(63 days)
Dornier Medilas Fibertome Laser Model 5100, Coherent's VersaPulse 2.1
Medilas 5100 (K964760)
No
The summary describes a laser device for surgical procedures and does not mention any AI or ML capabilities.
Yes
The device is intended for cutting, vaporization, ablation, and coagulation of soft tissue, which are all therapeutic actions on the body.
No
This device is described as a laser for cutting, vaporization, ablation, and coagulation of soft tissue, which are all therapeutic procedures, not diagnostic ones.
No
The device description clearly states it is a "Pulsed Holmium YAG Laser" which is a hardware device emitting laser radiation. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser 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 a diagnostic one.
- Device Description: The device description confirms it's a laser emitting radiation for surgical procedures.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are designed to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, the Dornier Medilas H Laser is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dornier Medilas H Laser, is intended to be used for cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, colonoscopes, or for open surgery for contact or noncontact surgery with or without hand pieces for use in coagulation, incision/exiciions, ablation and vaporization of soft tissue. The laser is indicated for use in medicine and surgery, in the following specialties: Arthroscopy, Urology, Lithotripsy, Pulmonology, 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 Medilas H and the 5100 laser have photoelectric power meters and both are automatically calibrated. Both laser have a 2-stage, waterproof and explosionproof, foot switch and both laser incorporate a watchdog monitored microprocessor. The Medilas H offers adjustable pulse durations, or continuous. The maximum power of both aiming beam at the aperture is 1 mW. Both the Medilas H and the 5100 laser incorporates a graphic display panel. The Medilas H graphic display shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas H offer only a software controlled Standard operating mode. -The Standard mode is used for non-contact coagulation and vaporization. Like the 5100 laser, the Medilas H has a cooling system which includes an aircooled, temperature controlled internal closed circuit water system. As a safety feature, the Medilas H and the 5100 has a single rotating magnetic shutter which moves the filter out of the laser beam. One microprocessor controls the shutters. The Medilas H and the 5100 laser is based on a single shutter with two parallel running microprocessors. Whenever one microprocessor runs differently from the other, the Medilas H laser hardware initiated a "system fault" routine. During any "system fault" laser production and release immediately halt.
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 825NDE 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.
Dornier Medilas Fibertome Laser Model 5100 and Coherent's VersaPulse 2.1.
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.
Medilas 5100 (K964760)
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
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 10027 South 51st Street Phoenix, AZ 85044
(770) 426-1315 Phone: (770) 514-6288 Facsimile:
Contact Person:
Carol Wernecke Director of Regulatory and Clinical Affairs 1155 Roberts Boulevard Kennesaw, GA 30144
May 14, 1998 Date Prepared:
Name of Device and Name/Address of Sponsor
Medilas H Pulsed Holmium YAG Laser .
Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144
Classification Name
HO: YAG lasers have not been specifically classified by FDA.
Predicate Devices
Dornier Medilas Fibertome Laser Model 5100 and Coherent's VersaPulse 2.1.
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Intended 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, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery. The Dornier Medilas H Laser is indicated for use in medicine and surgery, in the following specialities: 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 Medilas H has the same principles of operation and similar technological characteristics as previously cleared predicates, the Dornier Medilas fibertome 5100 and Coherent's VersaPulse 2.1.
The Medilas H and the 5100 laser have photoelectric power meters and both are automatically calibrated. Both laser have a 2-stage, waterproof and explosionproof, foot switch and both laser incorporate a watchdog monitored microprocessor.
There are minor differences between the Medilas H and its predicate, none of which present new issues of safety or effectiveness. The Medilas H and the 5100 offers adiustable pulse durations, or continuous. The maximum power of both aiming beam at the aperture is 1 mW.
Both the Medilas H and the 5100 laser incorporates a graphic display panel. The Medilas H graphic display shows laser operating parameters, application modes, time functions, system status and messages for the user.
Whereas, its predicate devices offers several modes of operation to include the standard, the Medilas H offer only a software controlled Standard operating mode. -The Standard mode is used for non-contact coagulation and vaporization.
Like the 5100 laser, the Medilas H has a cooling system which includes an aircooled, temperature controlled internal closed circuit water system. The cooling system in the Medilas H is identical to the system included in the previously cleared 510(k) for the Medilas 5100 (K964760). In order to conduct away the
2
heat produced by the laser pump lamp, the cooling circuit dissipates a maximum of approximately 1.5 kW of heat. This premits a maximum of approximately 15 minutes of uninterrupted operation at full laser power before the maximum permissible water temperature of 770 F (25oC) is reached.
As a safety feature, the Medilas H and the 5100 has a single rotating magnetic shutter which moves the filter out of the laser beam. One microprocessor controls the shutters. The Medilas H and the 5100 laser is based on a single shutter with two parallel running microprocessors. Whenever one microprocessor runs differently from the other, the Medilas H laser hardware initiated a "system fault" routine. During any "system fault" laser production and release immediately halt.
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 825NDE 0837/2.86.
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 eagle with three overlapping wing-like shapes, positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Dornier Surgical Products, Inc. ·c/o Ms. Carol Wernecke Director of Regulatory and Clinical Affairs Dornier Medical Systems, Inc. 1155 Robert Boulevard Kennesaw, Georgia 30144
Re: K981718
Trade Name: Dornier Medilas H Laser System Regulatory Class: II Product Code: GEX Dated: May 14, 1998 Received: May 15, 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
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.
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Page 2 - Ms. Carol Wernecke
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/dsmamain.html".
Sincerely yours,
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
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
K981718 510(k) Number:
Device Name: Dornier Medilas H Laser
Indication For Use:
The Dornier Medilas H Laser, is intended to be used for cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, colonoscopes, or for open surgery for contact or noncontact surgery with or without hand pieces for use in coagulation, incision/exiciions, ablation and vaporization of soft tissue. The laser is indicated for use in medicine and surgery, in the following specialties: Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery.
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 | K981718 |
|---|---|
| --------------- | --------- |