(22 days)
NOVA View Automated Fluorescence Microscope
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No
The document describes automated image acquisition and analysis, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The analysis is described as "computer controlled digital imaging and image analysis," which is a broader term that doesn't necessarily imply AI/ML.
No
Explanation: The device is an in vitro diagnostic (IVD) device used to acquire, analyze, store, and display digital images of stained indirect immunofluorescent slides to aid in the detection and classification of certain antibodies. It is not used for treating or curing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology" and "The device can only be used with cleared or approved in vitro diagnostic assays". These statements clearly indicate its purpose in diagnosis.
No
The device description explicitly states that the system consists of a fluorescence microscope and software, and also describes optional hardware accessories (AUTOLoader) that are part of the system. This indicates it is a hardware and software system, not software-only.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology." This clearly describes a diagnostic purpose performed in vitro (outside the body) on biological samples (stained slides).
- Use with IVD Assays: The text also states, "The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device." This further reinforces its role as a component within a larger IVD workflow.
- Diagnostic Aid: The phrase "intended as an aid in the detection and classification" signifies its contribution to the diagnostic process.
Therefore, the NOVA View® Automated Fluorescence Microscope fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NOVA View® Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device.
Product codes (comma separated list FDA assigned to the subject device)
PIV
Device Description
NOVA View is an automated fluorescence microscope that acquires, analyses, stores and displays digital images of stained indirect immunofluorescent slides.
The NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction.
AUTOLoader hardware components consist of a NOVA View alignment base, 3-position stack base, 3 slide carrier stacks (labelled as “Pending”, “Completed”, “and “Error”), telescoping arm with rotary gripper, and a 2D barcode scanner station. The AUTOLoader can be connected to up to two NOVA View devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
fluorescence microscope
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
A trained operator must confirm results generated with the device.
Description of the training set, sample size, data source, and annotation protocol
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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)
N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
NOVA View Automated Fluorescence Microscope
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.
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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).
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§ 866.4750 Automated indirect immunofluorescence microscope and software-assisted system.
(a)
Identification. An automated indirect immunofluorescence microscope and software assisted system is a device that acquires, analyzes, stores, and displays digital images of indirect immunofluorescent slides. It is intended to be used as an aid in the determination of antibody status in clinical samples. The device may include a fluorescence microscope with light source, a motorized microscope stage, dedicated instrument controls, a camera, a computer, a sample processor, or other hardware components. The device may use fluorescent signal acquisition and processing software, data storage and transferring mechanisms, or assay specific algorithms to suggest results. A trained operator must confirm results generated with the device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The labeling for the device must reference legally marketed assays intended for use with the device.
(2) Premarket notification submissions must include the following information:
(i) A detailed description of the device that includes:
(A) A detailed description of instrumentation and equipment, and illustrations or photographs of non-standard equipment or methods, if applicable;
(B) Detailed documentation of the software, including, but not limited to, stand-alone software applications and hardware-based devices that incorporate software, if applicable;
(C) A detailed description of appropriate internal and external quality controls that are recommended or provided. The description must identify those control elements that are incorporated into the recommended testing procedures;
(D) Detailed description and specifications for sample preparation, processing, and storage, if applicable;
(E) Methodology and protocols for detecting fluorescence and visualizing results; and
(F) Detailed specification of the criteria for test results interpretation and reporting.
