ICARE TONOMETER TA01I

K063873 · Tiolat OY · HKY · May 23, 2007 · Ophthalmic

Device Facts

• Record ID: K063873
• Device Name: ICARE TONOMETER TA01I
• Applicant: Tiolat OY
• Product Code: HKY · Ophthalmic
• Decision Date: May 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

The iCare Tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.

Device Story

The iCare Tonometer TA01i is a portable, handheld, battery-operated device used to measure intraocular pressure (IOP). It utilizes a rebound measurement principle: a lightweight (26.5 mg) disposable plastic probe is propelled at a slow speed (0.25-0.30 m/s) to make momentary contact with the cornea. The device measures the probe's speed during contact; this data is processed by an internal microprocessor to calculate IOP, which is then displayed on an LCD. The device is designed for use without topical anesthesia. It is operated by healthcare professionals in clinical settings. The low weight and speed of the probe ensure minimal force (8-16 mN) is applied to the eye, potentially increasing patient comfort and safety compared to traditional applanation tonometry.

Clinical Evidence

Clinical performance was evaluated by comparing the iCare TA01i against predicate devices, including the Goldmann-type applanation tonometer. Bench testing confirmed the device met acceptance criteria for operating range, accuracy, and repeatability. Biocompatibility of the probe was verified per ISO 10993-1:2003. Electrical safety and electromagnetic compatibility were confirmed per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Handheld, battery-operated (4x AA). Rebound measurement principle using a 26.5 mg disposable plastic probe (0.9 mm tip radius). Microprocessor-based signal processing. LCD display. No maintenance calibration required. Biocompatible materials per ISO 10993-1. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for the measurement of intraocular pressure (IOP) in the human eye. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• APPLANATION TONOMETER AT 900 (K981432)
• MEDTRONIC TONO-PEN XL (K053430)
• PASCAL DYNAMIC CONTOUR TONOMETER (K032967)
• Tonometer TGDc-01 "PRA" (K021937)

Submission Summary (Full Text)

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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 [phone] [phone]

#### 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 [phone] [phone]

#### 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)<br>measurement | Same |
| Design | Hand-held microprocessor<br>based | Slit lamp mounted manual dial |
| Measurement technique | Rebound | Applanation |
| Calibration | No maintenance calibration<br>required | |
| Contact tip | Lightweight, disposable, single<br>use, plastic probe (26.5mg) | Prism as applanation surface |
| Contact tip sterilization | Sterilized, disposable, single<br>use | Prisms need to be disinfected<br>after each patient |
| Patient interface | Probe briefly touches the eye | Held on patient's eye while<br>dial is adjusted |
| Force caused to eye by<br>measurement | 8-16 mN | 10-50 mN (1g = 1/100N<br>=10mN) |
| Display | 4 digit LCD (2 digit reading) | Scribed dial |
| Range of measurement | 7-50 mmHg (display range 1-<br>99 mmHg) | 0-80 |
| Versatility | Patient can be measured in any<br>position, but the tonometer<br>must be oriented horizontally | Patient can be measured in<br>sitting position |
| Anesthesia required | No | Yes |
| Weight | 5.47 oz. without batteries<br>(155 g) | 1.10 lb<br>(0.5 kg) |
| Dimensions | 1.26" × 3.15" × 9.06"<br>(32 mm × 80 mm × 230 mm) | (250 mm × 115 mm × 89 mm) |
| Power source | 4 × 1.5 Volt AA batteries | |

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| | 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

. .

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| | 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) |

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Table 5.3. iCare Tonometer TA01i vs. Pascal dynamic contour tonometer (DCT)

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| | 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 [phone]. 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 [phone] or [phone] 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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