Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P

K222787 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · IYO · Jan 9, 2023 · Radiology

Device Facts

• Record ID: K222787
• Device Name: Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P
• Applicant: Chongqing Sunkingdom Medical Instrument Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Jan 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

Sunkingdom Ophthalmic Ultrasound Examination Instrument can be used in ophthalmology clinical application under A(A-scan echography), P(Pachymetry) and B(B-scan echography) operation modes. A-scan echography applies to axial length measurement, including anterior chamber depth, crystal thickness, vitreous length; Pachymetry applies to corneal thickness measurement;and B-scan echography applies to ocular ultrasound imaging. The device should be operated by doctors or appropriately-trained healthcare professional and should be used in hospitals or large clinics. It is prohibited to use the device on patients with active ocular inflammatory lesions (such as acute conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis, iridocyclitis etc);and this device cannot be used on fetuses.

Device Story

Ophthalmic ultrasound system (models SK-3000A/B/C, SK-2000AP/A/P) utilizes A-scan, B-scan, and Pachymetry modes for ocular diagnostics. 10MHz A-probes measure axial length; 10MHz B-probes generate sectional echograms; 20MHz Pachymeter probes measure corneal thickness via time-interval reflection analysis. Operated by physicians or trained healthcare professionals in hospitals/clinics. System records patient data, supports video printer output, and interfaces with computer software for record management. Provides clinicians with biometric measurements and ultrasound images to assist in ophthalmic diagnosis and treatment planning.

Clinical Evidence

No clinical data. Bench testing only. Performance supported by biocompatibility testing (cytotoxicity, irritation, sensitization per ISO 10993), electrical safety/EMC testing (ANSI/AAMI/IEC 60601-1, 60601-1-2), and acoustic output testing (Track 1 per IEC 60601-2-37).

Technological Characteristics

Ultrasound imaging system; 10MHz (A/B) and 20MHz (P) probes. B-mode: 53° scan angle, 12 fps, 256 gray levels. A-mode: 15-35mm range, IOL calculation formulas. Pachymetry: 0.3-1.5mm range. Connectivity: video printer, computer interface. Power: 100-240V AC. Biocompatibility per ISO 10993. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37.

Indications for Use

Indicated for ophthalmology clinical applications including axial length measurement (anterior chamber depth, crystal thickness, vitreous length), corneal thickness measurement, and ocular ultrasound imaging. Contraindicated for patients with active ocular inflammatory lesions (e.g., conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis, iridocyclitis) and for use on fetuses.

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

• ODM-2100 & ODM-2200 Ultrasonic A/B Scan system for Ophthalmology (K063433)

Reference Devices

• MD-1000P Ultrasonic Pachymeter (K121243)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 9, 2023

Chongqing Sunkingdom Medical Instrument Co., Ltd. % Shulin Guo Registration manager 1010, Block A of China Resource Center No.55 of XieJiaWan JiuLongPo Chongaing, 400050 CHINA

## Re: K222787

Trade/Device Name: Sunkingdom Ophthalmic Ultrasound Examination Instrument: SK-3000A. SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: September 1, 2022 Received: December 8, 2022

Dear Shulin Guo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Yanna S. Kang -S

Yanna Kang Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222787

#### Device Name

Sunkingdom Ophthalmic Ultrasound Examination Instrument: SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P

#### Indications for Use (Describe)

Sunkingdom Ophthalmic Ultrasound Examination Instrument can be used in ophthalmology clinical application under A(A-scan echography), P(Pachymetry) and B(B-scan echography) operation modes. A-scan echography applies to axial length measurement, including anterior chamber depth, crystal thickness, vitreous length; Pachymetry applies to corneal thickness measurement; and B-scan echography applies to ocular ultrasound imaging.

The device should be operated by doctors or appropriately-trained healthcare professional and should be used in hospitals or large clinics. It is prohibited to use the device on patients with active ocular inflammatory lesions (such as acute conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis etc);and this device cannot be used on fetuses.

