(175 days)
NovaVision™ is intended for the diagnosis and improvement of visual functions in patients with impaired vision that may result from trauma, stroke, inflammation, surgical removal of brain tumors or brain surgery, and may also be used to improve visual function in patients with amblyopia.
NovaVision™ consists of two computer software programs: (1) one intended for health care professionals - for the precise diagnosis of patients' visual deficiencies, the development of patient-specific therapy programs, and the analysis of results of patient therapy (NovaVision™ Diagnosis Software and Training Program); and (2) one intended for patients - therapeutic software for use by patients in their homes to train and improve impaired visual functions (NovaVision™-Therapy).
The NovaVision Model 2.0 (K023623) is a diagnostic and therapeutic device intended for the diagnosis and improvement of visual functions. This response summarizes the available information regarding its acceptance criteria and supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or a specific threshold for improvement). Instead, it relies on demonstrating substantial equivalence to predicate devices (DynaVision 2000 and AA-1 System for the Treatment of Amblyopia) based on similar intended use, target population, functionality, and demonstrated safety and effectiveness in clinical studies.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Diagnosis of patients' visual deficiencies: Equivalent ability to collect and interpret diagnostic information concerning visual deficits. | "Two clinical studies have confirmed the effectiveness and reliability of NovaVision™ Diagnosis Software and Training Program in diagnosing patients' visual deficiencies..." |
| Improvement of visual functions: Equivalent ability to improve impaired visual functions. | "...and five clinical studies have confirmed the safety and effectiveness of patient use of NovaVision™-Therapy to improve visual functions." |
| Safety and Effectiveness: No new questions of safety and effectiveness compared to predicate devices. | "NovaVision™ has been demonstrated to be as safe and effective as the Dynavision 2000." |
| Amblyopia treatment: Correlates with improvement of vision in patients with amblyopia. | "Moreover, reference to a third-party clinical study strongly correlates with the capabilities of NovaVision™-Therapy to improve the vision of patients with amblyopia." |
2. Sample Sizes and Data Provenance
The provided document does not specify the exact sample sizes used for the test sets in the various clinical studies. It also does not explicitly state the country of origin or whether the studies were retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test sets.
4. Adjudication Method
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth in the test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided information does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance, nor does it specify any effect size for such a study.
6. Standalone (Algorithm Only) Performance Study
The document indicates that NovaVision™ consists of "two computer software programs," implying a software-only component for diagnosis and therapy. The statement "Two clinical studies have confirmed the effectiveness and reliability of NovaVision™ Diagnosis Software and Training Program in diagnosing patients' visual deficiencies" and "five clinical studies have confirmed the safety and effectiveness of patient use of NovaVision™-Therapy to improve visual functions" suggests that studies were conducted to assess the performance of the software. However, it does not explicitly differentiate between standalone (algorithm only) performance studies and human-in-the-loop studies. Given the nature of the device (presenting visual stimuli and interpreting patient responses), it is likely that the "device performance" inherently involves the algorithm's capability.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, for a device intended for "diagnosis and improvement of visual functions," ground truth would likely involve:
- For diagnosis: Clinical assessments of visual deficiencies by healthcare professionals (e.g., ophthalmologists or neurologists), potentially using established diagnostic criteria or other validated tests.
- For improvement: Objective measures of visual function (e.g., visual field tests, visual acuity) before and after therapy, or patient-reported outcomes, as assessed by healthcare professionals.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size used for the training set. The 510(k) summary focuses on clinical performance data rather than detailing the machine learning model development process.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established.
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July 22, 2021
NovaVision, Inc. Navroze S. Mehta President and CEO 3701 Fau Boulevard Suite 210 Boca Raton, Florida 33431
Re: K023623
Trade/Device Name: NovaVision, Model 2.0 Regulation Number: 21 CFR 886.1605 Regulation Name: Perimeter Regulatory Class: Class I Product Code: HPT
Dear Navroze S. Mehta:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 22, 2003. Specifically, FDA is updating this SE Letter as an administrative correction corresponding to the correct classification regulation number, regulation name, regulatory class, and product code.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Elvin Ng, OHT1: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, (240) 402-4662, Elvin.Ng@fda.hhs.gov.
