(406 days)
No
The description focuses on standard digital tonometer technology, image capture, storage, and basic data transfer. There is no mention of AI, ML, or advanced image processing that would suggest the use of these technologies for measurement or analysis.
No
The device measures intraocular pressure, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate a medical condition.
Yes
The device measures intraocular pressure, which is a key parameter used in the diagnosis of conditions like glaucoma. While the device itself doesn't provide a diagnosis, it gathers critical data that a healthcare professional uses to make a diagnostic determination.
No
The device description explicitly details hardware components such as a Li-ion battery, white LED, CMOS sensor, SD card, USB interface, TFT display, and keypad, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, the MiiS Horus Scope DPT 100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "measure intraocular pressure of eyeball." This is a measurement taken directly from a living patient's body (in vivo), not from a sample of bodily fluid, tissue, or other material taken from the body (in vitro).
- Device Description: The description details a device that interacts directly with the eye to perform a physical measurement. It uses optical components and a sensor to capture information about the eye itself.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are designed to perform tests on samples taken from the body to provide information about a person's health status. The MiiS Horus Scope DPT 100 is a diagnostic device, but it performs its diagnostic function by directly interacting with the patient's eye.
N/A
Intended Use / Indications for Use
MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of eyeball.
Product codes (comma separated list FDA assigned to the subject device)
HKX
Device Description
MiiS Horus Scope DPT 100 is a Li-ion battery-powered device. The Li-ion battery is rechargeable. It is a digital portable tonometer used to measure intraocular pressure of eyeball.
The device uses a white LED for illumination and capture image. The device has been tested according to the ISO 15004-2 (first edition, 2/15/2007) and been classified as Group I device.
The device has a CMOS sensor. The sensor accomplishes a task of capturing light and converting it into electrical signals.
The device store images to a SD card and have connectivity towards PC. The device uses an USB 2.0 interface to transfer data or picture to PC when connected.
The operation method of the device is described step by step in the attachment A1 "User manual". There is a graphical user interface color TFT display and keypad that is used for making adjustments before and during measure intraocular pressure of eyeball. Its' measure rang is 7-55 mmHg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyeball
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following data were provided in support of the substantial equivalence determination:
- EMC and electrical safety testing were conducted on the DPT 100. The device complies with IEC/EN 60601-1-2:2014/2015 for EMC and IEC/EN 60601-1:2005/2006+A1:2012/ 2013 for Safety.
- Software verification and validation testing was done according to IEC 62304.
- Risk management: DPT 100 was evaluated according to ISO 14971:2007 and EN ISO 14971:2012. All risks have been reduced to safe levels thus there is no conflict between risk and benefit.
- Tests for ophthalmic products: DPT 100 was tested in accordance with ISO 15004-2:2007 standards and was found to meet all requirements of the standards. For optical hazards was classified to Group 1.
- Biocompatibility: The contact part to patient is the holder of chin rest CR100. The holder material was tested in accordance with ISO10993-5:2009 and ISO10993-10:2010 standards.
- Tests for tonometer:
The performance of MiiS DPT 100 has been evaluated in bench test. The units under test met the acceptance criteria of the operating range, accuracy, repeatability and reproducibility with a manometer-controlled model. We also do Clinical Performance Test, and found a Goldmann applanation tonometry (GAT) Keeler Digital Applanation Tonometer (D-KAT) (K133234) to do the human eye Clinical performance test compared to MiiS DPT 100. Data was collected according to ISO 8612:2009 and ANSI Z80.10-2014 "Ophthalmic Instruments – Tonometers" (in accordance with FDA's extent of recognition) with the following results.
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.
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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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 21, 2019
Medimaging Integrated Solution Inc. (MiiS) Chih-Lu Hsu COO 1F, No.7, R&D Rd. II Hsinchu Science Park Hsinchu, 30076 Cn
Re: 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 Dated: June 14, 2019 Received: June 17, 2019
Dear Chih-Lu 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 (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 devicerelated 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/guidanceregulatory-information/postmarketing-safety-reporting-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-devicesafety/medical-device-reporting-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/medical-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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-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,
Bradley Cunningham 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K181260
Device Name MiiS Horus Scope DPT 100
Indications for Use (Describe)
MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of eyeball.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740
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Image /page/3/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 consists of concentric circles alternating between black, white, and shades of gray. The entire logo is enclosed in a rounded blue border.