(ii) Data demonstrating the performance characteristics of the device, which must include:
(A) A comparison study of the results obtained with the conventional manual method (
i.e., reference standard), the device, and the reading of the digital image without aid of the software, using the same set of patient samples for each. The study must use a legally marketed assay intended for use with the device. Patient samples must be from the assay-specific intended use population and differential diagnosis population. Samples must also cover the assay measuring range, if applicable;(B) Device clinical performance established by comparing device results at multiple U.S. sites to the clinical diagnostic standard used in the United States, using patient samples from the assay-specific intended use population and the differential diagnosis population. For all samples, the diagnostic clinical criteria and the demographic information must be collected and provided. Clinical validation must be based on the determination of clinical sensitivity and clinical specificity using the test results (
e.g., antibody status based on fluorescence to include pattern and titer, if applicable) compared to the clinical diagnosis of the subject from whom the clinical sample was obtained. The data must be summarized in tabular format comparing the result generated by automated, manual, and digital only interpretation to the disease status;(C) Device precision/reproducibility data generated from within-run, between-run, between-day, between-lot, between-operator, between-instruments, between-site, and total precision for multiple nonconsecutive days (as applicable) using multiple operators, multiple instruments and at multiple sites. A well-characterized panel of patient samples or pools from the associated assay specific intended use population must be used;
(D) Device linearity data generated from patient samples covering the assay measuring range, if applicable;
(E) Device analytical sensitivity data, including limit of blank, limit of detection, and limit of quantitation, if applicable;
(F) Device assay specific cutoff, if applicable;
(G) Device analytical specificity data, including interference by endogenous and exogenous substances, if applicable;
(H) Device instrument carryover data, if applicable;
(I) Device stability data including real-time stability under various storage times and temperatures, if applicable; and
(J) Information on traceability to a reference material and description of value assignment of calibrators and controls, if applicable.
(iii) Identification of risk mitigation elements used by the device, including description of all additional procedures, methods, and practices, incorporated into the directions for use that mitigate risks associated with testing.
(3) Your 21 CFR 809.10 compliant labeling must include:
(i) A warning statement that reads “The device is for use by a trained operator in a clinical laboratory setting”;
(ii) A warning statement that reads “All software-aided results must be confirmed by the trained operator”;
(iii) A warning statement that reads “This device is only for use with reagents that are indicated for use with the device”; and
(iv) A description of the protocol and performance studies performed in accordance with paragraph (b)(2)(ii) of this section and a summary of the results, if applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2016
INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS DIRECTOR OF ASSAY DEVELOPMENT 9900 OLD GROVE ROAD SAN DIEGO CA 92131
Re: K153150
Trade/Device Name: NOVA View automated fluorescence microscope with AUTOLoader Regulation Number: 21 CFR 866.4750 Regulation Name: Automated indirect immunofluorescence microscope and software-assisted system
Regulatory Class: II Product Code: PIV Dated October 29, 2015 Received: November 2, 2015
Dear Dr. Lakos:
This letter corrects our substantially equivalent letter of November 24, 2015.
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
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (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 Parts 801 and 809]), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Kelly Oliner -S
FOR
Leonthena R. Carrington, MS, MBA, MT (ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health (OIR) Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
NOVA View® Automated Fluorescence Microscope with AUTOLoader
Indications for Use (Describe)
NOVA View® Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device.
| 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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Inova Diagnostics
Special 510(k) Summary
NOVA View® Automated Fluorescence Microscope with AUTOLoader
510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Table of Contents
| 1. | Submitter | ||||
|---|---|---|---|---|---|
| 2. | Purpose of submission | ||||
| 3. | Devices in the submission | ||||
| 4. | Primary contact | ||||
| 5. | Secondary contact | ||||
| 6. | Product Information and Classification | ||||
| 6.1 | Proprietary and established names | ||||
| 6.2 | Regulatory information | ||||
| 7. | Intended Use | ||||
| 8. | Indications for Use | ||||
| 9. | Predicate device | ||||
| 10. Substantial equivalence information | |||||
| 11. Regulatory history | |||||
| 12. Type of the Product | |||||
| 13. System Description: | |||||
| 13.1. | Modes of Operation | ||||
| 13.2. | Software | ||||
| 14. Device description | |||||
| 15. Principle of the Method and Summary of the Procedure | |||||
| 16. Analytical performance characteristics | |||||
| 17. Clinical performance |
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1. Submitter
Inova Diagnostics, Inc 9900 Old Grove Road, San Diego, CA, 92131
2. Purpose of submission
Special (510) k submission.
The reason for submission is the addition of an optional hardware accessory, AUTOLoader to the NOVA View device.
