(329 days)
The VS Tabletop Tonometer is a digital tonometer intended to measure intraocular pressure of the human eye.
The VS Tabletop Tonometer (VS TT) is a non-contact, table-top tonometer used to measure intraocular pressure of the eye. The tonometer is based on the previously cleared MiiS tonometer, the Horus Scope DPT 100 (K181260). The core technology element of the VS TT is the air puff module, which is equivalent to the air puff module used in the DPT 100 predicate device. The measurement method and measurement algorithm of the VS TT and DPT 100 devices are the same. The main technological difference between the VS TT and the predicate DPT 100 is that the VS TT features an auto-alignment system that automatically brings the air puff module within a positional range with respect to the patient's cornea such that the air puff module is able to perform the IOP measurement. The auto-alignment system of the subject device performs the same pre-positioning adjustments that are performed manually by clinical staff with the DPT 100. Hence, the consequence of these design modifications is that a clinical staff member is not required to perform an intermediary, non-critical step in measurement acquisition. The VS TT device is intended to be used by patients in doctor's office with the assistance from eye care professional. Patients are first trained on how to use the device. The VS TT measures IOP in the range of 7-55 mmHg. It contains a graphical user interface on a color LCD touchscreen display where the IOP results are displayed. The device is powered by a rechargeable lithium-ion battery. It can either be used alone (i.e. not plugged in) or connected to a power adapter.
The information provided describes the VS Tabletop Tonometer (VS TT) and its substantial equivalence to predicate devices, but it does not include a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy against a gold standard).
The text focuses on demonstrating that the VS TT is substantially equivalent to existing devices based on technological characteristics and general performance/safety testing, rather than presenting a clinical study with detailed acceptance criteria for diagnostic accuracy.
However, based on the provided text, here's what can be extracted and inferred regarding performance and its supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria" in a quantitative diagnostic sense (e.g., a target sensitivity or specificity). Instead, it refers to performance specifications and the outcome of equivalence testing. The "reported device performance" primarily focuses on the device's measurement range, accuracy, and the auto-alignment feature.
| Acceptance Criteria (Inferred from Predicate Equivalence and Stated Performance) | Reported Device Performance (VS Tabletop Tonometer) |
|---|---|
| IOP Measurement Range: Same as primary predicate (7-55 mmHg) | 7-55 mmHg |
| IOP Measurement Accuracy: within 5 mmHg (Same as primary predicate) | within 5 mmHg |
| Auto-alignment Functionality: Successful alignment to a human eye | Successful alignment within 4.5 - 20 seconds |
| Technological Equivalence: Air puff module equivalent to DPT 100 | Air puff module is equivalent to DPT 100 |
| Measurement Method/Algorithm: Same as DPT 100 | Same as DPT 100 |
2. Sample Size for Test Set and Data Provenance
The document does not specify a distinct "test set" sample size for diagnostic performance.
- Sample Size for Auto-Alignment Clinical Validation: Not explicitly stated, but it was a "clinical validation performed on the VS TT" to demonstrate the auto-alignment feature.
- Data Provenance: Not explicitly stated. The submitter is from Hsinchu, Taiwan, which might suggest data could originate from there, but this is not confirmed. The study appears to be prospective for the auto-alignment feature.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The document does not describe a study involving expert readers establishing ground truth for diagnostic performance of the tonometer. The device's "accuracy" is described as being "within 5 mmHg" and is likely assessed against a reference tonometer rather than expert interpretation of images or symptoms.
4. Adjudication Method
Not applicable, as no expert-based ground truth establishment is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done or reported in this document. The focus is on the device's intrinsic measurement capabilities and the effectiveness of its auto-alignment feature, not on human-in-the-loop performance improvement with AI assistance.
6. Standalone Performance (Algorithm Only)
Yes, the performance discussed seems to be primarily standalone (algorithm only for IOP measurement and auto-alignment). The device performs the IOP measurement autonomously once aligned. The document states: "The measurement method and measurement algorithm of the VS TT and DPT 100 devices are the same." and "Obtaining the IOP measurement: Automatic. Once air puff module detects that the center of the eye is in the right position, pneumatic and applanation systems are automatically activated."
7. Type of Ground Truth Used
For IOP Measurement Accuracy: Not explicitly stated, but typically a reference tonometer (e.g., Goldmann Applanation Tonometer) would be used as the ground truth or reference standard for calibrating and validating non-contact tonometers to achieve "within 5 mmHg" accuracy.
For Auto-alignment Feature: The ground truth was likely determined by the successful physical alignment of the device to the human eye within the specified time, confirmed by observation or internal sensors.
