Dornier's Medilas H RFID Reusable Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:

Arthroscopy, .
Urology, .
Lithotripsy, .
Pulmonology, .
Gastroenterology, .
Gynecology, .
ENT, .
General Surgery. .

Device Description

The basic technological characteristics of the subject device are:

Use of a Silica-glass Fiber to transmit the laser energy; .
Use of a plastic SMA 905 connector for connection to the laser; .
t Other materials used in the manufacturing of the product: Natural Quartz Ferrule; Heat Shrink tubing; and SMA connector strain relief boot;
. All fibers are 3 meters (nominal) in length;
The fibers are sold in core diameter sizes of 272, 365, 550 and 940 microns. .
The basic principal of operation of the Laser Fibers is to transmit laser energy when connected to a Holmium Laser. The Laser Fibers that are the subject of this submission are identical to the predicate fibers (K121938) with the exception of being able to be reused.

AI/ML Overview

This is a 510(k) premarket notification for a reusable medical device, specifically laser fibers. The submission focuses on demonstrating substantial equivalence to previously cleared devices through performance data, largely related to the reprocessing capabilities and the integrity of the fiber after multiple uses.

Here's a breakdown of the requested information based on the provided text, with an important caveat: This document describes a medical device, not an AI/ML device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable or relevant to this type of regulatory submission. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of a medical device's performance testing for reusability and safety.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit from Text)	Reported Device Performance (from Text)
Intended Use/Indications	Device performs cutting, vaporization, ablation, and coagulation of soft tissue in specified medical specialties.	Same intended use/indications as predicate devices. The device functions as an accessory to transmit laser energy.
Technological Characteristics	Use of Silica-glass Fiber, plastic SMA 905 connector, Natural Quartz Ferrule, Heat Shrink tubing, SMA connector strain relief boot. Fibers are 3 meters (nominal) in length, with core diameter sizes of 272, 365, 550, and 940 microns.	Basic technological characteristics are identical to predicate devices.
Safety and Effectiveness (after reprocessing)	Maintain safety and effectiveness after undergoing reprocessing. (Implicit: such as maintaining laser energy transmission capabilities, structural integrity, and sterility where applicable, after multiple cycles of cleaning and sterilization).	"Performance data demonstrates that the Dornier Medilas H RFID Reusable Laser Fibers are as safe and effective as the listed predicates." (This statement implies tests were conducted to support reusability, but specific details of those tests are not provided in this excerpt).
Substantial Equivalence	Device must be substantially equivalent to predicate devices in terms of intended use, technological characteristics, and principles of operation, without raising new questions of safety or effectiveness.	Stated to be substantially equivalent. "The minor differences in the technological characteristics do not raise any new questions of safety or effectiveness."

Study Details (or why they are not applicable for this device type)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not explicitly stated in the provided text. For a device like this, testing would typically involve a certain number of fiber samples subjected to multiple reprocessing cycles. The documentation does not specify these numbers or the origin of the test data.
- Data Provenance: Not specified. Testing for reusability is typically conducted in a laboratory setting.
- Retrospective or Prospective: Not applicable in the context of this device's performance testing. This would be controlled lab testing or simulated-use testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission describes a physical medical device (laser fiber) and its reusability, not a diagnostic or AI/ML algorithm that requires expert "ground truth" to evaluate its output. Evaluation would rely on objective physical, chemical, and functional performance metrics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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 device is a laser fiber, not an AI/ML system. There are no "human readers" or "AI assistance" involved in its direct function.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for reusable medical devices is typically established through recognized standards for cleaning, disinfection, sterilization, material compatibility, and functional performance testing (e.g., laser transmission efficiency, optical integrity, structural integrity, sterility assurance levels) after specified numbers of reprocessing cycles. The "performance data" mentioned would be derived from such objective measurements.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the AI/ML context.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary for this specific device:

