(19 days)
No
The document describes a laser system with microprocessor control for basic functions like parameter display, system status, and safety interlocks. There is no mention of AI or ML capabilities for image processing, data analysis, or decision-making beyond standard device operation.
Yes
The device is described as a laser "intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue" and "indicated for use in medicine and surgery," which are therapeutic applications.
No
The device is described as a surgical laser used for cutting, vaporization, ablation, and coagulation of soft tissue. Its indicated uses are all therapeutic or interventional, not diagnostic.
No
The device description clearly outlines a physical laser system with hardware components such as a laser source, cooling system, footswitch, and display panel. While it mentions a microprocessor, the core functionality is based on the laser hardware, not solely on software.
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 states that the device is used for cutting, vaporization, ablation, and coagulation of soft tissue in the body (in conjunction with endoscopic equipment or in open surgery). IVD devices are used to examine specimens outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical laser system that interacts directly with tissue. This is consistent with a surgical device, not an IVD device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Dornier Medilas H Laser is a surgical device, not an IVD.
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
The Dornier Medilas H Pulsed Holmium YAG Laser is a compact pulsed HO: YAG laser emitting laser radiation in the invisible range of 2080 nm. The Medilas H provides a temperature-controlled method for contact cutting and non-contact coagulation and vaporization with a bare fiber.
The modified Medilas H has the same principles of operation and similar technological characteristics as the previously unmodified Medilas H (K981718).
The modified Medilas H and the unmodified Medilas H laser systems have photoelectric power meters and are automatically calibrated. They also have a 2-stage waterproof and explosion proof footswitch and both lasers incorporate a watchdog-monitored microprocessor.
Both Lasers depict a graphic display panel which show the laser operating parameters, application modes, time functions, system status and messages for the user.
The Medilas H lasers provide a temperature controlled method for contact cutting and non-contact coagulation and vaporization with fibers made of quartz glass with a bare fiber tip. These fibers are available in diameters of 400 and 600 µm.
The Medilas H lasers feature one mode of operation: Standard. The microprocessor controlled Dornier Medilas H lasers have been developed in accordance with the latest technical standards.
The lasers have a cooling system that includes an air-cooled, temperature controlled, internal closed circuit water system. The cooling systems are identical as concurred in 510(k) # K981718.
As a safety feature, both Medilas H lasers have a single rotating magnetic shutter which moves the filter out of the laser beam. One microprocessor controls the shutter. The Medilas H lasers contain a single shutter with two parallel running microprocessors. Whenever one microprocessor runs differently from the other, the Medilas H laser hardware initiates a "system fault" routine. During any "system fault" laser production and release immediately halt.
There are minor differences between the Medilas H laser, and the unmodified cleared Medilas H laser (K981718). The modified laser system aiming beam is 635 nm, maximum power at aperture 1mW and the unmodified cleared Medilas H laser aiming beam is 630 nm, maximum power at aperture 1mW. The modified Medilas H is contained in new housing. The dimensional specification is visually different from the predicate (unmodified Medilas H) laser system. These modifications do not present any new issues of safety or effectiveness of the device.
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
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)
While no performance standard have been established for HO: YAG lasers under Section 514 of the Federal Food, Drug and Cosmetic Act, the Dornier Medilas H laser is in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control Health and Safety Act of 1968. See 21 C.F.R. § 1040.10 and §1040.11. The laser also complies with the applicable requirements of the following voluntary standards: IEC-601, IEC 825/VDE 0837/2.86.
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.
Unmodified Dornier Medilas H Laser
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
NOV 25 1998
983962
510(k) SUMMARY Dornier Surgical Products, Inc's Medilas H Pulsed Laser
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Walter Payerl President 1155 Roberts Boulevard Kennesaw, GA 30144
Phone: (770) 426-1315 Facsimile: (770) 514-6288
Contact Person: Carol Wernecke Director of Regulatory and Clinical Affairs 1155 Roberts Boulevard Kennesaw, GA 30144
Date Prepared: November 5, 1998
Name of Device and Name/Address of Sponsor
Medilas H Pulsed Holmium YAG Laser
Dornier Surgical Products, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144
Classification Name
HO: FDA has not specifically classified YAG lasers.
