(145 days)
Not Found
No
The description focuses on the physical mechanism of measurement and does not mention any computational or algorithmic processing indicative of AI/ML.
No
The device is used for measurement (diagnosis) and does not provide therapy.
Yes
Explanation: The device measures intraocular pressure, which is a physiological parameter used to diagnose conditions like glaucoma.
No
The device description explicitly states it is a "portable, handheld, battery operated tonometer" and describes physical components like a probe, battery, and LCD, indicating it is a hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body ("in vitro").
- Device Function: The iCare Tonometer TA01i measures intraocular pressure by making momentary contact with the cornea of the eye. This is a direct measurement taken on the living body ("in vivo"), not on a sample taken from the body.
- Intended Use: The intended use is to measure intraocular pressure of the human eye, which is a physical measurement of a physiological parameter within the body.
Therefore, based on the provided information, the iCare Tonometer TA01i is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The iCare Tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.
Product codes (comma separated list FDA assigned to the subject device)
86HKX, HKX
Device Description
The iCare Tonometer TA01i is a portable, handheld, battery operated tonometer, which measures intraocular pressure (IOP). To measure IOP, a very light (26.5 mg) and a slow moving (0.25-0.30 m/s) probe makes momentary contact with the cornea of the eye. The device measures the speed of the probe during the time probe is in contact with cornea. Resulting IOP is displayed on a liquid crystal display (LCD). The force used for the measurement which is directed onto the eye is extremely small, because of the low weight and slow speed of the probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eye
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 performance of iCare Tonometer TA01i has been evaluated in bench testing. The units under test met the acceptance criteria of the operating range, accuracy and repeatability.
In clinical evaluation, the performance of iCare Tonometer TA01i was compared to predicate devices, including Goldmann type tonometer.
Based on the results of non-clinical and clinical testing, the performance of iCare Tonometer TA01i is judged to be substantially equivalent to predicate devices. The patient contacting probe is considered biocompatible. The appropriate tests for biocompatibility were performed according to "ISO 10993-1:2003, Biological evaluation of medical devices - Part 1 Evaluation and Testing".
The electromagnetic compatibility and electrical safety of the iCare Tonometer TA01i was tested and found to conform to the requirements of IEC 60601-1 and IEC 60601-1-2.
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.
K981432, K053430, K032967, K021937
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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063873
5. 510(k) Summary
MAY 2 3 2007
Summary prepared:
December 21, 2006
Submitted by
Company name: Company address:
Contact person: Phone number: Fax number:
Tiolat Oy Nuijamiestentie 5 B 00400 Helsinki Finland Kari Serjamaa, CEO +358 9 8775 1150 +358 9 728 6670
US Agent to respond to FDA requests:
Contact person: Company name: Company address:
Phone number:
Fax number:
Nelson Tobin Diagnostic Instrument Group 8404 Sunstate Street Tampa, FL 33634 (813) 926-3447 (813) 926-7954
Proposed Device
Tiolat Oy Manufacturer: Device name: iCare Tonometer Model name: TA01i Classification name: 86HKX Regulation number: 886.1930 Device class: Class II
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5.1 Intended Use
The iCare Tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.
5.2 Device Description
The iCare Tonometer TA01i is a portable, handheld, battery operated tonometer, which measures intraocular pressure (IOP). To measure IOP, a very light (26.5 mg) and a slow moving (0.25-0.30 m/s) probe makes momentary contact with the cornea of the eye. The device measures the speed of the probe during the time probe is in contact with cornea. Resulting IOP is displayed on a liquid crystal display (LCD). The force used for the measurement which is directed onto the eye is extremely small, because of the low weight and slow speed of the probe.
