(27 days)
Quanta Litho Laser (K163009)
No
The description mentions a "microprocessor-controlled" system for regulating laser parameters and system status, which is standard for medical devices and does not indicate the use of AI or ML. There is no mention of learning, adaptation, or data-driven decision-making beyond pre-programmed control logic.
Yes.
The device is used for "cutting, vaporization, and coagulation of soft tissue" and is indicated for use in various medical specialties, including "surgical, cosmetic, therapeutic and diagnostic laser equipment" as per IEC 60601-2-22:2007.
No
This device is intended for "cutting, vaporization, and coagulation of soft tissue," which are surgical, not diagnostic, functions. While it meets a standard for "diagnostic laser equipment" (IEC 60601-2-22), its primary stated "Intended Use" is therapeutic.
No
The device description clearly details hardware components such as a solid-state Holmium YAG Laser, cooling system, heat exchanger, and a physical control panel. While it mentions microprocessor control and software verification/validation, the core functionality and components are hardware-based.
Based on the provided information, the Solvo 35W 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, and coagulation of soft tissue in conjunction with endoscopic equipment or for open surgery. This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a laser that emits radiation to interact with tissue. This is consistent with a surgical device, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVD devices are designed to perform tests on these types of samples to diagnose conditions, monitor treatment, or screen for diseases.
The Solvo 35W is a surgical laser used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Solvo 35W is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Solvo 35W is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy
- Urology
- Lithotripsy
- Pulmonology
- Gastroenterology
- Gynecology
- ENT
- General Surgery
Product codes
GEX
Device Description
The Dornier Medilas H Solvo 35 Laser is a solid-state Holmium YAG Laser. The laser emits laser radiation in the invisible wavelength range of 2080 nm in either a continuous-wave or pulsed mode, which is absorbed primarily by water, with an average penetration depth of approximately 400 um (0.4mm). Due to the application-dependent optimization of the pulse time of 350 microseconds, the Solvo can be used in various medical applications including breaking up stones, cutting tissue, tissue ablation, coaqulation and vaporization.
The laser is microprocessor-controlled utilizing a watchdog-monitored microprocessor and operates with an internal cooling system and a heat exchanger. The bottom of the housing serves as a tank for cooling water and, at the same time, a base for the laser unit. A cooling circuit conducts away heat that is generated by the laser pump lamp. Water heated by the laser pump is conducted out of the cavity and into the stainless steel cooler. Following cooling, it is returned to the tanks.
A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the user. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser. There is a wireless remote display panel available as well that allows the user to see the control panel information without being in front of the unit.
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)
While no performance standards have been established for Holmium lasers under Section 514 of the Federal Food, Drug, and Cosmetic Act, the Dornier Medilas H Solvo 35 is in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968. The laser complies with the applicable requirements of the following voluntary standards:
- . IEC60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- . IEC 60601-2-22:2007 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1: 2014 Safety of laser products Part 1: Equipment classification, and . requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
- . IEC 60601-1-6:2010 Medical electrical equipment Part 1-6 General requirements for safety -Collateral Standard: Usability
- . Risk analysis activities, in compliance with the requirements of ISO 14971: 2007 Medical devices - Application of Risk Management to Medical Devices
In addition, software verification and validation in compliance with FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices was performed.
These tests verified that the subject laser performs according to its specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dornier Medilas H30 Solvo Laser (K122159)
Reference Device(s)
Quanta Litho Laser (K163009)
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration."
March 7, 2018
Dornier MedTech America John Hoffer VP Quality, Regulatory, Clinical 1155 Roberts Blvd Kennesaw, Georgia 30144
Re: K180350
Trade/Device Name: Dornier Medilas H Solvo 35 Laser 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 6, 2018 Received: February 8, 2018
Dear John Hoffer:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name Solvo 35W Laser
Indications for Use (Describe)
The Solvo 35W is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Solvo 35W is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy
- Urology
- Lithotripsy
- Pulmonology
- Gastroenterology
- Gynecology
- ENT
- General Surgery
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
[ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14)
3
510(k) SUMMARY
Dornier Medilas H Solvo 35
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Dornier MedTech America | Phone: 770-514-6163 |
|---|---|
| 1155 Roberts Blvd. | Fax: 770-514-6291 |
| Kennesaw, GA 30144 | Date Prepared: February 6, 2018 |
Contact Person: John Hoffer Phone: 770-514-6163
Name of Device and Name/Address of Sponsor
Dornier Medilas H Solvo 35
Dornier MedTech America 1155 Roberts Blvd. Kennesaw, GA 30144
Common or Usual Name
Holmium: Yttrium Aluminum Garnet (HO:YAG) Laser System
Classification Name
The General and Plastic Surgery Branch has classified Surgical Powered Laser Instruments (Product Code GEX) as a Class II device pursuant to 21 C.F.R. § 878.4810.
