(92 days)
No
The description focuses on standard ultrasonic imaging and biometric measurement techniques, signal processing (frame-averaging, pseudo-color, gamma correction), and image post-processing tools (filters, calipers, etc.). There is no mention of AI, ML, deep learning, or any algorithms that learn from data to improve performance. The performance studies are clinical validations comparing the device to a predicate, not evaluations of AI/ML model performance.
No.
The device is used for diagnostic purposes by acquiring images and measurements; it does not provide therapy.
Yes.
The device is explicitly stated to be for "ophthalmological ultrasonic diagnosis" and "AL biometric measurement," which are diagnostic activities. It includes "B-mode ultrasonic section imaging" and "A-mode axial biometric parameter measurement" to aid in diagnosis and provides parameters for clinical diagnosis and intraocular lens implantation.
No
The device description explicitly lists hardware components including a main unit, power adaptor, probes, footswitch, keyboard, and mouse. While it includes software for image processing and data analysis, it is not solely software.
Based on the provided information, the MD-2300S Ultrasonic A/B Scanner for Ophthalmology is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The MD-2300S is an ultrasonic imaging instrument that directly examines the eye in vivo (within the living body). It uses ultrasound waves to create images and measure structures within the eye.
- The intended use and device description clearly indicate direct patient interaction. The device is applied to the patient's eye for diagnosis and measurement.
- There is no mention of analyzing biological samples. The device does not process blood, urine, tissue, or any other bodily fluid or material.
Therefore, the MD-2300S Ultrasonic A/B Scanner for Ophthalmology falls under the category of a medical imaging device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MD-2300S Ultrasonic A/B Scanner for Ophthalmology is intended for ophthalmological ultrasonic diagnosis and AL biometric measurement.
The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure.
The device should be operated by trained medical staff.
Patients with eyelid trauma and severe eye infection are prohibited from using B-Scan; and patients and cornea trauma are prohibited from using A-Biometric scan.
The A-biometric scan should be used cautiously on patients without independent behavior abilities or who are highly sensitive to contacting measurements, whose ineffective cooperation may result in inaccurate measurements,
Product codes
IYO, ITX
Device Description
MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging instrument specialized in ophthalmological diagnosis. It consists of a main unit, a power adaptor, a 10MHz B-Scan probe, a 20MHz B-Probe, a 10MHz A-Probe, a footswitch, a keyboard and a mouse.
MD-2300S includes two most popular operation modes for ophthalmological clinical diagnosis: B-mode ultrasonic section imaging and A-mode axial biometric parameter measurement.
The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure.
The part of B-mode uses 10MHz and 20MHz mechanical sector-scan probes for scanning. It acquires echo signal through ultrasonic pulse transmitting and receiving circuits; and converts it into digital information to save in FIFO; the data information of each echo line is transmitted to the embedded board through USB port. The application software running on Windows XPE platform realizes real time display, saving and case report generation for images of eye tissue.
The part of A-mode uses 10MHz A-biometric probe for A-mode scanning. It acquires echo signal through ultrasonic pulse transmitting and receiving circuits; and converts it into digital information to save in FIFO; the data information of each echo line is transmitted to the embedded board through USB port. Based on the interface reflection of ultrasound wave in three different tissues of anterior chamber, lens and vitreous body, the application software running on Windows XPE platform measures the transmitting time of ultrasound wave in different tissues and then calculates distances of each segment according to the acoustic velocity of different tissues to get the axial length and generates case report of A-biometry automatically, thus provides parameters for intraocular lens implantation operation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Ophthalmological/Eye, intraocular, retina, orbit
Indicated Patient Age Range
The sex and age of patients are not restricted.
Intended User / Care Setting
trained medical staff
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
B-Mode clinical effectiveness validation:
- Data Source: Tianjin Eye Hospital, outpatients and inpatients selected randomly.
- Sample Size: Not specified.
- Annotation Protocol: Clinical doctors validate the intended use according to the image quality of B-Scan on orbit and intraocular tissues. The selection of diseases should cover typical cases of ultrasonic diagnosis for ophthalmology.