5.3 Predicate Devices
The iCare Tonometer TA01 is judged to be substantially equivalent in safety, effectiveness and intended use to the following legally marketed devices:
| Manufacturer: | HAAG-STREIT |
|---|---|
| Device name: | APPLANATION TONOMETER AT 900 |
| Classification name: | 86HK Y |
| Regulation number: | 886.1930 |
| Device class: | Class II |
| 510(k) number: | K981432 |
| Manufacturer: | MEDTRONIC |
| Device name: | MEDTRONIC TONO-PEN XL |
| Classification name: | 86HK Y |
| Regulation number: | 886.1930 |
| Device class: | Class II |
| 510(k) number: | K053430 |
| Manufacturer: | SMT SWISS MICROTECHNOLOGY AG |
| Model name: | PASCAL DYNAMIC CONTOUR TONOMETER |
| Classification name: | 86HKY |
| Regulation number: | 886.1930 |
| Device class: | Class II |
| 510(k) number: | K032967 |
| Manufacturer: | RYAZAN STATE INSTRUMENT-MAKING |
| ENTERPRISE | |
| Model name: | Tonometer TGDc-01 "PRA" |
| Classification name: | 86HKX |
| Regulation number: | 886.1930 |
| Device class: | Class II |
| 510(k) number: | K021937 |
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5.4 Substantial Equivalence Comparison
In Tables 5.1, 5.2, 5.3 and 5.4 the iCare Tonometer TA01i is compared to predicate devices to show the equivalence. The comparison of intended use and technological features of iCare Tonometer TA01 indicate that the device is substantially equivalent to legally marketed predicate devices.
Table 5.1. iCare Tonometer TA01i vs. Haag-Streit Applanation Tonometer AT-900 (Goldmann type) . .
| iCare Tonometer TA01i | Haag-Streit AT-900 | |
|---|---|---|
| Indication | Intraocular pressure (IOP) | |
| measurement | Same | |
| Design | Hand-held microprocessor | |
| based | Slit lamp mounted manual dial | |
| Measurement technique | Rebound | Applanation |
| Calibration | No maintenance calibration | |
| required | ||
| Contact tip | Lightweight, disposable, single | |
| use, plastic probe (26.5mg) | Prism as applanation surface | |
| Contact tip sterilization | Sterilized, disposable, single | |
| use | Prisms need to be disinfected | |
| after each patient | ||
| Patient interface | Probe briefly touches the eye | Held on patient's eye while |
| dial is adjusted | ||
| Force caused to eye by | ||
| measurement | 8-16 mN | 10-50 mN (1g = 1/100N |
| =10mN) | ||
| Display | 4 digit LCD (2 digit reading) | Scribed dial |
| Range of measurement | 7-50 mmHg (display range 1- | |
| 99 mmHg) | 0-80 | |
| Versatility | Patient can be measured in any | |
| position, but the tonometer | ||
| must be oriented horizontally | Patient can be measured in | |
| sitting position | ||
| Anesthesia required | No | Yes |
| Weight | 5.47 oz. without batteries | |
| (155 g) | 1.10 lb | |
| (0.5 kg) | ||
| Dimensions | 1.26" × 3.15" × 9.06" | |
| (32 mm × 80 mm × 230 mm) | (250 mm × 115 mm × 89 mm) | |
| Power source | 4 × 1.5 Volt AA batteries |
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3
| iCare Tonometer TA0li | Tono-Pen XL | |
|---|---|---|
| Indication | Intraocular pressure (IOP) measurement | Same |
| Design | Hand-held microprocessor based | Same |
| Measurement technique | Rebound | Applanation |
| Calibration | No maintenance calibration required | Same |
| Contact tip | Light weight, disposable, single use, plastic probe with tip radius of 0.9 mm | 1.0 mm transducer tip, applanation surface approximately 3 mm |
| Contact tip sterilization | Sterilized, disposable, single use | Sanitized natural latex tip covers |
| Patient interface | Probe briefly touches eye | Briefly touched against eye |
| Force caused to eye by measurement | 8-16 mN | Depending on user, uncontrolled |
| Display | 4 digit LCD (2 digit reading) | Same |
| Range of measurement | 7-50 mmHg (display range 1-99 mmHg) | 5-80 mmHg |
| Versatility | Patient can be measured in any position, but the tonometer must be oriented horizontally | Patient can be measured in any position |
| Anesthesia required | No | Same |
| Weight | 5.47 oz. without batteries (155 g) | 2.25 oz. (64 g) |
| Dimensions | 1.26" × 3.15" × 9.06" (32 mm × 80 mm × 230 mm) | 7 1/4" × 1" × 7/8" (184.2 mm × 25.4 mm × 22.2 mm) |
| Power source | 4 × 1.5 Volt AA batteries | 2 × OCU-CELTM XL batteries |
Table 5.2. iCare Tonometer TA01i vs. Tono-Pen XL
. .
.
