FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER

• K Number: K991840
• Device Name: FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
• Manufacturer: BERNARD B. FRESCO
• Date Cleared: 2000-03-20 ( 297 days)
• Product Code: HKY
• Regulation Number: 886.1930

Intended Use

Clinical testing of intraocular pressure . Self testing of intraocular pressure. Home monitoring of intraocular pressure. Screening studies, and outreach clinics. For Glaucoma, Ocular hypertensive, and general population groups.

Device Description

The phosphene tonometer is a pressure measuring device which consists of three ABS plastic components which are moulded, and a stainless 312 metal spring. These fit together and comprise the body of the instrument, a probe with the spring within and a fiduciary, with reset potential.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical measurement and statistical analysis, with no mention of AI/ML terms or processes.

Therapeutic

No
The device is a pressure measuring device used for clinical testing and monitoring of intraocular pressure, but it does not treat or alleviate a medical condition.

Diagnostic

Yes

The device is intended for "Clinical testing of intraocular pressure" and "Screening studies," aiming to measure a physiological parameter (intraocular pressure) for the purpose of identifying conditions like glaucoma and ocular hypertension. This falls under the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of physical components (ABS plastic, stainless steel spring) that form the body, probe, and fiduciary of the instrument. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, 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.
• Device Function: The description clearly states the device is a "pressure measuring device" used for "Clinical testing of intraocular pressure." This is a physical measurement taken directly on the body (specifically, the eyelid), not a test performed on a sample taken from the body.
• Intended Use: The intended use is to measure intraocular pressure, which is a physical parameter, not to analyze a biological sample.

Therefore, this device falls under the category of a medical device used for direct measurement on the body, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Tonometer for measuring intraocular pressure in clinical and home test use. Allows for self-testing, as it is applied to the eyelid, and has a subjective end point. Clinical testing of intraocular pressure. Self testing of intraocular pressure. Home monitoring of intraocular pressure. Screening studies, and outreach clinics. For Glaucoma, Ocular hypertensive, and general population groups.

Product codes (comma separated list FDA assigned to the subject device)

86 HKY

Device Description

The phosphene tonometer is a pressure measuring device which consists of three ABS plastic components which are moulded, and a stainless 312 metal spring. These fit together and comprise the body of the instrument, a probe with the spring within and a fiduciary, with reset potential.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Eyelid

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinical and home test use

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)

1. Clinically 90% of measurements with the device were within + and -3 mm Hg. Of Goldmann tonometry measurements, when measured by a clinician, or in self-testing of non-diagnostically specific patients.
2. Glaucoma sub groups yielded 82% within + and 3 mm Hg. of Goldmann tonometry.
3. Home self-testing for a ten day period was undertaken in a group of controlled glaucoma patients as well as non-glaucoma cases. Over 2000 measurements were obtained. For two days measurements were taken every hour. For the remaining eight days pressure was measured 6 times a day. The standard deviation for readings taken 6 times daily yielded 0.7 mm Hg for 500 weekly readings.
4. In cases of advanced visual field loss [greater than 14dB on central 24-2 Humphrey], the phosphene tonometer yielded higher readings than Goldmann tonometry [mean difference of 7 mm Hg.]. In these cases a calibration correction is necessary for home monitoring, which compensates for the individual difference on a case by case basis.
5. Successive measurements with the phosphene tonometer vielded no statistically significant difference in repeat testing at 1, 3, 5, 8, 10 and 15 minutes.
6. There were no adverse effects evident in any of the studies that were evaluated.

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.

Not Found

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

Regulation Number and Section

§ 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.

Summary

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MAR 2 0 2000

K991840

Bernard B Fresco 40 Saint Clair Avenue East #303 Toronto, Ontario M4T 1M9 Canada

Fax: [phone] Phone: [phone] Contact Person: Bernard B Fresco

Email: [e-mail]

SUMMARY

Trade Name: FPT/Fresco Phosphene Tonometer

Common Name: Pressure Phosphene Tonometer/Eyelid Tonometer

Classification Name: Tonometer for clinical and home self-testing, as per 21CFR § 886.1930

Description

The phosphene tonometer is a pressure measuring device which consists of three ABS plastic components which are moulded, and a stainless 312 metal spring. These fit together and comprise the body of the instrument, a probe with the spring within and a fiduciary, with reset potential.

Intended Use

Tonometer for measuring intraocular pressure in clinical and home test use. Allows for self-testing, as it is applied to the eyelid, and has a subjective end point.

Technological Characteristics

The pressure phosphene tonometer differs from the Goldmann tonometer in that it is utilised on a closed eyelid instead of the cornea, and it requires a subjective response [perception of a phosphene]. It has no power source requirements.

Study Results

• 1. Clinically 90% of measurements with the device were within + and -3 mm Hg. Of Goldmann tonometry measurements, when measured by a clinician, or in self-testing of non-diagnostically specific patients.

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7991840

• 2. Glaucoma sub groups yielded 82% within + and 3 mm Hg. of Goldmann tonometry.
• 3. Home self-testing for a ten day period was undertaken in a group of controlled glaucoma patients as well as non-glaucoma cases. Over 2000 measurements were obtained. For two days measurements were taken every hour. For the remaining eight days pressure was measured 6 times a day. The standard deviation for readings taken 6 times daily yielded 0.7 mm Hg for 500 weekly readings.
• 4. In cases of advanced visual field loss [greater than 14dB on central 24-2 Humphrey], the phosphene tonometer yielded higher readings than Goldmann tonometry [mean difference of 7 mm Hg.]. In these cases a calibration correction is necessary for home monitoring, which compensates for the individual difference on a case by case basis.
• 5. Successive measurements with the phosphene tonometer vielded no statistically significant difference in repeat testing at 1, 3, 5, 8, 10 and 15 minutes.
• 6. There were no adverse effects evident in any of the studies that were evaluated.

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Public Health Service

MAR 2 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Bernard B. Fresco 40 Saint Clair Avenue East #303 Toronto, Ontario M4T 1M9 Canada

Re: K991840 Trade Name: FPT/Fresco Phosphene Tonometer Regulatory Class: II Regulation: 886.1930 Product Code: 86 HKY Dated: May 25, 1999 Received: May 28, 1999

Dear Dr. Fresco:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2- Dr. Bernard B. Fresco

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN)

K991840

DEVICE NAME

Fresco Phosphene Tonometer and or Phosphene Tonometer and or FPT and or Eyelid Tonometer

INDICATIONS FOR USE

Clinical testing of intraocular pressure . Self testing of intraocular pressure. Home monitoring of intraocular pressure. Screening studies, and outreach clinics. For Glaucoma, Ocular hypertensive, and general population groups.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)	OR Over-The-Counter-Use ✓
(Optional Format 1-2-96)

Bruce Drum

(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number	K991840
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