A-Mode clinical effectiveness validation:
- Data Source: Tianjin Eye Hospital, outpatients and inpatients selected randomly.
- Sample Size: 50 eyes.
- Annotation Protocol: The expected user representatives use MD-2300S and ODM-2100 Ultrasonic A/B Scanner for Ophthalmology (K063433) to make axial length (AL) measurement on the same subject. The statistical processing results for AL measuring data with Bland-Altman statistical method should have no obvious difference.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical tests (Safety, EMC, Acoustic Output, Biocompatibility, Software Verification & Validation) and Clinical Evaluation/Validation.
Sample Size:
- B-Mode Clinical Validation: Not specified (randomly selected outpatients and inpatients).
- A-Mode Clinical Validation: 50 eyes (randomly selected outpatients and inpatients).
Key Results:
- Non-clinical tests:
- Safety (IEC60601-1, IEC 60601-2-37) and EMC (IEC 60601-1-2) testing results comply with requirements.
- Acoustic output parameters comply with IEC 60601-2-37 and FDA Guidance.
- Biocompatibility (ISO 10993) tests (in vitro cytotoxicity, skin sensitization, irritation) conform to requirements.
- Software and essential performance passed verification and validation, complying with requirements.
- Clinical Evaluation/Validation:
- B-Mode: "the B-Scan image of MD-2300S can display the intraocular structure clearly and provide valuable reference base for clinical diagnosis. The image resolution as well as the scanning scope, frame rate, gain adjustment, saving, image processing, cineloop, case management and other functions are able to satisfy the clinical demands."
- A-Mode: "the result of statistical processing for the AL measuring data showed that the measuring results of both products have good consistency."
- The intended use of MD-2300S meets clinical requirements and no new unacceptable risks were found.
- The MD-2300S is substantially equivalent in safety, effectiveness and performance to the legally marketed predicate devices.
AUC, MRMC, standalone performance: Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of three human profiles facing to the right, with flowing lines extending from their heads.
November 17, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MEDA CO.,LTD. % Mr. Kai Chen President Medtech International, Inc. 13505 Broadfield Drive POTOMAC MD 20854
Re: K152318 Trade/Device Name: MD-2300S Ultrasonic A/B Scanner for Ophthalmology Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: October 26, 2015 Received: November 2, 2015
Dear Mr. Chen:
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.
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oolo
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
MD-2300S Ultrasonic A/B Scanner for Ophthalmology
Indications for Use (Describe)
MD-2300S Ultrasonic A/B Scanner for Ophthalmology is intended for ophthalmological ultrasonic diagnosis and AL biometric measurement.
The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure.
The device should be operated by trained medical staff.
Patients with eyelid trauma and severe eye infection are prohibited from using B-Scan; and patients and cornea trauma are prohibited from using A-Biometric scan.
The A-biometric scan should be used cautiously on patients without independent behavior abilities or who are highly sensitive to contacting measurements, whose ineffective cooperation may result in inaccurate measurements,
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------- |
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Indications for Use Statement
MD-2300S Ultrasonic A/B Scanner for Ophthalmology
Diagnostic Ultrasound Indications for Use Format
MD-2300S Ultrasonic A/B Scanner for Ophthalmology System:
Transducer: 10MHz B-Probe (Prb2100B/10)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | P | ||||||
| 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 (Bladder) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
4
510(k) Submission of MEDA. CO., LTD
Indications for Use Statement
MD-2300S Ultrasonic A/B Scanner for Ophthalmology
System: MD-2300S Ultrasonic A/B Scanner for Ophthalmology
Transducer: 20MHz B-Probe (Prb2100B/20)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | P | |||||||
| 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 (Bladder) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
5
510(k) Submission of MEDA. CO., LTD
Indications for Use Statement
MD-2300S Ultrasonic A/B Scanner for Ophthalmology
System: MD-2300S Ultrasonic A/B Scanner for Ophthalmology
Transducer: Prb1000A/10-C
