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 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.

AI/ML Overview

The provided text describes a 510(k) submission for the Synergetics Disposable Directional Endo Ocular Laser Probe. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new, complex AI/software-driven device.

Therefore, much of the requested information regarding AI device testing (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this type of traditional medical device submission.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" for this conventional device are primarily based on demonstrating substantial equivalence to a predicate device (Gamp and Associates Disposable Endoocular Laser Probe, K954307) across key technical characteristics and intended use. The "reported device performance" is the direct comparison of these characteristics.

Criteria	Predicate Device - Gamp and Associates Disposable Endo Ocular Laser Probe - K954307	Synergetics Disposable Directional Endo Ocular Laser Probe	Assessment/Performance
Intended Use	Provides a mean for delivering endophotocoagulation during vitrectomy surgery.	Provides a mean for delivering endophotocoagulation during vitrectomy surgery.	Equivalent. The intended use is identical to the predicate device.
For Use With	HGM Laser, 905 SMA Connection	Lasers with 905 SMA Connection	Equivalent. Both devices are compatible with lasers using a 905 SMA connection.
Handle	Delrin	ABS with an ergonomic roller	Minor Difference. The material and design of the handle differ (Delrin vs. ABS with ergonomic roller). The submission implies this is a "slight difference" that "raises no new issues of safety and effectiveness," as supported by non-clinical testing.
Optical Fiber	Glass Optical Fiber - Silica Core	Glass Optical Fiber - Silica Core	Equivalent. Both use the same type of optical fiber.
Distal End	304 Stainless Steel Shaft	304 Stainless Steel Shaft with Nickel Titanium	Minor Difference. The Synergetics device includes Nickel Titanium in addition to 304 Stainless Steel for the distal end. Similar to the handle, this is presented as a "slight difference" that "raises no new issues of safety and effectiveness."
Jacket	PVC	PVC	Equivalent. Both use PVC for the jacket.
Coupling	SMA 905	SMA 905	Equivalent. Both use an SMA 905 coupling.
Single Use	Yes	Yes	Equivalent. Both are single-use devices.
Sterilization Method	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Equivalent. Both use Ethylene Oxide (EtO) sterilization.
Packaging	Double Tyvek Pouch	Double Tyvek Pouch	Equivalent. Both use a Double Tyvek Pouch. Synergetics' packaging validated to ISO 11607-1:2006.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission indicates "Bench testing, and comparative performance testing to the predicate device, was performed." This refers to physical, non-clinical tests on the device itself.

Sample Size: Not explicitly stated, but typically involves a number of manufactured units of the device. This is not patient or image data.
Data Provenance: Not applicable in the sense of patient data. The tests would have been performed by the manufacturer, Synergetics, Inc., likely at their facilities or a contracted testing lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a diagnostic AI device requiring expert-established ground truth from medical images or patient data. The "ground truth" here would be the physical properties and performance measurements of the device itself (e.g., laser power output, sterility, packaging integrity).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not a diagnostic AI device or clinical study involving expert interpretation with adjudication.

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 traditional surgical device, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a traditional surgical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be established through a series of engineering and physical measurements against predefined specifications and industry standards, as well as comparison to the predicate device's known characteristics. Examples include:

Laser power transmission efficiency
Fiber integrity and durability
Sterility (validated to AAMI/ISO 11135)
Packaging integrity (validated to ISO 11607-1:2006)
Biocompatibility (if applicable, though not explicitly detailed here)
Mechanical strength and component integrity

8. The sample size for the training set

Not applicable. This is a traditional hardware medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

{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.3845 Corporate Centre DriveO'Fallon, MO 63368
Contact Person:	Gary OliverosSynergetics, Inc.Senior Regulatory Affairs SpecialistTelephone Number: (636) 794-5107Fax Number: (636) 794-5120Email: goliveros@synergeticsusa.com
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 IIdevices
Classification Name:	Photocoagulator and Accessories
Product Code:	HQB
FDA Panel:	Ophthalmic
Predicate Device:	Gamp and Associates Disposable Endoocular Laser Probe,K954307

Device Description:

{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 andAssociates Disposable Endo OcularLaser Probe - K954307	Synergetics DisposableDirectional Endo Ocular LaserProbe
Intended Use	Provides a mean for deliveringendophotocoagulation duringvitrectomy surgery.	Provides a mean for deliveringendophotocoagulation duringvitrectomy surgery.
For Use With	HGM Laser, 905 SMA Connection	Lasers with 905 SMAConnection
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 withNickel 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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 amean for delivering endophotocoagulation during vitrectomysurgery.

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

Regulation Number and Section

§ 886.4690 Ophthalmic photocoagulator.

(a)
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.(b)
Classification. Class II.