(166 days)
Not Found
No
The description focuses on the device's function as a light stimulator and explicitly states that the triggering and acquisition system (which might involve analysis) is not part of this 510(k). There is no mention of AI or ML in the device description or performance studies.
No
The device is used to apply a light stimulus to the eyes for evoked response measurements or EEG activation, which are diagnostic purposes, not therapeutic.
No
Justification: The device is a stimulator that applies light to a patient's eyes to evoke a response, but it does not record, analyze, or process these responses itself. It is designed to be connected to a separate triggering and acquisition system that records and analyzes the patient's responses. Therefore, the SightSaver™ itself is not a diagnostic device.
No
The device description explicitly states that the device uses LEDs inside to flash light at the eye and is made with self-sticking adhesive foam padding, indicating it is a physical hardware device.
Based on the provided information, the SightSaver™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- SightSaver™ Function: The SightSaver™ applies a visible light stimulus to a patient's eyes to elicit a physiological response (evoked response or EEG activation). It does not analyze any biological specimens taken from the patient.
- Mechanism of Action: The device directly interacts with the patient's eyes to stimulate a response that is then measured by a separate triggering and acquisition system. This is an in vivo (within the living body) interaction, not in vitro (in glass/outside the body).
Therefore, the SightSaver™ falls under the category of a medical device used for physiological measurement or stimulation, not an IVD.
N/A
Intended Use / 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 settings by trained medical personnel and is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
GWE
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's eyes, periocular region of the patient's face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital and clinical settings by trained medical personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Summary
ﺖ
SightSaver™ Visual Stimulator K113785
| Applicant | Anschel Technology Inc.
David Anschel
1 Wildwood Road
Rocky Point, NY 11778 | |
|----------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Primary | Dr.Glen Park
Sr.Director, Clinical and Regulatory Affairs
Target Health Inc.
261 Madison Avenue, 24th Floor
New York, NY 10016
Phone: (212) 681-2032
Fax: (212) 682-2105
Gpark@targethealth.com |
| | Secondary | David Anschel
1 Wildwood Road
Rocky Point, NY 11778
Phone: 646-662-7453 |
| Device Name | SightSaver™ Visual Stimulator | ||
|---|---|---|---|
| Common/Usual | |||
| Name | SightSaver™ | ||
| Classification Names | |||
| / Numbers and Code | 21 CFR | ||
| 882.1890 | Classification Name | ||
| Evoked response photic stimulator | Code | ||
| GWE | |||
| 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 of | |||
| Device | 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). | | |
1
| Device 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 settings by trained medical personnel and is for
prescription use only. |
| Predicate Comparison Summary | |||
|---|---|---|---|
| Device Name | The SightSaverTM | ||
| Visual Stimulator | Cadwell LED | ||
| Goggles | XLTek Visual | ||
| Stimulator Goggles | |||
| K Number | K113785 | K831231 | K011794 |
| Same Intended Use / | |||
| Indications for Use | Yes | Yes* | Yes |
| Utilizes embedded | |||
| LED technology to | |||
| flash visible light into | |||
| the eyes for testing | |||
| purposes | Yes | Yes | Yes |
| Controlled by a | |||
| separate triggering | |||
| device | Yes | Yes | Yes |
| Typical use flash | |||
| repetition rate: 0.5Hz - | |||
| 1.0Hz | Yes | Yes | Yes |
| ISO 15004-2 | |||
| compliant | 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
2
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
3
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
4
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
Page 1 of
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K113785 510(k) Number