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (A-mode) | |||||||||
| Ophthalmic | Ophthalmic | P | |||||||
| 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 (Bladder) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
6
510(k) SUMMARY
1. Submitter Information
| Name: | MEDA Co., Ltd. | |||||
|---|---|---|---|---|---|---|
| Address: | F2C, F3D, F4C, F5, F6C, Building C2, Xinmao Science Skill Park | |||||
| Huayuan Industry Development Area, Tianjin 300384, P. R. China | ||||||
| Phone: | +86-22-83713808 | |||||
| Fax: | +86-22-83713880 | |||||
| Contact person: | KAI CHEN | |||||
| Medtech International, Inc. and | ||||||
| United States Designated Agent of MEDA Co., Ltd. | ||||||
| Address: 13505 Broadfield Drive, Potomac, MD 20854 | ||||||
| Tel: 240 888 4001 | ||||||
| Fax: 301 251 2881 | ||||||
| Email: Drkaichen@gmail.com |
Date Prepared: August 5, 2015
2. Device Information
Trade Name/Common Name: MD-2300S Ultrasonic A/B Scanner for Ophthalmology
| Classification Name: Ultrasonic Pulsed Echo Imaging System | |||
|---|---|---|---|
| Diagnostic Ultrasound Transducer |
Regulation Number: 892.1560; 892.1570
Product Code: IYO; ITX
3. Predicate Devices
- For B-mode and IOL Calculation (for the cases that patients have undergone refractive surgery)
Manufacturer: Quantel Medical Inc.
Trade Name: "Aviso" Ophthalmic Ultrasound System
Common Name: Ophthalmic A and B scan ultrasound System
510(k) Number: K051851
Although "Aviso" Ophthalmic Ultrasound System has A-mode, it is "STD-A" A-scan 8MHz which is different from the A-mode of MD-2300S. So, for A-mode, we selected the following product produced by our company:
- For A-mode and IOL Calculation (for the cases that patients have not undergone refractive surgery)
Manufacturer: MEDA CO., LTD
Device Name: MD-1000A Ultrasonic Biometer for Ophthalmology
510(k) Number: K121243
7
4. Device Description
MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging instrument specialized in ophthalmological diagnosis. It consists of a main unit, a power adaptor, a 10MHz B-Scan probe, a 20MHz B-Probe, a 10MHz A-Probe, a footswitch, a keyboard and a mouse.
MD-2300S includes two most popular operation modes for ophthalmological clinical diagnosis: B-mode ultrasonic section imaging and A-mode axial biometric parameter measurement.
The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure.
The part of B-mode uses 10MHz and 20MHz mechanical sector-scan probes for scanning. It acquires echo signal through ultrasonic pulse transmitting and receiving circuits; and converts it into digital information to save in FIFO; the data information of each echo line is transmitted to the embedded board through USB port. The application software running on Windows XPE platform realizes real time display, saving and case report generation for images of eye tissue.
The part of A-mode uses 10MHz A-biometric probe for A-mode scanning. It acquires echo signal through ultrasonic pulse transmitting and receiving circuits; and converts it into digital information to save in FIFO; the data information of each echo line is transmitted to the embedded board through USB port. Based on the interface reflection of ultrasound wave in three different tissues of anterior chamber, lens and vitreous body, the application software running on Windows XPE platform measures the transmitting time of ultrasound wave in different tissues and then calculates distances of each segment according to the acoustic velocity of different tissues to get the axial length and generates case report of A-biometry automatically, thus provides parameters for intraocular lens implantation operation.
5. Indications for Use
MD-2300S Ultrasonic A/B Scanner for Ophthalmology is intended for ophthalmological ultrasonic diagnosis and AL biometric measurement.
The device should be operated by trained medical staff.
Patients with eyelid trauma and severe eye infection are prohibited from using B-Scan; and patients with keratitis and cornea trauma are prohibited from using A-Biometric scan.
The A-biometric scan should be used cautiously on patients without independent behavior abilities or who are highly sensitive to contacting measurements, whose ineffective cooperation may result in inaccurate measurements.
6. Technological characteristics
a) Safety
The electrical, mechanical, environmental safety testing were conducted according to standard IEC60601-1: 2005 + AM1: 2012 and IEC 60601-2-37: 2007.
The EMC testing was conducted in accordance with standard IEC 60601-1-2: 2007.
The safety standards performed by the MD-2300S are substantially equivalent to the predicate products.
