(254 days)
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)
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.
The Nidek Optical Biometer AL-Scan (K133132) was tested for agreement with predicate devices (LenStar LS 900 and PacScan 300A for ultrasound measurements) and its own precision (repeatability and reproducibility).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for each measurement were implicitly defined by demonstrating agreement with the predicate devices within calculated 95% Confidence Intervals (CI) for the mean difference and 95% Limits of Agreement (LoA), as well as by achieving acceptable reproducibility and repeatability (measured by Standard Deviation (SD) and Coefficient of Variation (CV)).
Here's a summary of the reported device performance, highlighting key metrics, particularly for the "All Eye Populations Combined" data from Tables 1, 3, and 5. The agreement values represent the difference between the AL-Scan and the predicate device. The precision values (reproducibility and repeatability) are for the AL-Scan itself.
| Measure | Acceptance Criteria (Implicitly from Predicate Agreement/Precision) | AL-Scan Performance (Agreement with LenStar LS 900/PacScan 300A) | AL-Scan Performance (Precision - Reproducibility & Repeatability) |
|---|---|---|---|
| Axial Length (mm) | Small mean difference and narrow LoA with predicates; low SD/CV. | LenStar LS 900: Mean Diff: -0.007 ± 0.029, 95% CI: [-0.014; -0.001], 95% LoA: [-0.063, 0.049] PacScan 300A: Mean Diff: 0.034 ± 0.241, 95% CI: [-0.019; 0.088], 95% LoA: [-0.439, 0.507] | Reproducibility: SD: 0.034, %CV: 0.1%Repeatability: SD: 0.034, %CV: 0.1% |
| Keratometry SE (mm) | Small mean difference and narrow LoA with predicates; low SD/CV. | LenStar LS 900: Mean Diff: -0.015 ± 0.043, 95% CI: [-0.025; -0.005], 95% LoA: [-0.100, 0.070] | Reproducibility: SD: 0.060, %CV: 0.8%Repeatability: SD: 0.060, %CV: 0.8% |
| Corneal Cylinder Axis (°) | Small mean difference and narrow LoA with predicates; low SD/CV. | LenStar LS 900 (Cylinder < 0.75 D): Mean Diff: -9.0 ± 27.4, 95% CI: [-16.4; -1.6], 95% LoA: [-62.8, 44.7] LenStar LS 900 (Cylinder ≥ 0.75 D): Mean Diff: -0.8 ± 6.6, 95% CI: [-3.6; 2.1], 95% LoA: [-13.8, 12.3] | Reproducibility (Cylinder < 0.75 D): SD: 13.3, %CV: 17.4%Reproducibility (Cylinder ≥ 0.75 D): SD: 4.0, %CV: 4.5% |
| Anterior Chamber Depth (mm) | Small mean difference and narrow LoA with predicates; low SD/CV. | LenStar LS 900: Mean Diff: 0.021 ± 0.049, 95% CI: [0.008; 0.034], 95% LoA: [-0.075, 0.118] PacScan 300A: Mean Diff: 0.172 ± 0.244, 95% CI: [0.109; 0.235], 95% LoA: [-0.305, 0.649] | Reproducibility: SD: 0.033, %CV: 1.0%Repeatability: SD: 0.019, %CV: 0.5% |
| Central Corneal Thickness (μ) | Small mean difference and narrow LoA with predicates; low SD/CV. | LenStar LS 900: Mean Diff: -0.0 ± 8.3, 95% CI: [-1.9; 1.8], 95% LoA: [-16.3, 16.2] | Reproducibility: SD: 4.5, %CV: 0.8%Repeatability: SD: 3.6, %CV: 0.7% |
| White-to-White Distance (mm) | Small mean difference and narrow LoA with predicates; low SD/CV. | LenStar LS 900: Mean Diff: -0.15 ± 0.14, 95% CI: [-0.18; -0.12], 95% LoA: [-0.42, 0.12] | Reproducibility: SD: 0.27, %CV: 2.2%Repeatability: SD: 0.26, %CV: 2.2% |
| Pupil Diameter (mm) | Small mean difference and narrow LoA with predicates; low SD/CV. | LenStar LS 900: Mean Diff: 0.15 ± 0.60, 95% CI: [0.01; 0.29], 95% LoA: [-1.03, 1.33] | Reproducibility: SD: 0.37, %CV: 8.3%Repeatability: SD: 0.34, %CV: 7.7% |
Assessment: The clinical study concluded that the OPTICAL BIOMETER AL-Scan demonstrated agreement to the predicate device, LenStar LS 900, for axial length, keratometry, corneal cylinder axis, central corneal thickness, white-to-white distance, and pupil diameter, and to the PacScan 300A for axial length. Agreement was also shown for anterior chamber depth with both predicates, except for eyes without a natural lens, where the AL-Scan was unable to determine ACD. The precision (reproducibility and repeatability) of the AL-Scan was considered comparable to the predicate device. These findings support that the device meets the implicit acceptance criteria by performing comparably to established devices already on the market.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Agreement Portion: 80 subject eyes (20 eyes in each of four eye populations: Normal, Cataract, Aphakic/Pseudophakic, and Corneal Abnormality).