:
4
| iCare Tonometer TA0li | Pascal DCT | |
|---|---|---|
| Indication | Intraocular pressure (IOP) measurement | Same |
| Design | Hand-held microprocessor based | Slit lamp mounted microprocessor based |
| Measurement technique | Rebound | Dynamic contour |
| Calibration | No maintenance calibration required | Self calibrating |
| Contact tip | Light weight, disposable, single use, plastic probe with tip radius of 0.9 mm | Sensor tip 7 mm, pressure sensor 1.2 mm |
| Contact tip sterilization | Sterilized, disposable, single use | Sterile, single use disposable tip cover |
| Patient interface | Probe briefly touches the eye | |
| Force caused to eye by measurement | 8-16 mN | 10 mN (constant 1 gram) |
| Display | 4 digit LCD (2 digit reading) | LCD display |
| Range of measurement | 7-50 mmHg (display range 1–99 mmHg) | 5-200 mmHg |
| Versatility | Patient can be measured in any position, but the tonometer must be oriented horizontally | Same |
| Anesthesia required | No | Yes |
| Weight | 5.47 oz. without batteries (155 g) | 7.41 oz. (210 g) |
| Dimensions | 1.26" × 3.15" × 9.06" (32 mm × 80 mm × 230 mm) | 6.69" × 3.46" × 1.57" (170 mm × 88 mm × 40 mm) |
:
:
:
,
.
Table 5.3. iCare Tonometer TA01i vs. Pascal dynamic contour tonometer (DCT)
:
:
:
.
:
5
| iCare Tonometer TA01i | Tonometer TGDc-01 "PRA" | |
|---|---|---|
| Indication | Intraocular pressure (IOP) measurement | Same |
| Design | Hand-held microprocessor based | Hand-held microprocessor based |
| Measurement technique | Rebound | Same, but measurement to upper eyelid |
| Calibration | No maintenance calibration required | No maintenance calibration required |
| Contact tip | Light weight, disposable, single use, plastic probe with tip radius of 0.9 mm | – |
| Contact tip sterilization | Sterilized, disposable, single use | – |
| Patient interface | Probe briefly touches the eye | Touches the upper eyelid |
| Display | 4 digit LCD (2 digit reading) | 4 digit LCD (2 digit reading) |
| Range of measurement | 7-50 mmHg (display range 1–99 mmHg) | 0-60 |
| Versatility | Patient can be measured in any position, but the tonometer must be oriented horizontally | Patient can be measured in any position, but the tonometer must be oriented downwards |
| Anesthesia required | No | No |
| Weight | 5.47 oz. without batteries (155 g) | 2.79 oz. (79g) |
| Dimensions | 1.26" × 3.15" × 9.06" (32 mm × 80 mm × 230 mm) | 6.83" × 1.00" × 0.77" (173.5mm × 25.5mm × 19.5mm) |
| Power source | 4 × 1.5 Volt AA batteries | 4 × 1.5 Volt batteries (CR2032) |
Table 5.4. iCare Tonometer TA01ivs Tonometer TGDc-01 "PRA"
5.5 Summary of Non-Clinical and Clinical Testing
The performance of iCare Tonometer TA01i has been evaluated in bench testing. The units under test met the acceptance criteria of the operating range, accuracy and repeatability.
In clinical evaluation, the performance of iCare Tonometer TA01i was compared to predicate devices, including Goldmann type tonometer.
Based on the results of non-clinical and clinical testing, the performance of iCare Tonometer TA01i is judged to be substantially equivalent to predicate devices. The patient contacting probe is considered biocompatible. The appropriate tests for biocompatibility were performed according to "ISO 10993-1:2003, Biological evaluation of medical devices - Part 1 Evaluation and Testing".
The electromagnetic compatibility and electrical safety of the iCare Tonometer TA01i was tested and found to conform to the requirements of IEC 60601-1 and IEC 60601-1-2.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tiolat Oy c/o Mr. Nelson Tobin Diagnostic Instrument Group 8404 Sunstate Street Tampa, Fl 33634
MAY 2 3 2007
Re: K063873
Trade/Device Name: iCare Tonometer TA01i Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer Regulatory Class: Class II Product Code: HKX Dated: May 9, 2007 Received: May 10, 2007
Dear Mr. Tobin:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Nelson Tobin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelman, M.D.
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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4. Indications for Use Statement
Indications for Use
510(k) Number (if known): not assigned yet
Device Name: iCare Tonometer TA01i
Indications for Use:
The iCare Tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.
Prescription Use __ X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Dan L. Kautz
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K063873
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