(129 days)
Not Found
No
The device is described as a passive sensor that records bioelectric signals and transmits them to a separate recording system. There is no mention of any processing or analysis of these signals using AI or ML within the device itself.
No
The device is used for measuring and recording ERG signals to support diagnosis, not for treating a condition.
Yes
The device is described as "intended to be used for the measurement and recording of electroretinography (ERG) signals, to support the diagnosis of retinal dysfunctions" and is used in "diagnostic full-field electroretinogram (ERG) recording procedures", which clearly indicates its role in diagnosis.
No
The device is a physical contact lens electrode with multiple hardware components (contact lens, electrode ring, lead wire, heat shrink tubing) and is described as a passive sensor, not software.
Based on the provided information, the RM Electrode® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- RM Electrode® Function: The RM Electrode® is a contact lens electrode applied directly to the cornea to measure and record bioelectric signals (ERG signals) from the eye itself. It does not process or analyze specimens taken from the body.
- Intended Use: The intended use is to support the diagnosis of retinal dysfunctions by measuring electrical activity of the retina in vivo.
Therefore, the RM Electrode® falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The RM Electrode® is a contact lens electrode intended to be applied on the cornea and to be used for the measurement and recording of electroretinography (ERG) signals, to support the diagnosis of retinal dysfunctions. It is indicated for use in patients aged 12 years and above undergoing diagnostic full-field electroretinogram (ERG) recording procedures.
The RM Electrode® is a single use, disposable device.
Product codes
HLZ
Device Description
The RM Electrode® is a contact lens-type corneal electrode for use in electroretinography (ERG) procedures. Like other corneal electrodes classified under 21 CFR 886.1220 and cleared under product code HLZ, the RM Electrode is used for the measurement and recording of ERG signals, to support the diagnosis of retinal dysfunctions. It has four components, including (1) the contact lens (substrate), which supports the conductive element (electrode ring) and allows light from the stimulus source to enter the eye; (2) the electrode ring, which is the conductive element of the device; (3) the lead wire, which is connected to the electrode ring extension and terminates in an industry standard 1.5mm female "touchproof" connector that connects to a commercially available ERG recording system (not part of the subject device); and (4) heat shrink tubing which covers the electrode ring extension and junction with the lead wire. The device materials were demonstrated to be biocompatible.
The RM Electrode® is not a powered device. As with the predicate device (ERG Jet Electrode), it is a passive sensor for recording bioelectric signals from the surface of the eye and transmitting them to an ERG recording system. From an electrical perspective, the device is a single conductor that connects the eye surface to a data recorder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea
Indicated Patient Age Range
12 years and above
Intended User / Care Setting
Ophthalmologists, optometrists, trained medical technicians and professionals and vision science researchers, in hospitals, clinics, physician offices, research labs.
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: Biocompatibility Testing
Sample Size: Not Specified (for cytotoxicity and sensitization); 10 subjects (for human ocular irritation)
Key Results: Testing was successfully completed for cytotoxicity, sensitization and ocular irritation. Human ocular irritation involved 60 minutes of wear time in 10 subjects with both the subject and predicate devices. Bulbar redness, limbal redness, tarsal redness, and corneal abrasion associated with wear of the subject device were found to be equivalent to, or less than, that associated with wear of the predicate device.
Study Type: Bench Testing
Sample Size: Not Specified (for tensile load and electrical impedance)
Key Results: The subject device failure load for the lead wire-electrode ring junction was significantly higher (better) than that for the predicate device. All samples of the subject device met the prospectively defined acceptance criteria for the minimum failure load. At all frequencies tested, the electrical impedance of the subject device was equivalent to, or less than (better) that of the predicate device.
Study Type: Shelf Life Testing
Sample Size: Not Specified
Key Results: The device and its packaging successfully completed evaluations after accelerated aging to support the labeled shelf life. Integrity of the sterile packaging was confirmed. Device properties were confirmed, demonstrating no significant changes over the labeled shelf life.
Study Type: Clinical Testing
Sample Size: 15 subjects (for ERG signal comparison); 10 subjects (for human ocular irritation, also noted in biocompatibility section)
Data Source: Two sites for ERG signal comparison.
