(98 days)
No
The summary describes a standard tonometer and its accessories, focusing on the physical principle of applanation for measuring intraocular pressure. There is no mention of AI, ML, image processing, or any data analysis techniques that would suggest the use of such technologies. The predicate and reference devices are also traditional tonometry systems.
No
The device is described as being "for use in the diagnosis of glaucoma," indicating a diagnostic rather than therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states, "We intend the device for use in the diagnosis of glaucoma."
No
The device description explicitly mentions "a tonometer and accessories," which are physical devices used to measure intraocular pressure. This indicates the device includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device measures intraocular pressure by applying a force directly to the eye (in vivo). It does not analyze samples taken from the body.
- Intended Use: While the intended use is for the "diagnosis of glaucoma," the method of obtaining the diagnostic information is through a direct measurement on the patient's eye, not through the analysis of a biological specimen.
Therefore, this tonometer falls under the category of a medical device used for diagnosis, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A tonometer and acsessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye 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. We * intend the device for use in the diagnosis of glaucoma.
Product codes
86 HKY
Device Description
A tonometer and accessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye 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. We intend the device for use in the diagnosis of glaucoma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
globe of the eye / cornea
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.)
When compared with Goldmann tonometry, the OBF Tonometer degree of accuracy is
§ 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
JUN 17 1997
June 2, 1997 510(K) Notification 510(18) Notification
Paradigm Medical Industries, Inc., Blood Flow Analyzer
.
Enclosure 1.
510(K) Summary
| Submitted by: | Paradigm Medical Industries, Inc.
1772 West 2300 South
Salt Lake City, Utah 84119
(801) 977-8970 |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Richard Dirkson, Director of Regulatory Affairs |
| Prepared: | June 2, 1997 |
| | Trade Name - Blood Flow Analyzer Common Name - Tonometer and Accessories Classification Name - Tonometer and Accessories |
| Predicate Device: | Ocular Blood Flow Laboratories (OBF) Model 115
Computer Tonometer System (K873422, SE date 11/02/87) |
| | The OBF Labs' device was found equivalent to the Digilab OCVM-
Ocular Cerebral Vascular Monitor manufactured by Digilab and
the Alcon Applanation Pneumatograph manufactured by Alcon
laboratories, Inc. |
| Device Description: | A tonometer and accessories are devices intended to measure
intraocular pressure by applying a known force on the globe of the
eye 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.
We intend the device for use in the diagnosis of glaucoma. |
| Intended Use: | We intend the device for use in the diagnosis of glaucoma. |
| Degree of Accuracy: | When compared with Goldmann tonometry, the OBF Tonometer
degree of accuracy is