(86 days)
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.
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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study data for the Di-rhex Ophthalmic Diathermy System:
Summary of Device Performance Data and Acceptance Criteria:
This 510(k) submission for the Di-rhex Ophthalmic Diathermy System relies on substantial equivalence to predicate devices rather than establishing specific quantitative acceptance criteria and performing a rigorous statistical study to meet those criteria. The primary "acceptance criterion" appears to be demonstrating that the device is equivalent in safety and efficacy to existing legally marketed devices, as summarized in section (c) of the "Performance Data."
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Power Output Specifications Met | "The Di-rhex has had power output tests that confirm the specifications." (No specific range or numerical results provided.) |
| Safety Standards Compliance | "The Di-rhex has a safety test from the Canadian Standards Association." (Specific standard or results not detailed.) |
| Software Functionality and Reliability | "The system software has had extensive validation testing." (No details on the scope, methods, or results of validation.) |
| Clinical Safety and Efficacy for Intended Use | "The Di-rhex has had a clinical evaluation in Canada." (No details on the study design, sample size, endpoints, or specific outcomes. The conclusion merely states it's equivalent in safety and efficacy to predicate devices based on this evaluation, among other data.) |
| Equivalence to Predicate Devices (Dutch Ophthalmic USA system, Surgitron Diathermy System) in terms of Safety and Efficacy for intended uses: - Hemostasis in anterior/posterior eye - Conjunctival welding (coaptation) - Retinal coagulation - Cutting in ophthalmic surgery using HF current | "The OTI Di-thex Ophthalmic Diathermy System is equivalent in safety and efficacy to the legally-marketed predicate devices." This is a general statement based on the overall performance data (non-clinical and clinical), rather than a specific comparative study with defined endpoints relative to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Non-clinical Tests: No sample size is specified for power output tests or software validation. Data provenance would be from internal testing by Ophthalmic Technologies Inc.
- Clinical Tests: The document states "The Di-rhex has had a clinical evaluation in Canada."
- Sample Size: Not specified. No number of patients or procedures is mentioned.
- Data Provenance: Canada (prospective, as it was an "evaluation" of the new device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Clinical Evaluation: Not specified. The document does not describe how ground truth was established for the clinical evaluation. Given it was a "clinical evaluation," it would inherently involve medical professionals, but their number and specific qualifications (e.g., years of experience, subspecialty) are not provided.
- Non-clinical Tests: Ground truth for these would typically be defined by engineering standards and internal specifications, not expert consensus in the medical sense.
4. Adjudication Method for the Test Set:
- Not specified. There is no mention of an adjudication process for the clinical evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document does not mention an MRMC study. The clinical evaluation appears to be a single-center, uncontrolled assessment, rather than a comparative effectiveness trial involving multiple readers and cases. The claim of equivalence is based on the overall performance compared to predicate devices, not through a direct comparative study with human readers assisted by AI. (Note: Diathermy is a direct energy delivery device, not an imaging AI device, so an MRMC study in the context of interpreting results with AI assistance would not be applicable here.)
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- N/A. This device is a surgical instrument. "Standalone" performance with "algorithm only without human-in-the-loop performance" doesn't directly apply as it's not an AI diagnostic/interpretive algorithm. Its "standalone" performance lies in its ability to deliver the specified energy (which was assessed via power output tests) and function safely (software validation, safety tests). The intended use inherently involves a human operator.
7. The Type of Ground Truth Used:
- Non-clinical Tests: Ground truth for power output tests would be the device's engineering specifications and calibration standards. For software validation, it would be the software requirements and functional specifications.
- Clinical Evaluation: The type of ground truth used for the clinical evaluation is not explicitly stated. However, for a surgical device evaluation, it would implicitly be the clinical judgment of the operating surgeons and post-operative assessment of patient outcomes (e.g., successful hemostasis, coagulation effect) based on standard medical practice. It's not pathology, or a separate "consensus" in the diagnostic sense, but rather the observed clinical results.
8. The Sample Size for the Training Set:
- N/A. This device is a hardware system, not an AI algorithm that requires a "training set" of data in the machine learning sense. The device is designed, tested against specifications, and evaluated clinically.
9. How the Ground Truth for the Training Set Was Established:
- N/A. As above, it's not an AI algorithm with a training set. The "ground truth" for its design and testing would be engineering principles, safety standards, and clinical requirements for ophthalmic diathermy.
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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
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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.
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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 .
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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) |
§ 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.