(88 days)
Not Found
No
The 510(k) summary describes a laser system for soft tissue procedures and does not mention any AI or ML capabilities, image processing, or data-driven performance metrics.
Yes.
The device is a surgical laser system intended for medical and surgical procedures across various specialties, which are therapeutic applications.
No.
The document describes the device's intended use for cutting, vaporization, ablation, and coagulation of soft tissue in surgical procedures, not for diagnosing medical conditions.
No
The device description and intended use clearly describe a laser system, which is a hardware device, not software only.
Based on the provided information, the Dornier Medilas H/2 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.
- Anatomical Site: The anatomical site is "Soft tissue," which refers to tissues within the living body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
Therefore, the Dornier Medilas H/2 Laser is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dornier Medilas H/2 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
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
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medicine and surgery
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.
Not Found
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.
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Mar-23-99 04:31P
K 984591
510(k) SUMMARY Dornier Surgical Products, Inc's Medilas H/2 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: March 23, 1999
Name of Device and Name/Address of Sponsor
Medilas H/2 Laser
Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144
Classification Name
FDA has not specifically classified Ho:YAG lasers.
Predicate Devices
Dornier Medilas H Laser System (K983963)
Intended Use
The Dornier Medilas H/2 Laser is intended to be used in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparascopes, 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).
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. #11 #1
The Dornier Medilas H/2 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
From a clinical perspective and comparing design specifications, the Dornier Medilas H/2 Laser and the predicate devices are substantially equivalent and have the same intended use. The minor difference between the two laser systems is the replacement of a contraindication with a precaution statement regarding its use in fragmentation of kidney and bladder stones. Based on the technological characteristics and overall performance of the devices, Dornier Surgical Products, Inc. believes that no significant differences exist between the Dornier Medilas H/2 and the predicate devices: the Dornier Medilas H (K983963).
Dornier Surgical Products, Inc believes the minor differences of the Dornier Medilas H/2 and its predicate laser devices 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 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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 26 1999
Dornier Surgical Products, Inc. c/o Ms. Carol Wernecke Director of Regulatory and Clinical Affairs Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, Georgia 30144
K984591 Re: Trade Name: Dornier Medilas H/2 Laser Regulatory Class: II Product Code: GEX Dated: December 22, 1998 Received: December 28, 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 (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.
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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/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
510(k) Number:
K 984591
Dornier Medilas H/2 Laser Device Name:
Indications for Use:
The Dornier Medilas H/2 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
Over-the-Counter Use Prescription Use or
Concurrence of CDRH, Office of Device Evaluation (ODE)