Type of Use (Select one or both, as applicable)

| <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with 21 CFR 807.92.

| Submitter (510K Owner): | Chongqing Sunkingdom Medical Instrument Co., Lt<br>35-2, YingTian GuangDian GongGu, CaiJiaGang<br>Industrial Zone, BeiBei District, Chongqing, China<br>Contact Person: Shulin Guo<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail]<br>Registration #: 3010610157 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dayna Valente<br>83 Gerber RD West South Windsor<br>Connecticut, 06074, USA<br>Phone: [phone]<br>Fax: [phone] |
| Date of Preparation: | August 25th, 2022 |
| Proprietary Name: | Sunkingdom Ophthalmic Ultrasound Examination<br>Instrument SK-3000A, SK-3000B, SK-3000C,<br>SK-2000AP, SK-2000A, SK-2000P |
| Common or Usual Name: | Ultrasonic pulsed echo imaging system |
| Classification Name: | System, Imaging, Pulsed Echo, Ultrasonic<br>21CFR 892.1560, 21CFR 892.1570<br>Class II |
| Product Code: | IYO, ITX |
| Review Panel: | Radiology |

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# Predicate Devices

| Main predicate device | ODM-2100 & ODM-2200 Ultrasonic A/B<br>Scan system for Ophthalmology |
|-----------------------|---------------------------------------------------------------------|
| Manufacturer | MEDA CO., LTD |
| K# | K063433 for 10MHz A scan and 10MHz B scan |

| Reference device | MD- 1000P Ultrasonic Pachymeter |
|------------------|---------------------------------|
| Manufacturer | MEDA CO., LTD |
| K# | K121243 for 20MHz P scan |

# Intended Use/ Indication for use

Sunkingdom Ophthalmic Ultrasound Examination Instrument can be used in ophthalmology clinical application under A(A-scan echography), P(Pachymetry) and B(B-scan echography) operation modes. A-scan echography applies to axial length measurement, including anterior chamber depth, crystal thickness, vitreous length; Pachymetry applies to corneal thickness measurement;and B-scan echography applies to ocular ultrasound imaging.

The device should be operated by doctors or appropriately-trained healthcare professional and should be used in hospitals or large clinics. It is prohibited to use the device on patients with active ocular inflammatory lesions (such as acute conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis, iridocyclitis etc);and this device cannot be used on fetuses.

## Device Description

Sunkingdom Ophthalmic Ultrasound Examination Instrument, models SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P is an ultrasound imaging system intended for use in ophthalmic applications.

Model SK-3000A with A, P, B probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length), corneal thickness and to ocular ultrasound imaging.

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Model SK-3000B with A, B probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length) and to ocular ultrasound imaging.

Model SK-3000C with B probe is used to ocular ultrasound imaging.

Model SK-2000AP with A, P probes is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length) and corneal thickness.

Model SK-2000A with A probe is used to biometric measurement of axial length (including anterior chamber depth, crystal thickness and vitreous length).

Model SK-2000P with P probe is used to biometric measurement of corneal thickness.

Among them, the 10 MHz A probe transmits ultrasound wave into eye tissue, and measure the duration of the acoustic pulse from the A probe to anterior chamber, lens and vitreum and back to the A probe. This mode is mainly used for biometric measurement axial length, which including anterior chamber depth, lens thickness, vitreous depth of eyes.

The 10 MHz B probe transmits ultrasound wave into eye tissue, and to form a sectional echogram by means of the brightness of echogenic dots. This mode is mainly used for ocular ultrasound imaging.

The 20 MHz Pachymeter probe is to get the thickness of corneal by measurement of the time interval between the anterior and posterior interface reflection waves of cornea. This mode is mainly used for biometric measurement of corneal thickness.

All probes can work independently, and record patient data and connect to a video printer to print image report. It also can work with computer which has the software installed to manage patient record.

This device must be used by trained and qualified medical personnel.

Contraindication: Patients with active ocular inflammatory lesions (such as acute conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis, iridocyclitis etc) and the fetal cannot use the device.

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#### Technological characteristics

#### B mode:

Nominal frequency: 10MHz Detection depth: ≥50mm Lateral Resolution: ≤ 0.4mm Axial resolution: ≤0.2mm Horizontal geometric position accuracy: ≤ 10% Vertical geometric location accuracy: ≤5% Blind zone: <4mm Scan Mode: Magnetic drive motor Gain range: 0- 105dB Gray Levels: 256 Angle of scan: 53° Image Freezing: 20 pcs Display Mode: B. B+A Frame rate: ≥ 12 frames/s

#### A mode:

Nominal frequency: 10MHz Measurement error: ≤ 0.05mm Measurement Range: no narrower than 15mm~35mm Gain range: 0-99dB IOL Calculation: 6 different calculation formulas Calculation Method: mean, standard Deviation

#### Pachymeter:

Nominal frequency: 20MHz Measurement error: ≤0.01mm Measurement: Range: no narrower than 0.3mm ~1.5mm Gain range: 0-99dB

## Other Parameter:

Ambient temperature: 5C ~ 40C Relative humidity: ≤85% Atmospheric pressure: 700 hPa ~ 1060 hPa Power supply: AC100-240 V, 50/60 Hz

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# Substantial Equivalence Disscussion

The Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P are substantially equivalent to the main predicate device ODM-2100&ODM-2200 Ultrasonic A/B Scan system for Ophthalmology and reference predicate device MD- 1000P Ultrasonic Pachymeter, as they have the exactly same indication for use, working principle, also Sunkingdom Ophthalmic Ultrasound Examination Instrument use similar technology and perform similar functions to provide the physician with the intraocular pressure to make a diagnosis.

The Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicates.

| Device features | Main Predicate device | Reference Predicate device | Subject device |
|------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | ODM-2100& ODM-2200<br>Ultrasonic A/B Scan<br>system for<br>Ophthalmology | MD- 1000P<br>Ultrasonic<br>Pachymeter | Sunkingdom<br>Ophthalmic<br>Ultrasound<br>Examination<br>Instrument SK-<br>3000A, SK-3000B,<br>SK-3000C, SK-<br>2000AP, SK-2000A,<br>SK-2000P |
| 510k number | K063433 | K121243 | K222787 |
| Product code | IYO, ITX | IYO, ITX | Same |
| Intended use | To location and visualization of<br>ophthalmic disorders and<br>measurement of ocular distances | To measure corneal<br>thickness. | Same |
| General<br>description | Diagnostic ultrasound<br>system.To acquire ultrasound<br>data and to display the data in<br>A, B modes of operation. | Diagnostic ultrasound system.<br>To acquire ultrasound data and<br>to display the data in P mode<br>of operation. | Diagnostic ultrasound system.<br>To acquire ultrasound data<br>and<br>to display the data in A, B, P<br>modes of operation. |

# Comparison of the predicate device

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| Patient contact<br>materials | A, B probe | P probe | A, B, P probe |
|--------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------|
| Biocompatibility | All Probes tested for<br>biocompatibility under<br>ISO 10993 | All Probes tested for<br>biocompatibility under<br>ISO 10993 | same |
| Working<br>principal | Ultrasound transmission | Ultrasound transmission | Same |
| Imaging modes | A, B mode | P mode | A, B, P mode |
| Track | Track 1 | Track 1 | Same |
| Acoustic output<br>within FDA<br>guideline | IEC 60601-2-37 | IEC 60601-2-37 | Same |
| General safety | IEC 60601- 1,<br>IEC 60601- 1-2 | IEC 60601- 1,<br>IEC 60601- 1-2<br>IEC 60601-2-37 | Same: IEC 60601- 1,<br>IEC 60601- 1-2<br>IEC 60601-2-37 |
| labeling | Conforms to 21CRF part 801 | Conforms to 21CRF part 801 | Same |

# Performance Data

The following performance testing was completed to support the substantial equivalence determination.

## Biocompatibility testing

The biocompatibility evaluation for the patient contact material (A probe, B probe, P P probe) of Sunkingdom Ophthalmic Ultrasound examination instrument was conducted accordance with the 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies,

ISO 10993- 10:2010 Biological Evaluation of Medical Devices-Part 10: Tests For Irritation and Skin Sensitization

ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests For In Vitro Cytotoxicity As recognized by FDA

The A probe, B probe and P probe of Sunkingdom Ophthalmic Ultrasound examination instrument of testing included the following tests:

- In Vitro Cytotoxicity .
- Irritation .
- Skin Sensitization .

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The extract of applied sample is not cytotoxic in the framework of ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests For In Vitro Cytotoxicity.

No obvious evidence of skin sensitization was observed for the polar and non-polar extracts of the test item, in accordance with ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests For Irritation and Skin Sensitization.

## Electromagnetic compatibility and electrical safety testing

Electrical EMC and safety testing were conducted on the SK MED Ophthalmic Ultrasound SK-3000A with the following standard:

ANSI AAMI IEC 60601- 1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests;

ANSI AAMI ES 60601- 1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/ (R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601- 1:2005, MOD);

IEC 60601-2-37: 2007 + AMD1:2015 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

# Acoustic output testing

According to the "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" FDA Guidance document, issued on July 27, 2019, the test methodology and set-up follow Track 1 recommendations for diagnostic ultrasound systems and transducers.

# Clinical testing

Not applicable.

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#### Software Verification and Validation

The software and cybersecurity have passed verification and validation program. And the results comply with the requirements.

In all tests these devices are in compliance with above FDA recognized standards, therefore these devices are safe and effective.

#### Conclusions

Based on the technical characteristics and the results of the performance tests, we conclude conclude conthat so Sunkingdom Ophthalmic Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P are substantially equivalent and as safe and effective as the main predicate device MEDA Ultrasonic A/B Scanner (K063433) .