K Number
K063343
Device Name
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
Manufacturer
Date Cleared
2006-12-13

(37 days)

Product Code
Regulation Number
886.1570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.
Device Description
The Bioptigen Spectral Domain Ophthalmic Imaging System is a noninvasive imaging device which provides microscopic tomographic sectioning of the retina with <= 6 microns axial resolution. The Bioptigen System is capable of 20,000 A-Scans/second due to the nature of spectral domain optical coherence tomography. The Bioptigen Spectral Domain Ophthalmic system is composed of a host computer, engine, and probe. The OCT engine is driven by instrument cards in the computer. The device software will allow a user to create, display, load, and save image files (OCT files).
More Information

Not Found

No
The summary describes a standard OCT imaging system and its components. There is no mention of AI, ML, or any advanced image analysis techniques that would typically involve these technologies. The "image processing" mentioned refers to the standard processing inherent in OCT data acquisition and display.

No
The device is described as an imaging system used for evaluation and diagnosis, not for treatment or therapy.

Yes

The "Intended Use / Indications for Use" section states that the device is intended "as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue." This explicitly indicates a diagnostic purpose.

No

The device description explicitly states that the system is composed of a host computer, engine, and probe, indicating the presence of hardware components beyond just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health.
  • Device Function: The Bioptigen Spectral Domain Ophthalmic Imaging System is a non-invasive imaging device that directly images ocular tissue in vivo (within the living body). It does not analyze samples taken from the body.
  • Intended Use: The intended use is for imaging ocular tissue in routine clinical examinations and as an aid in the diagnosis of conditions affecting the optical scattering properties of ocular tissue. This is a diagnostic imaging function, not an in vitro diagnostic function.

Therefore, the device falls under the category of a diagnostic imaging device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.

Product codes (comma separated list FDA assigned to the subject device)

HFI, HLI

Device Description

The Bioptigen Spectral Domain Ophthalmic Imaging System is a noninvasive imaging device which provides microscopic tomographic sectioning of the retina with

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

0

K063343

Section 5: 510(k) Summary

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

| Sponsor/
Manufacturer: | Bioptigen, Inc.
104 T.W. Alexander Drive
Park Research Center, Building 2
Research Triangle Park, NC 27709
Ph: 919-314-5504 |

--------------------------------------------------------------------------------------------------------------------------------------------------------------------

Russ Pagano Contact: M Squared Associates, Inc. 719 A Street, NE Washington, DC 20002 Ph: 202-546-1262 Ext. 259 Fax: 202-546-3848 E-mail: rpagano@MSquaredAssociates.com

Date Prepared: October 4, 2006

Proposed Class: =

Bioptigen Spectral Domain Ophthalmic Imaging System Proprietary Name:

Common Name: Ophthalmic Imaging Device

Classification Name: Ophthalmoscope, A-C powered

Regulation Number: 21 CFR 886.1570

Product Code: HFI

Predicate Device: Carl Zeiss Meditec Stratus OCT (K033123), Carl Zeiss Humphrey OCT 3 (K012727)

Intended Use: The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.

Device Description: The Bioptigen Spectral Domain Ophthalmic Imaging System is a noninvasive imaging device which provides microscopic tomographic sectioning of the retina with ≤ 6 microns axial resolution. The Bioptigen System is capable of 20,000 A-Scans/second due to the nature of spectral domain optical coherence tomography.

DEC 1 3 2006

1

The Bioptigen Spectral Domain Ophthalmic system is composed of a host computer, engine, and probe. The OCT engine is driven by instrument cards in the computer. The device software will allow a user to create, display, load, and save image files (OCT files).

Summary of non-clinical tests: Conformance to standards including ISO 10942, ISO 15004-1, and ISO 15005-2.2 confirms the safety and performance of the proposed device. Safety analysis concludes that under normal operating conditions the energy exposure to the eye does not exceed the limits for human ocular exposure.

| | Zeiss OCT 3 | Zeiss StratusOCT | Bioptigen SDOCT Retinal
Imaging System |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K012727 | K033123 | Not assigned |
| Indication for Use | Viewing and axial cross
sectional imaging of
posterior ocular structures. It
is used for in vivo imaging
and measurement of the
retina, retinal nerve fiber
layer and optic disk. | Same- includes RNFL and
Macula Normative Database | The Bioptigen Spectral
Domain Ophthalmic
Imaging System is intended
to acquire, process, display,
and save depth-resolved
images of ocular tissue
microstructure using Spectra
Domain Optical Coherence
Tomography. |
| Category | Specification | Specification | Specification |
| Optical power |