Sunkingdom Applanation Tonometer is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea) to aid in the diagnosis of glaucoma.

Device Description

Sunkingdom SK-R, SJ-T, SK-Q are applanation tonometers, which are indicated for measurement of intraocular pressure (IOP). Intraocular pressure (IOP) is a very important physiological parameter and has always been an indispensable part of the diagnosis and treatment of ophthalmology, especially for glaucoma.

The operation principle is based on Goldmann applanation method, which is considered as the gold standard for measuring intraocular pressure. Therefore the applanation tonometer plays an important role in the diagnosis and treatment of ophthalmic diseases.

Sunkingdom series of Applanation tonometer are active medical devices powered by 3V button battery. In practice, it provides two ways to read the measured intraocular pressure value, one from the dial indicator in mmHg unit, the other from the LCD display in mmHg and KPa units. It is used in conjunction with a slit lamp, and the only difference among the SK- R, SK-T, SK-Q is the connection part. Each model differs from each other depending on the type of slit lamp to be used with it as shown in the figure below. All the other technical specifications are the same for these three models.

Model SK-Q is especially for the slit lamp with a large head size that cannot be configured for SK-R. Model SK-R can be left on the slit lamp permanently. It is fixed to the microscope on a mounting base and can be rotated in front of the microscope for examination. Model SK-T is mounted on the guide plate over the slit lamp axis for measurement purposes.

Components of the tonometer include applanation tonometer main body, Connection mechanical parts and screws, calibration rod, and applanation prism.

AI/ML Overview

The provided text describes a medical device, the Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q, and its substantial equivalence determination by the FDA. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information on the specific acceptance criteria for device performance or a comprehensive study report with the level of detail requested in your prompt.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Measurement Range	0-80mmHg	The proposed device has a wider measurement range than the predicate (5-65mmHg). This is noted as taking "professional's practice requirement into account and provides better practical applications for use."
Measurement Deviation	0.49 mN or 1.5% of measurement value, whichever is the greater	This matches the predicate device.
Biocompatibility	Extract of applied sample (MVLV48 LENTILLE) is not cytotoxic. Polar and non-polar extracts do not have to be classified as a skin sensitizer. Meets requirements of ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.	Specific acceptance limits for cytotoxicity, irritation, and sensitization are not explicitly stated, but compliance with ISO standards confirms acceptable performance.
Electrical Safety	Complies with ANSI AAMI IEC60601-1-2:2014, ANSI AAMIES 60601-1:2005, and ISO 15004-1:2006.	Specific limits for electrical safety are not provided, but compliance with recognized standards implies accepted performance.
Electromagnetic Compatibility (EMC)	Complies with ANSI AAMI IEC60601-1-2:2014, ANSI AAMIES 60601-1:2005, and ISO 15004-1:2006.	Specific limits for EMC are not provided, but compliance with recognized standards implies accepted performance.
Functional Performance (e.g., accuracy against known pressures)	"Verification bench testing using a balance system was carried to verify the measuring force, and conducted by an experimenter to measured each weight value for 10 times and by 2 experimenter to measured 3 weight values for 2 times in 3 devices. The testing was carried out in accordance with ANSI Z80.10-2014, Ophthalmic Instruments-Tonometer."	The document states compliance with ANSI Z80.10-2014, but does not provide the specific performance results (e.g., actual measured force vs. known force values, or the mean deviation and standard deviation against the Goldmann reference) that would demonstrate meeting the standard's accuracy requirements. It only describes the method of verification.

Missing Information: The document states that the testing was carried out in accordance with ANSI Z80.10-2014, Ophthalmic Instruments-Tonometer. This standard would define the specific acceptance criteria for performance (e.g., accuracy, repeatability). However, the document does not explicitly list those criteria or the detailed reported performance data against them. It only states that the devices "are in compliance with above FDA recognized standards."

