FIBERION OPHTHALMIC ENDOLASER PROBE

K133019 · Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim · HQF · Feb 20, 2015 · Ophthalmic

Device Facts

• Record ID: K133019
• Device Name: FIBERION OPHTHALMIC ENDOLASER PROBE
• Applicant: Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim
• Product Code: HQF · Ophthalmic
• Decision Date: Feb 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fiberion Ophthalmic Endolaser Probes are intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the illumination function is indicated for use to illuminate the interior of the eye. The probes are offered with straight or angled tips, and with a series of connectors that allows them to be used with compatible laser systems. The probes are cleared for use for the particular indications of the laser system to which they are attached.

Device Story

Fiberion Ophthalmic Endolaser Probes are fiber-optic delivery devices for ophthalmic laser photocoagulation; transmit laser energy from external laser systems to intraocular treatment sites; some models include additional fiber optics for illumination. Components include input connector, glass fiber optic, buffer coating, protective tubing, aluminum handle, and medical-grade stainless steel needle. Used in clinical settings by ophthalmologists; probes connect to compatible laser photocoagulators. Output is laser energy delivery and interior eye illumination; enables precise photocoagulation for various ophthalmic conditions. Benefits include targeted therapeutic energy delivery and visualization of the surgical field.

Clinical Evidence

Bench testing only. Testing included laser power transmission, beam divergence, beam density homogeneity, and illumination intensity/area. Laboratory testing confirmed sterility, biocompatibility, and acceptable levels of EO/ECH residues (<1.25 ug/device and <5 ug/device respectively) and endotoxins (<0.2 EU/device).

Technological Characteristics

Materials: aluminum handle, medical-grade stainless steel needle, glass optical fiber, thermoplastic rubber jacket. Sensing/Actuation: passive fiber-optic light/laser transmission. Energy: external laser source. Form factor: 20G, 23G, 25G, 27G needles; straight or angled tips; various connectors (SMA, ST, Cylindrical). Sterilization: Ethylene Oxide (ETO).

Indications for Use

Indicated for ophthalmic laser treatments requiring delivery of laser energy to the interior of the eye and illumination of the interior of the eye. Used in conjunction with compatible ophthalmic laser systems for the indications specified by those systems.

Regulatory Classification

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.

Predicate Devices

• IRIS Medical EndoProbe (K022228)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping heads or faces.

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

February 20, 2015

Emtron Elektronik Ve Mekanik Sanayi Ve Ticaret Lim Dr. Mehmet Melek President Bebek Yolu Sokagi 23/3 Etiler Istanbul, 34337 TR

Re: K133019

> Trade/Device Name: Fiberion Ophthalmic Endolaser Probe Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: January 9, 2015 Received: January 12, 2015

Dear Dr. Melek:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Kesia Y. Alexander -S

for Malvina B. Eydelman, MD Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133019

Device Name Fiberion Ophthalmic Endolaser Probe

Indications for Use (Describe)

Fiberion Ophthalmic Endolaser Probes are in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the illumination is indicated for use to illuminate the interior of the eye. The probes are offered with straight or angled tips, and with a series of connectors that allows them to be used with compatible laser systems. The probes are cleared for use for the particular indications of the laser system to which they are attached

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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#### 510(k) Summary EMTRON™ Corporation Fiberion™ Ophthalmic Endolaser Probes

## Submitter's Name, Address, Telephone Number, E-mail, Contact Person and Date Prepared

EMTRON Elektronik ve Mekanik Sanayi ve Ticaret Limited Sirketi Bebek Yolu Sokaqi 23/3 Etiler 34337 lstanbul Turkey [phone] [e-mail] Dr. Mehmet Melek Date Prepared: February 20, 2015

### Device Information

Trade Name: Fiberion Ophthalmic Endolaser Probes Classification Name: Laser, Ophthalmic, Accessory CFR Section: 886.4390 Class II Product Code: HQF

### Predicate Devices

Fiberion Ophthalmic Endolaser Probes is substantially equivalent in intended use and/or method of operation to other currently legally marketed laser probes of IRIDEX Corporation's IRIS Medical EndoProbe (K022228).

