(113 days)
The iFusion connects the iCam (K122572) and iVue (K121739) devices via a sliding bracket mechanism (iShuttle), to facilitate switching between the two devices. The iShuttle provides position adjustment ability of the iCam or iVue device during use.
The iFusion interfaces with the iCam and iVue devices to enable the operation of the iCam and iVue devices from one computer unit.
iFusion is a combination of the cleared iVue with NDB (K121739)("iVue") and the cleared iCam Fundus Camera (K122572)("iCam") on a shuttle platform, called the iShuttle. The iShuttle mounts to a joystick assembly using a central nut and bolt and four adjustable set screws. The iShuttle consists of a sliding metal plate supporting the iVue and the iCam. The iShuttle travels on tracks fitted to the X-Y-Z joystick assembly which helps position the iVue and the iCam devices. A release button is located at the front of the iShuttle to lock the iShuttle in position for the iVue and the iCam device. The iCam can be switched in position by pressing on the release button to unlock the iShuttle platform, then the iVue or the iCam can be pushed to slide to an opposite end until it is locked into position. In addition, the software of the iFusion system is created to allow the user to switch between the iVue and the iCam programs with the same computer. The iVue and the iCam programs use the same data communication and programming storage with a single shared database.
The provided document is a 510(k) summary for the Optovue iFusion device. This submission is for a combination device that integrates two previously cleared predicate devices (iVue and iCam) onto a new sliding bracket (iShuttle) and includes minor software changes. The primary goal of this type of submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than to prove clinical effectiveness and safety through de novo clinical studies with specific acceptance criteria related to disease diagnosis or treatment.
Therefore, the information typically found in acceptance criteria tables and detailed study reports for showing diagnostic/predictive performance (like sensitivity, specificity, AUC) or comparative effectiveness (like MRMC studies) is not present in this document. This submission focuses on demonstrating that the changes (the iShuttle and minor software updates) do not negatively impact the safety and effectiveness of the already cleared component devices.
Here's an breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria and reported device performance in the typical sense for diagnostic or prognostic claims (e.g., sensitivity, specificity, accuracy for a particular disease). Instead, the "acceptance criteria" for this 510(k) were focused on demonstrating that the new iFusion system, with its integrated iShuttle and minor software changes, maintained the safety and effectiveness of the predicate devices.
The "performance data" section states:
"Verifications and validations were performed for mechanical and functional testing according to IEC 60601-1 and 60601-1-2 for the new iShuttle bracket and the software changes."
"The results demonstrated that the changes in iFusion did not affect the intended use or alter the fundamental technological characteristics of the predicate devices and that the iFusion is substantially equivalent to its predicate devices."
This implies that the acceptance criteria for these tests would have been along the lines of "meet IEC 60601-1 and 60601-1-2 standards" and "no degradation in function or safety of iVue and iCam components." However, the specific quantitative results or acceptance thresholds for these engineering tests are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of this 510(k) submission. This is not a study assessing diagnostic performance on a patient dataset. The "test set" would have been the iFusion device itself subjected to mechanical and software integrity tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There's no clinical ground truth established for this submission as it's not a study on diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable for this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study was not described or performed for this 510(k) submission. The iFusion device is essentially a physical integration and software interface for two existing devices, not a new diagnostic algorithm requiring human-in-the-loop performance measurement.
6. If a Standalone Study Was Done
Not applicable in the sense of an algorithm-only diagnostic performance study. The "standalone" testing here refers to the verification and validation of the iShuttle's mechanical and functional aspects, and the software changes, to ensure they didn't compromise the existing functionalities of the iVue and iCam.
7. The Type of Ground Truth Used
Not applicable in the context of a clinical ground truth. The "ground truth" for this engineering/integration submission would be adherence to safety standards (IEC 60601-1, 60601-1-2) and confirmation that the iVue and iCam components function as intended when integrated into iFusion.
8. The Sample Size for the Training Set
Not applicable. There is no mention of an algorithm being "trained" in this submission. The software changes are "minor" and related to user interface and data communication/storage, not a new AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML algorithm.
