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

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.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for a medical device, the Dornier Medilas H Solvo 35 Laser. It describes the device, its intended use, technological characteristics, and its substantial equivalence to a predicate device.

Key takeaway regarding Acceptance Criteria and Study proving device meets criteria:

Based on the provided text, there is no specific clinical study with human patients described that establishes acceptance criteria for performance metrics like accuracy, sensitivity, or specificity for a diagnostic or AI-driven device. This document is for a surgical laser, a therapeutic device, and the evaluation for substantial equivalence primarily focuses on engineering specifications, safety standards, and technological characteristics compared to a previously cleared predicate device.

Therefore, many of the requested points regarding sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable or not mentioned in this type of submission for this particular device.

Here's how to address your request based on the information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety & Effectiveness within stated parameters	Laser complies with applicable voluntary standards (IEC 60601-1, -1-2, -2-22, 60825-1, 60601-1-6) and ISO 14971 (Risk Management). Software verification and validation performed per FDA Guidance.
Substantial Equivalence to Predicate Device	Same intended use, similar indications, technological characteristics, and principles of operation as Dornier Medilas H30 Solvo Laser (K122159). Minor differences (higher max power/frequency, remote output display, CPU board update, cooling system modification) do not raise new safety/effectiveness concerns.
Maximum Power Output	Accepted: Up to 35W (Predicate: 30W)
Pulse Frequency Range	Accepted: Up to 25 Hz (Predicate: 20 Hz)
Laser Energy Range	Accepted: 200-3500 mJ
Wavelength	Accepted: 2080 nm
Operating Modes	Accepted: Continuous-wave or Pulsed
Penetration Depth	Accepted: Approximately 400 um (0.4mm)
Pulse Time	Accepted: 350 microseconds

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this type of device and submission. This 510(k) is based on engineering verification and validation testing, compliance with standards, and comparison to a predicate device, not a clinical study on a patient test set to evaluate diagnostic performance. The "performance data" section refers to adherence to voluntary standards and software V&V, not clinical outcomes data from a specific patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical ground truth was established by experts for a test set in this submission. The "truth" for this device is its adherence to specified engineering parameters and safety standards, verified through bench testing and documentation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical laser, not an AI-driven diagnostic or assistive technology. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware surgical device, not an algorithm. Benchtop testing and engineering verification ensure its standalone performance against specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission revolves around engineering specifications, compliance with recognized voluntary standards (e.g., IEC standards for medical electrical equipment and laser safety), and risk management (ISO 14971). For software, software verification and validation serve as the "ground truth" that the software performs as intended. The "truth" is that the device, when manufactured and used correctly, is safe and effective within its specified parameters and is substantially equivalent to the predicate.

8. The sample size for the training set

Not applicable. This is a hardware device submission, not a machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an AI model.

In summary, the provided document is a regulatory submission for a medical device that is a surgical laser. The "acceptance criteria" and "study" described are primarily related to engineering validation, compliance with established safety and performance standards for medical electrical equipment and lasers, and demonstration of substantial equivalence to a legally marketed predicate device. It does not involve typical clinical study designs for diagnostic devices or AI algorithms that would require patient data, expert ground truth, or statistical performance metrics like sensitivity/specificity.

Summary

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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

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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

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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)

K180350

Device Name Solvo 35W Laser

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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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 ●

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Lithotripsy
Pulmonology
Gastroenterology ●
. Gynecology
ENT
General Surgery.

Device Description

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).

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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.

Regulation Number and Section

§ 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.