor and patient interface is in hospitals, long-term care, medical facilities, sleep laboratories, and subacute 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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5. "510(k) Summary" as required by section 807.92(c)
| Submitter: | Nonin Medical, Inc.13700 1st Ave. NorthPlymouth, MN 55441-5443 |
|---|---|
| Phone: | 763-553-9968 |
| Fax: | 763-553-7807 |
| Contact Person: | Nancy DeAngeloSenior Regulatory Affairs Specialist |
| Date Prepared: | February 28, 2019 |
| Trade Names: | Model 8006CA Reusable, Regional Oximetry SensorModel 8006PI Disposable Patient Interface |
| Common Name: | Regional oximetry sensor |
| Classification Name: | Oximeter, Tissue Saturation |
| Regulation Number: | Class II, 21 CFR 870.2700 (Oximeter) |
| Product Code, Panel: | MUD, Cardiovascular |
| Predicate Device(s): | The Nonin Model 8006CA Reusable, Regional Oximetry Sensorand Model 8006PI Disposable Patient Interface are predicated onNonin's Model 8004CA Regional Oximetry Sensor and Model8204CA Regional Oximetry Sensor cleared under K102715(December 17, 2010) and K151305 (August 27, 2015),respectively. |
| Device Description: | The Model 8006CA Reusable Regional Oximetry Sensor andModel 8006PI Disposable Patient Interface work together for usewith the Nonin Medical SenSmart Model X-100 UniversalOximetry System (Model X-100). |
| Intended Use: | Model 8006CA Reusable Regional Oximetry Sensor andModel 8006PI Disposable Patient InterfaceThe Model 8006CA reusable, non-sterile, regional oximetry sensois intended for use as an absolute real-time adjunct monitor ofregional hemoglobin oxygen saturation (rSO2) of bloodunderneath the sensor of adult and pediatric patients weighing ≥88 pounds (≥ 40 kilograms). The sensor and/or the patientinterface may be repositioned or replaced with another 8006CAsensor without baseline re-establishment. |
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K190560
Nonin's Model 8006PI single patient use, non-sterile disposable patient interface is designed for use with Nonin's Model 8006CA sensor.
The sensor and patient interface is intended for use in hospitals, long-term care, medical facilities, sleep laboratories, and subacute environments.
Testing: The Nonin Model 8006CA Reusable Regional Oximetry Sensor and Model 8006PI Disposable Patient Interface are supported by electrical safety, electromagnetic compatibility, device performance, and clinical analysis to ensure appropriate functionality and to demonstrate substantial equivalence to the predicate devices. The devices were tested with the Nonin's Medical Model X-100 SenSmart Universal Oximetry 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.
| Test | Reference | Result |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Pass |
| Temperature and Humidity | IEC 60601-1EN 1789IEC 60601-1-12 | Pass |
| Atmospheric Pressure (Altitude) | IEC 60601-1IEC 60601-1-12 | Pass |
| Electromagnetic Immunity andEmissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61IEC 60601-1IEC 60601-1-6IEC 60601-1-12IEC 62304ANSI/AAMI EC13ISO 14155 | Pass |
| Ingress Protection | IEC 60601-1ISO 80601-2-61 | Pass |
| Mechanical Durability | IEC 60601-1ISO 80601-2-61 | Pass |
| Biocompatibility | ISO 10993-1 | Biocompatible |
Tahla 1
Clinical Testing: Regional (rSO2) Accuracy testing
The critical sensor optics technology of the proposed devices remains unchanged from the predicate devices. rSO2 accuracy is demonstrated through detailed device comparison, analysis and testing. Thus, prior clinical testing provided in K102715 is applicable for the proposed Model 8006CA sensor and Model 8006PI patient interface.
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Testing conclusion: the proposed Model 8006CA sensor and 8006Pl patient interface meet all acceptance criteria. Based on test results, analysis and comparison to the legally marketed predicates, the Model 8006CA sensor and Model 8006Pl patient interface perform equivalently to the predicate sensors for their intended use.
