(208 days)
No
The summary describes a laser device for soft tissue procedures and does not mention any AI or ML capabilities. The testing focuses on laser performance, electrical safety, EMC, and software validation for a moderate level of concern, none of which indicate AI/ML.
Yes
The device is used for medical procedures like incision, vaporization, ablation, hemostasis, and coagulation of soft tissue, which directly provides therapy to patients.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is intended for "incision, vaporization, ablation, hemostasis and coagulation of soft tissue," which are all therapeutic or surgical procedures, not diagnostic ones.
No
The device description explicitly states it is a "compact diode laser" with a "laser diode as the beam source" and mentions hardware components like a "high resolution color touchscreen" and "optical fibers." It also details electrical safety and EMC testing on the "Diode laser console and optical fibers," indicating it is a physical hardware device. While it includes software, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "incision, vaporization, ablation, hemostasis and coagulation of soft tissue." This describes a device that directly interacts with and modifies tissue within the body (in vivo).
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening. They perform tests outside of the living body.
- Device Description: The description details a laser system that emits a beam to interact with tissue. This is consistent with a surgical or therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Indicators: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Reagents or test kits.
The Wolf 445nm is a surgical laser intended for direct treatment of soft tissue, which falls under the category of therapeutic or surgical medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Wolf 445nm is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Product codes
GEX
Device Description
The Wolf Diode Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode the laser system can radiate one wavelength with either 445nm, 980nm or 1470nm. This submission refers to and includes only one model, the Wolf 445nm.
The Wolf 445nm is a compact diode laser with a high resolution color touchscreen for user control. The laser utilizes a green (532nm) aiming beam diode to indicate the area to be irradiated by the laser beam.
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
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)
The safety and effectiveness determination of the 445nm subject device compared to the primary predicate with wavelength 532nm is supported by the Electrical Safety, EMC, Software, and non-clinical comparison bench tests provided in the submission.
Non clinical testing: A comparison bench test between 445 nm and 532 nm laser devices was conducted with the purpose of demonstrating that the Wolf 445 nm provides as safe & effective performance data as a KTP Laser (532 nm) in terms of tissue interaction processes. The cut depth (effectiveness) and thermal damage (safety) zones of the 445nm laser device were used for the purpose of comparison. Following the tests, histological samples were evaluated for areas of visible alteration of depth and width of the incision as well as zones of thermal and mechanical damage created by the tests.
Electrical Safety and EMC testing: Electrical safety and EMC testing were conducted on the Wolf 445nm, consisting of Diode laser console and optical fibers. The Wolf 445nm system has been tested for Electrical Safety according to IEC 60601-1:2005 A1:2012 and /or EN 60601-1:2006/A1:2013, for Laser Safety according to IEC 60825-1: 2014 (edition 3.0), for Safety of laser according to IEC 60825-1:2014 and IEC 60601-2-22:2007/A1:2012, for Usability with IEC 60601-1-6:2010/A1:2013 and IEC 62366:20017, AMD1:2014. Electromagnetic Compatibility was tested according to IEC 60601-1-2:2014, (edition 4.0).
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software is considered as a moderate level of concern and the documentation was provided accordingly.
Conclusion: The safety and effectiveness determination between the subject and the predicate devices is supported by the performance data provided in the submission, the electrical and EMC testing, the software verification and validation testing and the non-clinical bench test demonstrating that the Wolf 445nm performs comparably to the predicate device that is currently marketed for the same intended use.
Animal or clinical studies: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 17, 2020
A.R.C. Laser GmbH Angela Thyzel General Manager Bessemer St. 14 Nurnberg, 90411 De
Re: K192272 Trade/Device Name: Wolf 445nm Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: February 3, 2020 Received: February 10, 2020
Dear Angela Thyzel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Mavadia-Shukla, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192272
Device Name Wolf 445nm
Indications for Use (Describe)
The Wolf 445nm is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters. Below that, the word "LASER" is in a white box. Underneath the box, the phrase "enlighten your surgery." is written in a cursive font.
