K Number

Device Name

OPTICAL BIOMETER AL-SCAN

Manufacturer

NIDEK CO., LTD.

Date Cleared

2014-06-11

(254 days)

Product Code

HJO IYO

Regulation Number

886.1850

Intended Use

The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as: - axial length; - corneal thickness; - anterior chamber depth; - corneal curvature radii; - corneal cylinder axis; - white-to-white distance; and - pupil diameter. Axial length and corneal thickness can also be measured using ultrasound. The OPTICAL BIOMETER AL-Scan also performs calculations to assist physicians in determining the power of the intraocular lens for implantation. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (A-mode)

Device Description

The OPTICAL BIOMETER AL-Scan ("AL-Scan") measures ocular measurements including: axial length, corneal thickness, anterior chamber depth, corneal curvature radii, corneal cylinder axis, white-to-white distance, and pupil diameter. It measures these necessary values successively through a non-contact optical measurement method. The AL-Scan measures as a single unit the values necessary to calculate the power of an IOL for cataract surgery. Two optional ultrasonic probes (A-scan Probe and Pachymetry Probe) are available for use in the event the optical measurement is unsuccessful. The A-scan probe scans the axial length, anterior chamber depth, lens thickness and the pachymetry probe scans the corneal thickness. Both probes utilize an ultrasonic measurement function by touching the probe to the cornea. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K082891, K843696, K020876, K030719

Reference Devices

PacScan 300A

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on optical and ultrasonic measurement methods and standard IOL power calculations. There is no mention of AI/ML in the intended use, device description, or performance studies.

Therapeutic

No.
The device is described as a medical device that measures eye components and performs calculations to assist physicians in determining the power of an intraocular lens for implantation, indicating a diagnostic and assistive function rather than a direct therapeutic one.

Diagnostic

Yes
The device measures eye components and performs calculations to assist physicians in determining the power of intraocular lenses, which are diagnostic activities. Additionally, it explicitly mentions "Diagnostic ultrasound imaging" in its intended use.

SaMD (Software as a Medical Device)

The device description explicitly states it is a single unit that performs non-contact optical measurements and also has optional ultrasonic probes, indicating it is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the OPTICAL BIOMETER AL-Scan is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. The AL-Scan directly measures components of the eye using optical and ultrasonic methods. It does not analyze biological samples like blood, urine, or tissue.
The intended use is direct measurement and calculation for surgical planning. The device measures physical characteristics of the eye and performs calculations to assist in determining IOL power. This is a direct measurement and calculation process, not an analysis of a biological sample for diagnostic purposes in the traditional IVD sense.

The device is a medical device used for ophthalmic measurements and calculations, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as:

axial length;
corneal thickness;
anterior chamber depth;
corneal curvature radii;
corneal cylinder axis;
white-to-white distance; and
pupil diameter.

Axial length and corneal thickness can also be measured using ultrasound.

The OPTICAL BIOMETER AL-Scan also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

Diagnostic Ultrasound Indications for Use
System: OPTICAL BIOMETER AL-Scan
Transducer: A-scan probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ophthalmic, Mode of Operation: N (A-mode)

System: OPTICAL BIOMETER AL-Scan
Transducer: Pachymetry probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ophthalmic, Mode of Operation: N (A-mode)

Product codes

HJO, IYO

Device Description

Two optional ultrasonic probes (A-scan Probe and Pachymetry Probe) are available for use in the event the optical measurement is unsuccessful. The A-scan probe scans the axial length, anterior chamber depth, lens thickness and the pachymetry probe scans the corneal thickness. Both probes utilize an ultrasonic measurement function by touching the probe to the cornea.

The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical measurement, Ultrasound (A-mode)

Anatomical Site

Eye

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

The study was a prospective clinical study conducted at a single U.S. clinical site.
Sample Size:
Agreement Results: 80 subject eyes (20 eyes in each of four eye populations: Normal, Cataracts, Without a Natural Lens, Corneal Abnormality).
Precision Results: 40 subject eyes (10 eyes in each of four eye populations).

Data Source: A single U.S. clinical site.
Annotation Protocol:
For the Agreement portion: Each study eye was measured once with a randomly selected OPTICAL BIOMETER AL-Scan device, once with a randomly selected predicate device (LenStar LS 900), and once with the ultrasound reference device (PacScan 300A).
For the Precision portion: Each study eye was measured three times on each of the three OPTICAL BIOMETER AL-Scan devices (a total of 9 measures) and three times on each of the three predicate devices (a total of 9 measures).

