(134 days)
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 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.
The RetCam Envision system is a contact type wide-field fundus ophthalmic imaging system used for 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 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. A fundus camera comprised of handpiece, detachable lens piece, LED light sources, control panel, footswitch and application software running on a PC are used to acquire still images and video of the eye. The LED light is used to illuminate the retina uniformly and the image is transferred from the handpiece to the PC for display storage, review & transfer. The camera focus and image light intensity as well as the image capture is controlled by the user via a button panel on the cart or a footswitch. Controls are also available via the keyboard mouse and touchscreen.
The provided text describes a 510(k) premarket notification for the RetCam Envision ophthalmic camera, outlining its indications for use, technological characteristics, and comparison to a predicate device. However, it does not include a study specifically designed to demonstrate the device's performance against detailed acceptance criteria for its clinical indications (e.g., screening for ROP using a defined metric like sensitivity/specificity). Instead, the document focuses on demonstrating substantial equivalence to a predicate device through engineering and safety testing.
Therefore, many of the requested details about a study proving the device meets clinical acceptance criteria cannot be extracted from this document. The information primarily relates to electrical safety, electromagnetic compatibility, packaging, and internal performance verification against specifications, rather than clinical performance for its stated indications for use.
Here's an attempt to answer based on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
The document provides acceptance criteria in terms of compliance with various engineering and safety standards, and internal performance specifications. It does not provide quantitative clinical acceptance criteria (e.g., specific sensitivity, specificity, or image quality metrics for ROP screening) nor a study demonstrating performance against such criteria.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1-6: 2010, Am1: 2013; IEC 62366: 2007, Am1: 2014 | Verified for performance in accordance with the standard. |
| Electromagnetic Compatibility | IEC 60601-1-2 Edition4.0: 2014-02 | Verified for performance in accordance with the standard. |
| Packaging and Handling | ISTA-2B: Packaged Products weighing over 150 lbs (68 kg) | Successfully passed packaging and handling verification. |
| Performance Verification & Validation (Bench Testing) | Internal requirements and specifications (functional and performance characteristics), including: Image Comparison Test, Optics verification and Validation Test, Software Test, Mechanical design Test, Light Safety Test, EMC and Electrical Safety Test, Biocompatability Test, Packaging ISTA Test | Successfully passed performance verification and validation; met defined acceptance criteria. |
| Clinical Indication Performance | (Not specified in terms of quantitative metrics like sensitivity/specificity for ROP screening) | (Not a clinical study; document states "Verification and Validation were performed to ensure no new questions of safety or effectiveness are raised. The results of these activities demonstrate that the RetCam Envision is as safe, as effective, and performs as well as or better than the predicate device.") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes engineering bench testing and internal verification/validation. It does not mention a clinical test set sample size, data provenance, or whether it was retrospective or prospective. The "Performance Testing – Bench Verification & Validation" refers to internal testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Given that no clinical test set for ROP screening performance is described, there is no information provided on experts or ground truth establishment relevant to clinical indications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set is detailed, no adjudication method for a clinical ground truth is specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document makes no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss AI assistance or improvement of human readers. The device described is an ophthalmic camera, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an imaging system; it does not feature an AI algorithm for standalone diagnosis based on the provided text. Therefore, no standalone algorithm performance study was reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance aspects, the "ground truth" was likely established by reference to engineering specifications and standard requirements (e.g., electrical safety standards, packaging standards). For clinical ground truth for indications like ROP screening, this information is not provided because a clinical performance study is not described.
8. The sample size for the training set
Since no AI algorithm is detailed, there is no mention of a training set or its sample size.
9. How the ground truth for the training set was established
As there is no training set described, this information is not applicable.
Summary of what the document does provide regarding "studies":
The document primarily describes a comprehensive set of engineering and safety verification and validation activities to demonstrate that the RetCam Envision meets its predetermined specifications and applicable standards, and that it is substantially equivalent to existing predicate devices. These activities include:
- Electrical Safety testing: Compliance with IEC 60601-1-6 and IEC 62366.
- Electromagnetic Compatibility testing: Compliance with IEC 60601-1-2.
- Packaging and Handling Verification: Compliance with ISTA-2B.
- Bench Testing (Verification & Validation): Internal testing covering Image Comparison, Optics, Software, Mechanical design, Light Safety, EMC, Electrical Safety, Biocompatibility, and Packaging.
