(166 days)
The SightSaver™ is an evoked response photic stimulator that is used to apply a visible light stimulus to a patient's eyes for use in evoked response measurements or for electroencephalogram (EEG) activation.
The SightSaver™ Visual Stimulator is designed to be used in hospital and clinical settings by trained medical personnel and is for prescription use only.
The SightSaver™ Visual Stimulator is used to expose the eyes to light in order to elicit a physiological response. LEDs inside the device flash light at the eye. The SightSaver™ Visual Stimulator is disposable and made with specifically shaped self-sticking adhesive foam padding which conforms to the periocular region of the patient's face.
The SightSaver™ is designed to be connected to a triggering and acquisition system which records, analyzes, or processes the patient's responses.
The triggering and acquisition system is not included as part of the 510(k).
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly detail a table of acceptance criteria with corresponding device performance for the SightSaver™ Visual Stimulator. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than meeting specific performance metrics against predefined criteria.
However, it does implicitly suggest one key performance/safety criterion that the device meets or exceeds:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| ISO 15004-2 compliance (Safety/Performance Standard) | Yes, the SightSaver™ is ISO 15004-2 compliant. (This is presented as a superior standard compared to predicates). |
The document states: "The SightSaver™ Visual Stimulator has been tested to higher safety performance standards compared with the predicate devices but is the same as the predicate devices in: Intended use, Overall design and form factor, Technological characteristics." This implies that while specific performance metrics aren't listed, the device met or exceeded relevant safety and performance standards, notably ISO 15004-2, which the predicates did not.
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not contain any information about a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical study evaluating the SightSaver™ Visual Stimulator's performance. The submission primarily relies on a comparison to predicate devices and adherence to standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As there is no mention of a test set or clinical study in the provided text, there is no information regarding the number or qualifications of experts used to establish ground truth.
4. Adjudication method for the test set
Similarly, due to the absence of a described test set or clinical study, there is no information about an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
The SightSaver™ Visual Stimulator is described as an "evoked response photic stimulator" and not an AI-powered diagnostic device designed to assist human readers. Therefore, no MRMC comparative effectiveness study involving AI assistance for human readers was done or is relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a hardware stimulator and not an algorithm. Therefore, no standalone algorithm performance study was done or is relevant. The device functions by exposing eyes to light for evoked response measurements, and its performance would be assessed through its electrical and optical characteristics, not as a standalone diagnostic algorithm.
7. The type of ground truth used
Since no clinical study evaluating diagnostic accuracy or a similar measure is described, no specific type of ground truth (e.g., expert consensus, pathology, outcomes data) for such a study is mentioned. The "ground truth" for the device's function is its ability to produce a visible light stimulus according to specifications for evoked response measurements or EEG activation.
8. The sample size for the training set
The provided text does not contain any information about a training set since the device is a hardware stimulator and not a machine learning algorithm.
9. How the ground truth for the training set was established
As there is no mention of a training set, there is no information on how ground truth for a training set was established.
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510(k) Summary
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SightSaver™ Visual Stimulator K113785
| Applicant | Anschel Technology Inc.David Anschel1 Wildwood RoadRocky Point, NY 11778 | |
|---|---|---|
| Contact Person | Primary | Dr.Glen ParkSr.Director, Clinical and Regulatory AffairsTarget Health Inc.261 Madison Avenue, 24th FloorNew York, NY 10016Phone: (212) 681-2032Fax: (212) 682-2105Gpark@targethealth.com |
| Secondary | David Anschel1 Wildwood RoadRocky Point, NY 11778Phone: 646-662-7453 |
| Device Name | SightSaver™ Visual Stimulator | ||
|---|---|---|---|
| Common/UsualName | SightSaver™ | ||
| Classification Names/ Numbers and Code | 21 CFR882.1890 | Classification NameEvoked response photic stimulator | CodeGWE |
| Regulatory Class | II | ||
| Prescription Status | Prescription Device | ||
| Device /Classification Panels | Diagnostic Neurological Devices | ||
| Predicate Devices | Cadwell LED Goggles | K831231 | |
| XLTEK LED Visual Stimulator Goggles | K011794 | ||
| Technology | Embedded LEDs (Light-emitting diodes) | ||
| Description ofDevice | The SightSaver™ Visual Stimulator is used to expose the eyes tolight in order to elicit a physiological response. LEDs inside thedevice flash light at the eye. The SightSaver™ Visual Stimulator isdisposable and made with specifically shaped self-sticking adhesivefoam padding which conforms to the periocular region of thepatient's face.The SightSaver™ is designed to be connected to a triggering andacquisition system which records, analyzes, or processes thepatient's responses.The triggering and acquisition system is not included as part of the510(k). |
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| Device Indicationsfor Use | The SightSaver™ is an evoked response photic stimulator that isused to apply a visible light stimulus to a patient's eyes for use inevoked response measurements or for electroencephalogram (EEG)activation. |
|---|---|
| The SightSaver™ Visual Stimulator is designed to be used inhospital and clinical settings by trained medical personnel and is forprescription use only. |
| Predicate Comparison Summary | |||
|---|---|---|---|
| Device Name | The SightSaverTMVisual Stimulator | Cadwell LEDGoggles | XLTek VisualStimulator Goggles |
| K Number | K113785 | K831231 | K011794 |
| Same Intended Use /Indications for Use | Yes | Yes* | Yes |
| Utilizes embeddedLED technology toflash visible light intothe eyes for testingpurposes | Yes | Yes | Yes |
| Controlled by aseparate triggeringdevice | Yes | Yes | Yes |
| Typical use flashrepetition rate: 0.5Hz -1.0Hz | Yes | Yes | Yes |
| ISO 15004-2compliant | Yes | No | No |
Conclusion
The SightSaver"M Visual Stimulator has been tested to higher safety performance standards compared with the predicate devices but is the same as the predicate devices in:
- Intended use ■
- Overall design and form factor 8
- Technological characteristics l
The function and technology employed by the SightSaver™ Visual Stimulator is similar and introduces no new questions concerning safety and efficacy. Therefore, the SightSaver™ Visual Stimulator is substantially equivalent.
. 4.
- While Intended Use is the same, the specific wording of the Indications for Use was not available from the manufacturer of the Cadwell LED Goggles
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Anschel Technology Inc. c/o Dr. Glen Park Target Health Inc. 261 Madison Avenue, 24th Floor New York, NY 10016
Re: K113785
Trade/Device Name: SightSaver™ Visual Stimulator Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: Class II Product Code: GWE Dated: June 1, 2012 Received: June 4, 2012
Dear Dr. Park:
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. Ilsting 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.
JUN. - 6 2012
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Page 2 - Dr. Glen Park
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 (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kestia Alexander
for
Malvina B. Eydelman, M.D. 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
510(k) Number (if known): K113785
Device Name: SightSaver™ Visual Stimulator
Indications for Use:
The SightSaver™ is an evoked response photic stimulator that is used to apply a visible light stimulus to a patient's eyes for use in evoked response measurements or for electroencephalogram (EEG) activation.
The SightSaver™ Visual Stimulator is designed to be used in hospital and clinical THE Officaned medical personnel and is for prescription use only.
X Prescription Use
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kmith
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
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K113785 510(k) Number
§ 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).