(101 days)
Not Found
No
The document describes a standard scanning laser ophthalmoscope with embedded software for image capture and control. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is indicated for viewing and aiding in diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "aiding both in the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases." The term "diagnosis" clearly indicates a diagnostic purpose.
No
The device description clearly outlines multiple hardware components including a scanhead, chin support, touchscreen, and personal computer, in addition to the software.
Based on the provided information, the Daytona ICG scanning laser ophthalmoscope 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 for diagnosis, monitoring, or screening.
- Daytona ICG Function: The Daytona ICG device directly examines the living eye using a laser and indocyanine green dye administered to the patient. It captures images of the choroidal circulation in vivo.
- No Specimen Analysis: The device does not analyze a specimen in vitro (outside the body).
Therefore, the Daytona ICG falls under the category of an ophthalmic imaging device used for in vivo examination and diagnosis, not an IVD.
N/A
Intended Use / Indications for Use
The Daytona ICG scanning laser ophthalmoscope is indicated for use as a wide field scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using indocyanine green dye and for aiding both in the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.
Product codes (comma separated list FDA assigned to the subject device)
MYC
Device Description
The Optos P200TICG is a scanning laser ophthalmoscope that uses a laser as a light source to illuminate the eye. The device consists of the following components and accessories:
- A scanhead which houses the lasers, the scanning elements of the light input path and the . light return path including the detectors which convert light into electronic signal. With the exception of the chin support, the scanhead forms the key patient interface with a facepad and associated aperture where the eye is placed and a griphandle at each side of the scanhead. The image capture is controlled by a computer and associated embedded software including a safety module within the scanhead. This software runs on a Linux operating system.
- A chin support is juxta-positioned to the scanhead to support the patient head and reduce . patient movement when the eye is placed at the aperture of the scanhead.
- A touchscreen is attached by a cable to the scanhead to assist the operator in ootimal patient positioning and to initiate an image capture. An image is displayed on the screen to allow the operator to confirm a suitable image has been taken.
- A personal computer with a monitor to allow image review and storage in a Windows . environment.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanning Laser Ophthalmoscope
Anatomical Site
Eye / Choroidal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Ex Vivo testing: The use of equine blood with various concentrations of ICG pervading through a phantom eye was used to determine than an adequate pixel/grey scale range can be achieved to generate an image. This is for indocyanine green blood concentrations ranging from 0.05 mg/L to 50 mg/L. In vivo concentrations during an indocyanine procedure peak at approximately 25-30 mg per liter of blood.
Electrical Safety testing (general and electromagnetic compatibility): The Daytona ICG device meets the requirements of IEC 60601-1. There were no procedure deviations, no non-standard test methods were used and no additional testing deemed necessary. The Daytona is compliant to the specification IEC 60601-1-2 and 47 CFR Part 15 subpart B with no abnormalities or departures from the standard conditions.
IEC 60825 (Light Hazard standard): The Optos device is class I to standard IEC 60825. Class I is the lowest, safest classification.
ISO 10993 (Biocompatibility): As per ISO 10993-1, the contact is surface, intact skin for a limited duration (≤24 hours), requiring cytotoxicity, sensitization and irritation or intracutaneous reactivity. The patient contact points are the face pad and the chin cup and handgrips.
- Face pad: Cytotoxicity test ISO 10993-5 - Test article not considered to have cytotoxic potential. Tests for irritation and skin sensitization ISO 10993-10, intracutaneous injection - Test article sites did not show a significantly greater biological rate than control. Tests for irritation and skin sensitization ISO 10993-10, Kligman sensitization - A grade 1 sensitization rate is not considered significant and the test article meets the requirement.
- Chin cup and handgrips: Cytotoxicity test ISO 10993-5 - Test article not considered to have cytotoxic potential. Tests for irritation and skin sensitization ISO 10993-10, intracutaneous injection - Test article sites did not show a significantly greater biological rate than control. Tests for irritation and skin sensitization ISO 10993-10, Kligman sensitization - A grade 1 sensitization rate is not considered significant and the test article meets the requirement.
ISO 15004-2: Ophthalmic Instruments, light hazard protection: The device is a group 1 ophthalmic instrument.
IEC 60601-1-4 Medical electrical equipment. General requirements for safety. Collateral standard. General Requirements for programmable electrical medical svstems.: The product has been found to comply with the requirements of this specification.
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.
