(30 days)
No
The document describes a laser fiber accessory with a modified tip shape and mentions RFID for identification, but there is no mention of AI or ML in the device description, intended use, or performance testing.
Yes
The device is an accessory to a laser intended for cutting, vaporization, ablation, and coagulation of soft tissue, which are therapeutic medical procedures.
No
The device is described as an accessory for a laser intended for cutting, vaporization, ablation, and coagulation of soft tissue, which are therapeutic and surgical functions, not diagnostic ones.
No
The device description explicitly states it is a "Laser Fiber" made from "silica," which is a physical component, not software. The testing described also focuses on physical properties like emission pattern, power transmission, and tip fracture resistance.
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 system for cutting, vaporization, ablation, and coagulation of soft tissue during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a laser fiber, a physical component used to deliver laser energy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Dornier's Medilas H RFID 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, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy ●
- Urology ●
- Lithotripsv .
- Pulmonology ●
- Gastroenterology
- Gynecology ●
- . ENT
- General Surgery
Product codes
GEX
Device Description
The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H RFID Laser Fibers (K152591) to include a rounded, ball tip, distal end. The fiber core and cladding for the subject device are made from silica, which is same material used in the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical functional performance testing was conducted per internal test methods. The functional testing included:
- . Confirming that the emission pattern of the distal tip from the laser colored aiming beam is equivalent to the predicate device;
- . Confirming the power transmission of the laser fibers when used with a Dornier Medilas H30 Holmium Laser is equivalent to the predicate device;
- . Confirming the tip fracture resistance of the ball tip fiber is equivalent to the predicate device; and
- Confirming the ability of the ball tip laser fibers to be introduced into a deflected scope with minimal resistance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized depiction of a human face in profile, composed of three overlapping silhouettes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2016
Dornier MedTech America, Inc. Mr. John Hoffer VP Quality, Regulatory, Clinical 1155 Roberts Blvd., Suite 100 Kennesaw, GA 30144
Re: K161771
Trade/Device Name: Medilas H 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: June 26, 2016 Received: June 28, 2016
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
1
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 809); 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Christopher J. Ronk -S
For 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 Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
Dornier Medilas H RFID Gentle Flex Laser Fiber
Indications for Use (Describe)
Dornier's Medilas H RFID 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, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy ●
- Urology ●
- Lithotripsv .
- Pulmonology ●
- Gastroenterology
- Gynecology ●
- . ENT
- General Surgery
Type of Use (Select one or both, as applicable)
X 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (1/14)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
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510(k) SUMMARY
Dornier's Medilas H RFID Laser Fiber
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Dornier MedTech America | Phone: 770-514-6163 |
|---|---|
| 1155 Roberts Blvd. | Fax: 770-514-6291 |
| Kennesaw, GA 30144 | Date Prepared: June 26, 2016 |
Phone: 770-514-6163 Contact Person: John Hoffer
Name of Device and Name/Address of Sponsor
Medilas H RFID Gentle Flex Laser Fibers John Hoffer Dornier MedTech America 1155 Roberts Blvd. Kennesaw, GA 30144
Common or Usual Name
Holmium Laser Fibers
Classification Name
Laser Instrument, (Accessory); Product Code: GEX
Predicate and Reference Devices
Dornier Medilas H RFID Laser Fiber (K152591) (Predicate device) Boston Scientific Flexiva TracTip Laser Fiber (K110685) (Reference device)
Purpose of the Special 510(k) notice.
The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H RFID Laser Fibers (K152591) to include a rounded, ball tip, distal end.
Intended Use/Indications for Use
Dornier's Medilas H RFID 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, 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:
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- Arthroscopy,
- Urology,
- Lithotripsy, ●
- Pulmonology,
- Gastroenterology,
- Gynecology,
- o ENT.
- General Surgery.
Technological Characteristics
The Dornier Medilas H RFID Laser Fiber has the same technological characteristics and principles of operation as the predicate device. The fiber core and cladding for the subject device are made from silica, which is same material used in the predicate device. Additionally, the fiber is manufactured and tested in the identical fashion as the company's predicate device and functions in an equivalent manner.
Standards
ISO 14971:2007 Medical devices -- Application of risk management to medical devices ISO 10993-1:2009 Biological evaluation of medical devices ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide
Performance Data
Nonclinical functional performance testing was conducted per internal test methods. The functional testing included:
- . Confirming that the emission pattern of the distal tip from the laser colored aiming beam is equivalent to the predicate device;
- . Confirming the power transmission of the laser fibers when used with a Dornier Medilas H30 Holmium Laser is equivalent to the predicate device;
- . Confirming the tip fracture resistance of the ball tip fiber is equivalent to the predicate device; and
- Confirming the ability of the ball tip laser fibers to be introduced into a deflected scope with minimal resistance.
Substantial Equivalence
Dornier's Medilas H RFID Gentle Flex Laser Fiber has the same intended use/indications for use, as well as technological characteristics and principles of operation as the predicate device. The minor difference of the rounded distal tip does not raise any new questions of safety or effectiveness. Performance data demonstrates that the Dornier Medilas H RFID Gentle Flex Laser Fibers are substantially equivalent to the listed company predicate device. Thus, the Dornier Medilas H RFID GentleFlex Laser Fibers are substantially equivalent to its predicate and reference devices.