The Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is intended to be used in ophthalmic surgical procedures for retinal photocoagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

Device Description

The Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is connectable to Nidek laser photocoagulators such as NIDEK Multicolor Laser Photocoagulator System MC-500 or Green Laser Photocoagulator Model GYC-1000 and to the additional following surgical microscopes:. The delivery unit, which consists of a sterilized endophoto probe (available in 3 different sizes and 2 different shapes), protective filter unit, and carrying case, is used for endophotocoagulation. The photocoagulation system can be easily assembled by connecting the sterilized endophoto probe to the main laser device and connecting the protective filter to the laser device and surgical microscope. This photocoagulation system enables laser endophotocoagulation while observing the affected area through the surgical microscope.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Endophotocoagulation Delivery Unit.

Based on the provided text, the device in question is the "Endophotocoagulation Delivery Unit (for sterilized endophoto probe)". This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study report with detailed performance metrics against specific acceptance criteria. Therefore, much of the requested information about device performance, ground truth, and specific study details is not explicitly stated in this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit numerical acceptance criteria (e.g., minimum accuracy, maximum error) or specific quantitative device performance reports in terms of clinical outcomes. Instead, the acceptance criteria are framed in terms of meeting functional specifications, performance requirements, and compliance with international standards, particularly for safety and sterility.

Acceptance Criterion Type	Description from Document	Reported Device Performance
Functional Specifications & Performance Requirements	"We have verified and validated that the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) meets its functional specifications and performance requirements..."	The document states that the device "meets its functional specifications and performance requirements." Specific quantitative performance metrics (e.g., laser spot size accuracy, energy delivery precision, success rate of photocoagulation) are not provided. The device's intended use is for "retinal photocoagulation" and the "Spot size can be varied by altering the distance between the tissue and the probe tip," implying functionality in delivering laser energy for this purpose.
Biocompatibility/Sterility	Compliance with ISO 10993-1. For sterility, EO and ECH residual testing following ANSI/AAMI/ISO 10993-7:2008 (R2012) for a simulated extraction, ensuring residue levels are below limits for intraocular lenses (not exceeding 1.25 micrograms EO and 5 micrograms ECH), for the endophoto probe tip. Shelf life of 3 years based on seal integrity and product sterility tests at 3 accelerated or real years.	"The results demonstrate that the subject device complies with applicable international standards (ISO10993-1)." EO and ECH residual levels after sterilization of the endophoto probe were "below the current limits for intraocular lenses, it means not exceed 1.25 micrograms and 5 micrograms (respectively), testing just the endophoto probe tip." A shelf life of 3 years was "claimed" based on testing.
Electrical Safety	Testing according to IEC 60601-1.	"The electrical safety test report according to IEC 60601-1...were provided." The implication is that the device met these standards, though specific test results or pass/fail outcomes are not detailed.
Electromagnetic Compatibility (EMC)	Testing according to IEC 60601-1-2.	"The Electromagnetic Compatibility test report according IEC 60601-1-2 were provided." Similar to electrical safety, the implication is compliance.
Mechanical Properties	Testing of endophoto probes according to ISO 9626.	"The mechanical properties of all the endophoto probes were tested according to ISO 9626 and the results confirmed the ability of the device to withstand the forces it will be subjected during normal use." Again, specific quantitative data is absent, but compliance is asserted.
Substantial Equivalence	The device must be "substantially equivalent to the predicate devices with regard to design, function, technological characteristics, intended use and performance characteristics." Differences (maximum laser output/wavelength, endophoto probe length, fixed protective filter, cable length of protective filters) must not "affect the intended use or the indication for use or alter the fundamental scientific technology."	The document asserts: "The proposed Endophotocoagulation Delivery Unit shares the substantially equivalent indications for use, the substantially equivalent technological characteristics and substantially equivalent principle of operation as the predicate devices." The document implies that the non-clinical tests (sterility, electrical safety, EMC, mechanical) serve to support this claim by demonstrating that despite minor differences, the new device performs acceptably and safely, similar to the predicate. Specific comparative performance data showing equivalence is not detailed in the summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a sample size for a "test set" in the context of clinical validation or performance measurement against a ground truth. The testing described is primarily bench testing for safety, sterility, and mechanical properties.
Data Provenance: The testing described is non-clinical bench testing. There is no mention of human subject data, and thus no country of origin or retrospective/prospective designation applies in this context, beyond the device manufacturer being Nidek Co. Ltd, Japan, and the official correspondent being Nidek Technologies srl, Italy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable and not provided in the document. The studies mentioned are non-clinical engineering and materials tests (sterility, electrical safety, mechanical endurance). There is no "test set" requiring expert ground truth or assessment for clinical performance.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As there's no clinical "test set" with expert assessment, no adjudication method would be needed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. This document focuses on establishing substantial equivalence through non-clinical testing. It does not evaluate human reader performance with or without the AI assistance, as this is not an AI-based device, nor a diagnostic device that requires interpretation by readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done as this is not an AI algorithm but a medical device delivery unit. The testing reported focuses on the physical and functional aspects of the device components.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically understood in diagnostic or AI performance studies (e.g., pathology, expert consensus, outcomes data) is not applicable to the non-clinical testing described. The "ground truth" in this context would be the compliance with quantitative thresholds defined by international standards (e.g., acceptable levels of EO/ECH, mechanical strength thresholds, electrical safety limits).