Heidelberg Retina Angiography 2 (K971671)
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
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
510(k) SUMMARY
| Traditional 510k Summary | Optos Daytona ICG (P200TICG) Device |
|---|---|
| Name of Device: | Daytona ICG Ophthalmoscope (P200TICG) |
| Common or Usual Name: | Scanning laser ophthalmoscope |
| Classification Name: | Scanning laser ophthalmoscope (per 21 C.F.R. § 866.1570) |
| Product Code: | MYC |
| Submitter: | Optos plc, |
| Queensferry House, | |
| Carnegie Business Campus | |
| Dunfermline, | |
| Fife, | |
| KY11 8GR | |
| United Kingdom | |
| Phone: 011 44 1383 843300 | |
| Facsimile: 011 44 1383 843333 | |
| Contact Person: | Robert Tweedlie Ph.D. |
| Date Prepared: | April 10, 2014 |
| Predicate Device: | Heidelberg Retina Angiography 2 (K971671) |
Indications for Use
The Daytona ICG scanning laser ophthalmoscope is indicated for use as a wide field scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using indocyanine green dye and for aiding both in the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.
Device Description
The Optos P200TICG is a scanning laser ophthalmoscope that uses a laser as a light source to illuminate the eye. The device consists of the following components and accessories:
- A scanhead which houses the lasers, the scanning elements of the light input path and the . light return path including the detectors which convert light into electronic signal. With the exception of the chin support, the scanhead forms the key patient interface with a facepad and associated aperture where the eye is placed and a griphandle at each side of the scanhead. The image capture is controlled by a computer and associated embedded software including a safety module within the scanhead. This software runs on a Linux operating system.
- A chin support is juxta-positioned to the scanhead to support the patient head and reduce . patient movement when the eye is placed at the aperture of the scanhead.
1
- · A touchscreen is attached by a cable to the scanhead to assist the operator in ootimal patient positioning and to initiate an image capture. An image is displayed on the screen to allow the operator to confirm a suitable image has been taken.
- A personal computer with a monitor to allow image review and storage in a Windows . environment.
Principles of Operation and Technological Characteristics
The Optos P200TICG uses light that is scanned by a deflection system in two axes across the layers of the eye to generate an image. The returned light then travels back along the same path to a light detector that converts the light to an electrical signal is digitized and used to build up an electronic picture in a computer and output on a display screen.
A summary of the safety system is as follows:
- . Fast scan idle speed monitored. Power only supplied to beam delivery module if idle speed >7000rom.
- Fast scan operating speed monitored. Laser enable only permitted if fast scan speed >30.000rpm
- . Laser status monitored. Any conflict in laser status results in a system trip.
- . Laser powers monitored. If làser power is outside 25% of the nominal power, the system will trip.
- . Shutter status monitored. If conflict detected, system will trip.
- . Line start rate monitored as back up to fast scan speed monitor (this detects that the light pulse is not static).
The fast scan and line start signals are implemented as low-voltage differential signalling (LVDS signals) to prevent failure occurring and all functionality is monitored on dual channels. All monitoring and decision making is implemented in discrete logic.
The layer of the eye viewed is determined by the wavelength of the laser utilized to illuminate the eye and the return path configured for the light either reflected and/or emitted by fluorescensce. For the P200TICG, the laser illuminating the eye is infrared and the returned light is the fluorescence signal induced by the injection of indo cyanine green (ICG) dye. The detector used to capture this signal is optimized to detect infrared light and a filter is used to transmit only the fluoresced infra-red light which is at a slightly longer wavelength than the incident infra-red light entering the eye. This change in wavelength is a fundamental property of fluorescence.
Performance Data
In all instances, the Optos Daytona ICG device functioned as intended and compliance to electrical safety, light safety and biocompatibility has been established. The software development lifecycle and the associated verification & validation activities have no unresolved major or critical bugs and complied with IEC 60601-1-4. The light captured from the return path and translation to an electrical signal was as expected. Additionally this signal has the grey scale/ pixel characteristics to generate a satisfactory image over the indocyanine green (ICG) concentrations found in blood during an ICG angiography exam. >
A summary of the testing supporting this conclusion follows:
2
Ex Vivo testing
The use of equine blood with various concentrations of ICG pervading through a phantom eye was used to determine than an adequate pixel/grey scale range can be achieved to generate an image. This is for indocyanine green blood concentrations ranging from 0.05 mg/L to 50 mg/L. In vivo concentrations during an indocyanine procedure peak at approximately 25-30 mg per liter of blood.
Electrical Safety testing (general and electromagnetic compatibility)
The Daytona ICG device meets the requirements of IEC 60601-1. There were no procedure deviations, no non-standard test methods were used and no additional testing deemed necessary.