Summary of Substantial Equivalence:
The Model 8006CA and Model 8006PI have the following similarities to their respective predicate devices (see Table 2 below):
- Similar 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 the same manner
- Perform equivalently to the same specifications ●
- Similar construction and materials ●
| Category | Comments | Predicate Model8004CA Sensor(K102715, cleared Dec.17, 2010) | Predicate Model8204CA Sensor(K151305, cleared Aug.27, 2015) | Proposed Model8006CA Sensor andModel 8006PI PatientInterface |
|---|---|---|---|---|
| Indications forUse | Similar | The Model 8004CA single-patient use, non-sterile,disposable sensor isintended for use as anabsolute real-time adjunctmonitor of regionalhemoglobin oxygensaturation (rSO2) of bloodunderneath the sensor ofadult and pediatric patientsweighing ≥88 pounds (40kilograms). The sensormay be repositioned orreplaced with another8004CA sensor withoutbaseline re-establishment.It is intended for use inenvironments including theoperating room, surgicalrecovery, critical care,emergency room, long-termcare, and mobileenvironments. | The Model 8204CA single-patient use, non-sterile,disposable sensor isintended for use as anabsolute real-time adjunctmonitor of regionalhemoglobin oxygensaturation (rSO2) of bloodunderneath the sensor ofadult and pediatric patientsweighing ≥ 88 pounds (40kilograms). The sensor maybe repositioned or replacedwith another 8204CAsensor without baselinereestablishment. It isintended for use inenvironments including theoperating room, surgicalrecovery, critical care,emergency room, long-termcare, and mobileenvironments. | The Model 8006CAreusable, non-sterile,regional oximetry sensoris intended for use as anabsolute real-time adjunctmonitor of regionalhemoglobin oxygensaturation (rSO2) of bloodunderneath the sensor ofadult and pediatricpatients weighing ≥ 88pounds (≥ 40 kilograms).The sensor and/or thepatient interface may berepositioned or replacedwith another 8006CAsensor without baselinere-establishment.Nonin's Model 8006PIsingle patient use, non-sterile disposable patientinterface is designed foruse withNonin's Model 8006CAsensor.The sensor and patientinterface is intended foruse in hospitals, long-termcare, medical facilities,sleep laboratories, andsubacute environments. |
| Patientpopulation | Identical | Intended UseAdult and pediatric patients weighing ≥88 pounds (40 kilograms) |
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|---|---|---|---|---|
| ------ | ------ | --- | ---- | --- |
| Category | Comments | Predicate Model 8004CA Sensor (K102715, cleared Dec. 17, 2010) | Predicate Model 8204CA Sensor (K151305, cleared Aug. 27, 2015) | Proposed Model 8006CA Sensor and Model 8006PI Patient Interface | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Use environments | Similar | Operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments | Operating room, surgical recovery, critical care, and mobile environments | Hospitals, long-term care, medical facilities, sleep laboratories, and subacute environments. | ||||||||||||||||||
| Contraindications | Different | Do not use the device in an MR environment, in an explosive atmosphere, or in the presence of flammable anesthetic compounds. | Do not use the device in an MR environment, in an explosive atmosphere, or in the presence of flammable anesthetic compounds. | None. This contraindication has been moved to a Warning. | ||||||||||||||||||
| Sensor application sites | Identical | Cerebral or somatic site(s) | ||||||||||||||||||||
| Sterility | Identical | Non-sterile | ||||||||||||||||||||
| Patient Use/Reuse (sensor) | Different | Single-patient use, disposable sensor | Reusable sensor with disposable patient interface | |||||||||||||||||||
| Accuracy Specifications | ||||||||||||||||||||||
| rSO2 Accuracy (Arms *) | Identical | Accuracy Right Left Both Hypercapnia Hypocapnia Absolute 4.1 3.8 3.9 5.1 3.3 Trend 1.9 3.0 2.5 3.4 3.8 | *±1 Arms encompasses 68% of the population | |||||||||||||||||||
| Declared range | Identical | 50 - 100% | ||||||||||||||||||||
| Inter-/Intra-sensor repeatability | Identical | ± 2 digits | ||||||||||||||||||||
| Storage and Transport | ||||||||||||||||||||||
| Temperature | Identical | Operating: -5 °C to 40 °C (23 °F to 104 °F)Storage/transportation: -30 °C to 70 °C (-22 °F to 158 °F) | ||||||||||||||||||||
| Humidity | Identical | Operating: 10 % to 90 % non-condensingStorage/transportation: 10 % to 95 % non-condensing |
The following lists the differences and the rationale for those differences between the proposed sensors and their respective predicate devices:
- Model 8006CA and Model 8006Pl ●
- Indications for use the Model 8006CA sensor is reusable O unlike the predicate Model 8004CA and/or Model 8204CA sensors. However, the sensor and patient interface perform the same measurement on the identical patient population as the predicate sensors.
- Contraindications the contraindication regarding the use of O device in MR environment was deemed more appropriate as a warning. The proposed device was tested according to IEC 60601-1 (2005) and is labeled defibrillator proof when used with the Nonin X-100 system.
- O Primary Mode of Operation - Although the proposed device uses a reusable sensor and disposable patient interface, while the predicate sensors are one-piece designs, the LEDs and photodiodes operate identically in the proposed and predicate devices. The patient interface has holes to allow the encapsulant to contact the patient's skin in order to allow for the identical mode of operation of the LEDs and photodiodes.
- Construction and Materials the cable jacket is made from O PVC which is the same as the predicate sensors. The color
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K190560
has changed from black to white on the cable jacket. The overmold material on the sensor and the material used in the manufacture of the patient interface are different from the predicate sensors, but have been tested for biocompatibility. The construction of the proposed sensor is different in that it has an overmold on the head of the sensor.
Conclusion: Based on the results of the above referenced testing, the same critical optics technology, and risk management assessment, Nonin Medical considers the proposed Model 8006CA reusable regional oximetry sensor and Model 8006PI patient interface to be substantially equivalent to the predicate Nonin Model 8204CA and Model 8004CA disposable regional oximetry sensors.
§ 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).