Predicate Devices
Unmodified Dornier Medilas H Laser
1
Intended Use
The Dornier Medilas H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in coniunction 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.
Technological Characteristics and Substantial Equivalence
The Dornier Medilas H Pulsed Holmium YAG Laser is a compact pulsed HO: YAG laser emitting laser radiation in the invisible range of 2080 nm. The Medilas H provides a temperature-controlled method for contact cutting and non-contact coagulation and vaporization with a bare fiber.
The modified Medilas H has the same principles of operation and similar technological characteristics as the previously unmodified Medilas H (K981718).
The modified Medilas H and the unmodified Medilas H laser systems have photoelectric power meters and are automatically calibrated. They also have a 2-stage waterproof and explosion proof footswitch and both lasers incorporate a watchdog-monitored microprocessor.
Both Lasers depict a graphic display panel which show the laser operating parameters, application modes, time functions, system status and messages for the user.
The Medilas H lasers provide a temperature controlled method for contact cutting and non-contact coagulation and vaporization with fibers made of quartz glass with a bare fiber tip. These fibers are available in diameters of 400 and 600 µm.
The Medilas H lasers feature one mode of operation: Standard. The microprocessor controlled Dornier Medilas H lasers have been developed in accordance with the latest technical standards.
The lasers have a cooling system that includes an air-cooled, temperature controlled, internal closed circuit water system. The cooling systems are identical as concurred in 510(k) # K981718.
As a safety feature, both Medilas H lasers have a single rotating magnetic shutter which moves the filter out of the laser beam. One microprocessor controls the shutter. The Medilas H lasers contain a single shutter with two parallel running microprocessors. Whenever one microprocessor runs differently from the other, the Medilas H laser
2
hardware initiates a "system fault" routine. During any "system fault" laser production and release immediately halt.
There are minor differences between the Medilas H laser, and the unmodified cleared Medilas H laser (K981718). The modified laser system aiming beam is 635 nm, maximum power at aperture 1mW and the unmodified cleared Medilas H laser aiming beam is 630 nm, maximum power at aperture 1mW. The modified Medilas H is contained in new housing. The dimensional specification is visually different from the predicate (unmodified Medilas H) laser system. These modifications do not present any new issues of safety or effectiveness of the device.
Performance Data
While no performance standard have been established for HO: YAG lasers under Section 514 of the Federal Food, Drug and Cosmetic Act, the Dornier Medilas H laser is in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control Health and Safety Act of 1968. See 21 C.F.R. § 1040.10 and §1040.11. The laser also complies with the applicable requirements of the following voluntary standards: IEC-601, IEC 825/VDE 0837/2.86.
Advisory:
This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 1998
Ms. Carol Wernecke Director Regulatory and Clinical Affairs Dornier Medical Systems, Inc 1155 Roberts Boulevard Kennesaw, Georgia 30144
Re: K983963
Trade Name: Dornier Medilas H Laser (Modified) Regulatory Class: II Product Code: GEX Dated: November 05, 1998 Received: November 06, 1998
Dear Ms. Wernecke:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Carol Wernecke
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
foeele
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
| K9P 3963 | ||
|---|---|---|
| 510(k) Number: | K081718-Special 510(k): Device Modification | |
| Device Name: | Modified Dornier Medilas H Laser |
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 is indicated for use in medicine and surgery, in the following medical specialties:
- ◆ Urology
- ♦ Arthroscopy
- ◆ General Surgery
- ◆ Pulmonology
- · Gynecology
- · Gastroenterology
- ◆ ENT
- ◆ Lithotripsy
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| ------------------ | --- |
or
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | R983963 |