The Daytona is compliant to the specification IEC 60601-1-2 and 47 CFR Part 15 subpart B with no abnormalities or departures from the standard conditions.
IEC 60825 (Light Hazard standard)
The Optos device is class I to standard IEC 60825. Class I is the lowest, safest classification.
ISO 10993 (Biocompatibility)
As per ISO 10993-1 the contact is surface, intact skin for a limited duration (≤24 hours), requiring cytotoxicity, sensitization and irritation or intracutaneous reactivity. The patient contact points are the face pad and the chin cup and handgrips. The results are tabulated as follows:-
| Material | Test | Result |
|---|---|---|
| Face pad | Cytotoxicity test ISO 10993-5 | Test article not considered to have cytotoxic potential |
| Face pad | Tests for irritation and skin sensitization ISO 10993-10, intracutaneous injection | Test article sites did not show a significantly greater biological rate than control |
| Face pad | Tests for irritation and skin sensitization ISO 10993-10, Kligman sensitization | A grade 1 sensitization rate is not considered significant and the test article meets the requirement |
| Chin cup and handgrips | Cytotoxicity test ISO 10993-5 | Test article not considered to have cytotoxic potential |
| Chin cup and handgrips | Tests for irritation and skin sensitization ISO 10993-10, intracutaneous injection | Test article sites did not show a significantly greater biological rate than control |
| Chin cup and handgrips | Tests for irritation and skin sensitization ISO 10993-10, Kligman sensitization | A grade 1 sensitization rate is not considered significant and the test article meets the requirement |
ISO 15004-2: Ophthalmic Instruments, light hazard protection
The device is a group 1 ophthalmic instrument.
3
IEC 60601-1-4 Medical electrical equipment. General requirements for safety. Collateral standard. General Requirements for programmable electrical medical svstems.
The product has been found to comply with the requirements of this specification.
Substantial Equivalence
The Daytona ICG (P200TICG) device is as safe and effective as the predicate device, the Heidelberg Retina Angiography 2 (K971671).
The Panoramic Daytona ICG (P200TICG) has the same intended use and indications for use and similar principles of operation and technological characteristics as the predicate device for choroidal angiography. The predicate device also uses an infra-red light source of similar wavelength, requires an injection of indocyanine green dye, and is dependent on the fluorescent properties of this dye in the generation of images appropriate for aiding in the assessment of choroidal circulation and diagnosis of choroiditis or choroidal diseases. Similar to the Optos P200TICG, the predicate device requires the laser to be scanned horizontally and vertically and requires a filter in front of a detector to select only the fluorescent signal for detection. The detection converts the light to an electronic signal for subsequent display on a screen.
The predicate device is of similar construction and being an optomechanical electronic device utilizing a laser(s) is subject to the same general electrical, light hazard and software standards for such medical electrical equipment. Additionally, both the Optos and predicate device are class I in terms of laser power at the eye as defined by IEC 60825 so both devices are dependent on comparable incident light levels to possess this functionality.
The table below provides a side-by-side comparison of the Optos and predicate device:
4
OPTONA ICG (P200TICG) OPTOS PLC
SUBSTANTIAL EQUIVALENCE (P200TICG)
SUBSTANTIAL EQUIVALENCE CHART
.
| Device | Daytona ICG (P200TICG) | Heidelberg Retina
Angiograph 2 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Daytona ICG (P200TICG) | Heidelberg
Angiography 2 Retina |
| Common Name | Scanning Laser
Ophthalmoscope | Scanning Laser
Ophthalmoscope |
| 510(k) number | Pending | K971671 |
| Materials | No flammable materials are
used near the light source. | No flammable materials are
used near the light source. |
| Max. Temperature of accessible | Does not exceed ambient by
more than 10°C. | |
| Intended Use | To provide images that aid in
examining the eye | To provide images that aid
in examining the eye |
| Indications for Use | A wide field scanning laser
ophthalmoscope for viewing
choroidal circulation patterns
that are illuminated using
indocyanine green dye and
for aiding both in the
assessment of choroidal
circulation and in the
diagnosis of choroiditis or
choroidal diseases | Device is intended for
viewing the retinal and/or
choroidal circulation
patterns that are illuminated
using fluorescein or
indocyanine green dye, and
for aiding in the:
• Management of age-
related macular
degeneration (AMD)
• Detection of choroidal
neovascularization
(CNV)
• Assessment of diabetic
retinopathy
• Assessment of diabetic
maculopathy
• Treatment control of
diabetic maculopathy,
AMD,CNV
• Detection of retinal
vascular diseases
• Assessment of choroidal
circulation
• Diagnosis of choroiditis
or choroidal diseases |
| Method of Operation | Confocal laser scanning
system; laser light source;
deflection system; scans in
two orthogonal axes of the
retina; photosensitive device
that converts light into image
of retina; display system | Confocal laser scanning
system; laser light source;
deflection system; scans in
two orthogonal axes of the
retina; photosensitive device
that converts light into
image of retina; display
system |
| Device | Daytona ICG (P200TICG) | Heidelberg Retina
Angiograph 2 |
| Technological Characteristics | Scanning laser
ophthalmoscope | Scanning laser
Ophthalmoscope |
| Light Source | Laser | Laser |
| Wavelength and Color of Light | 802 nm infra-red | 488nm; blue
790nm; infrared |
| Exposure Parameters/laser class | Class 1 to IEC 60825 | Class 1 to IEC 60825 |
| Number of lasers Used per scan | 1 | 1 or 2 |
| Fixation Pattern | Array of LED's Group 1 to
ISO15004-2 | Array of LED's |
| Brightness Controls | Exempt from requirements
as a Class 1 laser | Exempt from requirements
as a Class 1 laser |
| Cleaning and
disinfection/sterilization | Sterilization not required.
