(42 days)
Not Found
No
The device description focuses on the physical characteristics and function of a laser fiber, which transmits laser energy. There is no mention of AI, ML, image processing, or any computational analysis of data. The changes from the predicate are related to reusability, not technological advancements in data processing.
No
The device is an accessory (reusable laser fiber) for a laser system. While the laser system itself is therapeutic, the fibers solely transmit the laser energy and do not directly perform the therapeutic action.
No.
The device, Dornier's Medilas H RFID Reusable Laser Fibers, is described as an accessory for a laser used for "cutting, vaporization, ablation, and coagulation of soft tissue." Its function is to transmit laser energy for therapeutic surgical procedures, not to diagnose medical conditions.
No
The device description explicitly details physical components such as silica-glass fibers, plastic connectors, and other materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the laser fibers are used as an accessory for a laser to perform surgical procedures on soft tissue. This involves direct interaction with the patient's body for therapeutic purposes (cutting, vaporization, ablation, coagulation).
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic or monitoring purposes.
- Device Description: The description focuses on the physical characteristics and function of the fiber in transmitting laser energy for surgical procedures. There is no mention of analyzing biological samples.
The device is a surgical accessory used in vivo (within the living body), not in vitro (in glass or outside the body) for diagnostic purposes.
N/A
Intended Use / 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 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. .
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medicine and surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data demonstrates that the Dornier Medilas H RFID Reusable Laser Fibers are as safe and effective as the listed predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Dornier Medilas H RFID Laser Fiber (K121938), Dornier Medilas H Laser Fiber Cables (K022544)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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
1
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.
2
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
3
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
4
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