(20 days)
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.
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.
This document is a 510(k) summary for a medical device (Dornier Medilas™ H Laser Fiber Cables). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one would for a novel AI/software medical device.
Therefore, the prompt's requested information, which is tailored for performance studies proving a device meets acceptance criteria (especially relevant for AI/ML devices), is not applicable in this context.
Here's why and how I'll address your request based on the provided text:
- No Acceptance Criteria or Performance Study: The document explicitly states: "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..." It further emphasizes: "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."
- Substantial Equivalence: The entire submission is built on the concept of substantial equivalence to a legally marketed predicate device (SlimLine Fibers in 365, 550 and 1,000 micron sizes, 510(k) #K980685). This means the manufacturer is asserting their device is as safe and effective as the predicate, not that it meets specific, novel performance metrics via a new study.
- No AI/Software Component: The device is a laser fiber cable, a hardware component. There is no mention or indication of any AI or software component, which would typically necessitate the kind of performance study and ground truth establishment described in your prompt.
Given this, I cannot provide the requested table or answer most of the questions because the information is not present in the provided 510(k) summary. The document does not describe a study to prove acceptance criteria in the manner of an AI/ML device.
Response based on available information:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics but implicitly the device must be "substantially equivalent" to the predicate device in terms of safety and effectiveness.
- Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity) or clinical study results are reported to demonstrate meeting novel acceptance criteria. The performance is asserted to be equivalent to the predicate.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. No new performance study or test set described.
-
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. No ground truth establishment for a performance study described.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication described.
-
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 cable, not an AI-assisted diagnostic or therapeutic device that would involve human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth for a performance study described.
-
The sample size for the training set:
- Not applicable. This device is a laser fiber cable. There is no AI/ML model requiring a training set.
-
How the ground truth for the training set was established:
- Not applicable. No AI/ML model or training set described.
In summary, this 510(k) submission relies on demonstrating substantial equivalence to a previously cleared device, not on presenting novel performance data from a clinical or analytical study with defined acceptance criteria.
{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.
{4}------------------------------------------------
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
{5}------------------------------------------------
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
§ 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.