## Device Description

Fiberion endolaser probes are designed to be connected to ophthalmic laser photocoagulators and to transmit laser energy inside the patient's eye. One end of the probe contains a connector for attachment to the laser unit, the other, a tip section to be introduced inside the eye. Device components are an input connector, a glass fiber optic protected by a buffer coating, a protective tubing, an aluminum handle with a medical grade stainless steel needle. The illuminating endolaser probe has an additional illumination fiber optic.

## List of Fiberion Ophthalmic Endolaser Probes

| SMA-S | : Standard SMA connector, straight 0,9mm (20 Gauge) tip |
|--------------|--------------------------------------------------------------------------|
| SMA-A | : Standard SMA connector, angled 0,9mm (20 Gauge) tip |
| E-SMA-S | : Extended SMA connector, straight 0,9mm (20 Gauge) tip |
| E-SMA-A | : Extended SMA connector, angled 0,9mm (20 Gauge) tip |
| E-CYL-S | : Cylindrical connector, straight 0,9mm (20 Gauge) tip |
| E-CYL-A | : Cylindrical connector, angled 0,9mm (20 Gauge) tip |
| E-906-S | : Extended SMA 906 connector, straight 0,9mm (20 Gauge) tip |
| E-906-A | : Extended SMA 906 connector, angled 0,9mm (20 Gauge) tip |
| U-SMA-S | : SMA connector with long handle, straight 0,9mm (20Gauge) tip |
| U-SMA-A | : SMA connector with long handle, angled 0,9mm (20Gauge) tip |
| SMA-400-S | : Standard SMA connector, 400 micron fiber, straight 0,9mm (20Gauge) tip |
| SMA-400-A | : Standard SMA connector, 400 micron fiber, angled 0,9mm (20Gauge) tip |
| STA-S | : ST connector with long ferrule, straight 0,9mm (20 Gauge) tip |
| STA-A | : ST connector with long ferrule, angled 0,9mm (20 Gauge) tip |
| SMA-23-S | : Standard SMA connector, straight 0,6mm (23 Gauge) tip |
| SMA-23-A | : Standard SMA connector, angled 0,6mm (23 Gauge) tip |
| E-SMA-23-S | : Extended SMA connector, straight 0,6mm (23 Gauge) tip |
| E-SMA-23-A | : Extended SMA connector, angled 0,6mm (23 Gauge) tip |
| E-CYL-23-S | : Cylindrical connector, straight 0,6mm (23 Gauge) tip |
| E-906-23-S | : Extended SMA 906 connector, straight 0,6mm (23 Gauge) tip |
| E-906-23-A | : Extended SMA 906 connector, angled 0,6mm (23 Gauge) tip |
| U-SMA-23-S | : SMA connector with long handle, straight 0,6mm (23Gauge) tip |
| U-SMA-23-A | : SMA connector with long handle, angled 0,6mm (23Gauge) tip |
| SMA-400-23-S | : Standard SMA connector, 400 micron fiber,straight 0,6mm (23 Gauge) tip |
| STA-23-S | : ST connector with long ferrule, straight 0,6mm (23 Gauge) tip |
| STA-23-A | : ST connector with long ferrule, angled 0,6mm (23 Gauge) tip |
| SMA-25-S | : Standard SMA connector, straight 0,5mm (25 Gauge) tip |
| SMA-25-A | : Standard SMA connector, angled 0,5mm (25 Gauge) tip |
| E-SMA-25-S | : Extended SMA connector, straight 0,5mm (25 Gauge) tip |
| E-SMA-25-A | : Extended SMA connector, angled 0,5mm (25 Gauge) tip |
| E-906-25-S | : Extended SMA 906 connector, straight 0,5mm (25 Gauge) tip |
| E-906-25-A | : Extended SMA 906 connector, angled 0,5mm (25 Gauge) tip |
| U-SMA-25-S | : SMA connector with long handle, straight 0,5mm (25Gauge) tip |
| STA-25-S | : ST connector with long ferrule, straight 0,5mm (25 Gauge) tip |
| STA-25-A | : ST connector with long ferrule, angled 0,5mm (25 Gauge) tip |
| SMA-27-S | : Standard SMA connector, straight 0,4mm (27 Gauge) tip |
| E-SMA-27-S | : Extended SMA connector, straight 0,4mm (27 Gauge) tip |
| E-906-27-S | : Extended SMA 906 connector, straight 0,4mm (27 Gauge) tip |
| STA-27-S | : ST connector with long ferrule, straight 0,4mm (27 Gauge) tip |
| ILL-SMA-S | : Standard SMA connector, straight 0,9mm (20 Gauge) tip |
| ILL-SMA-A | : Standard SMA connector, angled 0,9mm (20 Gauge) tip |
| ILL-E-SMA-S | : Extended SMA connector, straight 0,9mm (20 Gauge)tip |
| ILL-E-SMA-A | : Extended SMA connector, angled 0,9mm (20 Gauge) tip |
| ILL-E-906-S | : Extended SMA 906 connector, straight 0,9mm (20Gauge) tip |
| ILL-E-906-A | : Extended SMA 906 connector, angled 0,9mm (20Gauge) tip |
| ILL-U-SMA-S | : SMA connector with long handle, straight 0,9mm (20Gauge) tip |
| ILL-U-SMA-A | : SMA connector with long handle, angled 0,9mm (20Gauge) tip |
| ILL-STA-S | : ST connector with long ferrule, straight 0,9mm (20 Gauge) tip |
| ILL-STA-A | : ST connector with long ferrule, angled 0.9mm (20 Gauge) tip |

