(71 days)
No
The document describes a laser system with automated fiber recognition and safety monitoring, but there is no mention of AI or ML technologies being used for image processing, data analysis, or decision-making beyond basic system control and safety checks.
Yes
The device is intended for use in various surgical procedures, including cutting, ablation, vaporization, excision, incision, and coagulation of tissue, which are therapeutic actions.
No
Explanation: The device description and intended use clearly state that the MegaPulse Laser System is for surgical procedures involving breaking up stones, cutting, ablation, vaporization, excision, incision, and coagulation of tissue. These are therapeutic, not diagnostic, actions.
No
The device description explicitly states it is comprised of a Holmium YAG laser base unit with integrated cooling unit and system specific laser fibers, which are hardware components. While it includes software, it is not solely software.
Based on the provided text, the Richard Wolf Medical Instruments Corporation MegaPulse Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device being used in surgical procedures on the patient's body (breaking up stones, cutting tissue, ablation, etc.). IVD devices are used to examine specimens from the body (like blood, urine, tissue samples) to provide information about a patient's health.
- Device Description: The description details a laser system and fibers designed to deliver energy for surgical interventions. This aligns with a therapeutic or surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory tests.
Therefore, the MegaPulse Laser System is a surgical laser system used for therapeutic purposes, not an IVD.
N/A
Intended Use / Indications for Use
The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, and colonscopic) procedures, breaking up stones, cutting (i.e. structures), ablation, vaporization, excision, incision, and coagulation of tissue in the specialties as: Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is comprised of a Holmium YAG laser base unit with integrated cooling unit and system specific laser fibers.
The laser system base contains the switching elements and interfaces, the display unit, the fiber connection point, components inside the laser system, and software. For a safe operation, essential functions and components are monitored automatically. The MegaPulse Laser system is designed with automated fiber recognition to ensure only permissible parameters are used. A warning message appears on the touch screen monitor and is accompanied by a signal should a fault or error occur.
The MegaPulse Laser Fibers are intended to be used in with MegaPulse Laser System to deliver laser energy. The laser fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to provide access to the surgical procedure site. The laser fiber works on the principle of internal reflection. Laser energy is focused into the fiber at the proximal end and it travels the length of the fiber by means of total reflection. The fiber contains the laser beam and channels the laser energy from the proximal end of the fiber to its distal end. The laser fibers are single-use sterile packaged. They are similar if not equivalent in design and performance to other legally marketed laser fibers with an integrated fiber identification system designed to work only with the MegaPulse laser system base.
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
This device must only be used by adequately qualified and trained medical personnel.
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)
Bench testing of specifications were verified and validated and software validation was performed to assure safe and effective operation / control of software functions. The Richard Wolf MegaPulse Laser System meets the same safety standards as the named predicate devices.
No clinical data was required to confirm safety and effectiveness.
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
510(k) Summary
:
| Submitter: | |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Ron Haselhorst |
| Contact title: | Quality Assurance / Regulatory Affairs Manager |
| Date of Preparation: | March 11, 2009 |
|---|---|
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | (847) 913 1113 |
| FAX number (include area code): | (847) 913 0924 |
Product Information: (Base)
| Trade name: | MegaPulse Laser System |
|---|---|
| Model number: | 2285011 |
| Common name: | Laser Instrument, Surgical, Powered |
| Classification name: | Laser surgical instrument for use in general and plastic surgery and in dermatology, Class II. (21 CFR 878.4810, Product Code GEX) |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 K001243 | 1 Dornier Medilas H Laser | 1 Dornier |
| 2 K002308 | 2 Trimedyne OmniPulse Models 1210, 1210-VHP, and 1500-A | 2 Trimedyne, Inc. |
| 3 K051399 | 3 AURIGA | 3 WaveLight Laser Tech., AG. |
Product Information: (Laser Fibers)
| Trade name: | MegaPulse Laser Fibers |
|---|---|
| Model number: | 48750.xxx |
| Common name: | Laser Fibers, Single Use |
| Classification name: | Laser fibers have not been specifically classified by FDA. Laser fibers are an accessory to Laser-Powered Instruments. Class II. (21 CFR 878.4810, Product Code GEX) |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| K022544 | 1. Dornier Medilas H Laser Fiber Cables | 1. Dornier MedTech America, Inc. |
| K943445 | 2. Megabeam Fiber Optic Delivery System | 2. Ceramoptec, Inc. (Biolitec, Inc.) |
| K973172 | 3. Resposable Holmium Bare Fibers | 3. Trimedyne, Inc. |
:
·
,
1
Device Description:
The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is comprised of a Holmium YAG laser base unit with integrated cooling unit and system specific laser fibers.