- Precision Portion: 40 subject eyes (10 eyes in each of the four eye populations).
- Data Provenance: Prospective clinical study conducted at a single U.S. clinical site.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The study does not explicitly state the number of experts or their qualifications for establishing the "ground truth" for the test set. Instead, the study uses predicate devices (LenStar LS 900 and PacScan 300A) as the reference or "truth" for comparison, which are already legally marketed and established devices for ophthalmic measurements. This is a common approach in 510(k) submissions where substantial equivalence to existing devices is being demonstrated.
4. Adjudication Method for the Test Set
The study summary does not describe any specific "adjudication method" involving multiple human readers for disagreements. The comparison is between the AL-Scan measurements and the predicate device measurements. Discrepancies are quantitatively analyzed using statistical methods like 95% Confidence Intervals for the mean difference and 95% Limits of Agreement, rather than qualitative adjudication between human observers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study focuses on comparing the AL-Scan's measurements directly to predicate device measurements and assessing its own precision, not on evaluating how human readers' performance improves with or without AI assistance. This device is an optical biometer, a diagnostic measurement device, rather than an AI-assisted interpretation or detection system, so an MRMC study would generally not be applicable in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the study data presented primarily represent the standalone performance of the OPTICAL BIOMETER AL-Scan. The device mechanically measures ocular components, and its measurements are compared directly to those of other devices. While a human operator uses the device, the reported performance metrics (agreement and precision) are for the device's output itself, not for a human-plus-AI system. The "clinical accuracy and system sensitivity testing," "acoustic output testing," and "software verification and validation" further support its standalone performance.
7. Type of Ground Truth Used
The "ground truth" in this study is established by measurements obtained from legally marketed predicate devices: the LenStar LS 900 (an optical biometer) and the PacScan 300A (an ultrasound reference device). This approach is used to demonstrate substantial equivalence to existing technology, rather than comparing to a histological or pathology-confirmed "true" state.
8. Sample Size for the Training Set
The provided 510(k) summary does not mention a training set sample size. This is expected because the AL-Scan is a measurement device that performs optical and ultrasound biometry, not a machine learning or AI-driven diagnostic algorithm that requires a separate training phase with labeled data. Its underlying physics-based measurement principles do not necessitate a "training set" in the machine learning sense. The clinical study data described above served as verification and validation for its performance.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" and associated "ground truth" for training purposes is not applicable to this device, which relies on established physical measurement principles rather than machine learning algorithms.
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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) .
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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 | ColorDoppler | 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) |
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific (Tracks1 &3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other *(Specify) |
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | 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 (Tracks1 &3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other *(Specify) |
| Ophthalmic | Ophthalmic | N (A-mode) | ||||||
| Fetal Imaging& Other | FetalAbdominal | |||||||
| 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) |
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific (Tracks 1 &3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other *(Specify) |
| IntravascularOther (Specify) | ||||||||
| Cardiac | Cardiac AdultCardiac PediatricIntravascular(Cardiac)Trans-esoph.(Cardiac)Intra-cardiacOther (Specify) | |||||||
| PeripheralVessel | Peripheral VesselOther (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
PRODUCT 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.
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
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- 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:
-
- Normal eyes (phakic eyes without cataracts or corneal disease);
-
- Eves with cataracts:
-
- Eyes without a natural lens (including aphakic and pseudophakic eyes); and
-
- 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.