Detailed Breakdown of Missing and Available Information:

2. Sample size used for the test set and the data provenance

Sample Size: The document mentions "3 devices" were used for performance testing. For verification bench testing, it states an "experimenter measured each weight value for 10 times and by 2 experimenters measured 3 weight values for 2 times in 3 devices." This refers to specific test procedures and not necessarily a clinical test set in the traditional sense of patient data.
Data Provenance: Not specified. The performance testing appears to be bench testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The performance testing described is bench testing against known physical forces/weights, not a clinical study involving experts establishing ground truth for patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided as there is no human-involved "test set" or clinical study described in the provided text that would require adjudication.

5. 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

This information is not provided. The device is an applanation tonometer, a measurement instrument. There is no mention of AI assistance or human reader involvement in the context of improving diagnostic effectiveness.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a manual tonometer that requires a human operator for its use. It's not an automated diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance testing, the "ground truth" was established by known physical forces/weights applied using a balance system, as described in the calibration section and performance testing details. The principle is based on the Goldmann method's physics.

8. The sample size for the training set

This information is not applicable/not provided. The device is a mechanical/electronic measurement instrument based on physical principles, not a machine learning or AI-driven system that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable/not provided for the reasons mentioned in point 8.

In summary, the provided FDA document focuses on demonstrating substantial equivalence through comparison with a predicate device and compliance with recognized safety and performance standards for a medical measurement instrument. It lacks the detailed clinical study information and specific performance metrics often associated with AI-driven diagnostic devices or devices requiring human expert interpretation that your prompt implies. The "performance data" section primarily highlights biocompatibility, electrical safety, EMC, and a brief description of bench testing for measuring force.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 19, 2019

Chongqing Sunkingdom Medical Instrument Co., Ltd Shulin Guo 1012, Block A of China Resource Center No.55 of XieJiaWan JiuLongPo Chongqing, 400050 Cn

Re: K191314

Trade/Device Name: Sunkingdom Applanation Tonometer SK-R, SK-T, SK-O Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer And Accessories Regulatory Class: Class II Product Code: HKY Dated: October 20, 2019 Received: November 25, 2019

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.

{1}------------------------------------------------

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) 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

for Elvin Ng Acting Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191314

Device Name

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q

Indications for Use (Describe)

Sunkingdom Applanation Tonometer is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea) to aid in the diagnosis of glaucoma.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

This summary of 510k safety and effectiveness is being submitted in according with 21 CFR part 807.92

Chongqing Sunkingdom Medical Instrument Co., Ltd

	35-2, YingTianGuanTianGongGu, CaiJiaGang Industry Zone,BeiBei District, ChongQing, ChinaContact Person: Shulin GuoPhone: +86 2368677919Fax: +86 2368102793E-mail: 13346822@qq.comRegistration#: 3010610157
Official Correspondent:	Dayna Valente83 Gerber RD West South Windsor Connecticut, 06074, USAPhone: (860)6484906Fax: (860)6484906
Date of Preparation:	December 18, 2019
Proprietary Name:	Sunkingdom ApplanationTonometerSK-R, SK-T, SK-Q
Common or UsualName:	Manual Tonometer
Classification Name:	Tonometer and Accessories21C.F.R. 886.1930Class II
Productcode:	HKY
Review Panel:	Ophthalmic

{4}------------------------------------------------

Predicate Devices

Predicate devices	Digital Keeler Applanation Tonometer
Manufacturer	Keeler Ltd
K#	K142179 & K133234

Intended Use/ Indication for Use

Sunkingdom Applanation Tonometer is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea), to aid the diagnosis of glaucoma.

Device Description

Image /page/4/Figure/9 description: The image shows three different diagrams labeled SK-Q, SK-R, and SK-T. Each diagram depicts a mechanical device with a cylindrical component at the top. The devices have different configurations of arms and supports extending downwards. The diagrams appear to be technical drawings or schematics.

Components of the tonometer include applanation tonometer main body, Connection mechanical parts and screws, calibration rod, and applanation prism.

{5}------------------------------------------------

Principle of Operation

Applanation Tonometer is an appliance that serves to measure intraocular pressure according to the Goldmann method, also known as Goldmann Applanation Tonometer(GAT). The intraocular pressure, measured by applanation tonometer, is calculated from the force required to flatten a constant area of the cornea according to the principle of the Immant-Fick of the Goldmann applanation tonometer: Pt (intraocular pressure) = W (external force of the flattened cornea) / A (flattened area).