The "study that proves the device meets the acceptance criteria" in this context refers to these internal engineering and safety tests, which concluded that "the RetCam Envision system complies with its predetermined specifications and the applicable standards." The document does not present a clinical performance study with defined clinical acceptance criteria for its ROP screening indications.
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April 13, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a stacked format.
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Sanjay Mehta Director of Global Regulatory Affairs, QARA 2568 Bristol Circle Oakville, Ontario L6H 5S1 Canada
Re: K203500
Trade/Device Name: RetCam Envision Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: March 9, 2021 Received: March 10, 2021
Dear Mr. Mehta:
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/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.
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 803) for
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devices or postmarketing safety reporting (21 CFR 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 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 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).
Sincerely,
Elvin Y. Na -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203500
Device Name RetCam Envision
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 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.
| 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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Image /page/3/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are bold. There is a registered trademark symbol to the right of the letter "s".
510K Summary
Date: April 11, 2021
Submitted by: Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
- Contact Person: Sanjay Mehta Director, Global Regulatory Affairs Natus Medical Incorporated Tel.: (905) 287 5055 Fax .: (905) 829-5304 E-mail: sanjay.mehta@natus.com
Proprietary Name: RetCam Envision™
Common Name: Camera, Ophthalmic, Ac-Powered
Regulation Number : 21CFR 886.1120
Classification Name: Ophthalmic camera.
Product code: HKI
Device Class: Il
Predicate Device: RetCam 3 ; RetCam Shuttle ; RetCam Portable (K182263)
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Description:
Image /page/4/Picture/2 description: The image shows the word "natus" in a teal sans-serif font. The letters are spaced closely together, and the word appears to be a logo or brand name. A registered trademark symbol is located to the bottom right of the letter "s".
Overview: RetCam Envision
The RetCam Envision system is a contact type wide-field fundus ophthalmic imaging system used for 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 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.
Operating Principle of the RetCam Envision
A fundus camera comprised of handpiece, detachable lens piece, LED light sources, control panel, footswitch and application software running on a PC are used to acquire still images and video of the eye. The LED light is used to illuminate the retina uniformly and the image is transferred from the handpiece to the PC for display storage, review & transfer. The camera focus and image light intensity as well as the image capture is controlled by the user via a button panel on the cart or a footswitch. Controls are also available via the keyboard mouse and touchscreen.
RetCam Envision features includes:
- . Integrated Wide Field Digital Imaging System
- Light weight Handpiece with interchangeable lenses featuring RetCam light shaping . technology
- 130 Degree Field Of View (FOV) .
- . Brilliant Color, Red Free, and Fluorescein Angiography (FA) imaging capabilities
- High Resolution Still Image and Video Capture via console, footswitch or touchscreen .
- . Height adjustable system cart with touchscreen display and battery operation
- . Integrated, searchable patient database
- . Bidirectional DICOM interface
System Setup Overview
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510(k): K203500 RETCAM ENVISION
Image /page/5/Picture/1 description: The image shows the logo for Natus Medical Incorporated. The logo is in a teal color and features the word "natus" in a bold, sans-serif font. A registered trademark symbol is located to the right of the "s" in "natus."
The RetCam Envision Cart, Light Sources, Camera Handpiece, Lenses, Control pan Footswitch operate in conjunction with the RetCam 7 Software running on an onboard PC to enable the capture, review, annotation, storage, and transfer of images and video of the eye and it'
The LED light source provides illumination of the eye via the camera (handpiece and lenspiece). Still and video images are transmitted from the handpiece to the onboard PC for display on the monitor and storage on the PC. Image focus, illumination intensity and image/video capture are controlled by the user using either the buttons on the cart top control panel or via the footswitch. The user selects the white LED light source for color imaging and the blue LED light source for imaging during Fluorescein Angiography.
The user interacts with the RetCam software to enter or select patient demographics, start exams, capture images and video, review and select images for storage, exporting and transfer via bidirectional DICOM communication. The RetCam Envision display monitor is a touchscreen.
Image /page/5/Picture/5 description: The image shows a Natus RetCam Envision device, which is a medical imaging system used for pediatric ophthalmology. The device is mounted on a mobile cart with wheels and features a large display screen at the top, which shows a retinal image. Below the screen is a control panel with various buttons and a trackpad, and the base of the cart has foot pedals for hands-free operation. The device is white with teal accents.