The regulatory approval for the Dornier Medilas H RFID Reusable Laser Fibers is based on demonstrating substantial equivalence to existing predicate devices (Dornier Medilas H RFID Laser Fiber K121938 and Dornier Medilas H Laser Fiber Cables K022544). The key modification is the addition of reprocessing instructions to allow for reusability. The "study" that proves the device meets acceptance criteria would be a series of performance tests confirming that the fibers maintain their safety and effectiveness (e.g., laser energy transmission, structural integrity, biocompatibility, and sterility after multiple reprocessing cycles) despite being reused and going through the specified cleaning and sterilization processes. The document states "Performance data demonstrates that the Dornier Medilas H RFID Reusable Laser Fibers are as safe and effective as the listed predicates," implicitly confirming that these tests were conducted and the criteria met, though the specific details of these tests (like sample sizes, methods, and acceptance thresholds) are not provided in this specific excerpt.

Summary

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K123385

DEC 1 4 2012

510(k) SUMMARY

Dornier's Medilas H RFID Reusable Laser Fibers

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

Dornier MedTech America 1155 Roberts Blvd. Kennesaw, GA 30144 Phone: 770-514-6163 770-514-6291 Fax:

Contact Person: John Hoffer

Date Prepared: November 1, 2012

Name of Device and Name/Address of Sponsor

Medilas H RFID Reusable Laser Fibers 1155 Roberts Blvd. Kennesaw, GA 30144

Common or Usual Name

Holmium Laser Fibers

Classification Name

Laser Instrument, (Accessory); Product Code: GEX

Predicate Devices

Dornier Medilas H RFID Laser Fiber (K121938) Dornier Medilas H Laser Fiber Cables (K022544)

Purpose of the Special 510(k) Notice

The Medilas H RFID Reusable Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H RFID Laser Fibers (K121938) Specifically, the only minor modification to the cleared Medilas H RFID Laser Fibers includes the addition of reprocessing instructions in order for the user to be able to reprocess the Laser Fibers.

Intended Use

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STOR & I DEG

soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical DEC & 50 specialties:

Arthroscopy, .
Urology, .
Lithotripsy, .
Pulmonology, .
Gastroenterology, .
Gynecology, .
ENT, .
General Surgery. .

Technological Characteristics / Principles of Operation

The basic technological characteristics of the subject device are:

Use of a Silica-glass Fiber to transmit the laser energy; .
Use of a plastic SMA 905 connector for connection to the laser; .
t Other materials used in the manufacturing of the product: Natural Quartz Ferrule; Heat Shrink tubing; and SMA connector strain relief boot;
. All fibers are 3 meters (nominal) in length;
The fibers are sold in core diameter sizes of 272, 365, 550 and 940 microns. .

The basic principal of operation of the Laser Fibers is to transmit laser energy when connected to a Holmium Laser. The Laser Fibers that are the subject of this submission are identical to the predicate fibers (K121938) with the exception of being able to be reused.

Substantial Equivalence

Dornier's Medilas H RFID Laser Fibers has the same intended use / indications, technological characteristics and principles of operation as the predicate devices. The minor differences in the technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the Dornier Medilas H RFID Reusable Laser Fibers are as safe and effective as the listed predicates. Thus, the Dornier Medilas H RFID Reusable Laser Fibers are substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Dornier Medtech America, Incorporated % Mr. John Hoffer Vice President. Ouality, Regulatory, Clinical 1155 Roberts Boulevard Kennesaw, Georgia 30144

December 14, 2012

Re: K123385

Trade/Device Name: Dornier Medilas H RFID Reusable Laser Fibers 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: December 04, 2012 Received: December 05, 2012

Dear Mr. Hoffer:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. John Hoffer

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K123385

Device Name: Dornier Medilas H RFID Reusable Laser Fibers

Indications for Use:

Dornier's Medilas H RFID Reusable Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction.with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and.coagulation of soft tissuès. The Laser is indicated for use in medicine and surgery, in the following medical specialties:

Image /page/4/Picture/5 description: The image shows a list of medical specialties, including Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery. Next to each specialty is an "x". The image also indicates "Prescription Use" with an "x" and "Over-The-Counter Use".

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2012.12.11 16:12:45 -05'00'

{Division Sign-Off)

Division of Surgical Devices

510(k) Number K123385

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.