(383 days)
Not Found
No
The summary describes a standard non-contact tonometer using an air puff mechanism, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML models.
No
The device aids in screening and diagnosis, which are steps leading to treatment, but it does not directly administer therapy.
Yes
The device is indicated for "screening and diagnosis of glaucoma," which explicitly states a diagnostic purpose.
No
The device description explicitly states it is a "non-contact tonometer designed using a non-contact measurement system" and uses an "air puff" to measure pressure. This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the NON-CONTACT TONOMETER FT-1000 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is "to aid in the screening and diagnosis of glaucoma." This clearly indicates a diagnostic purpose.
- Measurement of a Physiological Parameter: It measures intraocular pressure, which is a physiological parameter used in the diagnosis of a disease (glaucoma).
- Non-Contact Measurement: While it's non-contact with the eye, the measurement itself is of a biological parameter within the body.
While the device description focuses on the measurement method (air puff), the intended use is the primary factor in determining if a device is an IVD. Devices used to measure physiological parameters for diagnostic purposes are generally considered IVDs.
N/A
Intended Use / Indications for Use
The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
Product codes
HKX
Device Description
The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of the human eye.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
1. Company Identification
TOMEY CORP. 2-11-33 Noritakeshinmachi, Nishi-ku, Nagoya, Aichi, JAPAN 451-0051 Tel: +81-52-581-5592 Fax: +81-52-581-5955
2. Official Correspondent
Tomoko Watanabe (Ms.) International Dept.
NOV 1 8 2008
-
- Date of Submission October 31, 2007
4. Device Trade name NON-CONTACT TONOMETER FT-1000
5. Common/Usual Name
Tonometer and accessories
6. Classification Number
Class II, 86HKX, 21 CFR 886.1930 - Tonometer AC-Powered
7. Predicate Device
Manufacturer : Canon Inc. : FULL AUTO TONOMETER TX-F Trade Name 510(k) No. : K023816
8. Description of Device
The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of the human eye.
9. Indication for use
The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraccular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
10. Technical Characteristics
Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are equivalent in the areas of fechnical characteristics, general functions.
1
Appendix 1: Comparison Table with Predicate Device
| Manufacturer/ Model | CANON TONOMETER TX-F
(K023816) | TOMEY
NON-CONTACT TONOMETER
FT-1000 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | Non-contact (air-puff) type | Same as TX-F |
| Indication for Use | The Canon FULL AUTO
TONOMETER TX-F is intended to
be used for the measurement of
intraocular pressure of the human
eye. | The NON-CONTACT
TONOMETER FT-1000 is
indicated for the measurement of
intraocular pressure without
contacting the eye to aid in the
screening and diagnosis of
glaucoma. |
| Measurable range | 0 to 60 mmHg
Includes automatic shifting
between 30/60 mmHg | 0 to 60 mmHg
(manually changing between 30/60
mmHg) |
| Measuring increment | 1 mmHg | Same as TX-F |
| Measuring unit | mmHg | mmHg / hPa |
| Fixation Target | LED(green) | LED(orange) |
| Operation distance | 11.3mm | 11.0mm |
| Observation range | Approx. 15 x 12 mm | Approx. 15 x 9 mm |
| Alignment | Full Auto/Auto/Manual
Full auto R/L, Alignment, Shot
Auto Alignment, Shot | Auto alignment
Auto shot
(These are set independently)
Touch alignment |
| Safety Mechanism | Software Controlled Stopper | Software Controlled Stopper(Same
as TX-F)
Touch Sensor |
| Memory | Max. 10 measurements for each
eye | Same as TX-F |
| Data output | RS232C | Same as TX-F |
| Power-saving system | Available | Same as TX-F |
| Display | 5-inch monochrome CRT monitor | 5.7-inch color LCD monitor |
| Printer | Thermal line printer | Same as TX-F |
| Chin Rest | Power assisted | Same as TX-F |
| Power Supply | AC100-240V,
50/60Hz,
0.4-0.8A,
Approx.80VA | AC100-240V,
50/60Hz,
85-110VA |
| Operating range
(Movable range) | Front/back: 40mm
Left/right: 90mm
Up/Down: 30mm | Front/back: 40mm
Left/right: 88mm
Up/Down: 45mm |
| Dimensions | 280(W)x520(D)x495(H)mm | 306(W)x493(D)x463(H)mm |
| Wight | 20.5kg(45.2lbs.) | Approx. 18kg |
2
Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. The overall design is simple and conveys a sense of official government branding.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tomey Corporation c/o Kojo Kubo Comos Corporation 3F, 2-17 Akebono-cho. Tachikawa Tokyo 190-0012 Japan
NOV 1 8 2008
Re: K073087
Trade Device Name: Non-Contact Tonometer FT-1000 Regulation Number: 21 CFR 886.1930 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: HKX Dated: November 7, 2008 Received: November 10, 2008
Dear Mr. Kubo:
This letter corrects our substantially equivalent letter of November 18, 2008.
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 (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 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.
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Malina Berglund
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
4
Indications for Use
510(k) Number (if known): K073087
Device Name : NON-CONTACT TONOMETER, FT-1000
Indications For Use:
The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Am I right
Division Sign-Off)
Division of Ophthalmic and Ear,
Nose and Throat Devices
510(k) Number K073087