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Device-patient interaction Accessories List:
The RetCam Envision is a contact type wide field fundus ophthalmic imaging system.
The lens piece concave tip is held over the eye which is covered in a transparent coupling gel. The lens tip is held in the gel so that there is no air gap between the lens tip and the eye to ensure no distortion of light or image capture. The RetCam Envision User Manual provides detailed instructions on the thorough cleaning and high level disinfection of the detachable lenses.
The Lenspiece is the only part of the device that may come in contact with the patient.
Image /page/6/Picture/5 description: The image shows a close-up of a blue and silver device. The device has a cylindrical shape with a silver tip. There is a silver band around the blue part of the device with the letters "LP1" visible on it. The background is a dark gray color.
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 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.
Comparison to Predicate Device
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510(к): K203500 RETCAM ENVISION
| Feature | Subject DeviceRetCam Envision | PREDICATE DEVICERetCam OphthalmicImaging Systems(K182263) | Similarities orDifferences |
|---|---|---|---|
| Indications forUse | General ophthalmicimaging includingretinal, corneal, andexternal imaging.Photodocumentation ofpediatric oculardiseases includingretinopathy ofprematurity (ROP)Screening for Type 2pre-thresholdretinopathy ofPrematurity (ROP)(zone1, stage 1 or 2,without plus disease, orzone 2 stage 3 withoutplus disease) ortreatmentrequiringROP, defined as Type1 ROP (zone 1, anystage, with plusdisease; zone 1, stage3 without plus disease;or zone 2, stage 2 or 3,with plus disease) orthreshold ROP (at least5 contiguous or 8 non-contiguous clock hoursof stage 3 in zone 1 or2, with plus disease)* in35-37 weekpostmenstrual infants. | General ophthalmicimaging including retinal,corneal, and externalimaging.Photodocumentation ofpediatric ocular diseasesincluding retinopathy ofprematurity (ROP)Screening for Type 2pre-threshold retinopathyof Prematurity (ROP)(zone1, stage 1 or 2,without plus disease, orzone 2 stage 3 withoutplus disease) ortreatmentrequiring ROP,defined as Type 1 ROP(zone 1, any stage, withplus disease; zone 1,stage 3 without plusdisease; or zone 2,stage 2 or 3, with plusdisease) or thresholdROP (at least 5contiguous or 8 non-contiguous clock hoursof stage 3 in zone 1 or 2,with plus disease)* in 35-37 week postmenstrualinfants. | Identical |
| Feature | Subject Device | PREDICATE DEVICE | Similarities orDifferences |
| RetCam Envision | RetCam OphthalmicImaging Systems(K182263) | ||
| Principle ofOperation | Digital camera in ahandpiece with multiplefield of view lensesused to capture colorophthalmic images. | Digital camera in ahandpiece with multiplefield of view lenses usedto capture colorophthalmic images. | On board computeronly |
| An on board computeris used to store, view,retrieve, and export thedigital ophthalmicimages. | An on board computer(RetCam 3) or laptopcomputer (RetCamShuttle and RetCamPortable) is used tostore, view, retrieve, andexport the digital | Light sourcereplaced with LED. | |
| A White or RGB, andBlue LED light sourceis used in all RetCamconfigurations toprovide illumination tothe eye through thehandpiece. | ophthalmic images.A standard Halogen lightsource is used in allRetCam configurationsto provide illumination tothe eye through thehandpiece. | Light safety meetsrequirements of ISO15004-2:2007 andANSI Z80.36:2016 | |
| Technological Characteristics | |||
| Imaging Options | Color, Red Free, Black& White | Color, Red Free, Black &White | Same |
| Eye contactmaterials | Biocompatible, coatedglass | Biocompatible, coatedglass | Identical eyecontact material |
| Lenses | Coated glass with 130degree common fieldsof view | Coated glass with 130,120, 80, 30 degreecommon fields of viewlens options) | Same lensmaterials and max(130 Deg) Field ofview. |
| Portrait lens (forexternal non-contact imaging | Yes | Yes | Same |
| DetachableLenses | Detachable andInterchangeable | Detachable andInterchangeable | Same |
| Feature | Subject DeviceRetCam Envision | PREDICATE DEVICERetCam OphthalmicImaging Systems(K182263) | Similarities orDifferences |
| Lens DisinfectionType | Supports High LevelDisinfection | Supports High LevelDisinfection | Same |