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#### Intended Use

Fiberion Ophthalmic Endolaser Probes are intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the illumination function is indicated for use to illuminate the interior of the eye. The probes are offered with straight or angled tips, and with a series of connectors that allows them to be used with compatible laser systems. The probes are cleared for use for the particular indications of the laser system to which they are attached.

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## Substantial equivalence

| Application for 510K | Substantial equivalence to |
|-----------------------------------------|-----------------------------------------|
| Fiberion Ophthalmic Endolaser Probes | IRIDEX Corporation's IRIS Medical |
| | EndoProbe (K022228) |
| Light transmission for photocoagulation | Light transmission for photocoagulation |
| Aluminum handpiece | Aluminum handpiece |
| Stainless steel needle | Stainless steel needle |
| Glass optical fiber | Glass optical fiber |
| Thermoplastic rubber jacket | Vinyl jacket |
| ETO sterilized. | ETO sterilized. |

## Differences between the Fiberion Ophthalmic Endolaser Probes and the predicate device

Some terminology differences exist in the intended use description due to trademark issues, but both devices' intended use is exactly the same.

Some models of the predicate device are not available in the Fiberion line. Fiberion probes offer a range of connectors that have been validated with the ophthalmic lasers listed in the instructions for use. The probes have been used internationally for years without safety or laser compatibility problems.

The protective tubing which does not come in contact with the patient is of a different material. Fiberion probes use thermoplastic rubber meeting FDA food grade requirements.

Hence, none of these differences are cause for safety or effectiveness concerns.

# Bench testing

Fiberion Ophthalmic Endolaser Probes and the predicate device were tested for laser power transmission, beam divergence, beam density homogeneity, and additionally for illuminating models, illumination intensity and illumination area diameter; and were found to be equivalent. Fiberion Ophthalmic Endolaser Probes were tested for safe delivery of the intended output power.

# Laboratory testing

Fiberion Ophthalmic Endolaser Probes were tested for sterility and their sections in contact with the patient for biocompatibility, EO-ECH residues and endotoxins and were found to fulfil the requirements. EO levels were determined to be < 1.25 micrograms per device, ECH levels < 5 micrograms per device, and Endotoxin levels < 0.2 Endotoxin units per device.

# Conclusion

Fiberion Ophthalmic Endolaser Probes shares similar indications for use, materials, and similar performance characteristics as, and thus are substantially equivalent to. IRIDEX Corporation's IRIS Medical EndoProbe (K022228).