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

K191314 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · HKY · Dec 19, 2019 · Ophthalmic

Device Facts

• Record ID: K191314
• Device Name: Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
• Applicant: Chongqing Sunkingdom Medical Instrument Co., Ltd.
• Product Code: HKY · Ophthalmic
• Decision Date: Dec 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended 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 in the diagnosis of glaucoma.

Device Story

Manual applanation tonometer; measures intraocular pressure (IOP) via Goldmann applanation method. Device consists of main body, connection parts, calibration rod, and disposable prism. Operated by clinician in professional healthcare facility using slit lamp. Prism contacts anesthetized cornea; examiner adjusts measurement drum until inner edges of semi-circles align. IOP value read from dial indicator or LCD display (mmHg/KPa). Device aids glaucoma diagnosis by quantifying force required to flatten constant corneal area. Powered by 3V button battery. Models SK-R, SK-T, SK-Q differ only by slit lamp mounting configuration.

Clinical Evidence

Bench testing only. Verification testing performed per ANSI Z80.10-2014 using balance system to verify measuring force across range. Biocompatibility testing conducted on patient-contacting prism per ISO 10993-5, -10, -11, and -12, confirming no cytotoxicity, irritation, or sensitization. Electrical safety and EMC testing performed per ANSI AAMI IEC 60601-1-2 and ANSI AAMI ES 60601-1.

Technological Characteristics

Manual contact tonometer; anodized aluminum body, medical-grade acrylic prism. Goldmann applanation principle. Powered by 3V button battery. LCD and mechanical dial display. Dimensions/mounting vary by model (SK-R, SK-T, SK-Q) for slit lamp compatibility. Standards: ISO 8612:2009 (calibration), ANSI Z80.10-2014 (performance), ISO 10993 (biocompatibility), IEC 60601-1 (safety).

Indications for Use

Indicated for measuring intraocular pressure in patients with high IOP to aid in the screening and diagnosis of glaucoma.

Regulatory Classification

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.

Predicate Devices

• Digital Keeler Applanation Tonometer (K142179 & K133234)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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)

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# 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,<br>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 Connecticut, 06074, USA<br>Phone: [phone]<br>Fax: [phone] |
| Date of Preparation: | December 18, 2019 |
| Proprietary Name: | Sunkingdom ApplanationTonometer<br>SK-R, SK-T, SK-Q |
| Common or Usual<br>Name: | Manual Tonometer |
| Classification Name: | Tonometer and Accessories<br>21C.F.R. 886.1930<br>Class II |
| Productcode: | HKY |
| Review Panel: | Ophthalmic |

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## 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

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.

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.

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.

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## 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.

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Comparison of the predicate device

| Descriptive<br>information | Predicate Device | Proposed Device | Description of differences<br>and discussion |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Keeler Ltd | Chongqing Sunkingdom<br>Medical Instrument<br>Co.,Ltd | |
| 510(k)Number | K142179 & K133234 | K191314 | |
| Proprietary or<br>Model Name | Digital Keeler<br>Applanation<br>Tonometer (D- KAT) | Sunkingdom<br>Applanation Tonometer<br>SK-R, SK-T, SK-Q | |
| Type | Manual contact<br>Tonometer | Manual contact<br>Tonometer | No change |
| Indications for<br>Use | Indicated for<br>measuring<br>intraocular pressure<br>to aid in the<br>screening and<br>diagnosis of<br>Glaucoma. | Indicated for<br>measuring<br>intraocular pressure<br>to aid in the<br>screening and<br>diagnosis of<br>Glaucoma. | No change |
| Indicated use | Intraocular Pressure<br>(IOP) measurement | Intraocular Pressure<br>(IOP) measurement | No change |
| Target<br>population | Patients with high IOP | Patients with high IOP | No change |
| Anatomical<br>sites | Cornea | Cornea | No change |
| Units of<br>measure | mmHg - millimetre of<br>mercury | mmHg - millimetre of<br>mercury<br>&Kpa-Kilo pascal | In the LCD displayer,<br>Sunkingdom Applanation<br>tonometer has an additional<br>Kpa unit. The internal |
| Display | Numerical display -<br>Direct reading of IOP<br>in mmHg from display | Numerical display -<br>Direct reading of IOP in<br>mmHg and Kpa from<br>display | equation of two units as<br>follow:<br>1mmHg=0.1333224KPa. It<br>takes the doctor's habits into<br>account and provides better<br>practical applications for use.<br>The change does not affect<br>the intended use, safety and<br>effectiveness or the<br>fundamental scientific<br>technology. |
| Descriptive<br>information | Predicate Device | Proposed Device | Description of differences<br>and discussion |
| Design | Mounted on top illuminating (Haag<br>Streit-style) and<br>bottom illuminating<br>(Zeiss style) Slit<br>lamp, manual dial | Mounted on top illuminating (Haag<br>Streit-style) and bottom<br>illuminating (Zeiss<br>style) Slitlamp,<br>manual dial | No change |
| Where Used | In a professional<br>healthcare facility<br>environment | In a professional<br>healthcare facility<br>environment | No change |
| Measurement<br>Range | 5-65mmHg | 0-80mmHg | Sunkingdom Applanation<br>tonometer has a wider<br>measurement range than that<br>of Keeler's. It takes<br>professional's practice<br>requirement into account and<br>provides better practical<br>applications for use.<br>The change does not affect<br>the intended use, safety and<br>effectiveness or the<br>fundamental scientific<br>technology. |
| Measurement<br>technique | Applanation | Applanation | No change |
| Measurement<br>Method | Goldmann method -<br>the measuring of<br>pressure to maintain a<br>uniform applanation<br>of the surface of the<br>eye. | Goldmann method - the<br>measuring of pressure to<br>maintain a uniform<br>applanation of the<br>surface of the eye. | No change |
| Measurement<br>deviation | $0.49 mN$ or 1.5% of<br>measurement value,<br>whichever is the<br>greater | $0.49 mN$ or 1.5% of<br>measurement value,<br>whichever is the greater | No change |
| Power<br>requirements | AA battery to power<br>digital display | 3V button battery to<br>power digital display | Sunkingdom Applanation<br>tonometer's battery is smaller<br>than that of Keeler's in<br>volume. It just for battery<br>space consideration nothing<br>about battery capacity.<br>The change does not affect<br>the intended use, safety and<br>effectiveness or the<br>fundamental scientific<br>technology |
| Descriptive<br>information | Predicate Device | Proposed Device | Description of differences<br>and discussion |
| Software | Contains software | Contains software | No change |
| Mounting<br>method on slit<br>lamp | Fixed (R-Type) and<br>Take-away (T-Type) | Fixed (R-Type, Q-<br>Type) and Take-away<br>(T-Type) | No change |
| Calibration | Maintenance and Maintenance and<br>calibration required<br>factory set calibration<br>arm assembly is<br>supplied with each<br>device to check<br>calibration | Maintenance and<br>calibration required<br>factory set calibration<br>arm assembly is<br>supplied with each<br>device to check<br>calibration | No change |
| Materials | Tonometer<br>body-anodized<br>aluminium;<br>Tonometer<br>prism-Medical<br>grade acrylic | Tonometer<br>body-anodize<br>aluminium;<br>Tonometer<br>prism-Medic<br>grade acrylic | No change |
| | for biocompatibility | Biocompatibilit y All materials are tested All materials are tested<br>for biocompatibility | No change |

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## 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.

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#### 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).