| Handpiece &Lens | Handpiece 0.8 lbsLens 0.2 lbsCombined 1 lbs(excluding cableweight). | Combined Handpieceand lens weight 2.7 lbs(Excluding cable) | Lighter, improvedover predicate. |
| Camera Specifications | |||
| Camera sensortype | 3 CMOS Chip, Color | 1 CMOS Chip; color | Similar withimprovedtechnology overpredicate |
| EffectivePixels/Resolution | 1920x1080 pixelsScaled to 4:3 780x600pixelsVideo: 30 frames persecond | 1600x1200 pixelsScaled to 4:3 780x600pixelsVideo: 14 frames persecond | Same resultingimage size 780x600improvedtechnology overpredicate |
| Interfaceconnection to theRetCamcomputer | USB 3 | USB 3 | Same as predicate |
| Ambientoperatingtemperature | 50° F to 95° F (10° Cto 35° C) | 0-50°C/32-122 °F | |
| Image sensorheight | 1/2.9" 2.1MP | 1/2" | Similar |
| RETCAM ENVISION | |||
| Feature | Subject DeviceRetCam Envision | PREDICATE DEVICERetCam OphthalmicImaging Systems(K182263) | Similarities orDifferences |
| Required power | Ratings: 100-240 V~50/60 Hz, 400 VAFuses: 3AG 6.3A 250Vslo-blo 5 x 20 mmPower consumption:400 W maximum withall optionsDetachable hospital-grade power cord | 100-2******************40V50/60Hz | |
| Light Source | White, and Blue LED | White and Blue Halogen | Improvement overpredicate, complieswith ISO and ANSIsafety standards |
| System Cart | Height adjustableIncludes integrateddevice controls | Fixed heightIncludes integrateddevice controls | Improved overpredicate |
| Foot switch forfocus, brightnessand imagecapture | Yes | Yes | Identical |
| DICOM | Yes | Yes | Same |
| Backup Battery | Lithium Ion | Lead Acid | Improvedtechnology |
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510(к): K203500 RETCAM ENVISION
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The RetCam Envision System and the predicate device RetCam Opthamlic Imaging System are equivalent in features and technical characteristics. There are no major differences that significantly alter the intended use or raise new issues of safety or effectiveness.
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Brief Summary of Performance Testing
Image /page/11/Picture/2 description: The image shows the word "natus" in a teal sans-serif font. The letters are closely spaced and have rounded edges. A small registered trademark symbol is located to the right of the letter "s".
| Electrical Safety | The RetCam Envision was verified for performance in accordance with the following standard:• IEC 60601-1-6: 2010, Am1: 2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, and IEC 62366: 2007, Am1: 2014, Medical devices - Application of usability engineering to medical devices |
|---|---|
| ElectromagneticCompatibility | The RetCam Envision was verified for performance in accordance with the following standard:• IEC 60601-1-2 Edition4.0: 2014-02, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests. |
| Packaging andHandling Verification | The packaged Natus RetCam Envision components have successfully passed packaging and handling verification per ISTA-2B: Packaged Products weighing over 150 lbs (68 kg). |
| Performance Testing– Bench Verification& Validation | The Natus RetCam Envision has successfully passed performance verification and validation in accordance with internal requirements and specifications at the system level.The Bench testing verification and validation was performed to confirm Device meets the functional and performance characteristics.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• Software Test• Mechanical design Test• Light Safety Test• EMC and Electrical Safety Test• Biocompatability Test• Packaging ISTA Test |
Results indicate that the RetCam Envision system complies with its predetermined specifications and the applicable standards.
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Image /page/12/Picture/1 description: The image shows the word "natus" in a teal sans-serif font. The letters are evenly spaced and the word is horizontally oriented. A registered trademark symbol is located to the right of the letter "s".
Conclusions
The substantial equivalence of the RetCam Envision with RetCam 3 (K182263) was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the RetCam Envision is similar to that of the predicate device(s). Verification and Validation were performed to ensure no new questions of safety or effectiveness are raised. The results of these activities demonstrate that the RetCam Envision is as safe, as effective, and performs as well as or better than the predicate device.
§ 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.