Clean/
disinfect contact points | Non optical surfaces can be
disinfected |
| Point of contact | Chin rest, face pad and grip
handles | Chin & head rest |
| Data collection and/or display
system | Light sensitive detector that
converts light into electrical
signal. Signal digitised and
computer or electronic
imaging device to convert
digital image for display | Light sensitive detector that
converts light into electrical
signal. Signal digitised and
computer or electronic
imaging device to convert
digital image for display |
| External field of view | 120° | 15°, 20°, 30° |
| Internal field of view | 200° | N/A |
| Wide Angle Digitised Image Size | 3900x3072 pixels | High speed:768x768 pixels
at 30° High Resolution:
1536x1536 pixels at 30° |
| Pupil Dilation | Normally advised for ICG but
determined by practitioner | Normally advised for ICG
but determined by
practitioner |
| Mains current
AC 115/240V | 6.3A | 230V 1.25AT
110V 2.5AT |
| Approx. weight | Scanhead 27 kg | N/A |
| Dimensions (l x w x h) | 500mm x 440mm x x795mm | N/A |
| Power Source | Mains powered | Mains powered |
| Safety Features | Laser overpower and correct
functioning of scanning
elements | Laser overpower and
correct functioning of
scanning elements |
| Biocompatibility | Contact points meet short
duration intact skin ISO
10993-1 criteria | Not known, but similar
contact points |
| Software | Embedded and application | Embedded and application |
| Standards with which the Device
Complies | IEC 60601-1, -1-2,-1-4, ISO
10993, ISO 15004-2, IEC
60824 | IEC 60601-1, IEC 60601-1-
2, IEC 60825 |
5
・
·
.
.
6
The minor technological differences between the P200TICG and the predicate device do not raise any new questions of safety and effectiveness. Performance data demonstrate that the Optos P200TICG is as safe and effective as the Heidelberg Retina Angiography 2 (K971671) Scanning Laser Ophthalmoscope (SLO).
Thus, the Optos Daytona ICG (P200TICG) Ophthalmoscope is substantially equivalent to legally marketed Heidelberg Retina Angiography 2 (K971671) Scanning Laser Ophthalmoscope (SLO).
Conclusions
The Optos Daytona ICG (P200TICG) has similar characteristics as determined by electrical, light hazard and biocompatibility type testing. Additionally the laser light wavelength, fluorescence barrier filter and non-clinical signal profiling demonstrate that the device is substantially equivalent to the predicate device.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three horizontal lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-0002
April 11, 2014
Optos plc % Mr. Randy J. Prebula, JD Partner Hogan Lovells, US LLP Columbia Square 555 Thirtcenth Street, NW Washington, DC 20004
Re: K134039
Trade/Device Name: Daytona ICG (P200TICG) Ophthalmoscope (Model A10642) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: March 6, 2014 Received: March 6, 2014
Dear Mr. Prebula:
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
8
Page 2 - Mr. Randy J. Prebula
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
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for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
Daytona ICG (P200TICG)
Indications for Use (Describe)
The Daytona ICG scanning laser ophthalmoscope is indicated for use as a wide field scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using indocyanine green dye and for aiding in both the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
:
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
10, 19200300, 100, 1.1=1300014022, cm-Ma Marsha L. Burke Nicholas - S 404 20 13:04:48 -04TH
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of Information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (1/14)
Page 1 of 1 FDA