Predicate Device
Dornier Medilas H30 Solvo Laser (K122159)
Reference Device
Quanta Litho Laser (K163009)
Purpose of the Special 510(k) Notice
The Dornier Medilas H Solvo 35 is a modification to Dornier's Medilas H30 Solvo Laser, K122159.
Intended Use
The Dornier Medilas H Solvo 35 is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Dornier Medilas H Solvo 35 is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy
- Urology ●
4
- Lithotripsy
- Pulmonology
- Gastroenterology ●
- . Gynecology
- ENT
- General Surgery.
Device Description
The Dornier Medilas H Solvo 35 Laser is a solid-state Holmium YAG Laser. The laser emits laser radiation in the invisible wavelength range of 2080 nm in either a continuous-wave or pulsed mode, which is absorbed primarily by water, with an average penetration depth of approximately 400 um (0.4mm). Due to the application-dependent optimization of the pulse time of 350 microseconds, the Solvo can be used in various medical applications including breaking up stones, cutting tissue, tissue ablation, coaqulation and vaporization.
The laser is microprocessor-controlled utilizing a watchdog-monitored microprocessor and operates with an internal cooling system and a heat exchanger. The bottom of the housing serves as a tank for cooling water and, at the same time, a base for the laser unit. A cooling circuit conducts away heat that is generated by the laser pump lamp. Water heated by the laser pump is conducted out of the cavity and into the stainless steel cooler. Following cooling, it is returned to the tanks.
A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the user. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser. There is a wireless remote display panel available as well that allows the user to see the control panel information without being in front of the unit.
Summary of Technological Characteristics
The Dornier Medilas H Solvo 35 has the same technological characteristics as the Dornier H30 Solvo Laser to which it is a modification. Both lasers are solid state Holmium HO:YAG lasers that operate at a wavelength of 2080 nm. They both operate using the same basic hardware and software platforms, as well as utilize identical laser delivery systems (fiber optic laser cables with SMA 905 connectors).
The primary difference in technical performance characteristics is the available maximum power and frequency and the option to use pre-set laser settings The Dornier Medilas H Solvo 35 has a maximum power of 35W while the Dornier H30 Solvo Laser has a maximum power of 30W. This difference in maximum power does not increase the laser energy range, which is 200- 3500 mJ. The pulse frequency range for the Dornier Medilas H Solvo 35 laser is 3-25 Hz while the range for the predicate Laser is 3-20Hz. This higher maximum power output and frequency is within the range of other cleared Holmium Lasers (Quanta Litho Laser. K163009). The use of a 35W laser for the stated indications is also well established by other cleared lasers. The pre-set laser settings are for user convenience.
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The other minor differences between the Dornier Medilas H Solvo 35 and the cleared device are the addition of a remote output display and other minor modifications to support the above noted changes. These include:
- Updated CPU board
- Modified cooling water circuit/pumps.
Performance Data
While no performance standards have been established for Holmium lasers under Section 514 of the Federal Food, Drug, and Cosmetic Act, the Dornier Medilas H Solvo 35 is in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968. The laser complies with the applicable requirements of the following voluntary standards:
- . IEC60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- . IEC 60601-2-22:2007 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1: 2014 Safety of laser products Part 1: Equipment classification, and . requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
- . IEC 60601-1-6:2010 Medical electrical equipment Part 1-6 General requirements for safety -Collateral Standard: Usability
- . Risk analysis activities, in compliance with the requirements of ISO 14971: 2007 Medical devices - Application of Risk Management to Medical Devices
In addition, software verification and validation in compliance with FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices was performed.
These tests verified that the subject laser performs according to its specifications.
Substantial Equivalence
From a clinical perspective and comparing design specifications, the Dornier Medilas H Solvo 35 and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics, design and overall performance of the devices, Dornier MedTech America believes that no significant differences exist between the Dornier Medilas H Solvo 35 and Dornier's Medilas H30 Solvo Laser (K122159).
6
The minor differences do not raise any concerns regarding the overall safety or effectiveness of the subject device compared to the predicate device. Thus, the Dornier Medilas H Solvo 35 is substantially equivalent to its predicate device.
Conclusion
The Dornier Medilas H Solvo 35 Laser is as safe and effective as the Dornier Solvo Laser. The Dornier Medilas H Solvo 35 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the Dornier Medilas H Solvo 35 and its predicate devices raise no new or different issues of safety or effectiveness. Thus, the Dornier Medilas H Solvo 35 is substantially equivalent.