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| LenStar LS 900 (All Eye Populations Combined) | |||||
|---|---|---|---|---|---|
| Measure | AL-Scan(Mean±SD) | LenStar LS900(Mean±SD) | Difference(Mean±SD) | 95% CIfor MeanDifference | 95% LoAforDifference |
| Axial Length (mm) | N=8024.12 ± 1.44 | N=8024.13 ± 1.45 | N=80-0.007 ± 0.029 | [-0.014; -0.001] | -0.063, 0.049 |
| Keratometry SE (mm) | N=807.744 ± 0.435 | N=797.784 ± 0.373 | N=79-0.015 ± 0.043 | [-0.025; -0.005] | -0.100, 0.070 |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | N=5686 ± 61 | N=5589 ± 59 | N=55-9.0 ± 27.4 | [-16.4; -1.6] | -62.8, 44.7 |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | N=24111 ± 63 | N=2489 ± 64 | N=24-0.8 ± 6.6 | [-3.6; 2.1] | -13.8, 12.3 |
| Anterior Chamber Depth(mm) | N=593.43 ± 0.38 | N=773.68 ± 0.64† | N=590.021 ± 0.049 | [0.008; 0.034] | -0.075, 0.118 |
| Central Corneal Thickness(μ) | N=79533 ± 42 | N=80531 ± 45 | N=79-0.0 ± 8.3 | [-1.9; 1.8] | -16.3, 16.2 |
| White-to-White Distance(mm) | N=7912.1 ± 0.4 | N=8012.2 ± 0.5 | N=79-0.15 ± 0.14 | [-0.18; -0.12] | -0.42, 0.12 |
| Pupil Diameter (mm) | N=784.6 ± 1.1 | N=794.5 ± 1.0 | N=770.15 ± 0.60 | [0.01; 0.29] | -1.03, 1.33 |
Summary of Ophthalmic Biometry Agreement Results for the AL-Scan and
LenStar I.S.900 (All Eve Populations Combined) Table 1:
Source: Summary.sas (20FEB14 11:59)
·
† The LenStar LS 900 results for the anterior chamber depth include the results from the "Eyes without a Natural Lens Population"
:
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| Measure | AL-Scan(Mean±SD) | LenStarLS 900(Mean±SD) | Difference(Mean±SD) | 95% CIfor MeanDifference | 95% LoAforDifference |
|---|---|---|---|---|---|
| Eye Population: Normal | |||||
| Axial Length (mm) | N=2023.52 ± 1.26 | N=2023.52 ± 1.27 | N=20-0.003 ± 0.021 | [-0.013; 0.006] | -0.044, 0.037 |
| Keratometry SE (mm) | N=207.600 ± 0.255 | N=207.611 ± 0.255 | N=20-0.011 ±0.021 | [-0.021; -0.001] | -0.053, 0.031 |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | N=1373 ± 61 | N=13તેડી = રેતે | N=13-6.2 ± 19.1 | [-17.8; 5.3] | -43.7, 31.3 |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | N=7121 ± 75 | N=773 ± 78 | N=7-3.1 ± 3.0 | [-5.9; -0.4] | -9.0, 2.7 |
| Anterior Chamber Depth(mm) | N=203.45 ± 0.34 | N=203.42 ± 0.34 | N=200.028 ± 0.043 | [0.008; 0.048] | -0.056, 0.112 |
| Central Corneal Thickness(μ) | N=20536 ± 29 | N=20538 + 32 | N=20-1.6 ± 6.8 | [-4.7; 1.6] | -14.9, 11.8 |
| White-to-White Distance(mm) | N=2012.1 ± 0.5 | N=2012.2 ± 0.6 | N=20-0.18 ± 0.16 | [-0.26; -0.11] | -0.50, 0.13 |
| Pupil Diameter (mm) | N=204.9 ± 0.9 | N=20રું 0 ± 0.8 | N=20-0.06 ± 0.53 | [-0.31; 0.18] | -1.10, 0.98 |
Summary of Ophthalmic Biometry Agreement Results for the AL-Scan and Table 2: LenStar LS 900 (by Eye Population)
(
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| Measure | AL-Scan(Mean±SD) | LenStarLS 900(Mean±SD) | Difference(Mean±SD) | 95% CIfor MeanDifference | 95% LoAforDifference |
|---|---|---|---|---|---|
| Eye Population: Cataract | |||||
| Axial Length (mm) | N=2024.19 ± 1.24 | N=2024.21 ± 1.26 | N=20-0.017 ± 0.035 | [-0.033; -0.001] | -0.086, 0.052 |
| Keratometry SE (mm) | N=207.763 ± 0.261 | N=207.773 ± 0.250 | N=20-0.010 ± 0.040 | [-0.029; 0.009] | -0.089, 0.069 |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | N=15104 ± 56 | N=1582 ± 60 | N=15-13.1 ± 25.9 | [-27.5; 1.2] | -63.8, 37.6 |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | N=573 ± 73 | N=574 ± 71 | N=5-1.0 ± 5.7 | [-8.0; 6.0] | -12.1, 10.1 |
| Anterior Chamber Depth(mm) | N=203.22 ± 0.40 | N=203.22 ± 0.39 | N=20-0.001 ± 0.040 | [-0.019; 0.018] | -0.079, 0.078 |
| Central Corneal Thickness(μ) | N=20540 ± 32 | N=20539 ± 34 | N=200.5 ± 8.2 | [-3.4; 4.3] | -15.5, 16.4 |
| White-to-White Distance(mm) | N=1912.0 ± 0.4 | N=2012.2 ± 0.4 | N=19-0.19 ± 0.12 | [-0.24; -0.13] | -0.42, 0.04 |
| Pupil Diameter (mm) | N=204.2 ± 1.3 | N=193.9 ± 0.8 | N=190.40 ± 0.61 | [0.11; 0.69] | -0.79, 1.59 |
Summary of Ophthalmic Biometry Agreement Results for the AL-Scan and Table 2: LenStar LS 900 (by Eye Population) - cont.
