(46 days)
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.
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.
Here's an analysis of the Nidek ECHOSCAN Model US-1800 acceptance criteria and performance study based on the provided text, structured to answer your specific questions:
The document provided is a 510(k) summary for the Nidek ECHOSCAN Model US-1800, which is a submission to the FDA to demonstrate substantial equivalence to a predicate device. As such, the "acceptance criteria" discussed are primarily focused on demonstrating that the new device shares fundamental technological characteristics with, and is as safe and effective as, its predicate. This is not a clinical trial report with predetermined performance metrics for a novel AI algorithm. Instead, it's a comparison to an already cleared device.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The term "acceptance criteria" in this context refers to the technological specifications and performance characteristics that the new device (US-1800) must meet to be considered substantially equivalent to the predicate device (US-2000). The "reported device performance" is how the US-1800 measures up against these established characteristics of the predicate, or to relevant standards.
| Feature / Criterion | Acceptance Criteria (Predicate Device US-2000) | Reported Device Performance (Nidek ECHOSCAN 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 Depth, Lens Thickness, Vitreous Length | Axial Length, Anterior Chamber Depth, Lens Thickness, Vitreous Body |
| Clinical Accuracy | ± 0.1 mm | ± 0.1 mm |
| Measurable Range | 36 mm | 12 to 40 mm |
| Amplifier Gain | Variable | Variable |
| Converted Ultrasonic Velocity (Axial Length - Phakic) | 1550m/s | 1550 m/s |
| Converted Ultrasonic Velocity (Axial Length - Aphakic) | 1532m/s | 1532 m/s |
| Converted Ultrasonic Velocity (AC) | 1532 m/s | 1532 m/s |
| Converted Ultrasonic Velocity (Lens Thickness) | 1641 m/s | 1641 m/s |
| Converted Ultrasonic Velocity (Vitreous Body) | 1532 m/s | 1532 m/s |
| IOL Power Calculation | Binkhorst, Holladay, Modified Regression II | Hoffer-Q, Holladay, Binkhorst, SRK, SRK-II, SRK-T |
| Display Resolution | 0.01 mm | 0.01 mm |
| CORNEAL THICKNESS MEASUREMENT: | ||
| Probe Type | Gel-Coupled Probe | Solid Probe |
| Frequency | 11 MHz | 11 MHz |
| Probe Tip Size | 1.5 mm Diameter | 1.5 mm Diameter |
| Measuring System | Ultrasonic Pulse Reflection | Ultrasonic Pulse Reflection |
| Measuring Point | 33 Points (max.) | 33 Points (max) |
| Accuracy | ± 5 µm | ± 5 µm |
| Measuring Range | 200 to 1300 µm | 200 to 1300 µm |
| Converted Ultrasonic Velocity | 1640 m/s | 1640 m/s |
| Display resolution | 1 µm | 1 µm |
| Measuring Formats | 10 Programmable Formats | 10 Programmable Formats |
| OTHER: | ||
| Electrical Safety | Compliance with EN 60601-1 and EN 60601-1-2 standards | Met all requirements of EN 60601-1 and EN 60601-1-2 |
| Programmable Electrical Medical Systems | Compliance with EN 60601-1-4 standard | Met all requirements of EN 60601-1-4 |
| Acoustic Output Field Emissions (Axial Length Probe) | Not explicitly stated as acceptance criteria, but predicate values are given | Spatial Peak-Temporal Average Intensity (mW/cm2): 0.083 (Water), 0.000531 (In Situ) Spatial Peak-Pulse Average Intensity (W/cm2): 1.02 (Water), 0.205 (In Situ) (Lower than predicate) |
| Acoustic Output Field Emissions (Corneal Thickness Probe) | Not explicitly stated as acceptance criteria, but predicate values are given | Spatial Peak-Temporal Average Intensity (mW/cm2): 0.45 (Water), 0.0186 (In Situ) Spatial Peak-Pulse Average Intensity (W/cm2): 13.0 (Water), 1.38 (In Situ) (Lower than predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document is a 510(k) summary focused on demonstrating substantial equivalence through technological comparison and compliance with standards. It does not describe a clinical study with a test set of patient data. Instead, the "testing" performed was:
- Electrical Safety Testing: In accordance with EN 60601-1 and EN 60601-1-2.
- Programmable Electrical Medical Systems testing: In accordance with EN 60601-1-4.
- Acoustic Output Test Measurements: In accordance with the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (May 1998).
