(260 days)
Not Found
No
The description focuses on the mechanical and optical principles of non-contact tonometry and does not mention any AI or ML components.
No
The device is a non-contact tonometer used to measure intraocular pressure, which is a diagnostic function, not a therapeutic one. It provides information about the eye's condition rather than directly treating it.
Yes
The device is described as a non-contact tonometer that measures intraocular pressure, which is a key diagnostic measurement for conditions like glaucoma. The "Intended Use / Indications for Use" section explicitly states its purpose is to "measure the intraocular pressure of the human eye in vivo." This measurement provides information for medical diagnosis.
No
The device description explicitly states it is a "full auto-alignment and All-In-One desktop type medical device with built-in thermal line printer" and provides physical dimensions and power input details, indicating it is a hardware device.
Based on the provided information, the TonoVue is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the TonoVue is designed to measure intraocular pressure of the human eye in vivo. This means it is used directly on a living patient, not on a sample of biological material taken from the body.
- Device Description: The description details a device that applies an air puff to the eye and uses an electro-optical system to monitor the cornea's deformation. This is a physical measurement performed on the patient's eye.
- Anatomical Site: The anatomical site is the "eye," which is a part of the living body.
- IVD Definition: In Vitro Diagnostics are defined as medical devices used to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The TonoVue does not use such specimens.
Therefore, the TonoVue is a medical device used for a physical measurement on a living patient, not an IVD.
N/A
Intended Use / Indications for Use
The TonoVue is a non-contact tonometer that intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism.
Product codes (comma separated list FDA assigned to the subject device)
HKX
Device Description
TonoVue Tonometer is designed to non-contact tonometer (NCT) that measures the intraocular pressure (IOP) by delivering a soft air puff without contacting eyes directly. It's designed as a full auto-alignment and All-In-One desktop type medical device with built-in thermal line printer. The dimensions of whole device are about 500mm (H) x 260mm (W) x 500mm (L). The AC power input port and a USB port are set at the bottom side of the device, but the USB port only for engineering use. Based on the Imbert-Fick principle, the IOP is calculated by dividing the amount of air pressure into the area of applanated surface. TonoVue utilizes a rapid air puff to apply force for flattening the cornea of human eye, and an advanced electro-optical system to monitor its deformation. The puff force increases until the cornea is applanated over the predetermined area and detected by the pressure sensor inside TonoVue, and the IOP can be calculated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
(a) Software Validation: The Software verification and validation testing were conducted and documentation was provided as recommended by FDA Guidance- "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Application of risk management to medical devices to show the software used in the TonoVue Tonometer is conform the safety principles.
(b) Biocompatibility Testing: Biocompatibility test evaluation for TonoVue non-contact The tonometer was conducted in accordance with the ISO10993-1. The test result of biocompatibility test is complies the ISO 10993-1 standard.
(c) Bench Testing: According to the FDA guidance of Tonometers - Premarket Notification Submissions requirement, the bench testing is performed to evaluate the accuracy and reproducibility of the TonoVue. According to the testing result of accuracy and reproducibility, its prove the TonoVue non-contact tonometer's IOP measurement result can meet our product's specification.
(d) Clinical Testing: This study is followed the requirement of ISO 8612:2009 Ophthalmic instruments-tonometers, to test the validity of NCT Tonometer. This clinical testing of TonoVue non-contact tonometer was study the 120 patients with less than 3 diopters of corneal astigmatism. The test result of the TonoVue non-contact tonometer is met the requirement of ISO 8612:2009: No more than 5% of the paired differences between the reference tonometer reading and the test tonometer reading for each pressure range are greater than the tolerance ±5mmHg. Thus, the test instrument should be feasible when use in clinical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
No more than 5% of the paired differences between the reference tonometer reading and the test tonometer reading for each pressure range are greater than the tolerance ±5mmHg.
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.
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July 22, 2021
Crystalvue Medical Corporation Oliver Lin Director Of Quality Assurance No. 116, Ln.956, Zhongshan Rd., Taoyuan Dist., Taovuan, 33072 Taiwan
Re: 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
Dear Oliver Lin:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 14, 2018. Specifically, FDA is updating this SE Letter as an administrative correction because we identified the typo in the tradename of your device referenced in your 510(k) Summary.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Elvin Ng, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, (240) 402-4662, elvin.ng(@fda.hhs.gov.
Sincerelv.
Charles Chiang -S
for 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
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December 14, 2018
Crystalvue Medical Corporation Oliver Lin Director of Quality Assurance No. 116, Ln.956, Zhongshan Rd., Taoyuan Dist., Taoyuan City 33072 Taiwan
Re: 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 Dated: November 2, 2018 Received: November 7, 2018
Dear Oliver Lin:
We have reviewed vour 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.
2
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Bradley S. Cunningham -A
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180820
Device Name TonoVue Non-Contact Tonometer
Indications for Use (Describe)
The TonoVue is a non-contact tonometer that intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism.
| 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/4/Picture/0 description: The image shows the word "Crystalvue" in a stylized font. The "C" in "Crystal" is replaced with a circular graphic that resembles a crystal or a lens. The word "Crystal" is written in black, while the "vue" portion of the word is written in a blue gradient.