Key Results: Clinical performance testing compared the subject and predicate devices in 15 healthy subjects. Amplitudes (a-wave, b-wave and flicker) and signal to noise ratios were substantially equivalent for both devices. No adverse events or complications related to the subject device were reported. In the human ocular irritation study (10 subjects, normally sighted, aged 18 and above), bulbar redness, limbal redness, tarsal redness, and corneal abrasion associated with wear of the subject device were found to be equivalent to, or less than, that associated with wear of the predicate device. No adverse events or complications related to the study device were reported.
Key Metrics
- Biocompatibility: Absence of cytotoxicity, ocular irritation (in animals or humans), or sensitization.
- Lead Wire Integrity (Bench Testing): Subject device failure load was significantly higher (better) than the predicate device. All samples met prospectively defined acceptance criteria.
- Electrical Impedance (Bench Testing): Subject device electrical impedance was equivalent to, or less than (better), that of the predicate device at all tested frequencies.
- Shelf Life: Device (material hardness and electrical impedance) and package integrity (seal strength and bubble leak) maintained after a 1-year shelf life.
- ERG Signal Quality (Clinical Testing): Amplitudes (a-wave, b-wave and flicker) and signal to noise ratios were substantially equivalent to the predicate device.
- Ocular Irritation (Clinical Testing): Bulbar redness, limbal redness, tarsal redness, and corneal abrasion were equivalent to, or less than, the predicate device.
- Adverse Events: No adverse events or complications were related to the subject device in clinical testing.
Predicate Device(s)
ERG Jet Electrode (K813399)
Reference Device(s)
Not Found
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.
0
December 7, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are displayed side-by-side.
RetMap, Inc. Shresta Patangay Chief of Staff 832 W Superior St, Suite 202 Chicago, Illinois 60642
Re: K232273
Trade/Device Name: RM Electrode (RMH 23-01) Regulation Number: 21 CFR 886.1220 Regulation Name: Corneal electrode Regulatory Class: Class II Product Code: HLZ Dated: November 3, 2023 Received: November 3, 2023
Dear Shresta Patangay:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Elvin Y.
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
RM Electrode (RMH 23-01)
Indications for Use (Describe)
The RM Electrode® is a contact lens electrode intended to be applied on the cornea and to be used for the measurement and recording of electroretinography (ERG) signals, to support the diagnosis of retinal dysfunctions. It is indicated for use in patients aged 12 years and above undergoing diagnostic full-field electroretinogram (ERG) recording procedures.
The RM Electrode® is a single use, disposable device.
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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3
510(k) Summary
K232273
| Submitter's Name | RetMap, Inc.
832 W Superior St., Suite 202
Chicago, IL 60642
Telephone: (312) 224-8938 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person | Shresta Patangay, PhD
Chief of Staff
RetMap, Inc.
832 W Superior St., Suite 202
Chicago, IL 60642 |
| Date Prepared | July 28, 2023 |
| Device Trade Name | RM Electrode |
| Device Common Name | Corneal or ERG Electrode |
| Classification Name | Corneal Electrode |
| Product Code | HLZ |
| Device Classification | Class II |
| Panel | Ophthalmology |
| Regulatory Classification | 21 CFR 886.1220 |
| Type of 510(k) Submission | Traditional |
| Legally Marketed Predicate Device | ERG Jet Electrode (K813399) |
Premarket Notification (510(k)) Number
4
Description
The RM Electrode® is a contact lens-type corneal electrode for use in electroretinography (ERG) procedures. Like other corneal electrodes classified under 21 CFR 886.1220 and cleared under product code HLZ, the RM Electrode is used for the measurement and recording of ERG signals, to support the diagnosis of retinal dysfunctions. It has four components, including (1) the contact lens (substrate), which supports the conductive element (electrode ring) and allows light from the stimulus source to enter the eye; (2) the electrode ring, which is the conductive element of the device; (3) the lead wire, which is connected to the electrode ring extension and terminates in an industry standard 1.5mm female "touchproof" connector that connects to a commercially available ERG recording system (not part of the subject device); and (4) heat shrink tubing which covers the electrode ring extension and junction with the lead wire. The device materials were demonstrated to be biocompatible.
The RM Electrode® is not a powered device. As with the predicate device (ERG Jet Electrode), it is a passive sensor for recording bioelectric signals from the surface of the eye and transmitting them to an ERG recording system. From an electrical perspective, the device is a single conductor that connects the eye surface to a data recorder.