8. Sample Size for the Training Set
Not applicable. The device's core IOP measurement algorithm is stated to be the same as the predicate DPT 100, implying it was previously developed and validated. The auto-alignment system is a new feature, but the document does not discuss a "training set" for it in the context of machine learning, rather its successful operation in clinical validation.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for a machine learning algorithm is discussed.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medimaging Integrated Solution Inc Luu Hsu Regulatory Affairs 3F, No. 24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu, Taiwan 30077
Re: K223739
Trade/Device Name: VS Tabletop Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer And Accessories Regulatory Class: Class II Product Code: HKX Dated: September 28, 2023 Received: September 29, 2023
Dear Luu Hsu:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
Sincerelv.
Elvin Ng 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) K223739
Device Name VS Tabletop Tonometer
Indications for Use (Describe)
The VS Tabletop Tonometer is a digital tonometer intraocular pressure of the human eve.
| 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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Image /page/3/Picture/0 description: The image is a logo with a circular target design at the top and the text "MiiS" at the bottom. The target consists of concentric rings divided into alternating black, dark gray, light gray, and white quadrants. The text "MiiS" is written in a bold, blue font. The entire logo is enclosed within a rounded rectangle with a blue border.
510(k) Summary
| Prepared | November 07, 2023 | ||
|---|---|---|---|
| Submitter | Medimaging Integrated Solution Inc. (MiiS) | ||
| Address: 3F, No. 24-2, Industry E. Rd. IV, Hsinchu Science Park,Hsinchu, Taiwan 30077 (R.O.C.) | |||
| Contact Person: Sandy Chou | |||
| Tel.: +886-3-5798860 Ext: 1701 | |||
| Email: sandy.chou@miis.com.tw and RA@miis.com.tw | |||
| Device: | Trade/Device Name: VS Tabletop Tonometer | ||
| Model name: IOP 100 | |||
| Regulation Number: 21 CFR 886.1930 | |||
| Regulation Name: Tonometer and accessories | |||
| Regulatory Class: Class II | |||
| Product Code: HKX | |||
| Predicate Device: | Primary predicate device: | ||
| K181260 | |||
| Trade/Device Name: MiiS Horus Scope DPT 100 | |||
| Regulation Number: 21 CFR 886.1930 | |||
| Regulation Name: Tonometer and accessories | |||
| Regulatory Class: Class II | |||
| Product Code: HKX | |||
| Secondary Predicate Device | |||
| K180820 | |||
| Trade/Device Name: Tono Vue Non-Contact Tonometer | |||
| Regulation Number: 21 CFR 886.1930 | |||
| Regulation Name: Tonometer and accessories | |||
| Regulatory Class: Class II | |||
| Product Code: HKX |
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Description of Device:
The VS Tabletop Tonometer (VS TT) is a non-contact, table-top tonometer used to measure intraocular pressure of the eye. The tonometer is based on the previously cleared MiiS tonometer, the Horus Scope DPT 100 (K181260). The core technology element of the VS TT is the air puff module, which is equivalent to the air puff module used in the DPT 100 predicate device. The measurement method and measurement algorithm of the VS TT and DPT 100 devices are the same.
The main technological difference between the VS TT and the predicate DPT 100 is that the VS TT features an auto-alignment system that automatically brings the air puff module within a positional range with respect to the patient's cornea such that the air puff module is able to perform the IOP measurement. The auto-alignment system of the subject device performs the same pre-positioning adjustments that are performed manually by clinical staff with the DPT 100. Hence, the consequence of these design modifications is that a clinical staff member is not required to perform an intermediary, non-critical step in measurement acquisition.
The VS TT device is intended to be used by patients in doctor's office with the assistance from eye care professional. Patients are first trained on how to use the device.
The VS TT measures IOP in the range of 7-55 mmHg. It contains a graphical user interface on a color LCD touchscreen display where the IOP results are displayed.
The device is powered by a rechargeable lithium-ion battery. It can either be used alone (i.e. not plugged in) or connected to a power adapter.
