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.

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.

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.

AI/ML Overview

The provided text details a 510(k) premarket notification for the Sunkingdom Ophthalmic Ultrasound Examination Instrument. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study or a study directly measuring performance against predefined metrics.

Therefore, many of the requested details about acceptance criteria, clinical study methodology, sample sizes, expert involvement, and ground truth establishment are explicitly stated as "Not applicable" or are not present in this type of regulatory submission.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence based on:

Same intended use/indications for use.
Similar technological characteristics and operating principles.
Compliance with recognized performance standards for electrical safety, electromagnetic compatibility, biocompatibility, and acoustic output.

The "Performance Data" section primarily describes pre-clinical testing to ensure safety and functionality, not clinical efficacy or diagnostic accuracy.

Table of "Acceptance Criteria" and "Reported Device Performance" (as inferred from the substantial equivalence argument):

"Acceptance Criteria" (Implicit for Substantial Equivalence)	Reported Device "Performance" (Demonstrated Compliance)
Intended Use: Used in ophthalmology for A, P, B scan modes (axial length, corneal thickness, ocular imaging).	Same as predicate devices (ODM-2100 & ODM-2200 Ultrasonic A/B Scan system for Ophthalmology; MD-1000P Ultrasonic Pachymeter).
Technological Characteristics: Specifications for B-mode, A-mode, and Pachymeter.	B-mode: Nominal freq: 10MHz, Depth: ≥50mm, Lat. Res: ≤0.4mm, Axial Res: ≤0.2mm, Horiz. Geom. Accuracy: ≤10%, Vert. Geom. Accuracy: ≤5%, Blind zone: <4mm, Gain: 0-105dB, Gray Levels: 256, Scan Angle: 53°, Frame rate: ≥12 frames/s. A-mode: Nominal freq: 10MHz, Error: ≤0.05mm, Range: 15mm~~35mm, Gain: 0-99dB. Pachymeter: Nominal freq: 20MHz, Error: ≤0.01mm, Range: 0.3mm~~1.5mm, Gain: 0-99dB. Comparison with predicates shows similar or equivalent specifications.
Biocompatibility: Patient-contact materials (A, B, P probes) must be biocompatible.	Passed Biocompatibility testing per ISO 10993-10:2010 (Irritation, Skin Sensitization) and ISO 10993-5:2009 (In Vitro Cytotoxicity). "Extract of applied sample is not cytotoxic." "No obvious evidence of skin sensitization."
Electromagnetic Compatibility (EMC) & Electrical Safety: Compliance with relevant standards.	Passed testing in accordance with: - ANSI AAMI IEC 60601-1-2:2014 (EMC) - ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012, A2:2010/(R)2012 (General Safety) - IEC 60601-2-37:2007 + AMD1:2015 (Ultrasonic equipment specific safety).
Acoustic Output: Within FDA guidelines.	Passed testing following "Track 1 recommendations for diagnostic ultrasound systems and transducers" per FDA Guidance (July 27, 2019).
Software Verification & Validation: Software functions correctly and securely.	"Passed verification and validation program." "Results comply with the requirements." (No specific metrics or details provided in this summary, but V&V indicates internal testing was performed against defined requirements).

Study Details (as related to clinical performance)

The document explicitly states "Clinical testing: Not applicable." This means no clinical study (human subject study) was conducted or deemed necessary for this 510(k) submission to demonstrate the device meets acceptance criteria related to diagnostic performance or clinical outcomes. The basis for clearance is substantial equivalence to legally marketed predicate devices through engineering and non-clinical performance testing.

Therefore, the following points cannot be answered from the provided text:

Sample sizes used for the test set and the data provenance: Not applicable as no clinical test set was used for performance evaluation that would necessitate these details.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrasound imaging instrument, not an AI-assisted diagnostic tool for image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical performance study since none was done. The "ground truth" for the non-clinical tests would be the established scientific principles and measured values from calibrated equipment.
The sample size for the training set: Not applicable as a clinical training set is not mentioned for this type of device and submission.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission successfully demonstrated substantial equivalence based on a comparison of intended use, technological characteristics, and compliance with recognized safety and performance standards for medical devices, rather than a clinical performance study with specific acceptance criteria.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ 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., Lt35-2, YingTian GuangDian GongGu, CaiJiaGangIndustrial Zone, BeiBei District, Chongqing, ChinaContact Person: Shulin GuoPhone: +86-23-68643990Fax: +86-23 -68677919E-Mail: regist01@cqsunkingdom.comRegistration #: 3010610157
Official Correspondent:	Dayna Valente83 Gerber RD West South WindsorConnecticut, 06074, USAPhone: (860)6484906Fax: (860) 6484906
Date of Preparation:	August 25th, 2022
Proprietary Name:	Sunkingdom Ophthalmic Ultrasound ExaminationInstrument SK-3000A, SK-3000B, SK-3000C,SK-2000AP, SK-2000A, SK-2000P
Common or Usual Name:	Ultrasonic pulsed echo imaging system
Classification Name:	System, Imaging, Pulsed Echo, Ultrasonic21CFR 892.1560, 21CFR 892.1570Class II
Product Code:	IYO, ITX
Review Panel:	Radiology

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Predicate Devices

Main predicate device	ODM-2100 & ODM-2200 Ultrasonic A/BScan 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.

Device Description

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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.

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.

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

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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-2200Ultrasonic A/B Scansystem forOphthalmology	MD- 1000PUltrasonicPachymeter	SunkingdomOphthalmicUltrasoundExaminationInstrument SK-3000A, SK-3000B,SK-3000C, SK-2000AP, SK-2000A,SK-2000P
510k number	K063433	K121243	K222787
Product code	IYO, ITX	IYO, ITX	Same
Intended use	To location and visualization ofophthalmic disorders andmeasurement of ocular distances	To measure cornealthickness.	Same
Generaldescription	Diagnostic ultrasoundsystem.To acquire ultrasounddata and to display the data inA, B modes of operation.	Diagnostic ultrasound system.To acquire ultrasound data andto display the data in P modeof operation.	Diagnostic ultrasound system.To acquire ultrasound dataandto display the data in A, B, Pmodes of operation.

Comparison of the predicate device

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Patient contactmaterials	A, B probe	P probe	A, B, P probe
Biocompatibility	All Probes tested forbiocompatibility underISO 10993	All Probes tested forbiocompatibility underISO 10993	same
Workingprincipal	Ultrasound transmission	Ultrasound transmission	Same
Imaging modes	A, B mode	P mode	A, B, P mode
Track	Track 1	Track 1	Same
Acoustic outputwithin FDAguideline	IEC 60601-2-37	IEC 60601-2-37	Same
General safety	IEC 60601- 1,IEC 60601- 1-2	IEC 60601- 1,IEC 60601- 1-2IEC 60601-2-37	Same: IEC 60601- 1,IEC 60601- 1-2IEC 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) .

Regulation Number and Section

§ 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.