Indications for Use
The RM Electrode® is a contact lens electrode intended to be applied on the cornea and to be used for the measurement and recording of electroretinography (ERG) signals, to support the diagnosis of retinal dysfunctions. It is indicated for use in patients aged 12 years and above undergoing diagnostic full-field electroretinogram (ERG) recording procedures.
The RM Electrode® is a single use, disposable device.
Predicate Device
The RM Electrode® is substantially equivalent to the ERG Jet Electrode cleared under K813399. Both devices are electrodes intended to be applied on the cornea for the measurement and recording of ERG signals, to support the diagnosis of retinal dysfunctions. Both the subject and predicate devices have the same intended use and similar technological characteristics, but the RM Electrode includes a softer eye contact material and design features that help prevent the wearer from blinking during the ERG test, improve positional stability, and keep the area of the pupil clear of obstructions.
5
Please refer to the Substantial Equivalence Summary Comparison Table below for a summary of the similarities and differences between the subject and predicate devices.
Description of Operation
As part of an ERG procedure, the device is filled with a lubricating ophthalmic solution and placed on the eye. The lead wire is gently draped over the ipsilateral ear, secured with tape if needed, and the connector is plugged into a compatible ERG recording system. The device can be used for any full-field ERG protocol to record bioelectric signals from the surface of the eye and transmit them to the ERG data recording system. After the ERG test procedure, the device is removed from the patient's eye.
Technological Characteristics Summary
The RM Electrode is substantially equivalent to the ERG Jet Electrode (K813399) with respect to intended use, design, principle of operation, technological characteristics and performance. Both devices include similar components, including a contact lens (eye contact) portion, electrode, and lead wire with connector. The RM Electrode includes a softer eye contact material and design features that help prevent the wearer from blinking during the ERG test, improve positional stability, and keep the area of the pupil clear of obstructions. These differences do not raise new questions of safety or effectiveness.
| Features | RM Electrode
(Subject Device) | ERG Jet Electrode
Predicate Device
K813399 | Comparison |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Corneal (contact lens) electrode to transmit the retinal electrical signal in diagnostic ERG procedures | Corneal (contact lens) electrode to transmit the retinal electrical signal in diagnostic ERG procedures | Identical |
| Product Code | HLZ | HLZ | Identical |
| Indications for Use | The RM Electrode® is a contact lens electrode intended to be applied on the cornea and to be used for the measurement and recording of | The ERG-Jet is a contact lens electrode intended to be applied on the cornea and to be used for the measurement and recording of | Equivalent. While the predicate device is intended for use in both full-field flash and multi-focal ERG procedures, the subject device is |
| | electroretinography
(ERG) signals, to
support the diagnosis of
retinal dysfunctions. It
is indicated for use in
patients aged 12 years
and above undergoing
diagnostic full-field
electroretinogram
(ERG) recording
procedures.
The RM Electrode® is a
single use, disposable
device. | electroretinography
(ERG) signals, to
support the diagnosis of
retinal dysfunctions.
The ERG-Jet is not
intended for multiple
use. If re-used, an
infection of the cornea
can occur, and the
measuring results are no
longer guaranteed. | currently intended
only for use in full-
field flash ERG
procedures. Full-
field flash protocols
represent the
majority
(approximately
80%) of the ERG
procedures
conducted in the
United States,
therefore this
difference is not
critical to the
intended use of the
device and does not
affect the safety or
effectiveness of the
device when used as
labeled. The device
labeling clearly
identifies the
intended use for full-
field flash
procedures only. |
| Target Population | Patients aged 12 years
and above undergoing
ERG recording
procedures | Patient population not
specified | Both devices are used
in patients undergoing
ERG procedures |
| Types of ERG
Procedures | Full-field flash ERG
protocols | Either full-field or
multifocal ERG protocols | The RM Electrode is
not intended for ERG
protocols that use
patterned visual
stimuli, such as the
multi-focal ERG
(mfERG). Full-field
flash protocols
represent
approximately 80% of
ERG procedures that |
| | | | are conducted in the |
| | | | US thus this |
| | | | difference is not |
| | | | critical to the intended |
| | | | use of the device and |
| | | | does not affect the |
| | | | safety or effectiveness |
| | | | of the device when |
| | | | used as labeled. |
| Wear Duration | Typically 20 minutes.