8
b) Characteristics
B-mode:
-
- Scanning method: mechanical sector scan
- Display mode: B, B+A 2.
-
- Scanning Angle: 53°
Display depth adjustable range: 10MHz: 28mm60mm; 20MHz: 19 mm40mm
-
- Variable delayed depth: 10MHz: 0 mm
15 mm; 20MHz: 0 mm10mm
- Variable delayed depth: 10MHz: 0 mm
- Adjustable Gain Scope: 1-105dB 5.
-
- TGC: -20dB dynamic range, manual sectional adjustment (6-section adjustable)
-
- Grey Scale: 256 Levels
-
- Frame Rate: 10 fps
-
- Image saving: 100 images
-
- Dynamic loop: 10s/100 images, loop or frame by frame playback
-
- Image processing and Signal Post-processing: Frame-Averaging, Pseudo-Color Codes, and Gamma Correction
-
- Axial Resolution
- a) 10MHz Probe: No more than 0.1mm;
- b) 20MHz Probe: No more than 0.08mm,
-
- Lateral Resolution
- a) 10MHz Probe: No more than 0.2mm;
- b) 20MHz Probe: No more than 0.15mm.
-
- Geometric Position Accuracy for Image Measurement
- a) Horizontal: No more than 5%
- b) Vertical: No more than 3%
A-mode:
- AL Biometric Measuring Range: Axial Length (AL): 15mm-40mm; 1.
-
- AL Biometric Measuring Accuracy: No more than ±0.05mm.
- Total gain: 98dB, users adjustable gain scope: 1~60dB 3.
-
- Measuring mode: 5 groups (Normal, Aphakic, Special, Cataract and manual measurement)
-
- Measuring method: Immersion/Contact
-
- IOL calculation: SRK-T, SRK-II, BINK-II, HOLLADAY, HOFFER-Q and HAIGIS
-
- Support IOL calculation after refractive surgery, two groups of formulas can be calculated contrastively and displayed simultaneously.
-
- Automatic measurement and 10 groups averaging and display standard deviation.
-
- 8 groups of IOL constants can be stored.
For the A-mode part of MD-2300S, the main specifications and IOL calculation for cases that have not undergone refractive surgery are substantially equivalent with those of MD-1000A;
9
whereas, the IOL calculation for cases that have undergone refractive surgery is identical with that of the Aviso.
For the B-mode part of MD-2300S, the display depth, focus, scanning angle, adjustable gain and TGC are substantially equivalent with those of the Aviso.
| Model | Subject Device | Predicate Device | |||
|---|---|---|---|---|---|
| Item | MD-2300S | Aviso | MD-1000A | ||
| B-Scan | 10MHz | Scanning angle | 53° | 50° | N/A |
| Display depth | 28mm to 60mm; | 20 to 60 mm | |||
| Focus | 20 to 26 mm | 24 to 26 mm | |||
| Axial resolution | 0.1 mm | 0.2 mm | |||
| Lateral resolution | 0.2 mm | 0.6 mm | |||
| 20MHz | Scanning angle | 53° | 50° | N/A | |
| Display depth | 19 mm to 40mm | — | |||
| Focus | 20 to 26 mm | 24 to 26 mm | |||
| Axial resolution | 0.08 mm | 0.1 mm | |||
| Lateral resolution | 0.15 mm | 0.25 mm | |||
| General | |||||
| features | Adjustable gain scope | 1-105dB | 20 to 110 dB | ||
| Time Gain Control | -20dB~20 dB | 0 to 30 dB | |||
| Storage capacity | Unlimited storage | ||||
| capacity for still | |||||
| images and video | |||||
| sequences (up to 10 | |||||
| second duration) | Unlimited storage | ||||
| capacity for still | |||||
| images and video | |||||
| sequences (up to 40 | |||||
| second duration) | |||||
| Image post-processing | |||||
| tools | Algorithmic & color | ||||
| image filters , calipers, | |||||
| areas, angles, | |||||
| markers, comments, | |||||
| magnify | Algorithmic & color | ||||
| image filters, calipers, | |||||
| areas, angles, | |||||
| markers, comments | |||||
| Probe | Total gain of receiver | 98dB | N/A | 100dB | |
| Adjustable gain scope | 1-60dB | N/A | 0-50dB | ||
| A-Scan | Axial | ||||
| length | |||||
| measure | |||||
| ments | Calculation of SD and AV | Automatic calculation | |||
| of standard deviation | |||||
| and average total | |||||
| length (series of 10 | |||||
| measurements) | N/A | Automatic calculation | |||
| of standard deviation | |||||
| and average total | |||||
| length (series of 8 | |||||
| measurements) | |||||
| User interface touch screen size | 12.1" | 3.4" (W) x 4.5" (H) | 6.4" | ||
| Power Adapter | FSP065-DHBM1(12V) | — | HES49-12040 12V/4A | ||
| (UL E164433) | |||||
| Foot Switch | MD-1000 ES 2 | — | MD-1000 ES 1 |
The differences of MD-2300S and its predicate devices are as follows:
From the above comparison, the axial resolution and lateral resolution of MD-2300S are better than those of the Aviso. In the field of storage capacity and image post-processing, MD-2300S provides the same function with those of the Aviso. MD-2300S added the function of "magnify"
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in post-processing tools.