510(k) Summary
| Prepared: | April 26, 2018 |
|---|---|
| Submitter/Owner's | |
| Name/Address | Medimaging Integrated Solution Inc. (MiiS) |
| 1F, No.7, R&D Rd. II, Hsinchu Science Park, Hsinchu, Taiwan | |
| 30076 (R.O.C.) | |
| Contact Person: | Mr. Luu Hsu |
| Telephone: Fax: | +886-3-5798860 Ext: 1700 |
| Email Address: | +886-3-5798011 |
| luu@miis.com.tw |
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Image /page/4/Picture/0 description: The image is a logo with a circular design at the top and the text "MiiS" at the bottom. The circular design consists of concentric rings divided into alternating black, white, and gray segments, resembling a target or radar screen. The text "MiiS" is written in a bold, blue font. The entire logo is enclosed within a rounded rectangular border with a blue outline.
Device Identification:
Trade/Device Name MiiS Horus Scope DPT 100 Regulation Number: 21 CFR 886.1930 Regulation Name: Non-Contact Tonometer Regulatory Class: Class II Product Code: HKX
Predicate Device:
K013259 Trade/Device Name: Reichert PT100 Portable (Tonometer) Regulation Number: 21 CFR 886.1930 Regulation Name: Non-Contact Tonometer Regulatory Class: Class II Product Code: HKX
K871335 Trade/Device Name: TOPCON COMPUTERIZED TONOMETER CT-80 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer, AC-Powered Regulatory Class: Class II Product Code: HKX
Description of Device:
MiiS Horus Scope DPT 100 is a Li-ion battery-powered device. The Li-ion battery is rechargeable. It is a digital portable tonometer used to measure intraocular pressure of eyeball.
The device uses a white LED for illumination and capture image. The device has been tested according to the ISO 15004-2 (first edition, 2/15/2007) and been classified as Group I device.
The device has a CMOS sensor. The sensor accomplishes a task of capturing light and converting it into electrical signals.
The device store images to a SD card and have connectivity towards PC. The device uses an USB 2.0 interface to transfer data or picture to PC when connected.
The operation method of the device is described step by step in the attachment A1 "User manual". There is a graphical user interface color TFT display and keypad that is used for making adjustments before and during measure intraocular pressure of eyeball. Its' measure rang is 7-55 mmHg.
Indications for Use:
MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of eyeball.
Substantial Equivalence Summary
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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 design consists of concentric circles alternating in shades of gray and black. The word "MiiS" is written in a bold, sans-serif font, and it is underlined. The entire logo is enclosed within a rounded blue border.
| NO. | Items | Device | Predicate Device 1 | Predicate
Device 2 | Same/Differen
ce
Interpretation |
|-----|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| 1 | Submitter | Medimaging
Integrated Solution
Inc. | Reichert, Ltd. | Topcon | Difference |
| | Product
Name | Digital Portable
Tonometer | Portable Non-
Contact Tonometer | Computerized
Tonometer | Equivalent |
| | Model Name | MiiS Horus Scope
DPT 100 | PT100 | CT-80 | |
| | K Number | K181260 | K013259 | K871335 | |
| | Product code
and
Classification | 21 CFR 886.1930,
HKX Class II | 21 CFR 886.1930,
HKX Class II | 21 CFR
886.1930, HKX
Class II | Same |
| 2 | Intended use | MiiS Horus Scope
DPT 100 is a digital
portable tonometer
used to measure
intraocular pressure
of eyeball. | The PT100 is a hand
held non contact
tonometer intended
to measure the
intraocular pressure
of the eye. | CT-80 is an
exact, non-
contact
intraocular
pressure
measurement
that can be done
by air ejection. | Same |
| 3 | Weight | 1060g | 1260g (Measurement
head) | 18kg | Difference |
| 4 | Dimension | 111mm x 105mm x
193mm | 254mm x 127mm x
205mm | 272(W)×505(D)
×430458(H)m240 VAC, 50/60
m | Difference |
| 5 | Contact area | non-contact | non-contact | non-contact | Same |
| 6 | Working
distance | 12mm | 12mm | 11mm | Equivalent |
| 7 | Measurement
range | 7-55mmHg | 0-60mmHg | 0-60mmHg | Equivalent |
| 8 | Measurement
scale | mmHg | mmHg | mmHg | Same |
| 9 | Inspection
Window | 3.5" Capacitive LCD
touch panel | Eyepiece | Monitor screen | Difference |
| 10 | Interface | Mini USB | USB | RS232C | Equivalent |
| 11 | Power source | Lithium-ion
rechargeable battery | Lithium-ion
rechargeable battery | Power cable
connect to the
wall power | Equivalent |
| 12 | Input voltage | 100
Hz | 100~240 VAC,
50/60 Hz | AC 100, 120,
220, 230 and
240V; 50/60Hz | Equivalent |
Key technological summaries and differences between the device and the predicate devices:
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Image /page/6/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 circular design consists of concentric rings of alternating shades of gray and white, creating a visual effect similar to a bullseye. The word "MiiS" is written in a bold, sans-serif font, with a horizontal line underneath it. The entire logo is enclosed within a rounded square with a blue border.