Indications for Use:
The VS Tabletop Tonometer is a digital tonometer intended to measure intraocular pressure of the human eye.
| Characteristic | VS TabletopTonometer (ModelIOP 100)Subject Device | Horus Scope (ModelDPT-100)K181260Primary PredicateDevice | TonoVueNon-ContactTonometerK180820Secondary Predicate | Comparison toPredicate Devices |
|---|---|---|---|---|
| General information | ||||
| Manufacturer | MedimagingIntegrated SolutionInc. (MiiS) | MedimagingIntegrated SolutionInc. (MiiS) | Crystalvue MedicalCorporation | - |
| Characteristic | VS TabletopTonometer (ModelIOP 100) | Horus Scope (ModelDPT-100)K181260 | TonoVueNon-ContactTonometerK180820 | Comparison toPredicate Devices |
| Subject Device | Primary PredicateDevice | Secondary Predicate | ||
| Device Classification | Class II | Class II | Class II | Same |
| ClassificationProduct Code | HKX | HKX | HKX | Same |
| RegulationNumber | 21 CFR 886.1930 | 21 CFR 886.1930 | 21 CFR 886.1930 | Same |
| Intended use | A digital tonometerintended tomeasure intraocularpressure of thehuman eye. | A digital tonometerintended to measureintraocular pressureof the human eye. | A digital tonometerintended to measureintraocular pressureof the human eye. | Same |
| Usingenvironment | Health careenvironment | Health careenvironment | Health careenvironment | Same |
| Specification | ||||
| Contact area | Non-contact | Non-contact | Non-contact | Same |
| Hand Held orTable Top | Table Top | Hand held | Table Top | Same asSecondaryPredicate. |
| Workingdistance | 12 mm | 12 mm | 11 mm | Same as PrimaryPredicate |
| MeasurementType | Air-puff | Air-puff | Air-puff | Same |
| IOPMeasurementrange | 7-55 mmHg | 7-55 mmHg | 1-60 mmHg | Same as PrimaryPredicate. Withinthe range of theSecondaryPredicate. |
| IOPMeasurementAccuracy | within 5 mmHg | within 5 mmHg | unknown | Same as PrimaryPredicate |
| Characteristic | VS TabletopTonometer (ModelIOP 100) | Horus Scope (ModelDPT-100)K181260 | TonoVueNon-ContactTonometerK180820 | Comparison toPredicate Devices |
| Subject Device | Primary PredicateDevice | Secondary Predicate | ||
| Principles of Operation | ||||
| Operator | Patientself-measurementin clinic with theassistance fromeye careprofessional | Measured by eyecare professional | Measured by eyecare professional | Different. Seediscussionbelow. |
| Headstabilization | Patient rests theirbrow and cheekbone against theeyepiece | Patient rests theirhead in a chin rest | Patient rests theirhead in a chin rest | Different. Seediscussionbelow. |
| Measurement ofrelative positionbetween the eyeand the air puffmodule | Glint DetectionSystem | Glint DetectionSystem | Unknown | Same as PrimaryPredicate |
| Positioning theair puff module | Auto-alignment | Manual alignment | Auto-alignment | Similar toSecondaryPredicate in thatboth devicesautomaticallyposition the airpuff module.Different from theprimary predicate.See discussionbelow. |
| Obtaining theIOPmeasurement | Automatic. Onceair puff moduledetects that thecenter of the eye isin the rightposition, pneumaticand applanationsystems areautomaticallyactivated | Automatic. Once airpuff module detectsthat the center of theeye is in the rightposition, pneumaticand applanationsystems areautomaticallyactivated | Automatic. Once airpuff module detectsthat the center of theeye is in the rightposition, pneumaticand applanationsystems areautomaticallyactivated | Same |
| Characteristic | VS TabletopTonometer (ModelIOP 100) | Horus Scope (ModelDPT-100)K181260 | TonoVueNon-ContactTonometerK180820 | Comparison toPredicate Devices |
| Subject Device | Primary PredicateDevice | Secondary Predicate | ||
| Interface and Power Specification | ||||
| User interface | LCD touch panel | LCD touch panel | LCD touch panel | Same |
| Communicationinterface | No interface | Mini USB | USB-A, RS-232 | Different. Sincethis differencepertains to datastorage anddevice interface, itdoes not affectsafety oreffectiveness. |
| Power source | Lithium-ionrechargeablebattery and/or ACpower | Lithium-ionrechargeable battery | AC power | Equivalent |
| Input voltage | 100~240 VAC,50/60 Hz | 100~240 VAC,50/60 Hz | 100~240 VAC,50/60 Hz | Same |
| Dimension and appearance | ||||
| Weight | 4 kg | 1.06 kg | 17 kg | Differences arebased onergonomic designdifferencesrequired for self-measurement.These differencesdo not affectsafety orEffectiveness. |
| Dimension | 319 mm x 166 mmx 260 mm | 111 mm x 105 mm x193 mm | 500 mm x 282 mm x500 mm | |
| Productappearance | Image: VS Tabletop Tonometer | Image: Horus Scope | Image: TonoVue Non-Contact Tonometer |
Comparison of Technological Characteristics with Predicate Devices
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Image /page/5/Picture/0 description: The image is a logo with a circular target-like design at the top and the word "MiiS" in blue at the bottom. The target consists of concentric rings divided into quadrants, with alternating black, gray, and white sections. The word "MiiS" is underlined with a blue line. The entire logo is enclosed in a rounded blue border.