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l
・
| Table 2: Summary of Ophthalmic Biometry Agreement Results for the AL-Scan and |
|---|
| LenStar LS 900 (by Eve Population) - cont. |
| Measure | AL-Scan(Mean±SD) | LenStarLS 900(Mean±SD) | Difference(Mean±SD) | 95% CIfor MeanDifference | 95% LoAforDifference |
|---|---|---|---|---|---|
| Eye Population: Without a Natural Lens | |||||
| Axial Length (mm) | N=2023.77 ± 0.73 | N=2023.77 ± 0.73 | N=200.002 ± 0.013 | [-0.004; 0.008] | -0.023, 0.027 |
| Keratometry SE (mm) | N=207.709 ± 0.245 | N=207.738 ± 0.233 | N=20-0.030 ± 0.050 | [-0.053; -0.006] | -0.127, 0.068 |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | N=1398 ± 65 | N=1380 ± 63 | N=13-9.8 ± 38.8 | [-33.3; 13.6] | -86.0, 66.3 |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | N=798 ± 38 | N=798 ± 34 | N=70.1 ± 8.3 | [-7.5; 7.8] | -16.1, 16.4 |
| Anterior Chamber Depth(mm) | -- | N=174.67 ± 0.31 | -- | -- | -- |
| Central Corneal Thickness(μ) | N=20554 ± 32 | N=20553 ± 31 | N=200.7 ± 8.1 | [-3.1; 4.5] | -15.1, 16.5 |
| White-to-White Distance(mm) | N=2012.1 ± 0.5 | N=2012.2 ± 0.5 | N=20-0.08 ± 0.11 | [-0.13; -0.03] | -0.30, 0.14 |
| Pupil Diameter (mm) | N=184.1 ± 0.7 | N=203.9 ± 0.6 | N=180.16 ± 0.40 | [-0.04; 0.36] | -0.62, 0.94 |
.
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| Measure | AL-Scan(Mean±SD) | LenStarLS 900(Mean±SD) | Difference(Mean±SD) | 95% CIfor MeanDifference | 95% LoAforDifference | |||
|---|---|---|---|---|---|---|---|---|
| Eye Population: Corneal Abnormality | ||||||||
| Axial Length (mm) | N=2025.01 ± 1.89 | N=2025.02 ± 1.92 | N=20-0.010 ± 0.037 | [-0.027; 0.007] | -0.083, 0.063 | |||
| Keratometry SE (mm) | N=207.904 ± 0.736 | N=198.024 ± 0.562 | N=19-0.009 ± 0.054 | [-0.035; 0.017] | -0.116, 0.097 | |||
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | N=1570 ± 62 | N=14102 ± 60 | N=14-6.4 ± 25.2 | [-21.0; 8.1] | -55.9, 43.0 | |||
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | N=5152 + 52 | N=5114 ± 78 | N=51.6 ± 9.3 | [-9.9; 13.1] | -16.6, 19.8 | |||
| Anterior Chamber Depth(mm) | N=193.64 ± 0.28 | N=203.58 ± 0.28 | N=190.037 ± 0.058 | [0.009; 0.065] | -0.076, 0.150 | |||
| Central Corneal Thickness(μ) | N=19502 + 53 | N=20495 + 57 | N=190.3 ± 10.3 | [-4.7; 5.2] | -19.9, 20.4 | |||
| White-to-White Distance(mm) | N=2012.2 ± 0.4 | N=2012.3 ± 0.4 | N=20-0.16 ± 0.14 | [-0.22; -0.09] | -0.43, 0.12 | |||
| Pupil Diameter (mm) | N=205.2 ± 1.2 | N=205.1 ± 1.0 | N=200.11 ± 0.75 | [-0.24; 0.47] | -1.36, 1.59 |
Summary of Ophthalmic Biometry Agreement Results for the AL-Scan and Table 2: LenStar LS 900 (by Eye Population) - cont.
Source: Summary.sas (20FEB14 11:59)
{10}------------------------------------------------
Table 3 provides a summary of the agreement results for axial length and anterior chamber depth for the OPTICAL BIOMETER AL-Scan and PacScan 300A, for all eye populations combined. Table 4 provides a summary of the agreement results summarized by eye population.
Summary of Ophthalmic Biometry Agreement Results for the AL-Scan and Table 3: PacScan 300A (All Eye Populations Combined)
| Measure | AL-Scan(Mean±SD) | PacScan300A(Mean±SD) | Difference(Mean±SD) | 95% CIfor MeanDifference | 95% LoAforDifference |
|---|---|---|---|---|---|
| Axial Length (mm) | N=8024.12 ± 1.44 | N=8024.09 ± 1.30 | N=800.034 ± 0.241 | [-0.019; 0.088] | -0.439. 0.507 |
| Anterior Chamber Depth (mm) | N=593.43 ± 0.38 | N=803.44 ± 0.55* | N=290.172 ± 0.244 | [0.109; 0.235] | -0.305, 0.649 |
Source: Summary sas (20FEB14 11:59)
- The PacScan 300A results for the anterior chamber depth include the results from the "Eyes without a Natural Lens Population".