510(k) Summary - K192272
| Submitter: | A.R.C. Laser GmbH
Bessemer St. 14
90411, Nurnberg
Germany |
|---------------------------------------------|-----------------------------------------------------------------------------------------------|
| Contact person :
Phone
Fax
E-Mail: | Angela Thyzel, General Manager
0911-21779-0
0911-21779-99
a.thyzel@arclaser.de |
| Date
Prepared: | March 6, 2020 |
| Device Trade
Name: | Wolf 445nm |
| Common
Name: | Diode Laser System |
| Classification
Name: | Laser surgical instrument for use in general and plastic surgery and in
dermatology |
| Device product
code: | GEX |
| Device
Classification | 21 CFR 878.4810 |
| Predicate
Devices: | Aura Laser System, K951034, Primary Predicate
SiroLaser Blue, K180044, Reference Predicate |
Device Description:
The Wolf Diode Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode the laser system can radiate one wavelength with either 445nm, 980nm or 1470nm. This submission refers to and includes only one model, the Wolf 445nm.
The Wolf 445nm is a compact diode laser with a high resolution color touchscreen for user control. The laser utilizes a green (532nm) aiming beam diode to indicate the area to be irradiated by the laser beam.
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Image /page/4/Picture/1 description: The image shows the logo for A.R.C. Laser. The logo is in a blue box with the text "A.R.C." in large, bold, white letters. Below that is the word "LASER" in smaller, white letters. Underneath the word laser is the company's slogan, "enlighten your surgery" in a cursive font.
510(k) Summary – K192272
Indications for Use: The Wolf 445nm is intended for incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Comparison of Technological Characteristics with the Predicate Devices
The primary predicate device is the Aura laser system (K951034), a KTP laser with a wavelength of 532nm with same intended use as the subject device.
The SiroLaser Blue, K180044, is a reference device, with the same intended use although is used for dental applications, shares the same wavelength, the same product code GEX, same device class and same classification name and number.
| Specification | Subject Device
Wolf 445nm | Primary Predicate Device
Aura Laser System | Reference Predicate
Device SIROLaserBlue |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K192272 | K951034 | K180044 |
| Regulation # | 878.4810 | 878.4810 | 878.4810 |
| Class Code | GEX | GEX | GEX & ILY |
| Class | II | II | II |
| Indications for
Use | The Wolf 445nm is intended for use
in incision/excision, vaporization,
ablation, hemostasis and coagulation
of soft tissue | Aura XP is intended for use in in
incision/excision, vaporization,
ablation, hemostasis and
coagulation of soft tissue | SIROLaserBlue is intended
for intra and extra oral
surgery including incision,
excision, hemostasis,
coagulation & vaporization
of soft tissue |
| Use of device | RX only | RX only | RX only |
| Laser type | Diode Laser | Flash Lamp Pulsed KTP Laser | Diode Laser |
| Laser power | 0.5 W to 10 W | 0.5 W to 15 W | 0.2 W - 3.0 W |
| Wavelength | 445 nm | 532 nm | 445 nm, 660 nm, 970 nm |
| Laser Class | 4 | 4 | 4 |
| Operation
mode | Pulsed, Continuous Wave (CW) or
Single Pulse (SP) | Pulsed, Quasi continuous wave | Continuous wave (CW) or
Pulsed |
| Pulse length/
duration | 4 Watt: 1 ms to 60 ms | 1 to 50 milliseconds in 1 ms
increments, then .1 to 1 sec in
0.1 increment, then .5 sec
increments to continuous | 10 µs to 0.99 sec. |
| Pulse
frequency | 4 Watt: 0.02 Hz to 6.6 Hz and SP | 0.5 Hz to 5 Hz | 1 Hz to 10 kHz |
| Aiming beam
wavelength | 532 nm | 635 nm | 660 ± 5 nm |
| Aiming beam
power |