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Image /page/6/Picture/0 description: The image shows a logo with a circular target-like design at the top and the word "MiiS" in blue at the bottom. The target design consists of concentric circles divided into quadrants, with alternating shades of black, white, and gray. The word "MiiS" is underlined with a thin blue line. The entire logo is enclosed in a rounded rectangular border with a white background.
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Image /page/7/Picture/0 description: The image is a logo with a white background and a blue border. Inside the border is a circular target-like design with alternating black, white, and gray sections. Below the target design, the text "MiiS" is written in blue, with a blue underline.
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Image /page/8/Picture/1 description: The image is a logo with a white background and rounded corners. The top portion of the logo features a circular target-like design with alternating black, white, and gray rings. The target is divided into quadrants, with the left quadrants being solid colors and the right quadrants being shaded. Below the target design, the word "MiiS" is written in large, bold, blue letters. The word is underlined with a thin blue line.
Discussion of Substantial Equivalence
- The VS TT has the same intended use and use environment as the predicate DPT 100 (K181260) and TonoVue (K180820) devices.
- . The VS TT utilizes the same IOP measurement type (air puff) as both predicate devices, and its air puff module has an equivalent design to the primary predicate DPT 100
- The VS TT has the same measurement range as the primary predicate and its . measurement range falls within the range of the second predicate.
- The VS TT has an equivalent method for positioning its air puff module as the Tono . Vue (Secondary Predicate).
- The VS TT is different from the predicate devices in that the VS TT is operated . primarily by the patient in clinic (with eye care professional assistance), whereas the predicate devices are operated by an eye care professional. However, since all 3 devices share the same air-puff technology, and the air puff module is only triggered once the patient's eye is positioned within the eye box of the air puff module in all 3 devices, this difference in who operates the devices does not affect the accuracy of the IOP measurement. Therefore, this difference does not affect the safety or effectiveness of the device.
- Other differences (i.e. head stabilization method, interfaces, dimensions and . appearance) are minor and do not affect device safety or effectiveness.
Performance and Safety data
Based on the risk analysis and design control requirements, a program of design verification and validation testing was performed on the VS TT that includes the following:
- Electromagnetic compatibility (IEC 60601-1-2: 2020-09) and electrical safety (IEC ● 60601-1:2005/AI:2012/A2:2020)
- Software verification and validation (IEC 62304: 2015-06) ●
- Biocompatibility testing (ISO 10993-1: 2018-08; ISO 10993-5: 2009-06; ISO ● 10993-10:2010-08)
- Fundamental requirements for ophthalmic instruments (ISO 15004-1: 2020-5) ●
- Optical radiation hazard testing and classification (ANSI Z80.36-2021) ●
- Performance testing ●
- Environment testing (ISTA-3A: 2018)
- Battery testing (IEC 62133-2:2017-02) ●
- Usability assessment (IEC 60601-1-6: 2013-10 and IEC 62366: 2015-02)
Since the air puff modules used in the predicate DPT 100 device and the subject VS TT device have the same technology and same performance specifications, the IOP
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Image /page/9/Picture/0 description: The image is a logo for MiiS. The logo is a blue square with rounded corners. Inside the square is a target-like design with alternating black, gray, and white rings. Below the target design is the word "MiiS" in blue, with a blue underline.
measurements made with the VS TT and the DPT 100 are equivalent. Clinical validation performed on the VS TT demonstrated the addition of the auto-alignment feature is successful in aligning to a human eye within a duration of 4.5 - 20 seconds.
Conclusion
The comparison of the VS TT to the predicate devices, the MiiS Horus Tonometer DPT 100 K181260) and the Tono Vue Non-contact Tonometer (K180820), demonstrate that the VS TT has the same intended use as the predicate devices and that the technological differences between the VS TT and the predicate devices do not raise new questions about safety and effectiveness of the VS TT. Bench testing has been performed to show that the VS TT meets performance and safety requirements. Clinical validation shows the VS TT automatically aligns to the eye in 4.5-20 seconds. Together, this evidence demonstrates that the VS TT is substantially equivalent to the predicate devices and effective for its intended use.
§ 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.