{11}------------------------------------------------
| Measure | AL-Scan(Mean±SD) | PacScan300A(Mean±SD) | Difference(Mean±SD) | 95% CIfor MeanDifference | 95% LoAforDifference |
|---|---|---|---|---|---|
| Eye Population: Normal | |||||
| Axial Length (mm) | N=2023.52 ± 1.26 | N=2023.47 ± 1.24 | N=200.042 ± 0.091 | [-0.001; 0.084] | -0.138, 0.221 |
| Anterior Chamber Depth (mm) | N=203.45 ± 0.34 | N=203.30 ± 0.48 | N=200.147 ± 0.239 | [0.035; 0.258] | -0.322, 0.615 |
| Eye Population: Cataract | |||||
| Axial Length (mm) | N=2024.19 ± 1.24 | N=2024.11 ± 1.13 | N=200.080 ± 0.207 | [-0.016; 0.177] | -0.325, 0.486 |
| Anterior Chamber Depth (mm) | N=203.22 ± 0.40 | N=203.04 ± 0.51 | N=200.180 ± 0.225 | [0.075; 0.285] | -0.261, 0.621 |
| Eye Population: Without a Natural Lens | |||||
| Axial Length (mm) | N=2023.77 ± 0.73 | N=2023.93 ± 0.74 | N=20-0.153 ± 0.198 | [-0.246; -0.061] | -0.542, 0.235 |
| Anterior Chamber Depth (mm) | -- | N=203.95 ± 0.35 | -- | -- | -- |
| Eye Population: Corneal Abnormality | |||||
| Axial Length (mm) | N=2025.01 ± 1.89 | N=2024.84 ± 1.65 | N=200.168 ± 0.306 | [0.025; 0.312] | -0.431, 0.768 |
| Anterior Chamber Depth (mm) | N=193.64 ± 0.28 | N=203.47 ± 0.41 | N=190.191 ± 0.276 | [0.058; 0.323] | -0.350, 0.731 |
Summary of Ophthalmic Biometry Agreement Results for the AL-Scan and Table 4: PacScan 300A (by Eye Population)
Source: Summary.sas (20FEB14 11:59)
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 and 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.
{12}------------------------------------------------
Precision Results
Forty (40) subject eyes were assessed in the Precision portion of the study, 10 eyes in each of four eye populations.
Table 5 provides the coefficient of variation (CV) and standard deviation (SD) for reproducibility and repeatability along with the sample size and mean for the OPTICAL BIOMETER AL-Scan, for all eye populations combined.
| Table 5: AL-Scan Precision Analysis with Reproducibility and Repeatability Coefficient |
|---|
| of Variation (CV) (All Eye Populations Combined) |
| Reproducibility | Repeatability | |||||
|---|---|---|---|---|---|---|
| Measure | Number ofEyes | Mean | SD | % CV | SD | % CV |
| Axial Length (mm) | 40 | 24.025 | 0.034 | 0.1% | 0.034 | 0.1% |
| Keratometry SE (mm) | 40 | 7.796 | 0.060 | 0.8% | 0.060 | 0.8% |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | 18 | 76.6 | 13.3 | 17.4% | 13.2 | 17.2% |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | 22 | 88.5 | 4.0 | 4.5% | 3.8 | 4.3% |
| Anterior Chamber Depth†(mm) | 30 | 3.453 | 0.033 | 1.0% | 0.019 | 0.5% |
| Central Corneal Thickness(μ) | 40 | 541.2 | 4.5 | 0.8% | 3.6 | 0.7% |
| White-to-White Distance(mm) | 40 | 12.11 | 0.27 | 2.2% | 0.26 | 2.2% |
| Pupil Diameter (mm) | 40 | 4.47 | 0.37 | 8.3% | 0.34 | 7.7% |
Source: prec_pooled.sas (10MAR14 13:54)
† Excludes eyes without a natural lens.