TonoVue 510(K) Premarket Notification
510(k) Summary
Crystalvue Medical Corporation TonoVue Non-Contact Tonometer
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
Submitter
| Company name: | Crystalvue Medical Corporation |
|---|---|
| Company Address: | No.116, Ln.956, Zhongshan Rd., |
| Taoyuan Dist., Taoyuan City 33072, Taiwan | |
| Contact Person: | Oliver Lin |
| Director of Quality Assurance | |
| Phone: | +886 3 360 7711 Ext.2051 |
| Fax: | +886 3 360 7722 |
| E-mail: | Oliver.Lin@crystalvue.com.tw |
Device Information
| Classification: | Class II |
|---|---|
| Trade Name: | TonoVue Non-Contact Tonometer |
| Common Name: | Non-Contact Tonometer |
| Classification Name: | Tonometer, AC-Powered |
| Product Code: | 21 CFR § 886.1930 |
Predicate Devices
Trade Name: Canon Full Auto Tonometer TX-20. Classification Name: HKX, Tonometer and accessories 510(k) Number: K111710
Intended Use
The TonoVue is a non-contact tonometer that is intended to measure the intraocular pressure of the human eye in vivo.
Indication for Use
The TonoVue is a non-contact tonometer that intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism.
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Image /page/5/Picture/1 description: The image shows the logo for Crystalvue. The logo features a stylized snowflake to the left of the word "Crystalvue". The word "Crystal" is in black, and the word "vue" is in blue.
Device Description
TonoVue Tonometer is designed to non-contact tonometer (NCT) that measures the intraocular pressure (IOP) by delivering a soft air puff without contacting eyes directly. It's designed as a full auto-alignment and All-In-One desktop type medical device with built-in thermal line printer. The dimensions of whole device are about 500mm (H) x 260mm (W) x 500mm (L). The AC power input port and a USB port are set at the bottom side of the device, but the USB port only for engineering use. Based on the Imbert-Fick principle, the IOP is calculated by dividing the amount of air pressure into the area of applanated surface. TonoVue utilizes a rapid air puff to apply force for flattening the cornea of human eye, and an advanced electro-optical system to monitor its deformation. The puff force increases until the cornea is applanated over the predetermined area and detected by the pressure sensor inside TonoVue, and the IOP can be calculated.
Safety
Electrical safety and EMC testing were conducted on the TonoVue device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.
Effectiveness
TonoVue tonometer is in general comparable to the predicate devices, regarding the use, design and technical characteristics.
The result of clinical testing is also proved the effectiveness of TonoVue tonometer in clinical use is same as other products available on the market.
Substantial Equivalence
The TonoVue is substantially equivalent to the predicate devices: CANON Full Auto Tonometer TX-20 (K111710). It has the same intended use, technological characteristics, and principles of operation as its predicate devices. Bench and clinical testing demonstrate substantially equivalent performance to the predicates. Performance data demonstrate that the TonoVue is as safe and effective as the predicate devices. Thus, the TonoVue is substantially equivalent with Canon TX-20.
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Image /page/6/Picture/0 description: The image shows the word "Crystalvue" in a stylized font. The "C" in "Crystal" is replaced with a circular, crystalline design, while the rest of the word "Crystal" is in black. The word "vue" is in a blue color, contrasting with the black of "Crystal". The overall design is clean and modern.
Performance Data
(a) Software Validation
The Software verification and validation testing were conducted and documentation was provided as recommended by FDA Guidance- "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Application of risk management to medical devices to show the software used in the TonoVue Tonometer is conform the safety principles.
(b) Biocompatibility Testing
Biocompatibility test evaluation for TonoVue non-contact The tonometer was conducted in accordance with the ISO10993-1. The test result of biocompatibility test is complies the ISO 10993-1 standard.
(c) Bench Testing
According to the FDA guidance of Tonometers - Premarket Notification Submissions requirement, the bench testing is performed to evaluate the accuracy and reproducibility of the TonoVue.
According to the testing result of accuracy and reproducibility, its prove the TonoVue non-contact tonometer's IOP measurement result can meet our product's specification.
(d) Clinical Testing
This study is followed the requirement of ISO 8612:2009 Ophthalmic instruments-tonometers, to test the validity of NCT Tonometer. This clinical testing of TonoVue non-contact tonometer was study the 120 patients with less than 3 diopters of corneal astigmatism.
The test result of the TonoVue non-contact tonometer is met the requirement of ISO 8612:2009:
No more than 5% of the paired differences between the reference tonometer reading and the test tonometer reading for each pressure range are greater than the tolerance ±5mmHg.
Thus, the test instrument should be feasible when use in clinical.
Conclusion
As described in this 510(k) Summary, comprehensive testing and
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TonoVue 510(K) Premarket Notification
Orystalvue
analysis was conducted on the TonoVue to ensure that the device is safe and effective for its intended use when used in accordance with its instructions for use.
The Performance Data demonstrate that TonoVue is as safe and effective as predicate device, Canon Full Auto Tonometer TX-20. Based on the information in this submission, the TonoVue has the same intended use, technological characteristics, and principles of operation as its predicate devices. Therefore, the TonoVue is substantially equivalent to the predicate device.