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Bench testing, clinical testing, prospective comparative clinical study for precision and agreement.
Sample Size: 80 subject eyes for agreement study, 40 subject eyes for precision study.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:

The OPTICAL BIOMETER AL-Scan demonstrated agreement to the LenStar LS 900 for the assessment of axial length, keratometry, corneal cylinder axis, central corneal thickness, white-to-white distance and pupil diameter.
The OPTICAL BIOMETER AL-Scan demonstrated agreement to the PacScan 300A for axial length.
The OPTICAL BIOMETER AL-Scan also demonstrated agreement to the LenStar LS 900 and the PacScan 300A for the assessment of anterior chamber depth in normal eyes, eyes with cataracts and eyes with a corneal abnormality.
The OPTICAL BIOMETER AL-Scan was unable to determine the anterior chamber depth for eyes without a natural lens.
The reproducibility and repeatability for the OPTICAL BIOMETER AL-Scan is considered to be comparable to the LenStar LS 900 for axial length, keratometry, corneal cylinder axis, central corneal thickness, white distance and pupil diameter.
The reproducibility and repeatability for the OPTICAL BIOMETER AL-Scan was comparable to the LenStar LS 900 for anterior chamber depth in normal eyes, eyes with cataracts and eyes with a corneal abnormality.
IOL power calculations were successfully performed using various formulas (Regression, Regression II, Formula/T, Holladay, Hoffer-O, Haigis, Binkhorst, Camellin-Calossi, Shammas-PL).
No safety events associated with the device, predicate device, or reference devices.
The device has the necessary accuracy and precision for its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Agreement: Mean difference, 95% CI for Mean Difference, 95% LoA for Difference for various ocular measurements.
Precision: Coefficient of Variation (CV) and Standard Deviation (SD) for reproducibility and repeatability for various ocular measurements.

Predicate Device(s)

K082891, K843696, K020876, K030719

Reference Device(s)

PacScan 300A (Sonomed)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Summary

510(k) SUMMARY

510(k) Notification K133132

GENERAL INFORMATION

JUN 1 1 2014

Applicant:

Nidek Co., Ltd. 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi, 443-0038 Japan Phone: +81-533-67-8901 Fax: +81-533-67-6628

Contact Person:

Darlene Crockett-Billig Co-Founder & President Experien Group, LLC. 755 N. Mathilda Ave., Suite 100 Sunnyvale, CA, 94085 U.S.A. Phone: 408-400-0856 FAX: 408-400-0865

Date Prepared: May 6, 2014

DEVICE INFORMATION

Trade Name: OPTICAL BIOMETER AL-Scan

Generic/Common Name:

AC-powered Slitlamp Biomicroscope

Classification:

21 CFR §886.1850, Class II 21 CFR §892.1560, Class II

Product Code: HJO IYO

PREDICATE DEVICE(S)

. LenStar LS 900 (K082891)
PacScan 300 (K843696) �
EchoScan Model US-1800 (K020876) .
Pentacam (K030719) .

INDICATIONS FOR USE

OPTICAL BIOMETER AL-Scan Indications for Use

The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as:

. axial length;
corneal thickness; ●
. anterior chamber depth;
corneal curvature radii; .
corneal cylinder axis; .
white-to-white distance; and .
pupil diameter. ●

Axial length and corneal thickness can also be measured using ultrasound.

The OPTICAL BIOMETER AL-Scan also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

Diagnostic Ultrasound Indications for Use

System: OPTICAL BIOMETER AL-Scan

Transducer: A-scan probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific (Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other *
(Specify)
Ophthalmic	Ophthalmic						N (A-mode)
Fetal Imaging
& Other	Fetal
	Abdominal
Fetal Imaging
& Other	Intra-operative
(Specify)
	Intra-operative
(Neuro)
	Laparoscopic
	Pediatric
	Small Organ
(Specify)
	Neonatal
	Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skeletal
(Conventional)

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific (Tracks
1 &3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other *
(Specify)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular
(Cardiac)
	Trans-esoph.
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral Vessel
	Other (Specif6)

N = new indication; P = previously cleared by FDA; E = added under this appendix

System: OPTICAL BIOMETER AL-Scan

Transducer: Pachymetry probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific (Tracks
1 &3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other *
(Specify)
Ophthalmic	Ophthalmic					N (A-mode)
Fetal Imaging
& Other	Fetal
Abdominal
Fetal Imaging
& Other	Intra-operative
(Specify)
	Intra-operative
(Neuro)
	Laparoscopic
	Pediatric
	Small Organ
(Specify)
	Neonatal
	Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific (Tracks 1 &3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other *
(Specify)
	Intravascular
Other (Specify)
Cardiac	Cardiac Adult
Cardiac Pediatric
Intravascular
(Cardiac)
Trans-esoph.
(Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
Vessel	Peripheral Vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

PRODUCT DESCRIPTION

The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.