3. Devices in the submission
NOVA View Automated Fluorescence Microscope with AUTOLoader
4. Primary contact
Gabriella Lakos, Director of Assay development Inova Diagnostics, Inc 9900 Old Grove Road, San Diego, CA, 92131 Phone: 858-586-9900/1393 email: glakos@inovadx.com
5. Secondary contact
Ronda Elliott, VP of Quality Systems and Regulatory Affairs Inova Diagnostics, Inc. 9900 Old Grove Road, San Diego, CA, 92131 Phone: 858-586-9900/1381 Fax: 858-863-0025/1351 email: relliott@inovadx.com
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6. Product Information and Classification
6.1 Proprietary and established names
| Proprietary name: | NOVA View® with AUTOLoader |
|---|---|
| Common name: | Automated Fluorescence Microscope with AUTOLoader |
| Classification name: | Automated indirect immunofluorescence microscope and software |
| assisted system for clinical use |
6.2 Regulatory information
| Regulation Description | Automated indirect immunofluorescence microscope and software-
assisted system for clinical use |
|------------------------------|----------------------------------------------------------------------------------------------------|
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Product Code | PIV |
| Regulation Number | 866.4750 |
| Device Class | II |
7. Intended Use
NOVA View Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device.
8. Indications for Use
NOVA View Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device.
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9. Predicate device
NOVA View Automated Fluorescence Microscope
10. Substantial equivalence information
| Comparison to the predicate device | ||
|---|---|---|
| Item | NOVA View with AUTOLoader | Predicate Device: NOVA View |
| Intended use | NOVA View is an automated system | |
| consisting of a fluorescence microscope and | ||
| software that acquires, analyses, stores and | ||
| displays digital images of stained indirect | ||
| immunofluorescent slides. It is intended as an | ||
| aid for the trained operator in the detection | ||
| and classification of certain antibodies with | ||
| the indirect immunofluorescent technology. | ||
| NOVA View can only be used with reagents | ||
| that have been approved for use on the | ||
| system. Results generated by the NOVA View | ||
| must be confirmed by trained operator. | Same | |
| Technology | Automated indirect immunofluorescence | |
| microscope and software-assisted system for | ||
| clinical use | Same |
11. Regulatory history
De novo submission: DEN140039
12. Type of the Product
Device technology: indirect immunofluorescence and computer controlled digital imaging and image analysis.
13. System Description
Modes of Operation 13.1.
The instrument does not process samples. The instrument acquires digital images of representative areas of stained indirect immunofluorescent slides can be loaded onto the device either manually, or by the AUTOLoader. The use of AUTOLoader is optional.
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13.2. Software
The NOVA View instrument is operated by the NOVA View software. Software version is 2.1.4. The AUTOLoader is controlled by the NOVA View software. A module ("AUTOLoader" module) was added to the NOVA View software. This module interfaces between the NOVA View software and the AUTOLoader firmware. In the AUTOLoader tab the user can view the AUTOLoader log files, error messages (if applicable) and can interact with the AUTOLoader. All new functions were tested during software verification, and regression testing has been performed to demonstrate that NOVA View functionality has not changed.
Level of Concern
Based on FDA Guidance, "Guidance for the Contents of Premarket Submissions for Software Contained in Medical Devices" the NOVA View software 2.1.4 has "Moderate" level of concern.
14. Device description
NOVA View is an automated fluorescence microscope that acquires, analyses, stores and displays digital images of stained indirect immunofluorescent slides.
The NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction.
AUTOLoader hardware components consist of a NOVA View alignment base, 3-position stack base, 3 slide carrier stacks (labelled as "Pending", "Completed", "and "Error"), telescoping arm with rotary gripper, and a 2D barcode scanner station. The AUTOLoader can be connected to up to two NOVA View devices.
15. Principle of the Method and Summary of the Procedure
Slides (from NOVA Lite DAPI ANA Kit) are placed in 5-slide carriers fit on the microscope stage of NOVA View. Carriers to be scanned on the NOVA View are placed in the Pending stack of the AUTOLoader. One stack can accommodate up to 12 carriers. The AUTOLoader is started by the initiation of the NOVA View software. The AUTOLoader picks up the first slide carrier from the Pending stack, transports it to the barcode station, takes off the slide carrier lid, captures an image of the barcodes on the slides, re-places the slide carrier lid, and then proceeds to place the carrier on the NOVA View stage for scanning. After scanning is complete, the AUTOLoader picks up the slide carrier and transports it to the Completed or Error slide carrier stack (depending on the scanning). This procedure is automatically repeated with the rest of the carriers that are in the Pending stack.
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16. Analytical performance characteristics
n/A
17. Clinical performance
n/a