{13}------------------------------------------------
Table 6 provides the coefficient of variation (CV) and standard deviation (SD) for reproducibility and repeatability along with the sample size and mean for the OPTICAL BIOMETER AL-Scan, by eye population.
| Table 6: AL-Scan Precision Analysis with Reproducibility and Repeatability Coefficient |
|---|
| of Variation (CV) (by Eye Population)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Measure | Number ofEyes | Mean | Reproducibility | Repeatability | ||
|---|---|---|---|---|---|---|
| SD | % CV | SD | % CV | |||
| Eye Population: Normal | ||||||
| Axial Length (mm) | 10 | 23.743 | 0.045 | 0.2% | 0.045 | 0.2% |
| Keratometry SE (mm) | 10 | 7.672 | 0.112 | 1.5% | 0.112 | 1.5% |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | 4 | 64.6 | 5.5 | 8.4% | 5.0 | 7.7% |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | 6 | 69.8 | 5.2 | 7.4% | 4.7 | 6.7% |
| Anterior Chamber Depth(mm) | 10 | 3.455 | 0.027 | 0.8% | 0.019 | 0.5% |
| Central Corneal Thickness(μ) | 10 | 539.7 | 4.9 | 0.9% | 1.7 | 0.3% |
| White-to-White Distance(mm) | 10 | 12.15 | 0.06 | 0.5% | 0.06 | 0.5% |
| Pupil Diameter (mm) | 10 | 5.06 | 0.39 | 7.8% | 0.36 | 7.2% |
{14}------------------------------------------------
| Reproducibility | Repeatability | |||||||
|---|---|---|---|---|---|---|---|---|
| Measure | Number ofEyes | Mean | SD | % CV | SD | % CV | ||
| Eye Population: Cataract | ||||||||
| Axial Length (mm) | 10 | 24.047 | 0.009 | 0.0% | 0.008 | 0.0% | ||
| Keratometry SE (mm) | 10 | 7.696 | 0.025 | 0.3% | 0.023 | 0.3% | ||
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | 2 | 94.2 | 10.8 | 11.4% | 9.6 | 10.2% | ||
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | 8 | 100.2 | 3.1 | 3.1% | 3.0 | 3.0% | ||
| Anterior Chamber Depth(mm) | 10 | 3.311 | 0.051 | 1.5% | 0.041 | 1.2% | ||
| Central Corneal Thickness(μ) | 10 | 554.2 | 5.4 | 1.0% | 2.4 | 0.4% | ||
| White-to-White Distance(mm) | 10 | 12.12 | 0.21 | 1.7% | 0.21 | 1.7% | ||
| Pupil Diameter (mm) | 10 | 3.75 | 0.36 | 9.7% | 0.31 | 8.3% | ||
| Eye Population: Without a Natural Lens | ||||||||
| Axial Length (mm) | 10 | 23.529 | 0.007 | 0.0% | 0.006 | 0.0% | ||
| Keratometry SE (mm) | 10 | 7.632 | 0.022 | 0.3% | 0.021 | 0.3% | ||
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | 6 | 97.4 | 19.3 | 19.9% | 19.3 | 19.9% | ||
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | 4 | 81.2 | 4.8 | 5.9% | 4.6 | 5.7% | ||
| Anterior Chamber Depth(mm) | 0 | -- | -- | -- | -- | -- | ||
| Central Corneal Thickness(μ) | 10 | 578.6 | 3.8 | 0.7% | 2.3 | 0.4% | ||
| White-to-White Distance(mm) | 10 | 11.84 | 0.45 | 3.8% | 0.44 | 3.7% | ||
| Pupil Diameter (mm) | 10 | 3.70 | 0.24 | 6.4% | 0.21 | 5.6% |
AL-Scan Precision Analysis with Reproducibility and Repeatability Coefficient Table 6: of Variation (CV) (by Eye Population) - cont.
{15}------------------------------------------------
| Number ofEyes | Reproducibility | Repeatability | ||||
|---|---|---|---|---|---|---|
| Measure | Mean | SD | % CV | SD | % CV | |
| Eye Population: Corneal Abnormality | ||||||
| Axial Length (mm) | 1 0 | 24.781 | 0.051 | 0.2% | 0.051 | 0.2% |
| Keratometry SE (mm) | 10 | 8.181 | 0.030 | 0.4% | 0.029 | 0.3% |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | б | 58.0 | 10.5 | 18.2% | 10.1 | 17.5% |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | 4 | 100.5 | 2.5 | 2.5% | 2.1 | 2.1% |
| Anterior Chamber Depth(mm) | I O | 3.603 | 0.034 | 1.0% | 0.027 | 0.7% |
| Central Corneal Thickness(μ) | 10 | 490.4 | 5.5 | 1.1% | 2.3 | 0.5% |
| White-to-White Distance(mm) | 10 | 12.33 | 0.21 | 1.7% | 0.20 | 1.7% |
| Pupil Diameter (mm) | 10 | 5.35 | 0.46 | 8.5% | 0.43 | 8.0% |
AL-Scan Precision Analysis with Reproducibility and Repeatability Coefficient Table 6: of Variation (CV) (by Eye Population) - cont.
