The OBERON, laser surgery fiber, Side Fire laser surgery fibers are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. (Diode Laser 532nm- 2100mm) OBERON laser surgery fiber is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, 1.44YAG and Diode Lasers (532mm - 2100mm) with peak and continuous power from 1-100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

Device Description

OBERON's laser surgery fiber contains the same components and the same technological characteristics as the predicate devices. The fiber core and cladding or fibers with no cladding are made from silica which is the same material used in all the predicate devices. As mentioned, the optical fiber is made out of silica with a coaxially mounted protective sheath. The fiber distal tip can be several configurations and the fiber can be also used with hand pieces.

AI/ML Overview

The document provided is a 510(k) summary for the OBERON Laser Surgery Fiber, indicating that it has been found substantially equivalent to predicate devices. This type of submission focuses on demonstrating equivalence rather than proving device performance against specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the document does not contain a table of acceptance criteria and reported device performance as it relates to clinical efficacy or accuracy metrics. Instead, it asserts substantial equivalence based on technical characteristics and intended use.

Here's an analysis of the information that can be extracted or deduced from the provided text, and what is explicitly not present:

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

Not explicitly available in the provided document. The document states, "The performance of the OBERON's laser surgery fiber is well established and documented so no performance testing is included." This implies reliance on the performance of the predicate devices.
The table in section {4} ("Predicate Devices - 1 - Per 21 CFR 807.92 item (6) Summary with comparison values") provides a comparison of technical characteristics and intended use between the OBERON device and several predicate devices (MED-Fibers, Inc. K124003 and Fiberoptic Fab K120810). It does not present quantitative performance data against specific acceptance criteria.

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

Not applicable/Not provided. Since no specific performance testing against acceptance criteria is included in this 510(k) summary, there is no mention of a test set, its sample size, or data provenance. The submission relies on the "well established and documented" performance of the technology in general and the predicate devices.

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/Not provided. As no specific performance testing is documented, there is no mention of experts or ground truth establishment for a test set.

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

Not applicable/Not provided. No test set is described.

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:

No, not done. This device is a laser surgery fiber, a physical medical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant or applicable.

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

Not applicable/Not provided. This is a hardware device, not an algorithm.

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

Not applicable/Not provided. No specific performance study with ground truth is described.

8. The sample size for the training set:

Not applicable/Not provided. This is a physical device, and machine learning training sets are not relevant.

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

Not applicable/Not provided.

Summary of what is available from the document regarding acceptance and studies:

The document is a 510(k) Pre-market Notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically involves comparing the new device's technological characteristics, intended use, and safety/effectiveness data (or lack thereof, if equivalence is strong) to the predicate.

Acceptance Criteria (Implied by 510(k) process): The ultimate acceptance criterion for a 510(k) submission is that the device is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
Study Proving Acceptance: The "study" is the 510(k) submission itself, which presents a comparative analysis. The document states:
- "The performance of the OBERON's laser surgery fiber is well established and documented so no performance testing is included."
- "The OBERON's laser surgery fiber delivery system operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices."
- "The OBERON's laser surgery fibers are as safe and effective for the indications for use as the Laser Peripherals, Leoni, Lumenis, MED-Fibers, Cynosure, Fiberoptic Fabrications and CermaOptec fiber optic laser delivery systems previously cleared thus the OBERON's laser surgery fibers are substantially equivalent."

This means the "proof" is the argument of equivalence based on the shared fundamental technology and intended use with multiple predicate devices, rather than a novel study designed to meet specific performance targets for a new technology or application.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be flowing or merging together.

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

October 15, 2014

OBERON GmbH Fiber Technologies % Dr. Armin Kaus MED-Fibers Incorporated 7404 West Detroit Street, Suite 140 Chandler, Arizona 85226

Re: K140470

Trade Name: OBERON Laser Surgery Fiber 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 Dated: September 12, 2014 Received: September 17, 2014

Dear Dr. Kaus:

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours, Binita S. Ashar -S 2014.10.15 15:29:03 -04'00'

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) K140470

Device Name OBERON Laser Surgery Fiber

Indications for Use (Describe)

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

2 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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510 (k) SUMMARY

This 510(k) summary of safety and effectiveness is submitted in accordance with all of the requirements and follows Office of Device Evaluation guidance concerning the organization of a 510 (k) summary.

OBERON 's Laser Surgery Fiber

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

OBERON GmbH Fiber Technologies Freiheitstrasse 120 15745 Wildau GERMANY Phone: +49 3375 21500-0 Fax: +49 3375 21500-10

Official Correspondent:

Dr. Armin Kaus, Ph.D. 7404 W. Detroit Street, STE 140 Chandler, AZ 85226

Date Prepared: October 7, 2014

Name of Device and Name of Sponsor

OBERON Laser Surgery Fiber

OBERON GmbH Fiber Technologies Freiheitsstrasse 120 15745 Wildau, GERMANY

Common or Usual Name

Nd:YAG-, Ho:YAG-, KTP- and Diode Laser -- Laser Fiber Delivery Systems

Classification Name

Surgical Laser Accessory Regulation: 21 CFR §878.4810 Classification: II Product Code: GEX