The MD-2300S, Aviso and MD-1000A use different power adapters and foot switches, and the screen size is different, but they all meet the requirements of IEC 60601-1.
While there are some differences between the MD-2300S and its predicate devices, they do not affect the safety or effectiveness.
7. Brief Discussion of Non-clinical Tests
The safety and EMC testing were conducted on the MD-2300S and the testing results comply with the requirements of IEC 60601-1 and IEC 60601-2-37 for safety and the IEC 60601-1-2 for EMC. The acoustic output parameters comply with the requirements of IEC 60601-2-37 and FDA Guidance on diagnostic ultrasound systems and transducers.
The biocompatibility evaluation has been made according to ISO 10993. Tests for in vitro cytotoxicity, skin sensitization and irritation were conducted on the patient-contacting materials, and they conform to the biocompatibility requirements.
The software and essential performance have passed verification and validation, and the results comply with the requirements.
8. Brief Discussion of Clinical Evaluation and Validation
The clinical literature retrieval was conducted and Clinical Evaluation Report was completed according to the requirements of 93/42/EEC MEDDEV. 2.7.1 Rev.3. It showed that MD-2300S conforms to the requirements of its intended use and no unacceptable risks were found.
As part of the product design validation, we have entrusted Tianjin Eye Hospital to make clinical effectiveness validation. Following is a summary of the details about the clinical validation study:
B-Mode: select randomly outpatients and inpatients that need to make B-mode ultrasonic examination, the selection of diseases should cover typical cases of ultrasonic diagnosis for ophthalmology. Use 10MHz B-Probe of MD-2300S to make ultrasonic inspection; if further details of intraocular and retina tissues need to be observed, use 20MHz B-Probe. Clinical doctors validate the intended use according to the image quality of B-Scan on orbit and intraocular tissues.
A-Mode: the expected user representatives use MD-2300S and ODM-2100 Ultrasonic A/B Scanner for Ophthalmology (K063433) which was already cleared to make axial length (AL) measurement on the same subject.
Select 50 eyes randomly from outpatients and inpatients that need to measure axial length (AL). The sex and age of patients are not restricted.
The statistical processing results for AL measuring data with Bland-Altman statistical method should have no obvious difference.
The validation results show:
B-Mode: the B-Scan image of MD-2300S can display the intraocular structure clearly and provide valuable reference base for clinical diagnosis. The image resolution as well as the
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scanning scope, frame rate, gain adjustment, saving, image processing, cineloop, case management and other functions are able to satisfy the clinical demands.
A-Mode: the result of statistical processing for the AL measuring data showed that the measuring results of both products have good consistency.
The intended use of MD-2300S meets the clinical requirements and no new unacceptable risks were found.
9. Conclusions
The results of non-clinical tests as well as clinical evaluation and validation demonstrate that the MD-2300S Ultrasonic A/B Scanner for Ophthalmology is substantially equivalent in safety, effectiveness and performance to the legally marketed predicate devices.