(20 days)
No
The summary describes a laser system and fiber cables for surgical procedures, with no mention of AI or ML capabilities.
Yes
The device is described as a surgical laser used in various medical specialties for cutting, vaporization, ablation, and coagulation of soft tissue, all of which are therapeutic interventions.
No
The device is described as a surgical laser intended for cutting, vaporization, ablation, and coagulation of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "Laser Fiber Cable," which is a hardware component used with a laser system. The summary describes a physical accessory, not a software-only device.
Based on the provided information, the Dornier Medilas™ H Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for cutting, vaporization, ablation, and coagulation of soft tissue within the body, either endoscopically or in open surgery. This is a therapeutic and surgical application, not an in vitro diagnostic test performed on samples outside the body.
- Device Description: The description focuses on the laser system and fiber cables used for delivering the laser energy for surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Dornier Medilas™ H Laser's function is to directly interact with and modify tissue within the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Dornier Medilas™ H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).
The Dornier Medilas™ H Laser is indicated for use in medicine and surgery, in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Not Found
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)
Not Found
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.
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.
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
10F3
K 02254
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Medilas™ H Laser Fiber Cables
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Dornier Medilas™ H Laser Fiber Cables are based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device which is the SlimLine Fibers in 365, 550 and 1,000 micron sizes included in the Lumenis Modified Coherent VersaPulse Dual Wavelength Surqical Lasers and Delivery Accessories 510(k) #K980685
1. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Dornier MedTech America, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144
Contact Person:
Tim Thomas Directory, Requlatory, Quality, & Clinical
Telephone number: 770-514-6163 Facsimile number: 770-514-6288
Date Prepared: July 12, 2002
2. Device Name and Name/Address of Sponsor
Classification Name: Diode lasers have not been specifically classified by FDA.
Dornier Medilas™ H Laser Fiber Cables Proprietary Name(s):
Dornier MedTech America, Inc. Sponsor: 1155 Roberts Boulevard Kennesaw, GA 30144
1
3. Predicate Device
SlimLine Fibers in 365, 550 and 1,000 micron sizes included in the Lumenis Modified Coherent VersaPulse Dual Wavelength Surgical Lasers and Delivery Accessories 510(k) #K980685
4. Indications for Use
The Dornier Medilas™ H Laser Fiber Cables used in this premarket notification are the same accessory devices as in the previously cleared Dornier Medilas™ H Laser System under 510(k) #K984591 and maintain the same previously cleared indications for use as stated below.
The Dornier Medilas™ H Laser is intended to be used in cutting, vaporization, ablation, and coaqulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coaqulation of soft tissue in contact or non-contact open surgery (with or without hand piece).
The Dornier Medilas™ H Laser is indicated for use in medicine and surgery, in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.
5. Description of Technological Characteristics and Substantial Equivalence
From a clinical perspective and comparing design specifications, the Dornier Medilas™ H Laser Fiber Cables and the predicate device. SlimLine Fibers in 365, 550 and 1,000 micron sizes included in the Lumenis Modified Coherent VersaPulse Dual Wavelength Surgical Lasers and Delivery Accessories clearance, are substantially equivalent.
An analysis of equivalence has been conducted according to the "510(k) Substantial Equivalence Decision-Making Process" flowchart from the Blue Book Memorandum #86-3 and included as an attachment to this notification. Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that no significant differences exist between the Dornier Medilas™ H Laser Fiber Cables and the predicate device.
Dornier believes the minor differences of the Dornier Medilas™ H Laser Fiber Cables and its predicate laser device should not raise any concerns regarding the overall safety or effectiveness.
- Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that
Dornier Medilas H Laser Fiber Cables • Special 510(k) Submission for Increased Power Rating July 12, 2002
Dornier MedTech America, Inc.
2
the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2002
Mr. Tim Thomas Director, Regulatory, Quality and Clinical Dornier MedTech America, Inc. 1155 Roberts Boulevard Kennesaw, Georgia 30144
Received: August 1, 2002
Re: K022544
Trade/Device Name: Dornier Medilas™ H Laser Fiber Cables Regulation Number: 21CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: July 30, 2002
Dear Mr. Thomas:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Tim Thomas
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark n Mella
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number:
A2254
Device Name: Dornier's Medilas™ H Laser Fiber Cables
Indications for Use:
Dornier MedTech America, Inc. is requesting that the modified Dornier Medilas™ Laser Fiber Cables previously cleared as an accessory under Dornier Medilas™ H Laser Systems as 510(k) K984591, maintain the same indications for use. The modified and currently marketed Dornier Medilas™ Laser Fiber Cables will have the following indications for use.
The Dornier Medilas™H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).
The Dornier Medilas™ H Laser is indicated for use in medicine and surgery, in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
(Division Sign-Off)
f General, Restorative and Neurological Devices
510(k) Number _
Dornier MedTech America, Inc.
Over-the-Counter Use
Division C Divisio and Neurologica
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Dornier Medilas H Laser Fiber Cables · Special 510(k) Submission for Increased Power Rating July 12, 2002