Sincerely,
Charles Chiang -S
for Elvin Ng
Assistant Director Retinal and Diagnostic Devices Team DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2003
Mr. Navroze S. Mehta President and CEO NovaVision Inc. 3701 Fau Boulevard Suite 210 Boca Raton, Florida 33431
Re: K023623
Trade/Device Name: NovaVision Model 2.0 Regulation Number: Unclassified Regulation Name: Attention Task Performance Recorder Regulatory Class: Unclassified Product Code: LQD Dated: February 13, 2003 Received: February 19, 2003
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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III. Indications for Use Statement
Applicant: NovaVision, Inc.
510(k) Number (if known): K023623
Device Name: NovaVision™
Indications For Use: NovaVision™ is intended for the diagnosis and improvement of visual functions in patients with impaired vision that may result from trauma, stroke, inflammation, surgical removal of brain tumors or brain surgery, and may also be used to improve visual function in patients with amblyopia.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023623
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X. 510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. § 807.92.
| 510(k) Submitter | NovaVision, Inc.Reservoir Place, Suite 2051601 Trapelo RoadWaltham, MA 02451 |
|---|---|
| Contact: Bernhard A. Sabel, Ph.D.Tel: +49-391-611 7100Fax: +49-391-611 7103 | |
| Date summarywas prepared | October 25, 2002 |
| Trade Name | NovaVision™ |
| Common Name | Attention Task Performance Recorder |
| Classification Name | Recorder, attention task performance |
| Product code | LQD |
| Predicate Devices | DynaVision 2000 (K911938)AA-1 System for the Treatment of Amblyopia (K012530) |
| Description | NovaVision™ consists of two computer softwareprograms: (1) one intended for health care professionals -for the precise diagnosis of patients' visual deficiencies,the development of patient-specific therapy programs, andthe analysis of results of patient therapy (NovaVision™Diagnosis Software and Training Program); and (2) oneintended for patients - therapeutic software for use bypatients in their homes to train and improve impaired visualfunctions (NovaVision™-Therapy). |
| Intended Use | NovaVision™ is intended for the diagnosis andimprovement of visual functions in patients with impairedvision that may result from trauma, stroke, inflammation,surgical removal of brain tumors or brain surgery, and mayalso be used to improve visual function in patients withamblyopia. |
Comparison of technological characteristics to predicate device
NovaVision™ is substantially equivalent to the DynaVision 2000. These systems have the same intended use/indications, target population, and functionality, i e , the diagnosis and improvement of visual functions in patients with impaired vision by repetitively
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presenting visual stimuli. NovaVision™ consists of different technology than the Dynavision 2000. but these differences do not raise new questions of safety and effectiveness, and NovaVision™ has been demonstrated to be as safe and effective as the Dynavision 2000.
NovaVision™ presents visual stimuli on a computer screen, while the Dynavision 2000 presents visual stimuli on a large light board. Further, NovaVision™'s computerization of visual stimuli makes it possible for patients to train at home.
NovaVision™ is also substantially equivalent to the AA-1 System for the Treatment of Amblyopia, a device consisting of software and accessories that is intended to treat amblyopia in patients nine years or older. Both devices consist of software that (1) collects and interprets diagnostic information concerning the extent of visual deficits in the form of patient responses to visual diagnostic tests: (2) reports diagnostic information useful for further diagnosis or treatment: and (3) presents visual training tasks individualized to each patient's specific diagnosis.
Clinical performance data and support of substantial equivalence determination
Two clinical studies have confirmed the effectiveness and reliability of NovaVision™ Diagnosis Software and Training Program in diagnosing patients' visual deficiencies, and five clinical studies have confirmed the safety and effectiveness of patient use of NovaVision™-Therapy to improve visual functions. Moreover, reference to a third-party clinical study strongly correlates with the capabilities of NovaVision™-Therapy to improve the vision of patients with amblyopia.
§ 886.1605 Perimeter.
(a)
Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.