(90 days)
The Nidek DC-3300 Laser Diode Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The DC-3300 is used in combination with various delivery systems, such as slit lamps, binocular indirect ophthalmoscopes, endoprobes, and transscleral probes.
The DC-3300 Laser Diode Photocoagulator is an 808 nm continuous wave device. The DC-3300 consists of a compact, lightweight main console, footswitch and carrying case. The aiming laser of the DC-3300 is a red diode with a wavelength of 633 nm. A number of delivery systems are available with the DC-3300. A Slit Lamp Delivery Unit (Nidek SL-1600) Multipurpose Delivery Unit for the attachment of slit lamps (Nidek SL-1600), Endophotocoagulation Set, Binocular Indirect Ophthalmoscope (Models A and B), and Transscleral Photocoagulation probes.
The Nidek DC-3300 Laser Diode Photocoagulator is a device for ophthalmic photocoagulation procedures.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to IEC 60601-1 (medical electrical equipment general requirements) | Device found in conformance. |
| Conformance to IEC 60601-1-2 (electromagnetic compatibility) | Device found in conformance. |
| Conformance to IEC 60601-1-4 (programmable electrical medical systems) | Device found in conformance. |
| Conformance to IEC 60601-2-22 (safety of surgical, therapeutic and cosmetic laser equipment and accessories) | Device found in conformance. |
| Conformance to IEC 60825-1 (safety of laser products) | Device found in conformance. |
| Conformance to UL 2601-1 (medical electrical equipment safety standard) | Device found in conformance. |
| Performance as intended | "The DC-3300 was found to perform as intended." and "The DC-3300 Laser Diode Photocoagulator was found to perform as intended during validation testing." |
| Substantial equivalence to predicate devices (Nidek DC-3000 and Iriderm Iris OcuLight SLx) | "The DC-3300 is substantially equivalent to the Nidek DC-3000 and Iriderm Iris OcuLight SLx devices." "Product specifications and technical characteristics are within the same range of specifications for the predicate devices." |
2. Sample size used for the test set and the data provenance
The provided text does not specify a sample size for a test set in the context of clinical performance data for patients. The performance data described relates to compliance with safety standards and functional specifications of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study is based on engineering and safety standard compliance, not clinical ground truth established by experts.
4. Adjudication method for the test set
Not applicable. There is no clinical test set requiring adjudication in the provided information.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for laser photocoagulation, not an AI-assisted diagnostic or imaging device requiring human reader assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone medical laser device, and its performance is evaluated in terms of its technical specifications and compliance with safety standards, not as an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is its conformance to established international and national safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, IEC 60825-1, UL 2601-1) and its adherence to product specifications and risk analysis findings.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model for which a training set would be required.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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FEB 1 1 2002
K013760 1/3
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 14:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 14.1
| a. | Company Name: | Nidek, Inc. |
|---|---|---|
| b. | Company Address: | 47651 Westinghouse DriveFremont, CA 94539 |
| c. | Company Phone:Company Facsimile: | (510) 226-5700(510) 226-5750 |
| d. | Contact Person: | Hiro MatsuzakiQuality Assurance Manager |
| e. | Date Summary Prepared: | February 4, 2002 |
DEVICE IDENTIFICATION 14.2.
| a. Trade/Proprietary Name: | DC-3300 Laser Diode Photocoagulation |
|---|---|
| b. Classification Name: | Ophthalmic Laser21 CFR 886.4390 HQF |
IDENTIFICATION OF PREDICATE DEVICES 14.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Nidek, Inc. | DC-3000 Laser DiodePhotocoagulator | K903639 | 02/04/1991 |
| Iriderm | Iris OcuLight SLx | K913430 | 11/15/1991 |
| Iriderm | Iris OcuLight Diode LaserWith Slit Lamp Adapter | K912918 | 08/23/1991 |
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K613760 2/3
DEVICE DESCRIPTION 14.4
The DC-3300 Laser Diode Photocoagulator is an 808 nm continuous wave device. The DC-3300 consists of a compact, lightweight main console, footswitch and carrying case. The aiming laser of the DC-3300 is a red diode with a wavelength of 633 nm. A number of delivery systems are available with the DC-3300. A Slit Lamp Delivery Unit (Nidek SL-1600) Multipurpose Delivery Unit for the attachment of slit lamps (Nidek SL-1600), Endophotocoagulation Set, Binocular Indirect Ophthalmoscope (Models A and B), and Transscleral Photocoagulation probes.