Source: Prec_by_Pop.sas (10MAR14 14:15)
{16}------------------------------------------------
Table 7 provides the coefficient of variation (CV) and standard deviation (SD) for reproducibility and repeatability along with the sample size and mean for the LenStar LS 900, for all eye populations combined.
| Coefficient of Variation (CV) (All Eye Populations Combined) | ||||||
|---|---|---|---|---|---|---|
| Measure | Number of Eyes | Mean | SD | Reproducibility% CV | RepeatabilitySD | Repeatability% CV |
| Axial Length (mm) | 40 | 23.998 | 0.266 | 1.1% | 0.264 | 1.1% |
| Keratometry SE (mm) | 40 | 7.805 | 0.034 | 0.4% | 0.033 | 0.4% |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | 15 | 74.8 | 7.9 | 10.6% | 7.9 | 10.6% |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | 25 | 81.9 | 5.1 | 6.2% | 5.0 | 6.1% |
| Anterior Chamber Depth (mm) | 39 | 3.680 | 0.097 | 2.6% | 0.097 | 2.6% |
| Central Corneal Thickness (μ) | 40 | 542.4 | 1.8 | 0.3% | 1.8 | 0.3% |
| White-to-White Distance (mm) | 40 | 12.26 | 0.11 | 0.9% | 0.11 | 0.9% |
| Pupil Diameter (mm) | 39 | 4.49 | 0.47 | 10.4% | 0.44 | 9.8% |
| Table 7: LenStar LS 900 Precision Analysis with Reproducibility and Repeatability |
|---|
| Coefficient of Variation (CV) (All Eye Populations Combined) |
Source: prec_pooled.sas (10MAR14 13:54)
{17}------------------------------------------------
Table 8 provides the coefficient of variation (CV) and standard deviation (SD) for reproducibility and repeatability along with the sample size and mean for the LenStar LS 900, by eye population.
| Reproducibility | Repeatability | |||||
|---|---|---|---|---|---|---|
| Measure | Number ofEyes | Mean | SD | % CV | SD | % CV |
| Eye Population: Normal | ||||||
| Axial Length (mm) | 10 | 23.760 | 0.013 | 0.1% | 0.010 | 0.0% |
| Keratometry SE (mm) | 10 | 7.679 | 0.012 | 0.2% | 0.012 | 0.2% |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | 4 | 64.9 | 6.4 | 9.8% | 5.7 | 8.8% |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | 6 | 69.9 | 2.9 | 4.2% | 2.8 | 4.0% |
| Anterior Chamber Depth(mm) | 10 | 3.401 | 0.024 | 0.7% | 0.024 | 0.7% |
| Central Corneal Thickness(μ) | 10 | 541.3 | 1.4 | 0.3% | 1.4 | 0.3% |
| White-to-White Distance(mm) | 10 | 12.28 | 0.10 | 0.8% | 0.10 | 0.8% |
| Pupil Diameter (mm) | 10 | 4.81 | 0.47 | 9.8% | 0.42 | 8.7% |
| Measure | Number ofEyes | Mean | SD | % CV | SD | % CV |
| Eye Population: Cataract | ||||||
| Axial Length (mm) | 10 | 23.911 | 0.536 | 2.2% | 0.513 | 2.1% |
| Keratometry SE (mm) | 10 | 7.704 | 0.011 | 0.1% | 0.011 | 0.1% |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | 1 | 39.4 | 11.8 | 29.8% | 6.3 | 16.1% |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | 9 | 107.0 | 3.0 | 2.8% | 2.9 | 2.7% |
| Anterior Chamber Depth(mm) | 10 | 3.311 | 0.009 | 0.3% | 0.008 | 0.2% |
| Central Corneal Thickness(μ) | 10 | 557.8 | 1.6 | 0.3% | 1.5 | 0.3% |
| White-to-White Distance(mm) | 10 | 12.27 | 0.08 | 0.6% | 0.07 | 0.6% |
| Pupil Diameter (mm) | 10 | 3.86 | 0.35 | 9.0% | 0.32 | 8.2% |
| Eye Population: Without a Natural Lens | ||||||
| Axial Length (mm) | 10 | 23.526 | 0.009 | 0.0% | 0.007 | 0.0% |
| Keratometry SE (mm) | 10 | 7.637 | 0.020 | 0.3% | 0.020 | 0.3% |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | 6 | 90.7 | 8.7 | 9.5% | 8.6 | 9.5% |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | 4 | 58.5 | 8.5 | 14.5% | 7.8 | 13.4% |
| Anterior Chamber Depth(mm) | 9 | 4.617 | 0.039 | 0.9% | 0.039 | 0.9% |
| Central Corneal Thickness(μ) | 10 | 578.8 | 1.7 | 0.3% | 1.7 | 0.3% |
| White-to-White Distance(mm) | 10 | 11.98 | 0.16 | 1.3% | 0.16 | 1.3% |
| Pupil Diameter (mm) | 9 | 4.06 | 0.39 | 9.7% | 0.39 | 9.7% |
| Reproducibility | Repeatability | |||||
| Measure | Number ofEyes | Mean | SD | % CV | SD | % CV |
| Eye Population: Corneal Abnormality | ||||||
| Axial Length (mm) | 10 | 24.794 | 0.011 | 0.0% | 0.008 | 0.0% |
| Keratometry SE (mm) | 10 | 8.200 | 0.063 | 0.8% | 0.060 | 0.7% |
| Corneal Cylinder Axis (°),with Cylinder < 0.75 D | 4 | 69.3 | 8.6 | 12.4% | 8.6 | 12.4% |
| Corneal Cylinder Axis (°),with Cylinder ≥ 0.75 D | б | 71.9 | 6.3 | 8.8% | 6.1 | 8.5% |
| Anterior Chamber Depth(mm) | 10 | 3.546 | 0.021 | 0.6% | 0.020 | 0.6% |
| Central Corneal Thickness(μ) | 10 | 491.6 | 2.3 | 0.5% | 2.3 | 0.5% |