Method of Operation

A sterile disposable measurement prism is mounted on the tonometer head at the end of the measurement arm and placed against the cornea after the cornea has been anaesthetized. Set the illumination light of the slit lamp to be cobalt blue and the angle between illumination arm and microscope to be in the range of 40-60 degrees.

By moving the slit lamp, the measuring prism comes into contact with the cornea over the pupillary area. The examiner then uses the cobalt blue filter to view the semi circle in view, then adjust the measurement drum on applanation tonometer to apply force to the tonometer head until the inner edges of the semi circle in the view meet, then read the display value on the screen or on dial indicator.

Calibration

During factory calibration procedure, known pressures covering the measurement range are applied to the measurement arm using a calibration arm according to the calibration procedure outlined in the Tonometer standard ISO 8612:2009.

The calibration procedure establishes a relationship between the pressure applied to the measurement arm and the position of the measurement drum. Linear interpolation is used between calibration points.

Substantial Equivalence

The Sunkingdom SK-R, SK-T, SK-Q are considered to be substantially equivalent to the predicate device Keeler Ltd Digital Keeler Applanation Tonometer (K142179 &K133234) as the Sunkingdom applanation tonometer SK-R, SK-T, SK-Q have the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicates.

{6}------------------------------------------------

Comparison of the predicate device

Descriptiveinformation	Predicate Device	Proposed Device	Description of differencesand discussion
Manufacturer	Keeler Ltd	Chongqing SunkingdomMedical InstrumentCo.,Ltd
510(k)Number	K142179 & K133234	K191314
Proprietary orModel Name	Digital KeelerApplanationTonometer (D- KAT)	SunkingdomApplanation TonometerSK-R, SK-T, SK-Q
Type	Manual contactTonometer	Manual contactTonometer	No change
Indications forUse	Indicated formeasuringintraocular pressureto aid in thescreening anddiagnosis ofGlaucoma.	Indicated formeasuringintraocular pressureto aid in thescreening anddiagnosis ofGlaucoma.	No change
Indicated use	Intraocular Pressure(IOP) measurement	Intraocular Pressure(IOP) measurement	No change
Targetpopulation	Patients with high IOP	Patients with high IOP	No change
Anatomicalsites	Cornea	Cornea	No change
Units ofmeasure	mmHg - millimetre ofmercury	mmHg - millimetre ofmercury&Kpa-Kilo pascal	In the LCD displayer,Sunkingdom Applanationtonometer has an additionalKpa unit. The internal
Display	Numerical display -Direct reading of IOPin mmHg from display	Numerical display -Direct reading of IOP inmmHg and Kpa fromdisplay	equation of two units asfollow:1mmHg=0.1333224KPa. Ittakes the doctor's habits intoaccount and provides betterpractical applications for use.The change does not affectthe intended use, safety andeffectiveness or thefundamental scientifictechnology.
Descriptiveinformation	Predicate Device	Proposed Device	Description of differencesand discussion
Design	Mounted on top illuminating (HaagStreit-style) andbottom illuminating(Zeiss style) Slitlamp, manual dial	Mounted on top illuminating (HaagStreit-style) and bottomilluminating (Zeissstyle) Slitlamp,manual dial	No change
Where Used	In a professionalhealthcare facilityenvironment	In a professionalhealthcare facilityenvironment	No change
MeasurementRange	5-65mmHg	0-80mmHg	Sunkingdom Applanationtonometer has a widermeasurement range than thatof Keeler's. It takesprofessional's practicerequirement into account andprovides better practicalapplications for use.The change does not affectthe intended use, safety andeffectiveness or thefundamental scientifictechnology.
Measurementtechnique	Applanation	Applanation	No change
MeasurementMethod	Goldmann method -the measuring ofpressure to maintain auniform applanationof the surface of theeye.	Goldmann method - themeasuring of pressure tomaintain a uniformapplanation of thesurface of the eye.	No change
Measurementdeviation	$0.49 mN$ or 1.5% ofmeasurement value,whichever is thegreater	$0.49 mN$ or 1.5% ofmeasurement value,whichever is the greater	No change
Powerrequirements	AA battery to powerdigital display	3V button battery topower digital display	Sunkingdom Applanationtonometer's battery is smallerthan that of Keeler's involume. It just for batteryspace consideration nothingabout battery capacity.The change does not affectthe intended use, safety andeffectiveness or thefundamental scientifictechnology
Descriptiveinformation	Predicate Device	Proposed Device	Description of differencesand discussion
Software	Contains software	Contains software	No change
Mountingmethod on slitlamp	Fixed (R-Type) andTake-away (T-Type)	Fixed (R-Type, Q-Type) and Take-away(T-Type)	No change
Calibration	Maintenance and Maintenance andcalibration requiredfactory set calibrationarm assembly issupplied with eachdevice to checkcalibration	Maintenance andcalibration requiredfactory set calibrationarm assembly issupplied with eachdevice to checkcalibration	No change
Materials	Tonometerbody-anodizedaluminium;Tonometerprism-Medicalgrade acrylic	Tonometerbody-anodizealuminium;Tonometerprism-Medicgrade acrylic	No change
	for biocompatibility	Biocompatibilit y All materials are tested All materials are testedfor biocompatibility	No change