14.5 SUBSTANTIAL EQUIVALENCE
The DC-3300 Laser Diode Photocoagulator is substantially equivalent to the Nidek DC-3000 Laser Diode Photocoagulator and the Iriderm Iris OcuLight SLx.
The fundamental technical characteristics and device specifications of the DC-3300 Laser Diode Photocoagulator are the same as those of the predicate devices. The DC-3300 and the predicate devices are diode photocoagulation lasers with a wavelength of 810 nm. The DC-3300 and the OcuLight SLx use a variety of delivery systems, including slit lamps, indirect ophthalmoscopes, endoprobes, and transscleral probes. The DC-3300 and the OcuLight SLx are indicated for all retinal photocoagulation and glaucoma procedures.
INDICATIONS FOR USE 14.6
The Nidek DC-3300 Laser Diode Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The DC-3300 is used in combination with various delivery systems, such as slit lamps, binocular indirect ophthalmoscopes, endoprobes and transscleral probes.
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Nidek DC3300 Laser Diode Photocoagulator Original Premarket 510(k) Notification
14.7 TECHNOLOGICAL CHARACTERISTICS
The DC-3300 Laser Diode Photocoagulator is a continuous wave 808 nm laser for ophthalmic photocoagulation procedures. The compact design of the system makes it portable and easily relocated. The aiming laser of the DC-3300 is a red diode with a wavelength of 633 nm. The delivery systems include the Slit Lamp for the attachment of the Nidek SL-1600, the Multipurpose for the attachment of the Nidek SL-1600 slit lamp, Endoprobes (two angled and two straight configurations), Transscleral probes (contact, non-contact and retinal), and two models of the Binocular Indirect Ophthalomoscope (Keeler All-Pupil and Heine Omega 180). The technological characteristics of the DC-3300 are equivalent to those of the predicate devices.
KO137b0 3/3
14.8 PERFORMANCE DATA
Performance testing was conducted on the DC-3300 Laser Diode Photocoagulator and delivery systems. System and component testing was completed based on product specifications and hazard effects determined from the risk analysis. The device was found to be in conformance with the following international safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, IEC 60825-1, and UL 2601-1. The DC-3300 was found to perform as intended.
14.9 CONCLUSION
This notification contains all information required by 21 CFR 807.87. The DC-3300 Laser Diode Photocoagulator was found to perform as intended during validation testing. The DC-3300 is substantially equivalent to the Nidek DC-3000 and Iriderm Iris OcuLight SLx devices. Product specifications and technical characteristics are within the same range of specifications for the predicate devices. The evaluation of the product specifications, performance testing and risk analysis does not raise any new issues of safety or effectiveness. The DC-3300 is intended for all retinal photocoagulation and glaucoma procedures and is combined with various delivery systems to perform its intended use.
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Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a stylized image of an eagle with three heads.
FEB 1 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nidek. Inc. Ms. Carol Patterson c/o Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, California 92630
Re: K013760
Trade Name: Nidek C-3300 Laser Diode Photocoagulation Regulation Number: 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: II Product Code: HQF; GEX Dated: November 9, 2001 Received: November 13, 2001
Dear Ms. Patterson:
We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (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 such 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.
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Page 2 - Ms. Carol Patterson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Nidek DC-3300 Laser Diode Photocoagulator Nidex DC-5500 Lasel Dk) Notification: #K013760
INDICATION FOR USE
| 510(k) Number: | K013760 |
|---|---|
| Device Name: | Nidek DC-3300 Laser Diode Photocoagulator |
| Indications for Use: | The Nidek DC-3300 Laser Diode Photocoagulator is indicatedfor all retinal photocoagulation procedures, such as limited andpan-retinal, transpupillary laser photocoagulation,endophotocoagulation and transscleral photocoagulation, andglaucoma procedures, such as laser trabeculoplasty andiridotomy. The DC-3300 is used in combination with variousdelivery systems, such as slit lamps, binocular indirectophthalmoscopes, endoprobes, and transscleral probes. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Miriam Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices | |
|---|---|
| Prescription Use | X 510(k) Number K013760 |
| OR | |
| Over-The-Counter Use | |
| (Per 21 CFR 801.109) |
: : … "
:
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.