SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE

K113857 · Synergetics, Inc. · HQB · Apr 23, 2012 · Ophthalmic

Device Facts

• Record ID: K113857
• Device Name: SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
• Applicant: Synergetics, Inc.
• Product Code: HQB · Ophthalmic
• Decision Date: Apr 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synergetics Disposable Directional Endo Ocular Laser Probe provides a mean for delivering endophotocoagulation during vitrectomy surgery.

Device Story

Sterile, single-use ophthalmic laser delivery device; transmits laser energy from external source to ocular tissue. Consists of handpiece, glass silica optic fiber, PVC tubing, and SMA 905 coupling. Distal tip features rounded edge and smooth surface to minimize tissue trauma during scleral insertion at pars plana. Operated by ophthalmologist during vitrectomy surgery. Laser energy focused into proximal fiber end; traverses fiber via total internal reflection; exits distal tip to perform endophotocoagulation. Ergonomic roller on handpiece allows directional control. Benefits patient by enabling precise laser delivery to target retinal tissue during surgery.

Clinical Evidence

Bench testing only. Comparative performance testing against the predicate device was conducted to verify functional equivalence. No clinical data provided.

Technological Characteristics

Materials: ABS handle, glass silica optical fiber, PVC tubing, 304 stainless steel shaft with nickel-titanium. Energy: External laser source (905 SMA connection). Form factor: Handheld probe. Sterilization: Ethylene Oxide (EtO) per AAMI/ISO 11135. Packaging: Double Tyvek pouch per ISO 11607-1:2006.

Indications for Use

Indicated for patients undergoing vitrectomy surgery requiring endophotocoagulation.

Regulatory Classification

Identification

An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.

Predicate Devices

• Gamp and Associates Disposable Endoocular Laser Probe (K954307)

Submission Summary (Full Text)

{0}------------------------------------------------

Synergetics™

line and

APR 2 3 2012

X113857

### 510 (k) Summary of Safety and Effectiveness Synergetics Single Use Directional Endo Ocular Laser Probe Submitted in accordance with the requirements of 21 CFR 807.92

| Applicant's Name and Address: | Synergetics, Inc.<br>3845 Corporate Centre Drive<br>O'Fallon, MO 63368 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Oliveros<br>Synergetics, Inc.<br>Senior Regulatory Affairs Specialist<br>Telephone Number: [phone]<br>Fax Number: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 29, 2011 |
| Device Trade Name: | Synergetics™ Disposable Directional Endo Ocular Laser Probe |
| Common Name: | Sterile Single Use Endo Ocular Laser Probe |
| Device Classification: | 21 CFR Part 886.4690, Ophthalmic Photocoagulater are Class II<br>devices |
| Classification Name: | Photocoagulator and Accessories |
| Product Code: | HQB |
| FDA Panel: | Ophthalmic |
| Predicate Device: | Gamp and Associates Disposable Endoocular Laser Probe,<br>K954307 |

#### Device Description:

The Synergetics™ Disposable Directional Endo Ocular Laser Probe is a sterile single use ophthalmic laser delivery device. The Laser Probe assembly includes a probe tip (distal end), a handpiece and a coupling means (proximal end) for connecting the Laser Probe to a commercially available laser source. Glass optic fiber protected by PVC tubing is provided between the handpiece and the coupling means. The probe tip, handpiece, tubing and coupling include a passageway for an optic fiber to transmit laser energy from the proximal end through the assembly to the distal end of the probe tip includes a rounded circumferential edge and smooth distal end surface to minimize tearing or snagging of tissue during insertion of the probe assembly through an incision at the sclera at pars plana.

The laser fibers work on the principle of total reflection. Laser energy is focused into the glass silica fiber at the proximal end of the probe and traverses the length of the fiber by means of total reflection. The fiber is

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the word "Synergetics" in bold, black font. To the left of the word is a geometric shape that looks like a diamond made up of smaller squares and triangles. To the right of the word, there is a superscript "TM" symbol.

able to contain the laser beam and funnels the laser through the proximal end through the assembly to the distal end of the laser probe.

#### Intended Use:

The Synergetics Disposable Directional Endo Ocular Laser Probe provides a mean for delivering endophotocoagulation during vitrectomy surgery.

| Criteria | Predicate Device - Gamp and<br>Associates Disposable Endo Ocular<br>Laser Probe - K954307 | Synergetics Disposable<br>Directional Endo Ocular Laser<br>Probe |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Intended Use | Provides a mean for delivering<br>endophotocoagulation during<br>vitrectomy surgery. | Provides a mean for delivering<br>endophotocoagulation during<br>vitrectomy surgery. |
| For Use With | HGM Laser, 905 SMA Connection | Lasers with 905 SMA<br>Connection |
| Handle | Delrin | ABS with an ergonomic roller |
| Optical Fiber | Glass Optical Fiber - Silica Core | Glass Optical Fiber - Silica Core |
| Distal End | 304 Stainless Steel Shaft | 304 Stainless Steel Shaft with<br>Nickel Titanium |
| Jacket | PVC | PVC |
| Coupling | SMA 905 | SMA 905 |
| Single Use | Yes | Yes |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Packaging | Double Tyvek Pouch | Double Tyvek Pouch |
| Note 1: Synergetics packaging configuration has been validated in accordance with ISO 11607-1:2006, | | |
| Packaging for Terminally Sterilized Medical Devices- Part 1: Requirements for Materials, Sterile Barrier | | |
| Systems and Packaging Systems | | |

#### Comparison of Technical Characteristics:

#### Risk Management:

Risk Management has been implemented and complies with ISO 14971, Medical Devices -- Application of Risk Management to Medical Devices.

#### Sterilization Method:

Synergetics Disposable Directional Endo Ocular Laser Probes are sterilized in accordance with AAMI/ISO 11135 Medical Devices --- Validation and routine control of ethylene oxide sterilization (EtO), Overkill Method for a sterility assurance level of 104.

### Summary of Non-clinical Testing:

Bench testing, and comparative performance testing to the predicate device, was performed on the Synergetics Disposable Directional Endo Ocular Laser Probe. The non-clinical testing indicates the device performance is substantially equivalent to the predicate and the slight differences raise no new issues of safety and effectiveness.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

APR 2 3 2012

Synergetics USA, Inc. % Mr. Gary Oliveros Senior Regulatory Affairs Specialist 3845 Corporate Center Drive O'Fallon, MO 63368

Re: K113857

Trade/Device Name: Synergetics Disposable Directional Endocular Laser Probe Regulation Number: 21 CFR 886.4690 Regulation Name: Ophthalmic photocoagulator Regulatory Class: Class II Product Code: HQB Dated: March 12, 2012 Received: March 13, 2012

Dear Mr. Oliveros:

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

{3}------------------------------------------------

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

n

Sincerely vours.

Kesia Alexander

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric logo that is diamond-shaped and made up of smaller squares and triangles. The letters are black, and there is a trademark symbol in the upper right corner of the word.

# Synergetics™ 510 (k) Submission Synergetics Single Use Directional Endo Ocular Laser Probe Section 4 - Indications for Use

| 510(k) Number (if known): | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synergetics Directional Endo Ocular Laser Probe |
| Indications for Use: | The Synergetics Directional Endo Ocular Laser Probe provides a<br>mean for delivering endophotocoagulation during vitrectomy<br>surgery. |

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

T. em.

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K113857

Section 4 - Page 1 of 1