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

Performance Data

The following performance data were provided to support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the patient contact material (measuring prism) of Sunkingdom Applanation tonometer was conducted accordance with the 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies,

ISO 10993-1:2009 "Biological evaluation of Medical Devices Part .1 =Evaluation and testing within a risk management process"

ISO 10993-10:2010 "Biological Evaluation of Medical Devices-Part 10: Tests For Irritation And Skin Sensitization", Jul, 26, 2016

ISO 10993-12:2012 "Biological evaluation of Medical devices Part.12 - Sample preparations and reference materials"

ISO 10993-5:2009 "Biological Evaluation of Medical Devices-Part 5: Tests For In Vitro Cytotoxicity", Dec, 23, 2016,

ISO 10993-11:2009 "Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity"

as recognized by FDA.

The Applanation tonometer prism of testing included the following tests:

Vitro Cytotoxicity Irritation Skin Sensitization Systemictoxicity

The extract of applied sample obtained from MVLV48 LENTILLE is not cytotoxic in accordance with ISO 10993-5:2009 "Biological Evaluation of Medical Devices- Part 5: Tests for In Vitro Cytotoxicity".

The polar and non-polar extracts of the test item MVLV48 LENTILLE do not have to be classified as a skin sensitizer, in accordance with ISO 10993-10:2010 "Biological Evaluation of Medical Devices-Part 10:Tests For Irritation And Skin Sensitization". It also meets the requirement of ISO 10993-11:2006 and ISO 10993- 10:2010.

{10}------------------------------------------------

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q. The system complies with the following standard:

ANSI AAMI IEC60601-1-2:2014, standard for EMC,

ANSI AAMIES 60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 and A2:2010/ (R) 2012Jul, 09, 2014, standard for safety,

ISO 15004-1:2006 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 1: General requirements applicable to all ophthalmic instruments.

Performance Testing

Verification bench testing has been carried out in accordance to the FDA guidance Tonometers-Premarket Notification [510(k)] Submissions. Bench testing using a balance system was carried to verify the measuring force, and conducted by an experimenter to measured each weight value for 10 times and by 2 experimenter to measured 3 weight values for 2 times in 3 devices. The testing was carried out in accordance with ANSI Z80.10-2014, Ophthalmic Instruments-Tonometer.

In all tests these devices are in compliance with above FDA recognized standards.

Conclusions

In accordance to 21 CFR 807.92(d) and based on the technical characteristics and the results of the performance tests we conclude that Sunkingdom Applanation Tonometers SK-R, SK-Q are substantially equivalent and as safe and effective as the predicate device Digital Keeler Applanation Tonometer (D-KAT) from Keeler Ltd (K142179 &K133234).

Regulation Number and Section

§ 886.1930 Tonometer and accessories.

(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.