(364 days)
No
The summary describes a passive electrode for measuring ERG signals and does not mention any computational processing or analysis of these signals using AI/ML.
No
The device is described as an electrode for measuring and recording ERG signals, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as being "intended for use in the measurement and recording of ERG signals from the ocular surfaces of the eye." Measuring and recording ERG signals are diagnostic functions, as they provide information about the eye's physiological state to aid in diagnosis.
No
The device description clearly outlines a physical electrode made of silver-impregnated nylon fibers and a wire, which are hardware components. The performance studies also focus on physical properties like elution, irritation, sterilization, and biocompatibility.
Based on the provided information, the Tomey DTL Electrode is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended for the measurement and recording of ERG signals from the ocular surfaces of the eye. This is a physiological measurement taken directly from a living organism (in vivo), not a test performed on samples of biological material (in vitro).
- Device Description: The description details a physical electrode placed on the eye, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other biological samples.
Therefore, the Tomey DTL Electrode is an in vivo diagnostic device, specifically an electrode used for electroretinography (ERG).
N/A
Intended Use / Indications for Use
The Tomey DTL Electrode is intended for use in the measurement and recording of ERG signals from the ocular surfaces of the eye. These measurements are only to be performed by licensed practitioners and trained technicians within a medical environment.
There are no differences with respect to the predicate devices for indications for use, or target population.
Product codes
Not Found
Device Description
Tomey DTL Electrode consists of soft silver impregnated nylon fiber threads that are normally placed under the lower eye lid. The electrodes are constructed with 3 to 10 individual fibers between 5 and 20 microns in diameter. The fibers are stabilized at both ends with adhesive attachments. A thin wire is connected to an adaptor cable that permits the electrodes to be used with various ERG Recording systems including the Tomey PE-400/PS-400.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular surfaces of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed practitioners and trained technicians within a medical environment.
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
This section summarizes the performance testing that Tomey Corporation carried out on the Tomey DTL Electrode. This testing addressed the following issues:
-
Elution testing
The Tomey DTL Electrode passed the Elution test performed according to the requirements of the Ministry of Health and Welfare in Japan. -
Rabbit Eye irritation testing
An eye irritation test was performed by Juridical Foundation, Japan Food Research Laboratory which indicates that the Tomey DTL Electrode does not cause irritation to the eye when used according to prescribed instructions. -
Sterilization
The Tomey DTL Electrode is supplied to the user in a factory sealed package and is intended to be disinfected by the end user employing procedures recommended in the product labeling. -
Biocompatibility
The Tomey DTL Electrode is for short term ERG recording purposes. Extensive use by many investigators, including Dawson, Prager and Lachapelle, has not revealed any biocompatibility problems with this type of an electrode. Eye Irritation studies performed by Tomey, also indicate that short term biocompatibility is not a problem for the Tomey DTL Electrode. -
Other Safety and Compatibility
The Tomey DTL Electrode, by means of adaptor cables, is compatible with commercially available ERG recording systems that employ protected electrode leads.
The Tomey DTL Electrode is unable to be mistakenly connected to an a/c or d/c power source.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1220 Corneal electrode.
(a)
Identification. A corneal electrode is an AC-powered device, usually part of a special contact lens, intended to be applied directly to the cornea to provide data showing the changes in electrical potential in the retina after electroretinography (stimulation by light).(b)
Classification. Class II.
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MAY - 9 1997
SECTION VI
510(k) SUMMARY
Tomey DTL Electrode
Common/Classification Name: Electrode Corneal, 21 CFR 886.1220
Applicant:
Tomey Corporation 2-22-10 Noritakeshinnmachi Nishi ku, Nagoya 451 Japan Attn: Mr. Susumu Nozowa (Manager /Regulatory) (052) 281-2595 (052) 581-5596 (FAX)
Correspondent:
Tomey Corporation (USA) 325 Vassar Street, Cambridge, MA 02139 Contact: Dave MacLellan (Engineer) (617) 864-6488 (617) 864-6897 (FAX)
February 25, 1997 Prepared:
LEGALLY MARKETED PREDICATE DEVICES A.
The Tomey DTL Electrode is substantially equivalent in design and function to the DTL Electrode as manufactured by Sauquoit Industries, Inc., Scranton, PA (as cleared in K844409), the Gold Foil ERG Electrodes as manufactured by Cadwell Laboratories, Inc., Kennewick, WA (as cleared in K820254), and the ERG-JET Electrode as manufactured by Life Tech, Houston, TX (as cleared in K823767).
The Tomey DTL Electrode is also similar to the ERG electrode that was included with the Tomey PE-400/PS-400 Portable ERG system under K932571.
Tomey Corporation DTL Electrode, Section VI
1
DEVICE DESCRIPTION B.
Tomey DTL Electrode consists of soft silver impregnated nylon fiber threads that are normally placed under the lower eye lid. The electrodes are constructed with 3 to 10 individual fibers between 5 and 20 microns in diameter. The fibers are stabilized at both ends with adhesive attachments. A thin wire is connected to an adaptor cable that permits the electrodes to be used with various ERG Recording systems including the Tomey PE-400/PS-400.
INTENDED USE C.
The Tomey DTL Electrode is intended for use in the measurement and recording of ERG signals from the ocular surfaces of the eye. These measurements are only to be performed by licensed practitioners and trained technicians within a medical environment.
There are no differences with respect to the predicate devices for indications for use, or target population.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The Tomey Corporation device has the same intended use and target population as the predicate devices, and has equivalent effectiveness for its intended use.
NON-CLINICAL TESTING E.
This section summarizes the performance testing that Tomey Corporation carried out on the Tomey DTL Electrode. This testing addressed the following issues:
1. Elution testing
The Tomey DTL Electrode passed the Elution test performed according to the requirements of the Ministry of Health and Welfare in Japan.
2. Rabbit Eye irritation testing
An eve irritation test was performed by Juridical Foundation, Japan Food Research Laboratory which indicates that the Tomey DTL Electrode does not cause irritation to the eye when used according to prescribed instructions.
2
Sterilization 3.
The Tomey DTL Electrode is supplied to the user in a factory sealed package and is intended to be disinfected by the end user employing procedures recommended in the product labeling.
Biocompatibility 4.
The Tomey DTL Electrode is for short term ERG recording purposes. Extensive use by many investigators, including Dawson, Prager and Lachapelle, has not revealed any biocompatibility problems with this type of an electrode. Eye Irritation studies performed by Tomey, also indicate that short term biocompatibility is not a problem for the Tomey DTL Electrode.
Other Safety and Compatibility 5.
The Tomey DTL Electrode, by means of adaptor cables, is compatible with commercially available ERG recording systems that employ protected electrode leads.
The Tomey DTL Electrode is unable to be mistakenly connected to an a/c or d/c power source.
F. CONCLUSIONS
Tomey Corporation has demonstrated that its evaluation of the Tomey DTL Electrode and its review of the literature shows equivalent safety and effectiveness with respect to performance, biocompatibility issues, comfort and corneal surface damage, although no specific claim for these attributes is being made.
Image /page/2/Picture/9 description: The image shows the text "Tomey Corporation DTL Electrode, Section VI". The text appears to be a title or heading, possibly from a document or manual. The text is in a clear, sans-serif font and is easily readable. The words "Tomey Corporation" are followed by "DTL Electrode, Section VI".
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