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Predicate Devices

1 - Per 21 CFR 807.92 item (6) Summary with comparison values

	OBERON GmbHThe fiber optic laser deliverydevices are intended fordelivery of laser light to softtissue in the contact andnoncontact mode duringsurgical procedures includingvia endoscopes andcystoscopes. The laser fiberis intended for use with anycleared surgical laser with anSMA 905 andcompatible connectors.	MED-Fibers, Inc.K124003The surgical fiber opticLaser delivery devicesare intended for deliveryof laser light to soft tissuein the contact and non con-tact mode during surgicalprocedures. The delivery deviceis intended for use with anysurgical lasers with clearedlaser with a compatible SMA905 and compatible connectors.	Fiberoptic FabK120810The fiber optic laser deliverysystem is intended for deliveryof laser light to soft tissue inthe contact and noncontact mode during surgicalprocedures. The fiber opticdelivery System is intendedfor use with any clearedsurgical laser with an SMA905.
Intended use
Delivery Systems
Fiber	Flexible Fiber	Flexible Fiber	Flexible Fiber
Material	Quartz Glass	Quartz Glass	Quartz Glass
Core DiameterProximal end	200 - 600 micronSMA 905 and othercompatible connectors	200 - 1000 micronSMA 905 and othercompatible connectors	200 - 1000 micronSMA 905, SMA906 and other compatibleconnectors
Distal end	flat, shaped, ball,round, side fire, radial	flat, side fire and differentshapes	flat, shaped, side fire
Sterile (Yes/No)	Yes	Yes	Yes
Max Recommended Power	Core Size: 200, 272 μ $20 W$365 μ $40 W$500 μ $100 W$400, 600 μ HPCS $30 W$600 µIRHCN $100 W$800 and 1000μ N/A	up to $45 W$up to $60 W$up to $100 W$up to $40 W$up to $100 W$up to $200W$	up to $45 W$up to $113 W$N/AN/Aup to $100 W$up to $200 W$
Indication for use	The laser delivery devicesare intended for use inlaser based surgicalapplication to deliverthe laser light to softtissue during surgicalapplications. The deliverydevice is cleared forsurgical lasers withcompatible SMA 905connectors. It is indicatedfor use in general surgeryapplications for incision,excision, vaporization,ablation and or coagulation.It is indicated for use insoft tissue procedures withcleared surgical laser systemswith different wavelength.It is also indicated for usewith cleared compatiblelaser systems in lithotripsyfor the desired application.	The surgical fiber optic laserdelivery devices, Endo-ENTfibers, side fire Fibers and Endoprobes in the contact and non-contact mode during surgicalprocedures including viaendoscopes and cysto-scopes. Thesurgical laserfiber is intended for use with anycleared surgical laser with anSMA 905 and compatibleconnectors. The surgical fibersare indicated for use in generalsurgery applications for incision,excision, vaporization, ablation,hemostasis, or coagulation. It isalso indicated for use In open orclosed endo- scopic applicationswhere incision, excision, tissuedissection, excision of ex-ternal tumors and lesionscomplete or partial resection ofintern. organs, It is also intendedas an aid for otology procedures.In addition all surgical devicesare intended for use in lithotripsyapplications with cleared laserSystems.	The fiber optic laser deliverysystem is indicated for use ingeneral surgery applications forincision, excision vaporization,ablation, hemostasis orcoagulation, of soft tissue in acontact or non-contact mode.It is also indicated for use inopen or closed endoscopicapplications, where incision,excision, tissue dissection,excision of external tumors orlesions, complete or partialresection of internal organs,tumors or lesions, tissue vapo-rization, hemostasis and orcoagulation may be indicated.It is also indicated for use inlithotripsy with a compatiblelaser cleared for the desiredapplication. Its intended to usefor different cleared lasers withpeak and continuouspower from 1W - 200W.

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Intended Use / Indications of Use

The OBERON's, laser surgery fiber, is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 or compatible connectors.

The OBERON, laser surgery fibers, Side Fire Laser surgery fibers and Dental Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fibers are intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers laser are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode. It is also indicated for use in open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. (Diode Laser 532nm - 2100nm) QBERON laser surgery fiber is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, Nd;YAG, 1.44YAG and Diode Lasers (532nm - 2100nm) with peak and continuous power from 1 - 100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gastroenterology, gynecology,

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vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

Technical Characteristics

OBERON's laser surgery fiber has no differences in technology and as such does not raise any new questions on safety or efficacy. Various core diameter sizes (200, 272, 365, 400, 550, 600microns) are offered.

Performance Data

The performance of the OBERON's laser surgery fiber is well established and documented so no performance testing is included. The OBERON's laser surgery fiber delivery system operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices.

Substantial Equivalence

The OBERON's laser surgery fibers are as safe and effective for the indications for use as the Laser Peripherals, Leoni, Lumenis, MED-Fibers, Cynosure, Fiberoptic Fabrications and CermaOptec fiber optic laser delivery systems previously cleared thus the OBERON's laser surgery fibers are substantially equivalent.

Signed:
Dr. Armin Kaus, Ph.D.
Official Correspondent

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.