(171 days)
The Natus Photic Stimulator is indicated for photic activation of the EEG study and in the generation of visual evoked potentials.
The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Photic Stimulator is used by trained medical staff in a medical environment to apply photic flashes to the patient during neurophysiology studies such as electroencephalographic (EEG) studies, where it is used as an activation to test photo-sensibility related to epilepsy.
The Natus Photic Stimulator is typically used by EEG technicians in the hospital environment in fixed, mobile or portable systems, and with patients of all ages. The lamp head assembly is mounted on an arm allowing easy placement at 30 cm away from the patient's face. The arm is ergonomically designed so that the lamp can be move and rotated in the direction of the patient using a handgrip on the lamp.
Trigger pulses applied to the trigger input of the Natus Photic Stimulator generate 1 millisecond photic flashes at specific frequencies, typically in the range of 0.5 Hz to 60 Hz by a white light emitting diode (LED) lamp. The basic operating mode consists of generating a single flash per trigger pulse applied. Flash intensity has a maximum range from 22,000 lux up to 75,000 lux measured at 30 cm from the LED lamp at the position of highest intensity and 3,520 lux to 12,000 lux calculated at 75cm. The frequency and intensity of the flash is controlled by the acquisition software.
It can also be used along with evoked potential devices for stimulating visual evoked potentials.
This document describes the Natus Photic Stimulator, a device used in neurophysiology studies. The information provided focuses on the device's technical specifications and compliance with regulatory standards, rather than clinical performance or AI integration.
Therefore, the following information regarding acceptance criteria and study details cannot be fully extracted as it pertains to clinical performance and AI, which are not the primary focus of this submission. The document primarily reports on technical and safety performance testing.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) akin to what would be provided for a diagnostic AI device. Instead, the "acceptance criteria" are compliance with various technical and safety standards.
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| Electrical Safety: | The Natus Photic Stimulator complies with: |
| IEC 60601-1: 2005, Am1: 2012 | Results indicate that the Natus Photic Stimulator complies with the applicable standards. |
| Electromagnetic Compatibility: | The Natus Photic Stimulator complies with: |
| IEC 60601-1-2: 2007 | Results indicate that the Natus Photic Stimulator complies with the applicable standards. |
| IEC 60601-2-40: 2016 | Results indicate that the Natus Photic Stimulator complies with the applicable standards. |
| Bench Performance Testing: | The Natus Photic Stimulator complies with its predetermined specifications and applicable standards, including: |
| Internal requirements | Results indicate that the Natus Photic Stimulator complies with its predetermined specifications and the applicable standards. |
| IEC 60601-1-6: 2010, Am1: 2013 | Verified for performance in accordance with internal requirements and the applicable clauses of the standards. |
| IEC 60601-2-40: 2016 | Verified for performance in accordance with internal requirements and the applicable clauses of the standards. |
| IEC 62366: 2007, Am1: 2014 | Verified for performance in accordance with internal requirements and the applicable clauses of the standards. |
| IEC 62471: 2006 | Verified for performance in accordance with internal requirements and the applicable clauses of the standards. |
| ANSI Z80.36-2016 | Verified for performance in accordance with internal requirements and the applicable clauses of the standards. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The performance testing described is bench testing against technical and safety standards, not a clinical study on a patient population.
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)
This is not applicable as the submission describes device safety and performance testing against engineering standards, not a clinical evaluation requiring expert interpretation of ground truth in patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The performance testing involves engineering verification and validation, not clinical adjudication of patient cases.
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
There is no mention of AI assistance or a MRMC study in this document. This submission is for a photic stimulator, which is a hardware device for neurophysiology studies, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a hardware photic stimulator, and the performance testing focuses on its compliance with safety and technical standards as a standalone physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is compliance with established international and national technical, electrical, electromagnetic, usability, and photobiological safety standards (e.g., IEC 60601 series, IEC 62366, IEC 62471, ANSI Z80.36). This is verified through objective measurements and tests against those standards, not through clinical ground truth like pathology or expert consensus on patient outcomes.
8. The sample size for the training set
This is not applicable. This device is not an AI algorithm trained on data.
9. How the ground truth for the training set was established
This is not applicable. This device is not an AI algorithm trained on data.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 15, 2018
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta Director, Quality Assurance & Regulatory Affairs 2568 Bristol Circle Oakville, ON L6H 5S1 Canada
Re: K173936
Trade/Device Name: Natus Photic Stimulator Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked Response Photic Stimulator Regulatory Class: Class II Product Code: GWE Dated: May 14, 2018 Received: May 16, 2018
Dear Sanjay Mehta:
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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Sanjay Mehta
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 medical devices and radiation-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,
Jay R. Gupta -S
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173936
Device Name Natus Photic Stimulator
Indications for Use (Describe)
The Natus Photic Stimulator is indicated for photic activation of the EEG study and in the generation of visual evoked potentials.
Type of Use (Select one or both, as applicable)
X 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 contains the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a small registered trademark symbol next to the "s". Below "natus" is the word "neurology" in a smaller, italicized, black sans-serif font. The logo is simple and clean, with a focus on the company name.