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided. As there is no training set mentioned.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 12, 2014

NIDEK Company, LTD % Mr. Enrico Bisson Nidek Technologies srl Via dell'Artigianato, 6/A 35020 Albignasego (Padova), Italy

Re: K133358 Trade/Device Name: Endophotocoagulation Delivery Unit (for sterilized endophoto probe) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX, HQF Dated: July 9, 2014 Received: July 21, 2014

Dear Mr. Bisson:

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K133358

Device Name

Endophotocoagulation Delivery Unit (for sterilized endophoto probe)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(K) SUMMARY

This summary of the 510(k) premarket notification for the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

510(k) Notification K133358

GENERAL INFORMATION

Applicant:

NIDEK CO., LTD. 34-14 Maehama, Hiroishi Gamagori, Aichi, 443-0038 Japan

Contact Person:	Yoneji Mizuno
Contact Title:	Senior Manager, Regulatory Affairs Department
Contact Phone Number:	+81-533-67-8901
Contact Fax Number:	+81-533-67-6628
E-mail:	Yoneji_Mizuno@nidek.co.jp.
Official Correspondent:	Enrico Bisson
Contact Title:	Manager, Regulatory Affairs Department
	Nidek Technologies Srl
	Via dell'Artigianato, 6/A,
	35020 Albignasego (Padova) , Italy
Contact Phone Number:	+39-049 8629200
Contact Fax Number:	+39-049 8626824
E-mail:	enricobisson@nidektechncologies.it

Date Prepared: August 7, 2014 Classification:

21 CFR§878.4810 and §886.4390, Class II

Classification name:

Laser surgical instrument for use in general and plastic surgery and in dermatology

Product Code:

GEX, HQF

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Trade Name:

Endophotocoagulation Delivery Unit (for sterilized endophoto probe)

Generic/Common Name:

Endophotocoagulation Delivery Unit (for sterilized endophoto probe)

Predicate Device

Multicolor Laser Photocoagulator System MC-500 (K110228) OphthalMed 20G and 25G SMA Laser Fibers (K021696) Peregrine 23ga Curved Illuminating Laser Probe (K122997) Green Laser Photocoagulator GYC-1000 (K032085)

Indications for use

Product Description

Surgical microscope manufacturer	Surgical microscope model
CARL ZEISS MEDITEC	OPMI VISU 140
	OPMI Lumera i
	OPMI Lumera T
TOPCON	OMS-800
	OMS-710
	OMS-90
TAKAGI SEIKO	OM-18
LEICA MICROSYSTEMS (formerly WILD)	M844/M820
	M620

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The delivery unit, which consists of a sterilized endophoto probe (available in 3 different sizes and 2 different shapes), protective filter unit, and carrying case, is used for endophotocoagulation.

The photocoagulation system can be easily assembled by connecting the sterilized endophoto probe to the main laser device and connecting the protective filter to the laser device and surgical microscope.

This photocoagulation system enables laser endophotocoagulation while observing the affected area through the surgical microscope.

Substantial Equivalence

The Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is substantially equivalent to the predicate devices with regard to design, function, technological characteristics, intended use and performance characteristics.

The differences between the proposed and predicate devices and justifications as to why these differences do not raise safety or efficacy concerns are as follows:

• The maximum laser output and the wavelength of the proposed device is different from those of the predicate devices.

The total length of the endophoto probes of the proposed device is different from that of the predicate devices.
The fixed protective filter is not covered by the predicate devices.
The cable length of the protective filters of the proposed device is different from that of the predicate devices.

The design modifications outlined in this Traditional 510(k) premarket notification do not (1) affect the intended use or the indication for use or (2) alter the fundamental scientific technology of the device. The proposed Endophotocoagulation Delivery Unit shares the substantially equivalent indications for use, the substantially equivalent technological characteristics and substantially equivalent principle of operation as the predicate devices. Therefore, based on the similarities between the devices, the proposed Endophotocoagulation Delivery Unit is substantially equivalent to

OphthalMed 20G and 25G SMA Laser Fibers (K021696)
. SL-1800 attachable delivery unit Multicolor Laser Photocoagulator System MC-500 (K110228)
. Peregrine Surgical 23ga Curved Illuminating Laser Probe (K122997), a probe with a similar irradiance

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Green Laser Photocoagulator GYC-1000 (K032085) .

Testing in Support of Substantial Equivalence Determination

We have verified and validated that the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) meets its functional specifications and performance requirements, and complies with applicable international standards (ISO10993-1).

As mentioned, all necessary bench testing was conducted on the modifications, the addition of the proposed Endophotocoagulation Delivery Unit (for sterilized endophoto probe), to support a determination of substantial equivalence to the predicate devices.

Non clinical sterility testing

The sterilization re-validation protocol was provided and the EO and ECH residual testing of the subject devices following the procedures, methods, and limits for a simulated extraction (since the product is categorized as a limited exposure device), described in the FDA-recognized standard, ANSI/AAMI/ISO 10993-7:2008 (R2012) "Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals" was conducted. This testing demonstrated that EO and ECH residue levels after sterilization of the endophoto probe are below the current limits for intraocular lenses, it means not exceed 1.25 micrograms and 5 micrograms (respectively), testing just the endophoto probe tip.

Regarding expiration date, the sterilized endophoto probes have a shelf life of 3 years. As the basis for setting the shelf life, the seal integrity and product sterility were tested at 3 accelerated or real years and finally concluded that the shelf life of 3 years is claimed.

Non clinical safety testing

Both the electrical safety test report according to IEC 60601-1 and the Electromagnetic Compatibility test report according IEC 60601-1-2 were provided. The mechanical properties of all the endophoto probes were tested according to ISO 9626 and the results confirmed the ability of the device to withstand the forces it will be subjected during normal use.

Summary of Safety and Effectiveness

The results demonstrate that the subject device complies with applicable international standards (ISO10993-1). All the necessary non clinical performance tests in support of substantial equivalence determination were conducted.

Thus the proposed Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.