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ptovue. Ir
JUL 0 3 2013
This 510(k) summary for the iFusion is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
General Information
Manufacturer:
Optovue, Inc. 2800 Bayview Drive, Fremont, CA 94538 Phone: (510) 623-8868 Fax: (510) 623-8668 Registration No .: 3005950902
Contact Person:
William "Bill" Jackson VP Regulatory/Quality Assurance Optovue, Inc. Phone: (510) 623-8868 x205 e-mail: bill jackson@optovue.com
Device Information
| Trade Name: | iFusion |
|---|---|
| Common Name: | Ophthalmic CamerasOptical Coherence Tomographers |
| Classification Name: | AC-powered Ophthalmic Camera (21 C.F.R. § 886.1120) |
| Classification: | Class II |
| Product Code: | HKIOBO |
Predicate Devices
Purpose of the Special 510(k) notice
iFusion is a combination of the cleared iVue with NDB (K121739)("iVue") and the cleared iCam Fundus Camera (K122572)("iCam") on a shuttle platform, called the iShuttle. The
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Image /page/1/Picture/0 description: The image shows the word "optovue" in a stylized font. The letter "o" in "optovue" is replaced with an image of an eye. There is a curved line above the word "optovue".
iShuttle mounts to a joystick assembly using a central nut and bolt and four adjustable set screws. The iShuttle consists of a sliding metal plate supporting the iVue and the iCam. The iShuttle travels on tracks fitted to the X-Y-Z joystick assembly which helps position the iVue and the iCam devices. A release button is located at the front of the iShuttle to lock the iShuttle in position for the iVue and the iCam device. The iCam can be switched in position by pressing on the release button to unlock the iShuttle platform, then the iVue or the iCam can be pushed to slide to an opposite end until it is locked into position. In addition, the software of the iFusion system is created to allow the user to switch between the iVue and the iCam programs with the same computer. The iVue and the iCam programs use the same data communication and programming storage with a single shared database.
Intended Use
iCam Fundus Camera (K122572) - The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease.
AND
iVue with Normative Database (K121739) – The iVue is a non-contact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, threedimensional imaging and measurement of anterior ocular structures, including retinal nerve fiber laver, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.
Indications for Use
The iFusion connects the iCam (K122572) and iVue (K121739) devices via a sliding bracket mechanism (iShuttle), to facilitate switching between the two devices. The iShuttle provides position adjustment ability of the iCam or iVue device during use.
The iFusion interfaces with the iCam and iVue devices to enable the operation of the iCam and iVue devices from one computer unit.
Technological Characteristics
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Image /page/2/Picture/0 description: The image shows the word "optovue" in a simple, sans-serif font. The "o" is followed by a "p", then a "t" that is shaped like a cross. The "o" in the middle of the word is replaced by an image of an eye. A curved line is drawn above the word.
iFusion combines the cleared iVue with NDB (K121739) and the cleared iCam Fundus Camera (K122572). The iVue and iCam are mounted onto the iShuttle to form a new device called the iFusion.
iFusion has the same technological characteristics as its component predicate devices iVue and iCam except the addition of the iShuttle. The iShuttle is a metal bracket that slides the iVue and the iCam into position for operation and does not affect the functionality of either system. The iShuttle merely allows the user to select between the devices. Minor software changes were made to allow the users to switch between the iCam program in the iFusion software, and to export images and data from iCam to iVue.
The iShuttle does not affect the functionality of the systems. Software verification validation testing has shown that the minor software changes did not raise any question about safety and effectiveness. Therefore, the iFusion is substantially equivalent to its predicate devices.
Performance Data
The iFusion system has the same intended use and indications for use as the predicate devices, namely the iVue and the iCam. The technological characteristics and the principles of operation for its component predicate devices are the same.
There is no significant change of the iVue with NDB and the iCam previously cleared under K121739 and K122572, respectively. The safety and effectiveness of these devices have not changed.
iFusion has been designed and tested to applicable safety standards and Optovue SOPs, including design controls and risk analysis. Verifications and validations were performed for mechanical and functional testing according to IEC 60601-1 and 60601-1-2 for the new iShuttle bracket and the software changes.
The results demonstrated that the changes in iFusion did not affect the intended use or alter the fundamental technological characteristics of the predicate devices and that the iFusion is substantially equivalent to its predicate devices.
Conclusion
The iVue with NDB and the iCam of the iFusion have the same intended use and indications for use, same principles of operation, and same technological characteristics as the cleared devices. Therefore, the iFusion is substantially equivalent to its predicates.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
July 3, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Optovue, Inc. % Mr. Bill Jackson VP Regulatory & Quality Assurance 2800 Bayview Drive Fremont, CA 94538
Re: K130656
Trade/Device Name: iFusion Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI, OBO Dated: June 6, 2013 Received: June 7, 2013
Dear Mr. Jackson:
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.
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Page 2 - Mr. Bill Jackson
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); good manufacturing practice requirements as set forth in the quality systems (QS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Y. Alexander -S
for Malvina B. Evdelman, 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): K130656
Device Name: iFusion
Indications For Use:
The iFusion connects the iCam (K122572) and iVue (K121739) devices via a sliding bracket mechanism (iShuttle), to facilitate switching between the two devices. The iShuttle provides position adjustment ability of the iCam or iVue device during use.
The iFusion interfaces with the iCam and iVue devices to enable the operation of the iCam and iVue devices from one computer unit.
Prescription Use_ × (part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number: K 130656
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§ 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.