Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ophthalmic imaging system with digital camera technology and image storage/viewing capabilities. There is no mention of AI, ML, or any advanced image analysis beyond basic storage and viewing. The modifications are related to hardware upgrades and communication features, not AI/ML functionality.

Therapeutic

No
The device is used for imaging and photodocumentation, primarily for screening and diagnosis, not for treating any condition.

Diagnostic

Yes

The device is intended for "photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP)" and "Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) or treatment-requiring ROP," which clearly indicates its use in the diagnosis and screening of medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it utilizes a digital camera in a handpiece, an on-board or laptop computer, and a light source, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. The device description clearly states that the RetCam Ophthalmic Imaging Systems utilize a digital camera to capture images of the eye (retinal, corneal, and external). It does not analyze blood, tissue, urine, or any other biological sample.
The intended use is for imaging and photodocumentation. The primary function is to capture visual information of the eye for diagnosis and monitoring, not to perform tests on biological specimens.

The device is an ophthalmic imaging system, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

General ophthalmic imaging including retinal, corneal, and external imaging.
-Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP).
-Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.

Product codes

HKI

Device Description

RetCam Ophthalmic Imaging Systems utilize a digital camera in a handpiece (with multiple field of view lenses) to capture color ophthalmic images including retinal, corneal, and external images. An on board computer (RetCam 3 Ophthalmic Imaging System) or laptop computer (RetCam Shuttle Ophthalmic Imaging System and RetCam Portable Ophthalmic Imaging System) is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used in all RetCam Ophthalmic Imaging Systems to provide illumination to the eye through the handpiece. An optional Fluorescein light source is also available on the RetCam 3 Ophthalmic Imaging System. Light intensity, camera focus, and image capture are controlled by the use of the footswitch on all RetCam Ophthalmic Imaging Systems and can also be controlled by a keyboard on the RetCam 3 Ophthalmic Imaging System console. A console monitor is provided with the RetCam 3 Ophthalmic Imaging System for viewing images. The laptop monitor is used with the RetCam Shuttle Ophthalmic Imaging System and RetCam Portable Ophthalmic Imaging System. Proprietary software is installed on the computers to capture, store, view, retrieve, and export ophthalmic images.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

retinal, corneal, and external

Indicated Patient Age Range

35-37 week postmenstrual infants.

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

The modified/subject devices are modified versions of the previously cleared RetCam Ophthalmic Imaging Systems cleared under K090326 (predicate). The modifications were made to upgrade the camera (due to obsolescence), add DICOM communication features, and update the software to support the modifications. The fundamental scientific technology and indications for use for the modified/subject devices are unchanged. The modified/subject RetCam Ophthalmic Imaging Systems have been tested and found to comply with the following recognized consensus standards: IEC 60601-1:2005, (MOD) Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2007/(R) 2012 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests DICOM (Digital Imaging and Communications in Medicine) -Developed by the American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1-3.20 (2016). Additionally, the modified/subject RetCam Ophthalmic Imaging Systems have been tested internally and met defined acceptance criteria. The tests included: Image Comparison Test, Optics verification and Validation Test, ISTA Test.

Key Metrics

Not Found

Predicate Device(s)

K090326

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 7, 2018

Natus Medical Incorporated Brian Ackley Manager, Ouality and Regulatory Affairs 1183 Quarry Lane. Suite A Pleasanton, CA 94566

Re: K182263

Trade/Device Name: RetCam 3; RetCam Shuttle; RetCam Portable Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: August 16, 2018 Received: August 22, 2018

Dear Brian Ackley:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpm/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.

1

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 devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Bradley S. Cunningham -A

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

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Indications for Use

510(k) Number (if known) K182263

Device Name

RetCam Ophthalmic Imaging Systems RetCam 3 Ophthalmic Imaging System RetCam Shuttle Ophthalmic Imaging System, RetCam Portable Ophthalmic Imaging System

Indications for Use (Describe)

General ophthalmic imaging including retinal, corneal, and external imaging.

-Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP).

-Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.

*References:

Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Archives of Ophthalmology 1988; 106(4):471-479.
Early Treatment for Retinopathy of Prematurity Cooperative Group. Revised indications for the treatment of retinopathy of prematurity: results of the Early Treatment for Retinopathy Randomized Trial. Archives of Ophthalmology 2003; 121(12):1684-1694.

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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510(k) Summary RetCam Ophthalmic Imaging Systems

Submitter Name:	Natus Medical Inc.
Submitter Address:	1183 Quarry Lane, Suite A
Pleasanton, CA 94566 USA
Contact Person:	Brian Ackley
Phone Number:	925-201-1680
Fax Number:	925-251-0078
Date Prepared:	August 16, 2018
Device Trade Names:	RetCam Ophthalmic Imaging Systems
RetCam 3 Ophthalmic Imaging System
RetCam Shuttle Ophthalmic Imaging System
RetCam Portable Ophthalmic Imaging System
Device Common Name:	Ophthalmic Imaging System

Product Code: HKI

Classification: Ophthalmic Imaging Systems have been classified as Class II according to 21 C.F.R. § 886.1120

Predicate Device: RetCam Ophthalmic Imaging Systems, K090326

Device Description:

RetCam Ophthalmic Imaging Systems utilize a digital camera in a handpiece (with multiple field of view lenses) to capture color ophthalmic images including retinal, corneal, and external images. An on board computer (RetCam 3 Ophthalmic Imaging System) or laptop computer (RetCam Shuttle Ophthalmic Imaging System and RetCam Portable Ophthalmic Imaging System) is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used in all RetCam Ophthalmic Imaging Systems to provide illumination to the eye through the handpiece. An optional Fluorescein light source is also available on the RetCam 3 Ophthalmic Imaging System.