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| Submission Date: | 20 December 2017 | ||
|---|---|---|---|
| Submitter: | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)2568 Bristol CircleOakville, Ontario, L6H 5S1Canada | ||
| Submitter andApplicationCorrespondent | Mr. Sanjay MehtaPhone: +1 (905) 287-5055Fax: +1 (905) 829-5304Email: sanjay.mehta@natus.com | ||
| Manufacturing Site: | Creation Technologies LP6820 Creditview RoadMississauga, Ontario L5N 0A9Canada | ||
| Trade Name: | Natus Photic Stimulator | ||
| Common andClassificationName: | Stimulator, Photic, Evoked Response | ||
| ClassificationRegulation: | 21 CFR §882.1890 | ||
| Product Code: | GWE | ||
| SubstantiallyEquivalent Devices: | New XLTEK Model | Predicate 510(k)Number | PredicateManufacturer / Model |
| XLTEK / Natus PhoticStimulator | K101691 | Lifelines Ltd. / LifelinePhotic Stimulator | |
| 510(k): NATUS PHOTIC STIMULATOR510(k) SUMMARY | |||
| PAGE 2 of 4 | |||
| Device Description: | The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Photic Stimulator is used by trained medical staff in a medical environment to apply photic flashes to the patient during neurophysiology studies such as electroencephalographic (EEG) studies, where it is used as an activation to test photo-sensibility related to epilepsy.The Natus Photic Stimulator is typically used by EEG technicians in the hospital environment in fixed, mobile or portable systems, and with patients of all ages. The lamp head assembly is mounted on an arm allowing easy placement at 30 cm away from the patient's face. The arm is ergonomically designed so that the lamp can be move and rotated in the direction of the patient using a handgrip on the lamp.Trigger pulses applied to the trigger input of the Natus Photic Stimulator generate 1 millisecond photic flashes at specific frequencies, typically in the range of 0.5 Hz to 60 Hz by a white light emitting diode (LED) lamp. The basic operating mode consists of generating a single flash per trigger pulse applied. Flash intensity has a maximum range from 22,000 lux up to 75,000 lux measured at 30 cm from the LED lamp at the position of highest intensity and 3,520 lux to 12,000 lux calculated at 75cm. The frequency and intensity of the flash is controlled by the acquisition software.It can also be used along with evoked potential devices for stimulating visual evoked potentials. | ||
| Intended Use: | The Natus Photic Stimulator is indicated for photic activation of the EEG during an EEG study and in the generation of visual evoked potentials. | ||
| Technology Comparison: | The Natus Photic Stimulator employs the same technological characteristics as the predicate device. | ||
| System Characteristic | Lifelines Ltd.Lifelines Photic Stimulator(K101691) | Excel-Tech Ltd. (XLTEK)Natus Photic Stimulator(Proposed Device) | |
| Indications for Use | The Lifelines PhoticSimulator is indicated forphotic activation of the EEGduring an EEG study and inthe generation of visualevoked potentials. | The Natus Photic Stimulator isindicated for photic activationof the EEG during an EEGstudy and in the generation ofvisual evoked potentials. | |
| Mode of Operation | Arm-mounted photicstimulator generates flashesof white light by means oflight emitting diode (LED) | Arm-mounted photicstimulator generates flashes ofwhite light by means of LEDs. | |
| Light Source | Single, high-intensity LED | Surface mounted, high-intensity LED array | |
| SystemCharacteristic | Lifelines Ltd.Lifelines Photic Stimulator(K101691) | Excel-Tech Ltd. (XLTEK)Natus Photic Stimulator(Proposed Device) | |
| Luminous Flux | 700 lm typical, 900 lm max13,000 lux at one (1) foot | Intensity measured at 30 cm (~1 foot) distance, position 12:● Minimum: 22,000 lux● Maximum: 75,000 luxTypical observed intensity is39,900 lux. | |
| Flash Rate | 1 to 60 Hz or single manualflash | 0.5 to 60 Hz or single manualflash |
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Image /page/5/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal, sans-serif font, with a registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, italicized, sans-serif font, also in teal.
Summary of Performance Testing:
| Electrical Safety | The Natus Photic Stimulator was verified for performance in accordancewith the following standard: |
|---|---|
| • IEC 60601-1: 2005, Am1: 2012, Medical electrical equipment – Part1: General requirements for basic safety and essential performance. | |
| Results indicate that the Natus Photic Stimulator complies with theapplicable standards. | |
| ElectromagneticCompatibility | The Natus Photic Stimulator was verified for performance in accordancewith the following standard: |
| • IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2:General requirements for basic safety and essential performance –Collateral standard: Electromagnetic compatibility – Requirementsand tests. | |
| • IEC 60601-2-40: 2016, Medical electrical equipment – Part 2-40:Particular requirements for the basic safety and essentialperformance of electromyographs and evoked response equipment. | |
| Results indicate that the Natus Photic Stimulator complies with theapplicable standards. |
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Image /page/6/Picture/1 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal color and in a larger font. Below that, the word "neurology" is in black and in a smaller font. The logo is simple and modern.
| PerformanceTesting – Bench | The Natus Photic Stimulator was verified for performance in accordancewith internal requirements and the applicable clauses of the followingstandards:IEC 60601-1-6: 2010, Am1: 2013, Medical electrical equipment –Part 1-6: General requirements for basic safety and essentialperformance - Collateral standard: Usability. IEC 60601-2-40: 2016, Medical electrical equipment – Part 2-40:Particular requirements for the basic safety and essentialperformance of electromyographs and evoked response equipment. IEC 62366: 2007, Am1: 2014, Medical devices – Application ofusability engineering to medical devices. IEC 62471: 2006, Photobiological safety of lamps and lamp systems. ANSI Z80.36-2016, Light Hazard Protection for OphthalmicInstruments. |
|---|---|
| Results indicate that the Natus Photic Stimulator complies with itspredetermined specifications and the applicable standards. | |
| Conclusion | Verification and validation activities were conducted to establish theperformance and safety characteristics of the device modifications madeto the Natus Photic Stimulator. The results of these activities demonstratethat the Natus Photic Stimulator is as safe, as effective, and performs aswell as or better than the predicate devices.Therefore, the Natus Photic Stimulator is considered substantiallyequivalent to the predicate devices. |
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).