SUBSTANTIAL EQUIVALENCE

The OPTICAL BIOMETER AL-Scan is similar in technological characteristics, performance and has similar indications for use as the predicate devices. Any differences in technological characteristics between the proposed device and the predicate devices do not raise any new issues of safety or effectiveness. Thus, the OPTICAL BIOMETER AL-Scan is substantially equivalent to the predicate devices.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary bench and clinical testing was conducted on the OPTICAL BIOMETER AL-Scan to support a determination of substantial equivalence to the predicate devices. The tests performed include:

Ophthalmic Testing per ISO 15004-1 and ISO 15004-2 .
. Clinical Accuracy and System Sensitivity Testing

Acoustic Output Testing ●
. Software Verification and Validation
. Usability Testing
. Electrical Safety and Electromagnetic Compatibility
. Prospective Comparative Clinical Study for Precision and Agreement to the predicate devices. (Summary of results are provided below.)

The collective performance testing demonstrate that the AL-Scan does not raise any .new questions of safety or effectiveness when compared to the predicate devices. The results of the performance testing demonstrate that the OPTICAL BIOMETER AL-Scan performs as intended.

Summary of Clinical Results

Nidek conducted a prospective clinical study at a single U.S. clinical site assessing the agreement of the OPTICAL BIOMETER AL-Scan to the predicate. LenStar LS 900 (Haag-Streit AG), as well as an ultrasound reference device, the PacScan 300A (Sonomed). The study also assessed the precision of the OPTICAL BIOMETER AL-Scan and the LenStar LS 900. The study utilized three OPTICAL BIOMETER AL-Scan devices, three predicate devices and one ultrasound reference device. Subjects were enrolled for each portion of the study, Agreement and Precision, in equal number from four eye populations. The four eye populations consisted of:

1. Normal eyes (phakic eyes without cataracts or corneal disease);
1. Eves with cataracts:
1. Eyes without a natural lens (including aphakic and pseudophakic eyes); and
1. Eyes with corneal abnormality (including eyes post-keratorefractive surgery).

For the Agreement portion of the study, each study eye was measured once with a randomly selected OPTICAL BIOMETER AL-Scan device, once with a randomly selected predicate device and once with the ultrasound reference device. For the Precision portion of the study, each study eye was measured three times on each of the three OPTICAL BIOMETER AL-Scan devices (a total of 9 measures) and three times on each of the three predicate devices (a total of 9 measures).

Agreement Results

Eighty (80) subject eves were assessed in the Agreement portion of the study, 20 eves in each of the four eve populations.

Table 1 provides a summary of the agreement results for axial length, keratometry, corneal cylinder axis, anterior chamber depth, central corneal thickness, white-to-white distance and pupil diameter for the OPTICAL BIOMETER AL-Scan and LenStar LS 900, for all eye populations combined. Table 2 provides a summary of the agreement results summarized by eve population.

LenStar LS 900 (All Eye Populations Combined)
Measure	AL-Scan
(Mean±SD)	LenStar LS
900
(Mean±SD)	Difference
(Mean±SD)	95% CI
for Mean
Difference	95% LoA
for
Difference
Axial Length (mm)	N=80
24.12 ± 1.44	N=80
24.13 ± 1.45	N=80
-0.007 ± 0.029	[-0.014; -0.001]	-0.063, 0.049
Keratometry SE (mm)	N=80
7.744 ± 0.435	N=79
7.784 ± 0.373	N=79
-0.015 ± 0.043	[-0.025; -0.005]	-0.100, 0.070
Corneal Cylinder Axis (°),
with Cylinder Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Diagnostic Ultrasound Indications for Use

510(k) Number: K133132

System: OPTICAL BIOMETER AL-Scan

Transducer: A-scan probe

r ransacc. 11 Sound proco

【:】【:】【

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific (Tracks 1 & 3)	B	M	PWD	CWD	Color Doppler	Combined (Specify)	Other* (Specify)
N (A-mode)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Specify)
	Intra-operative
(Neuro)
	Laparoscopic
	Pediatric
	Small Organ
(Specify)
Fetal Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular
(Cardiac)
	Trans-esoph.
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral Vessel
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

. …

Diagnostic Ultrasound indications for Use

510(k) Number: K133132

System: OPTICAL BIOMETER AL-Scan

Transducer: Pachymetry probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific (Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic						N (A-mode)
	Fetal
	Abdominal
	Intra-operative
(Specify)
	Intra-operative
(Neuro)
	Laparoscopic
	Pediatric
	Small Organ
(Specify)
	Fetal Imaging & Neonatal Cephalic
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Intravascular
(Cardiac)
Trans-esoph.
(Cardiac)
Intra-cardiac
Other (Specify)
Peripheral Vessel		Peripheral Vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix