ECHOSCAN, MODEL US-1800

K020876 · Nidek, Inc. · IYO · May 3, 2002 · Radiology

Device Facts

• Record ID: K020876
• Device Name: ECHOSCAN, MODEL US-1800
• Applicant: Nidek, Inc.
• Product Code: IYO · Radiology
• Decision Date: May 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Nidek ECHOSCAN Model US-1800 is a diagnostic instrument that is intended for use in the measurement of the axial length of the eye and corneal thickness.

Device Story

Diagnostic ultrasound instrument for ophthalmic biometry; measures axial length and corneal thickness. Operates via ultrasound pulse reflection; probe transmits pulses into eye; echoes reflected from ocular structures (cornea, lens, retina) received by probe. Device converts echoes to electronic signals; calculates tissue lengths based on time difference and known sonic velocities. Used in clinical settings by eye care professionals. Output displayed on LCD as amplitude and numerical measurements; assists clinicians in ocular assessment and IOL power calculations. Benefits include precise biometric data for surgical planning.

Clinical Evidence

Bench testing only. Includes electrical safety (EN 60601-1), electromagnetic compatibility (EN 60601-1-2), programmable electrical medical systems (EN 60601-1-4), and acoustic output measurements per 1998 FDA standard. No clinical data presented.

Technological Characteristics

Ultrasonic pulsed echo imaging system; 10 MHz (axial) and 11 MHz (pachymetry) transducers. Solid probe design. 10.4-inch color LCD display. Connectivity includes graphic thermal printer. Power: 115VAC. Software performs IOL power calculations (Hoffer-Q, Holladay, Binkhorst, SRK, SRK-II, SRK-T).

Indications for Use

Indicated for ophthalmic diagnostic ultrasound measurement of axial length and corneal thickness in patients requiring ocular biometry.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• ECHOSCAN Model US-2000 (K903326)

Submission Summary (Full Text)

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MAY 0-3-2002

NIDEK INCORPORATED

2.

Image /page/0/Picture/2 description: The image shows the text "K020874" in a handwritten style. Below this, the words "SPECIAL 510(K)" and "MODEL US-1800" are printed in a smaller, more formal font. The text suggests that the image may be related to a medical device or product that has been reviewed under section 510(k) of the Food and Drug Administration (FDA) regulations.

## 510(k) SUMMARY Nidek ECHOSCAN Model US-1800

### SUBMITTER INFORMATION 1.

| A. | Company Name: | Nidek Incorporated |
|----|--------------------------------|-----------------------------------------------------------------------|
| B. | Company Address: | 47651 Westinghouse Drive.<br>Fremont, CA 94539-7474 |
| C. | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D. | Contact Person: | Mr. Hiro Matsuzaki<br>Quality Assurance Manager<br>Nidek Incorporated |
| E. | Date Summary Prepared: | March 13, 2002 |
| | DEVICE IDENTIFICATION | |
| A. | Classification Name: | Ultrasonic Pulsed Echo Imaging System |
| B. | Trade/Proprietary Name: | Nidek ECHOSCAN Model US-1800 |
| C. | Device Classification: | Class II (per 21 CFR 892.1560) |

IYO D. Product Code:

### 3. SUBSTANTIAL EQUIVALENCE

The Nidek Incorporated US-1800 device is of comparable type and is substantially equivalent to the following predicate device:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|----------------------------|----------------|------------|--------------|
| ECHOSCAN Model US-<br>2000 | Nidek Co. Ltd. | K903326 | 11-21-90 |

342

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NIDEK INCORPORATED

#### DEVICE DESCRIPTION 4.

The EchoScan Model US-1800 is a diagnostic instrument that is indicated for use in the measurement of the axial length of the eye and corneal thickness.

The instrument is used to measure the axial length of the eye and the thickness of the cornea by the application of an ultrasound pulse reflection method. During axial length measurement, the cornea is touched with a probe, and the ultrasonic pulse sent by the transducer in the probe is reflected within each part of the eye (cornea, anterior chamber, lens, vitreous body, retina, etc.) and their echoes are received by the same probe. The received echoes are converted to electronic acoustic signals and indicated on the LCD as an amplitude. In addition, the time difference of each echo is measured and the length of each tissue (AC depth, lens thickness, vitreous body length, and axial length) is calculated according to the time difference and known inherent sonic velocity of each tissue.

For corneal thickness measurement, the ultrasonic pulses are transmitted when the probe is put on the cornea. Part of the pulses are reflected and the front and rear surface of the cornea. When the probe receives the reflected echoes, the time difference of each echo is measured and the corneal thickness is calculated according to the time difference and known inherent sonic velocity of the cornea.

#### 5. INTENDED USE

The Nidek ECHOSCAN Model US-1800 is a diagnostic instrument that is intended for use in the measurement of the axial length of the eye and corneal thickness.

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### TECHNOLOGICAL CHARACTERISTICS 6.

A comparison of the technological characteristics of the Nidek Model US-1800 and the predicate device Model US-2000 has been performed, and the results are summarized in the table below. The results of this comparison demonstrate that the Nidek Model US-1800 uses the same fundamental scientific technology and as the predicate device Model US-2000. The differences between the Nidek Model US-1800 and the predicate device are insignificant and do not affect the safety or effectiveness of the device.

| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:<br>US-1800 VS. US-2000 | | |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device Model<br>US-2000 (K903326) | Model US-1800 |
| AXIAL LENGTH MEASUREMENT: | | |
| Probe Type | Solid Probe | Solid Probe |
| Frequency | 10 MHz Transducer | 10 MHz Transducer |
| Internal Fixation | LED (Red) | LED (Red) |
| Measuring System | Ultrasonic Pulse Reflection Method | Ultrasonic Pulse Reflection Method |
| Measurable Value | Axial Length, Anterior Chamber<br>Depth, Lens Thickness, Vitreous<br>Length | Axial Length, Anterior Chamber<br>Depth, Lens Thickness, Vitreous<br>Body |
| Clinical Accuracy | ± 0.1 mm | ± 0.1 mm |
| Measurable Range | 36 mm | 12 to 40 mm |
| Amplifier Gain | Variable | Variable |
| Converted Ultrasonic<br>Velocity | Axial Length: 1550m/s (Phakic eye)<br>1532m/s (Aphakic Eye)<br>Anterior Chamber: 1532 m/s<br>Lens Thickness: 1641 m/s<br>Vitreous Body: 1532 m/s | Axial Length: 1550 m/s (Phakic Eye)<br>1532 m/s (Aphakic Eye)<br>2760 m/s (PMMA Pseudophakic<br>Eye)<br>Anterior Chamber: 1532 m/s<br>Lens Thickness: 1641 m/s<br>Vitreous Body: 1532 m/s |
| IOL Power Calculation | Binkhorst, Holladay, Modified<br>Regression II | Hoffer-Q, Holladay, Binkhorst, SRK<br>SRK-II, SRK-T |
| Display Resolution | 0.01 mm | 0.01 mm |
| CORNEAL THICKNESS MEASUREMENT: | | |
| Probe Type | Gel-Coupled Probe | Solid Probe |

| Probe Type | Gel-Coupled Probe | Solid Probe |
|----------------|-------------------|-----------------|
| Frequency | 11 MHz | 11 MHz |
| Probe Tip Size | 1.5 mm Diameter | 1.5 mm Diameter |

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:

:

| <b>COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:</b> |
|-----------------------------------------------------|
| <b>US-1800 VS. US-2000</b> |

| | Predicate Device Model<br>US-2000 (K903326) | Model US-1800 | | | |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------|-------|----------|-----------|
| Measuring System | Ultrasonic Pulse Reflection | Ultrasonic Pulse Reflection | | | |
| Measuring Point | 33 Points (max.) | 33 Points (max) | | | |
| Accuracy | $\pm 5\mu m$ | $\pm 5\mu m$ | | | |
| Measuring Range | 200 to 1300 $\mu m$ | 200 to 1300 $\mu m$ | | | |
| Converted Ultrasonic<br>velocity | 1640 m/s | 1640 m/s | | | |
| Display resolution | 1 $\mu m$ | 1 $\mu m$ | | | |
| Measuring Formats | 10 Programmable Formats | 10 Programmable Formats | | | |
| Monitor | CRT 5.5 inches | Color LCD<br>10.4 inches (640 x 480 dots) | | | |
| Printer | Thermal Printer | Graphic Thermal Printer | | | |
| Power Requirements | 100, 120, 220, or 240VAC 50 or 60Hz,<br>Less than 100VA | 115VAC, 50 or 60Hz,<br>50VA or less | | | |
| Dimensions | Main Body:<br>378 (W) x 300 (D) x 300 (H) mm<br>Keyboard:<br>370 (W) x 185 (D) x 38 (H) mm | 312 (W) x 262.5 (D) x 202.5 (H) mm | | | |
| Weight | 14 Kg | 6 Kg | | | |
| ACOUSTIC FIELD EMISSIONS COMPARISON: | | | | | |
| | Water | In Situ | Water | In Situ | |
| AXIAL LENGTH<br>MEASUREMENT PROBE: | | | | | |
| Spatial Peak-Temporal Average<br>Intensity (mW/cm2) | | 0.612 | 0.083 | 0.000531 | 0.0000734 |
| Spatial Peak-Pulse Average<br>Intensity (W/cm2) | | 7.55 | 1.02 | 1.48 | 0.205 |
| CORNEAL THICKNESS<br>MEASUREMENT PROBE: | | | | | |
| Spatial Peak-Temporal Average<br>Intensity (mW/cm2) | | 0.501 | 0.45 | 0.0186 | 0.0186 |
| Spatial Peak-Pulse Average<br>Intensity (W/cm2) | | 14.58 | 13.0 | 1.38 | 1.38 |

1

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#### 7. PERFORMANCE DATA

The following testing was performed on the Nidek Model US-1800 to demonstrate that it meets all specified requirements and is equivalent to the predicate device:

A. Electrical Safety Testing & Electromagnetic Compatibility

> The Nidek Model US-1800 was tested in accordance with EN 60601-1 and EN 60601-1-2, and was found to meet all requirements of both standards.

B. Programmable Electrical Medical Systems

> The Nidek Model US-1800 was tested in accordance with EN 60601-1-4 and was found to meet all requirements of the standard.

C. Acoustic Output Test Measurements

> The Nidek Model US-1800 was tested in accordance with the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (May 1998). The acoustic field emissions for the Model US-1800 were lower than the acoustic emissions for the predicate device Model US-2000.

#### CONCLUSIONS 8.

Nidek Incorporated has demonstrated through its evaluation of the Nidek Model US-1800 that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness.

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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**MAY 03 2002**

Nidek Incorporated % Ms. Carol L. Patterson Consultant Patterson Consulting Group, Inc. 21911 Erie Lane LAKE FOREST CA 92630

.

Re: K020876

Trade Name: Nidek EchoScan Model US-1800 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and 90 ITX Dated: March 28, 2002 Received: April 3, 2002

Dear Ms. Patterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the EchoScan Model US-1800, as described in your premarket notification:

Transducer Model Number

A-Scan Probe Pachymetry Probe

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it may or sucjoct to Cach of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may bublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be actived and I Drimination that your device complies with other requirements of the Act that I Dr Hab mace a cond regulations administered by other Federal agencies. You must or any I carated and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Pat 6077; laooning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers m / Ippendix O, (encrosse of Diagnostic Ultrasound Systems and Transducers." If the special beenting thanks areasans unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and rnowinently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone]. ..

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Nidek EchoScan Model US-1800

System

Appendix F

### Diagnostic Ultrasound Indications for Use Form

# Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | P | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

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

Additional Comments:_

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

-510(k) Numb

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A-Scan Probe

Appendix F

## Diagnostic Ultrasound Indications for Use Form

# Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | ✓ | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:_

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C Brogdon

(Division Sign-Off) Division of Reproductive, and Radiological Devices F-3510(k) Number

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Pachymetry Probe

Appendix F

### Diagnostic Ultrasound Indications for Use Form

## Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | P | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:_

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Hodgdon

(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices FB10(k) Number _