4

Light intensity, camera focus, and image capture are controlled by the use of the footswitch on all RetCam Ophthalmic Imaging Systems and can also be controlled by a keyboard on the RetCam 3 Ophthalmic Imaging System console. A console monitor is provided with the RetCam 3 Ophthalmic Imaging System for viewing images. The laptop monitor is used with the RetCam Shuttle Ophthalmic Imaging System and RetCam Portable Ophthalmic Imaging System. Proprietary software is installed on the computers to capture, store, view, retrieve, and export ophthalmic images.

Intended Use/Indications for Use:

General ophthalmic imaging including retinal, corneal, and external imaging.
. Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP)
. Screening for Type 2 pre-threshold retinopathy of Prematurity (ROP) (zone1, stage 1 or 2, without plus disease, or zone 2 stage 3 without plus disease) or treatmentrequiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.

* References:

Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Archives of Ophthalmology 1988; 106(4): 471-479.
Early Treatment for Retinopathy of Prematurity Cooperative Group. Revised indications for the treatment of retinopathy of prematurity: results of the Early Treatment for Retinopathy of Prematurity Randomized Trial. Archives of Ophthalmology 2003; 121(12):1684-1694.

Performance Data:

The modified/subject devices are modified versions of the previously cleared RetCam Ophthalmic Imaging Systems cleared under K090326 (predicate).

The modifications were made to upgrade the camera (due to obsolescence), add DICOM communication features, and update the software to support the modifications. The fundamental scientific technology and indications for use for the modified/subject devices are unchanged.

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The modified/subject RetCam Ophthalmic Imaging Systems have been tested and found to comply with the following recognized consensus standards:

IEC 60601-1:2005, (MOD) Medical electrical equipment Part 1: General requirements ● for basic safety and essential performance
. IEC 60601-1-2:2007/(R) 2012 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
DICOM (Digital Imaging and Communications in Medicine) -Developed by the . American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1-3.20 (2016)

Natus Medical Inc. followed the FDA guidance document, "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices May 11, 2005," to classify the RetCam Ophthalmic Imaging Systems software as a "moderate level of concern." The software was verified and validated, and the software verification and validation documents were prepared and presented in accordance with FDA's guidance document. Additionally, the modified/subject RetCam Ophthalmic Imaging Systems have been tested internally and met defined acceptance criteria. The tests included:

-Image Comparison Test -Optics verification and Validation Test -ISTA Test

Substantial Equivalence:

The modified/subject RetCam Ophthalmic Imaging Systems: RetCam 3 Ophthalmic Imaging System, RetCam Shuttle Ophthalmic Imaging System, and RetCam Portable Ophthalmic Imaging System

have the following similarities to the predicate RetCam Ophthalmic Imaging Systems cleared under 510(k) K090326:

have the same indications for use, ●
has the same fundamental scientific technology .
uses the same operating principle ●
. incorporates the same basic design, and
incorporates the same materials

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natus.

| Feature | Modified/Subject DEVICE
RetCam Ophthalmic Imaging Systems | PREDICATE DEVICE
RetCam Ophthalmic Imaging Systems
(K090326) | Similarities or
Differences |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Indications for Use | -General ophthalmic imaging including
retinal, corneal, and external imaging.
-Photodocumentation of pediatric ocular
diseases including retinopathy of
prematurity (ROP)
-Screening for Type 2 pre-threshold
retinopathy of Prematurity (ROP) (zone1,
stage 1 or 2, without plus disease, or zone
2 stage 3 without plus disease) or
treatment-requiring ROP, defined as Type
1 ROP (zone 1, any stage, with plus
disease; zone 1, stage 3 without plus
disease; or zone 2, stage 2 or 3, with plus
disease) or threshold ROP (at least 5
contiguous or 8 non-contiguous clock
hours of stage 3 in zone 1 or 2, with plus
disease)* in 35-37 week postmenstrual
infants. | -General ophthalmic imaging including
retinal, corneal, and external imaging.
-Photodocumentation of pediatric ocular
diseases including retinopathy of
prematurity (ROP)
-Screening for Type 2 pre-threshold
retinopathy of Prematurity (ROP) (zone1,
stage 1 or 2, without plus disease, or zone
2 stage 3 without plus disease) or
treatment-requiring ROP, defined as Type
1 ROP (zone 1, any stage, with plus
disease; zone 1, stage 3 without plus
disease; or zone 2, stage 2 or 3, with plus
disease) or threshold ROP (at least 5
contiguous or 8 non-contiguous clock
hours of stage 3 in zone 1 or 2, with plus
disease)* in 35-37 week postmenstrual
infants. | No changes |

7

natus.

| Feature | Modified/Subject DEVICE
RetCam Ophthalmic Imaging Systems | PREDICATE DEVICE
RetCam Ophthalmic Imaging Systems
(K090326) | Similarities or
Differences |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Principle of Operation | Digital camera in a handpiece with
multiple field of view lenses used to
capture color ophthalmic images.

An on board computer (RetCam 3) or
laptop computer (RetCam Shuttle and
RetCam Portable) is used to store, view,
retrieve, and export the digital ophthalmic
images.

A standard Halogen light source is used
in all RetCam configurations to provide
illumination to the eye through the
handpiece. | Digital camera in a handpiece with
multiple field of view lenses used to
capture color ophthalmic images.

An on board computer (RetCam 3) or
laptop computer (RetCam Shuttle and
RetCam Portable) is used to store, view,
retrieve, and export the digital ophthalmic
images.

In summary, the modified/subject RetCam Ophthalmic Imaging Systems:

RetCam 3 Ophthalmic Imaging System,

RetCam Shuttle Ophthalmic Imaging System, and

RetCam Portable Ophthalmic Imaging System

described in this submission are substantially equivalent to the predicate device.