| White-to-White Distance(mm) | 10 | 12.50 | 0.07 | 0.5% | 0.07 | 0.5% |
| Pupil Diameter (mm) | 10 | 5.08 | 0.55 | 10.8% | 0.48 | 9.5% |
LenStar LS 900 Precision Analysis with Reproducibility and Repeatability Table 8: Coefficient of Variation (CV) (by Eve Population)
{18}------------------------------------------------
Table 8: LenStar LS 900 Precision Analysis with Reproducibility and Repeatability Coefficient of Variation (CV) (by Eye Population) - cont.
{19}------------------------------------------------
LenStar LS 900 Precision Analysis with Reproducibility and Repeatability
Coefficient of Variation (CV) (bv Eve Population) – cont. Table 8:
Source: Prec_by_Pop.sas (10MAR14 14:15)
{20}------------------------------------------------
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. Similarly, 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. The OPTICAL BIOMETER AL-Scan was unable to determine the anterior chamber depth for eyes without a natural lens.
IOL Power Calculations
IOL power calculations were performed for subjects in the Agreement Portion of the study. The calculations were successfully performed using the Regression. Regression II. Formula/T, Holladay, Hoffer-O, Haigis and Binkhorst Formulas for all eyes. In addition, the Camellin-Calossi and Shammas-PL IOL power calculation formulas were successfully performed for subjects in the corneal abnormality eye population that previously had keratorefractive surgery.
Safety Results
There were no safety events associated with the OPTICAL BIOMETER AL-Scan, the predicate device, or the reference devices utilized for this study.
Clinical Study Conclusions
The OPTICAL BIOMETER AL-Scan demonstrated agreement to the predicate device, LenStar LS 900, and the ultrasound reference device, PacScan 300A. The precision of the OPTICAL BIOMETER AL-Scan is considered to be comparable to the predicate device. The OPTICAL BIOMETER AL-Scan is capable of providing the specified IOL power calculations. The OPTICAL BIOMETER AL-Scan has the necessary accuracy and precision for its intended use.
CONCLUSION
(
In summary, Nidek Co., Ltd. is of the opinion that the OPTICAL BIOMETER AL-Scan does not introduce any new potential safety risks, is as effective and performs as well as the predicate devices, and concludes that the OPTICAL BIOMETER AL-Scan is substantially equivalent to the predicate devices.
SUMMARY
The OPTICAL BIOMETER AL-Scan is substantially equivalent to the predicate devices.
{21}------------------------------------------------
Image /page/21/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
June 11, 2014
Nidek Co., Ltd. c/o Ms. Darlene Crockett-Billig Experian Group, LLC. 755 N. Mathilda Ave., Suite 100 Sunnyvale, CA 94085
Re: K133132
Trade/Device Name: OPTICAL BIOMETER AL-Scan Regulation Number: 21 CFR 886.1850 Regulation Name: Biomicroscope, Slit-Lamp, AC-powered Regulatory Class: Class II Product Code: HJO, IYO Dated: May 6, 2014 Received: May 7, 2014
Dear Ms. Crockett-Billig:
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.
{22}------------------------------------------------
Page 2 - Ms. Darlene Crockett-Billig
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); 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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
..
Sincerely yours,
Deborah L. Falls -S
for Malvina B. Eydelman, M.D. Director
Division of Ophthalmic and Ear, Nose
and Throat Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
{23}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133132
Device Name OPTICAL BIOMETER AL-Scan
Indications for Use (Describe) 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Jan C. Callawav -S. 2014.06.05 13:34:23 -04'00'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
{24}------------------------------------------------
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) | ||||||||
| PeripheralVessel | Peripheral Vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
. …
.
.
{25}------------------------------------------------
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 | ColorDoppler | 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
§ 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.