(218 days)
Not Found
No
The description details a manual, mechanical device based on the Goldmann applanation method, with no mention of AI, ML, or any computational analysis of data beyond displaying measured values.
No.
The device is used for measurement and diagnosis, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis of glaucoma." Additionally, the "Device Description" mentions that intraocular pressure measurement is "an indispensable part of the diagnosis and treatment of ophthalmology" and that the tonometer "plays an important role in the diagnosis and treatment of ophthalmic diseases."
No
The device description explicitly states it is a "manual device" and an "active medical device powered by 3V button battery." It also lists physical components like the main body, connection parts, calibration rod, and applanation prism. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Sunkingdom Applanation Tonometer measures intraocular pressure by directly interacting with the cornea of the eye. It does not analyze a specimen taken from the body.
- Intended Use: The intended use is to measure intraocular pressure to aid in the diagnosis of glaucoma. This is a direct measurement on the patient, not an analysis of a biological sample.
Therefore, based on the provided information, the Sunkingdom Applanation Tonometer is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 in the diagnosis of glaucoma.
Product codes (comma separated list FDA assigned to the subject device)
HKY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
In a professional healthcare facility environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data was provided to support the substantial equivalence determination.
Biocompatibility Testing: The biocompatibility evaluation for the patient contact material (measuring prism) of Sunkingdom Applanation tonometer was conducted in accordance with 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies, ISO 10993-1:2009, ISO 10993-10:2010, ISO 10993-12:2012, ISO 10993-5:2009, and ISO 10993-11:2009. The testing included Vitro Cytotoxicity, Irritation, Skin Sensitization, and Systemictoxicity. Key results: The extract of applied sample MVLV48 LENTILLE is not cytotoxic. The polar and non-polar extracts of test item MVLV48 LENTILLE do not have to be classified as a skin sensitizer. It also meets the requirement of ISO 10993-11:2006 and ISO 10993- 10:2010.
Electrical Safety and Electromagnetic Compatibility (EMC): Testing was conducted on the Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q. The system complies with ANSI AAMI IEC60601-1-2:2014 (EMC), ANSI AAMIES 60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 and A2:2010/ (R) 2012Jul, 09, 2014 (safety), and ISO 15004-1:2006 (General requirements for ophthalmic instruments).
Performance Testing: Verification bench testing was carried out in accordance with 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. Key results: In all tests, these devices are in compliance with above FDA recognized standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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, China
Contact Person: Shulin Guo
Phone: +86 2368677919
Fax: +86 2368102793
E-mail: 13346822@qq.com
Registration#: 3010610157 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dayna Valente
83 Gerber RD West South Windsor Connecticut, 06074, USA
Phone: (860)6484906
Fax: (860)6484906 |
| Date of Preparation: | December 18, 2019 |
| Proprietary Name: | Sunkingdom ApplanationTonometer
SK-R, SK-T, SK-Q |
| Common or Usual
Name: | Manual Tonometer |
| Classification Name: | Tonometer and Accessories
21C.F.R. 886.1930
Class 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
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.
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.
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Comparison of the predicate device
| Descriptive
information | Predicate Device | Proposed Device | Description of differences
and discussion |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Keeler Ltd | Chongqing Sunkingdom
Medical Instrument
Co.,Ltd | |
| 510(k)Number | K142179 & K133234 | K191314 | |
| Proprietary or
Model Name | Digital Keeler
Applanation
Tonometer (D- KAT) | Sunkingdom
Applanation Tonometer
SK-R, SK-T, SK-Q | |
| Type | Manual contact
Tonometer | Manual contact
Tonometer | No change |
| Indications for
Use | Indicated for
measuring
intraocular pressure
to aid in the
screening and
diagnosis of
Glaucoma. | Indicated for
measuring
intraocular pressure
to aid in the
screening and
diagnosis of
Glaucoma. | No change |
| Indicated use | Intraocular Pressure
(IOP) measurement | Intraocular Pressure
(IOP) measurement | No change |
| Target
population | Patients with high IOP | Patients with high IOP | No change |
| Anatomical
sites | Cornea | Cornea | No change |
| Units of
measure | mmHg - millimetre of
mercury | mmHg - millimetre of
mercury
&Kpa-Kilo pascal | In the LCD displayer,
Sunkingdom Applanation
tonometer has an additional
Kpa unit. The internal |
| Display | Numerical display -
Direct reading of IOP
in mmHg from display | Numerical display -
Direct reading of IOP in
mmHg and Kpa from
display | equation of two units as
follow:
1mmHg=0.1333224KPa. It
takes the doctor's habits into
account and provides better
practical applications for use.
The change does not affect
the intended use, safety and
effectiveness or the
fundamental scientific
technology. |
| Descriptive
information | Predicate Device | Proposed Device | Description of differences
and discussion |
| Design | Mounted on top illuminating (Haag
Streit-style) and
bottom illuminating
(Zeiss style) Slit
lamp, manual dial | Mounted on top illuminating (Haag
Streit-style) and bottom
illuminating (Zeiss
style) Slitlamp,
manual dial | No change |
| Where Used | In a professional
healthcare facility
environment | In a professional
healthcare facility
environment | No change |
| Measurement
Range | 5-65mmHg | 0-80mmHg | Sunkingdom Applanation
tonometer has a wider
measurement range than that
of Keeler's. It takes
professional's practice
requirement into account and
provides better practical
applications for use.
The change does not affect
the intended use, safety and
effectiveness or the
fundamental scientific
technology. |
| Measurement
technique | Applanation | Applanation | No change |
| Measurement
Method | Goldmann method -
the measuring of
pressure to maintain a
uniform applanation
of the surface of the
eye. | Goldmann method - the
measuring of pressure to
maintain a uniform
applanation of the
surface of the eye. | No change |
| Measurement
deviation | $0.49 mN$ or 1.5% of
measurement value,
whichever is the
greater | $0.49 mN$ or 1.5% of
measurement value,
whichever is the greater | No change |
| Power
requirements | AA battery to power
digital display | 3V button battery to
power digital display | Sunkingdom Applanation
tonometer's battery is smaller
than that of Keeler's in
volume. It just for battery
space consideration nothing
about battery capacity.
The change does not affect
the intended use, safety and
effectiveness or the
fundamental scientific
technology |
| Descriptive
information | Predicate Device | Proposed Device | Description of differences
and discussion |
| Software | Contains software | Contains software | No change |
| Mounting
method on slit
lamp | Fixed (R-Type) and
Take-away (T-Type) | Fixed (R-Type, Q-
Type) and Take-away
(T-Type) | No change |
| Calibration | Maintenance and Maintenance and
calibration required
factory set calibration
arm assembly is
supplied with each
device to check
calibration | Maintenance and
calibration required
factory set calibration
arm assembly is
supplied with each
device to check
calibration | No change |
| Materials | Tonometer
body-anodized
aluminium;
Tonometer
prism-Medical
grade acrylic | Tonometer
body-anodize
aluminium;
Tonometer
prism-Medic
grade acrylic | No change |
| | for biocompatibility | Biocompatibilit y All materials are tested All materials are tested
for 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).