(86 days)
Not Found
No
The description mentions microprocessor control and software validation, but there is no indication of AI or ML being used for decision-making, image analysis, or any other function. The device appears to be a standard diathermy unit with safety features and power control.
Yes
The device is described as an "Ophthalmic Diathermy Unit" intended for various ophthalmological procedures like "producing haemostasis", "conjunctival welding", "retinal coagulation", and "cutting in ophthalmic surgery". These are therapeutic interventions.
No
Explanation: The device is intended for surgical procedures such as producing hemostasis, coagulation, and cutting, rather than for diagnosing conditions.
No
The device description clearly states the system consists of a "central control unit that supplies radio frequency energy to a handpiece," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The OTI Di-thex Ophthalmic Diathermy Unit is used directly on the patient's eye during surgery to produce haemeostasis, perform coagulation, and cut tissue. It applies energy to the body, rather than analyzing samples taken from the body.
- Intended Use: The intended use clearly describes surgical procedures performed in vivo (within the living body).
Therefore, this device falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OTI Di-thex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, and for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.
Product codes
86 HQR
Device Description
The system consists of a central control unit that supplies radio frequency energy to a handpiece. The unit can be used for standard diathermy procedures, and can be also used as a cutting instrument for membrane dissection in the eye with the appropriate handpieces and tips. Power level is microprocessor-controlled, and the power-level setting is shown by a bar-graph display on the front panel. The system has a set of alarms which alert the user and suspend operation for such cases as overtemperature, overvoltage, and computer errors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior segment of the 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)
Non-clinical tests: The Di-rhex has had power output tests that confirm the specifications. The Di-rhex has a safety test from the Canadian Standards Association. The system software has had extensive validation testing.
Clinical tests: The Di-rhex has had a clinical evaluation in Canada.
Conclusions: The OTI Di-thex Ophthalmic Diathermy System is equivalent in safety and efficacy to the legally-marketed predicate devices.
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
§ 886.4100 Radiofrequency electrosurgical cautery apparatus.
(a)
Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.(b)
Classification. Class II.
0
APR - 7 1999
い
K990064, p. 1/2
Ophthalmic Technologies Inc. 510(k) Submission Di-rhex Ophthalmic Diathermy System
510(k) Summary
(1) Submitter Information
Name: Ophthalmic Technologies Inc.
Address:
37 Kodiak Crescent Downsview, Canada M3J 3E5
Telephone Number: 416-631-9123
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: January 6, 1999
(2) Name of Device
Trade Name: Di-rhex Ophthalmic Diathermy System Common Name: Ophthalmic Diathermy System Classification name: Radio Frequency, Electrosurgical, Cautery Apparatus
- (3) Equivalent legally-marketed devices.
- Dutch Ophthalmic USA system, "D.O.R.C. Microdiathermy System," K962135. 2. Surgitron Diathermy System, K980170
(4) Description
The system consists of a central control unit that supplies radio frequency energy to a handpiece. The unit can be used for standard diathermy procedures, and can be also used as a cutting instrument for membrane dissection in the eye with the appropriate
1
K990064, p. 2/2
handpieces and tips. Power level is microprocessor-controlled, and the power-level setting is shown by a bar-graph display on the front panel. The system has a set of alarms which alert the user and suspend operation for such cases as overtemperature, overvoltage, and computer errors.
(5) Intended Use
The OTI Di-rhex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, and for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.
(6) Performance Data
(a) Non-clinical tests
The Di-rhex has had power output tests that confirm the specifications. The Di-rhex has a safety test from the Canadian Standards Association. The system software has had extensive validation testing.
(b) Clinical tests
The Di-rhex has had a clinical evaluation in Canada.
(c) Conclusions
The OTI Di-thex Ophthalmic Diathermy System is equivalent in safety and efficacy to the legally-marketed predicate devices.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with wavy lines below them, possibly representing water or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 1999
Ophthalmic Technologies, Inc. George H. Myers, Sc.D. c/o Medsys, Inc. 377 Route 17 South Hasbrouck Heights, N.J. 07604
Re: K990064 Trade Name: Di-Rhex Ophthalmic Diathermy System Regulatory Class: II Product Code: 86 HQR Dated: January 6, 1999 Received: January 8, 1999
Dear Dr. Myers:
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 .
3
Page 2 - George H. Myers, Sc.D.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
AlrepL. Rosenthal
A. Ralph Rosenthal, M.D.
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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Page __ 1 __ of ______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K990064
Indications for Use Form
Device Name: Ophthalmic Technologies Di-rhex Ophthalmic Diathermy System
Indications for Use:
The OTI Di-thex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, and for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Quynh Hoang, Scientific Reviewer | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Devices | |
| 510(k) Number | K990064 |
| Prescription Use | X | OR | Over-the-Counter |
|---|---|---|---|
| (Per 21 CFR 810.109) | (Optional Format 1-2-96) |