Image /page/6/Picture/2 description: The image shows three different medical devices used for eye examinations. The first device has a square screen and a handle on the side. The second device is handheld and has a display screen on top. The third device is a larger, stationary machine with a screen and a joystick.
Substantial Equivalence Discussion
Similarities:
- MiiS Horus scope DPT 100 and predicate device, Reichert PT100 Portable (Tonometer) have the same intended use. Both devices have same specifications, such as contact area, working distance, power source and input voltage. DPT 100 has similar specifications to Reichert PT100 Portable (Tonometer), such as the measurement range, measurement scale, weight, dimension and connection interface.
- -MiiS Horus scope DPT 100 and predicate device, Topcon CT-80 Computerized Tonometer have the same intended use. DPT 100 has similar specifications to Topcon CT-80 Computerized Tonometer, such as the working distance, measurement range, measurement scale and input voltage.
Differences:
- The major differences are inspection window. MiiS Horus scope DPT 100 has 3.5" -Capacitive LCD touch panel. But, Reichert, Ltd. PT100 use eyepiece to observe.
- -The major differences between MiiS Horus scope DPT 100 and Topcon CT-80 Computerized Tonometer are weight, dimension, inspection window, interface, power source and product appearance.
- -These variants don't impact on device safety and effectiveness.
Non-clinical and Clinical Tests
The following data were provided in support of the substantial equivalence determination:
-
- EMC and electrical safety testing were conducted on the DPT 100. The device complies with IEC/EN 60601-1-2:2014/2015 for EMC and IEC/EN 60601-1:2005/2006+A1:2012/ 2013 for Safety.
-
- Software verification and validation testing was done according to IEC 62304.
-
- Risk management: DPT 100 was evaluated according to ISO 14971:2007 and EN ISO 14971:2012. All risks have been reduced to safe levels thus there is no conflict between risk and benefit.
-
- Tests for ophthalmic products: DPT 100 was tested in accordance with ISO 15004-2:2007 standards and was found to meet all requirements of the standards. For optical hazards was classified to Group 1.
7
Image /page/7/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 alternating between black, white, and gray shades. The word "MiiS" is written in a bold, sans-serif font and is underlined with a blue line. The entire logo is enclosed within a rounded rectangle with a white background.
-
- Biocompatibility: The contact part to patient is the holder of chin rest CR100. The holder material was tested in accordance with ISO10993-5:2009 and ISO10993-10:2010 standards.
-
- Tests for tonometer:
The performance of MiiS DPT 100 has been evaluated in bench test. The units under test met the acceptance criteria of the operating range, accuracy, repeatability and reproducibility with a manometer-controlled model. We also do Clinical Performance Test, and found a Goldmann applanation tonometry (GAT) Keeler Digital Applanation Tonometer (D-KAT) (K133234) to do the human eye Clinical performance test compared to MiiS DPT 100. Data was collected according to ISO 8612:2009 and ANSI Z80.10-2014 "Ophthalmic Instruments – Tonometers" (in accordance with FDA's extent of recognition) with the following results.
Conclusion
Substantial equivalence comparison and bench performance tests support the conclusion of substantial equivalence of MiiS Horus scope DPT 100 to the predicate devices.