AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000

K153150 · Inova Diagnostics, Inc. · PIV · Nov 24, 2015 · Immunology

Device Facts

• Record ID: K153150
• Device Name: AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
• Applicant: Inova Diagnostics, Inc.
• Product Code: PIV · Immunology
• Decision Date: Nov 24, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.4750
• Device Class: Class 2

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.

Device Story

NOVA View is an automated fluorescence microscope system with an optional AUTOLoader accessory; it acquires, analyzes, stores, and displays digital images of stained indirect immunofluorescent slides. The AUTOLoader automates slide carrier transport to/from the microscope stage using a telescoping arm, rotary gripper, and 2D barcode scanner, enabling continuous loading without human interaction. The system is used in clinical laboratory settings by trained operators. The software processes images to assist in antibody detection; however, all results require confirmation by a trained operator. The device benefits patients by increasing laboratory throughput and efficiency in immunofluorescence testing.

Clinical Evidence

No clinical data provided; bench testing only. Software verification and regression testing were performed to validate the AUTOLoader integration.

Technological Characteristics

Automated fluorescence microscope; includes optional AUTOLoader hardware accessory; fundamental scientific technology unchanged from predicate device.

Indications for Use

Indicated for use as an aid in the detection and classification of certain antibodies via indirect immunofluorescence technology in patients undergoing diagnostic testing. Requires use with cleared/approved in vitro diagnostic assays and confirmation of results by a trained operator.

Regulatory Classification

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.

Special Controls

Automated indirect immunofluorescence (IIF) microscope and software-assisted system must comply with the following special controls:

*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.

Predicate Devices

• NOVA View Automated Fluorescence Microscope (DEN140039)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K153150

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
NOVA View Automated Fluorescence Microscope, DEN140039

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the addition of an optional hardware accessory to the NOVA View device, the AUTOLoader.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including intended use and technology.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.