The laser system base contains the switching elements and interfaces, the display unit, the fiber connection point, components inside the laser system, and software. For a safe operation, essential functions and components are monitored automatically. The MegaPulse Laser system is designed with automated fiber recognition to ensure only permissible parameters are used. A warning message appears on the touch screen monitor and is accompanied by a signal should a fault or error occur.
The MegaPulse Laser Fibers are intended to be used in with MegaPulse Laser System to deliver laser energy. The laser fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to provide access to the surgical procedure site. The laser fiber works on the principle of internal reflection. Laser energy is focused into the fiber at the proximal end and it travels the length of the fiber by means of total reflection. The fiber contains the laser beam and channels the laser energy from the proximal end of the fiber to its distal end. The laser fibers are single-use sterile packaged. They are similar if not equivalent in design and performance to other legally marketed laser fibers with an integrated fiber identification system designed to work only with the MegaPulse laser system base.
Intended Use:
The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, and colonscopic) procedures, breaking up stone, cutting (i.e. structures), ablation, vaporization, excision, incision, and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery.
Indications and Field of Use:
The MegaPulse 2285 is a Class 4 laser emitting laser radiation at a wavelength of approx. 2080 nm. This particular wavelength is transmitted by a fiberoptic wave guide (glassfiber) allowing efficient treatment in conjunction with the application - related preselected parameters with at the same time minimum stress for the adjacent tissue.
This device must only be used by adequately qualified and trained medical personnel.
These indications and field of use are equivalent if not identical to the named predicate devices.
2
Technological Characteristics:
The Richard Wolf MegaPulse Laser System and its predicate devices may have minor differences in the technological characteristics; however, those differences do not raise new questions of safety or efficacy. Thus the Richard Wolf Medical Instruments Corporation MegaPulse Laser System is substantially equivalent to the predicate devices in terms of technological characteristics.
Performance Data:
Bench testing of specifications were verified and validated and software validation was performed to assure safe and effective operation / control of software functions. The Richard Wolf MegaPulse Laser System meets the same safety standards as the named predicate devices.
Clinical Data:
No clinical data was required to confirm safety and effectiveness.
Rational for Substantial Equivalence:
The Richard Wolf Medical Instruments Corporation MegaPulse Laser System laser fibers perform the same function, have basically the same material composition and are substantially equivalent to the lasers fiber delivery systems cleared for Dornier MedTech. America, Inc. (K022544), Biolitec Inc. (K943445), and Trimedyne (K973172).
The Richard Wolf Medical Instruments Corporation MegaPulse Laser base shares the same general indications for use and has similar functional features and technological characteristics as the named predicate devices. These minor differences do not raise new questions of safety or efficacy. For these reasons The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is substantially equivalent to the existing 510(k) cleared devices sold by: Dornier (K001243), Wavelight Laser Technologies (K051399), and Trimedyne (K002308).
Thus the Richard Wolf Medical Instruments Corporation MegaPulse Laser System is substantially equivalent to the predicate devices.
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 stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
JUN - 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard Wolf Medical Instruments Corporation ' % Mr. Ron Haselhorst Quality Assurance/Regulatory Affairs Manager 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K090776
Trade/Device Name; MegaPulse Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: II Product Code: GEX Dated: March 11, 2009 Received: March 23, 2009
Dear Mr. Haselhorst:
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 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); medical device reporting
4
Page 2- Mr. Ron Haselhorst
(reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the " Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K 090776.
Device Name: MegaPulse Laser System
Intended Use:
The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, and colonscopic) procedures, breaking up stones, cutting (i.e. structures), ablation, vaporization, excision, incision, and coagulation of tissue in the specialties as: Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery.
Prescription use (Part 21 CFR 801 Subpart D)
and / or
Over-The Counter Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ANOTHER PAGE IF NEEDED
currence of CDHR office of Device Evaluation (ODE)
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090776
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