Therefore, there is no patient-based test set or associated sample size, or data provenance (e.g., country of origin, retrospective/prospective) mentioned in this document. The "tests" were device-centric against engineering and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As there was no patient-based clinical "test set" and no "ground truth" derived from patient data in the context of diagnostic accuracy, this information is not applicable to this document. The "ground truth" for the engineering performance tests would be the established values and limits within the specified international standards (EN 60601-1, EN 60601-1-2, EN 60601-1-4, and the Acoustic Output Measurement Standard). The experts involved would be the test engineers performing the measurements and verifying compliance with these standards.
4. Adjudication Method for the Test Set
Since there was no patient-based clinical "test set" requiring interpretation or consensus among experts for ground truth, an adjudication method like 2+1 or 3+1 is not applicable. The "adjudication" was based on whether the device's measured performance met the technical specifications and safety limits defined by the referenced standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document is a 510(k) summary focusing on demonstrating substantial equivalence based on technological characteristics and compliance with safety standards, not a clinical study comparing the diagnostic performance of human readers with and without AI assistance. This device is an ultrasound measurement instrument, not an AI-powered diagnostic image interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. The Nidek ECHOSCAN Model US-1800 is a diagnostic ultrasound instrument that performs measurements (not an AI algorithm that renders a diagnostic interpretation). Its "performance" is its ability to accurately measure axial length and corneal thickness, which are direct physical measurements, not AI-driven interpretations. The intrinsic accuracy of these measurements (±0.1mm for axial length, ±5µm for corneal thickness) is a standalone performance metric for the device, but it's not an AI algorithm.
7. The Type of Ground Truth Used
For the performance metrics listed (e.g., Clinical Accuracy ± 0.1 mm, Accuracy ± 5 µm), the "ground truth" implicitly refers to the physical accuracy of the measurement when compared against a known standard or highly precise reference measurement. This is standard metrological practice, not expert consensus, pathology, or outcomes data in the clinical diagnostic sense. For the other tests (electrical safety, EMC, acoustic output), the "ground truth" is compliance with the limits and requirements set forth in the specific international and acoustic measurement standards referenced (EN 60601-1, EN 60601-1-2, EN 60601-1-4, and the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment).
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI algorithm and no training set, this question does not apply.
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MAY 0-3-2002
NIDEK INCORPORATED
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.Fremont, CA 94539-7474 |
| C. | Company Phone:Company Fax: | (510) 353-7722(510) 226-5750 |
| D. | Contact Person: | Mr. Hiro MatsuzakiQuality Assurance ManagerNidek 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-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:US-1800 VS. US-2000 | ||
|---|---|---|
| Predicate Device ModelUS-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 ChamberDepth, Lens Thickness, VitreousLength | Axial Length, Anterior ChamberDepth, Lens Thickness, VitreousBody |
| Clinical Accuracy | ± 0.1 mm | ± 0.1 mm |
| Measurable Range | 36 mm | 12 to 40 mm |
| Amplifier Gain | Variable | Variable |
| Converted UltrasonicVelocity | Axial Length: 1550m/s (Phakic eye)1532m/s (Aphakic Eye)Anterior Chamber: 1532 m/sLens Thickness: 1641 m/sVitreous Body: 1532 m/s | Axial Length: 1550 m/s (Phakic Eye)1532 m/s (Aphakic Eye)2760 m/s (PMMA PseudophakicEye)Anterior Chamber: 1532 m/sLens Thickness: 1641 m/sVitreous Body: 1532 m/s |
| IOL Power Calculation | Binkhorst, Holladay, ModifiedRegression II | Hoffer-Q, Holladay, Binkhorst, SRKSRK-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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:
:
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: |
|---|
| US-1800 VS. US-2000 |
| Predicate Device ModelUS-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 Ultrasonicvelocity | 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 LCD10.4 inches (640 x 480 dots) | |||
| Printer | Thermal Printer | Graphic Thermal Printer | |||
| Power Requirements | 100, 120, 220, or 240VAC 50 or 60Hz,Less than 100VA | 115VAC, 50 or 60Hz,50VA or less | |||
| Dimensions | Main Body:378 (W) x 300 (D) x 300 (H) mmKeyboard: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 LENGTHMEASUREMENT PROBE: | |||||
| Spatial Peak-Temporal AverageIntensity (mW/cm2) | 0.612 | 0.083 | 0.000531 | 0.0000734 | |
| Spatial Peak-Pulse AverageIntensity (W/cm2) | 7.55 | 1.02 | 1.48 | 0.205 | |
| CORNEAL THICKNESSMEASUREMENT PROBE: | |||||
| Spatial Peak-Temporal AverageIntensity (mW/cm2) | 0.501 | 0.45 | 0.0186 | 0.0186 | |
| Spatial Peak-Pulse AverageIntensity (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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212. ..
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | 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-skeletalConventional | |||||||||||
| 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 _
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.