The Dornier Thulio Laser is intended for minimally-invasive stone fragmentation, surgical tissue preparation such as cutting, ablation, coagulation and vaporization, in the following medical specialties: Urology a) Lithotripsy - Endoscopic fragmentation and pulverization of urethral, ureteral, bladder and renal stones - b) Benign Prostatic Hyperplasia (BPH) - c) Urethral Strictures - d) Bladder Neck Incision of the Prostate (BNI) e) Superficial and invasive bladder, urethral and ureteral tumors

Device Description

The Dornier Thulio is a compact, mobile, diode pumped Thulium, pulsed, single wavelength surgical laser with a wavelength of 2013 nm. The Dornier Thulio laser is comprised two functional components: (1) a laser console and (2) a dual pedal footswitch (wired or wireless). The laser console emits laser radiation which is transmitted to the application site by a sterile fiber optic delivery system (fiber cable) with a SMA 905 connector. 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. Laser energy is transmitted by depressing a foot pedals, both the wired and wireless models, are water-proof and explosion-proof. The Dornier Thulio laser also has the same principles of operation as other currently available medical lasers (switch on the device, set energy, set frequency, set laser mode, connect the lightguide, prepare the footswitch, activate the laser device). The laser energy is transmitted via the use of a laser fiber connected to the Thulio laser.

AI/ML Overview

The Dornier Thulio Laser, a Thulium-doped YAG laser operating at 2013 nm, was evaluated against established performance criteria primarily through non-clinical bench testing and literature review to demonstrate its substantial equivalence to predicate devices, especially the Lumenis Pulse™ 100H/120H (K170121).

Here's a breakdown of the acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The direct acceptance criteria with specific numerical targets are not explicitly stated as "acceptance criteria" in the provided text. Instead, the evaluation focuses on demonstrating comparability and equivalence to known predicate and reference devices regarding clinical functions. Therefore, the "acceptance criteria" are implied to be achieving comparable performance to the predicate/reference devices in key urological applications.

Acceptance Criterion (Implied)	Reported Device Performance (Dornier Thulio Laser)
Similar Pressure Generation (Lithotripsy)	Produced similar pressure in almost all investigated settings compared to Medilas H Solvo 35 Ho:YAG. Comparable risk profile for laser lithotripsy.
Comparable Dusting Performance (Lithotripsy)	Dusting performance proved to be comparable to Medilas H Solvo 35 Ho:YAG laser device at similar settings.
Similar Fragmentation Efficiency (Lithotripsy)	Fragmentation efficiency was similar to Ho:YAG lasers (specifically Medilas H Solvo 35 Ho:YAG).
Comparable Retropulsion Force (Lithotripsy)	When compared to Medilas H Solvo 35 Ho:YAG at the same settings, both devices gave comparable values with a slight tendency towards lower retropulsion forces with the Dornier Thulio.
Comparable Tissue Cutting and Coagulation Performance	Enucleation performance rated comparable to high-power Ho:YAG (Dornier Medilas H140) and low-power Ho:YAG (Dornier Medilas H Solvo 35).
Compliance with Safety and Performance Standards	Evaluated according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC60601-1-6.
Software Verification and Validation	Performed in accordance with FDA Guidance for Industry and FDA Staff.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify exact "sample sizes" in terms of number of cases or experimental repetitions for the non-clinical bench testing mentioned. The descriptions refer to "in-vitro experiments" and "a study" for lithotripsy and cutting/coagulation.
Data Provenance: The studies were non-clinical bench tests (in-vitro experiments). Therefore, there is no country of origin for human data, as no human or animal subjects were involved. The provenance is laboratory-based testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. As the studies were non-clinical bench tests (in-vitro), the concept of "experts establishing ground truth for a test set" in a clinical sense does not directly apply. The 'ground truth' for these tests would be the physical measurements and observations made during the bench testing, with the comparison being against established performance characteristics of the reference Ho:YAG lasers.

4. Adjudication Method for the Test Set

Since the studies were non-clinical bench tests focusing on physical properties and performance metrics (pressure, dusting, fragmentation, retropulsion, enucleation), an adjudication method as typically applied to human-read medical imaging or clinical outcomes (e.g., 2+1, 3+1 consensus) is not applicable or described. The results would likely be based on direct measurements and quantitative analysis of the physical parameters.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The studies described are non-clinical bench tests comparing the physical effects of the Dornier Thulio Laser to other laser devices. There is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only) Performance

This question is not applicable to this device. The Dornier Thulio Laser is a physical surgical laser device, not an AI algorithm or software. Its performance is inherent to its hardware and operational parameters, not a standalone algorithm.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance studies was primarily based on:

Physical measurements and quantitative analysis of laser effects in an in-vitro (bench test) environment (e.g., pressure produced, fragmentation efficiency, retropulsion force, tissue cutting/coagulation depth/area).
Comparison against the known and established performance characteristics of the predicate and reference Ho:YAG lasers (Medilas H Solvo 35 and Medilas H140), which serve as the "ground truth" for what is considered acceptable or comparable performance in the field.

8. Sample Size for the Training Set

This information is not applicable as the Dornier Thulio Laser is a hardware device (surgical laser) and not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device does not use a training set.

Summary

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July 27, 2022

Dornier MedTech America, Inc. John Hoffer VP Quality, Regulatory, Clinical 1155 Roberts Blvd. Suite 100 Kennesaw, GA 30144

Re: K213252

Trade/Device Name: Dornier Thulio Laser 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: June 21, 2022 Received: June 21, 2022

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. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Reginald K. Avery, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213252

Device Name Dornier Thulio Laser

Indications for Use (Describe)

Urology

a) Lithotripsy - Endoscopic fragmentation and pulverization of urethral, ureteral, bladder and renal stones

b) Benign Prostatic Hyperplasia (BPH)
c) Urethral Strictures
d) Bladder Neck Incision of the Prostate (BNI)

e) Superficial and invasive bladder, urethral and ureteral tumors

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Dornier MedTech America's Thulio Laser

Submitter

Dornier MedTech America 1155 Roberts Blvd. Kennesaw, GA 30144 Phone: 770-514-6163 Fax: 770-514-6291 Contact Person: John Hoffer

Date Prepared: July 27, 2022

Trade Name: Dornier Thulio Laser

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology.

Regulation Number: 21 C.F.R. § 878.4810

Common or Usual Name: Surgical Powered Laser Instrument

Classification Panel: General & Plastic Surgery

Regulatory Class: Class II

Product Code: GEX

Predicate Device

Lumenis Pulse™ 100H/120H (K170121)

Reference Devices

Dornier Medilas H Solvo 35 Laser (K180350) Dornier Medilas H140 (K161257)

Device Description

The laser console emits laser radiation which is transmitted to the application site by a sterile fiber optic delivery system (fiber cable) with a SMA 905 connector. A graphic control panel regulates anddisplays 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 tocontrol the functions of the laser. Laser energy is transmitted by depressing a foot pedals, both the wired and wireless models, are water-proof and explosion-proof.

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The Dornier Thulio laser also has the same principles of operation as other currently available medical lasers (switch on the device, set energy, set frequency, set laser mode, connect the lightguide, prepare thefootswitch, activate the laser device).

The laser energy is transmitted via the use of a laser fiber connected to the Thulio laser. The fibers as noted below, are the same design as cleared in 510k's K984591, K121938, K152591 and K161771.

Core diameter [um]	Packing unit [pcs]	Color code(at sleeve)	Item number
200*	3	white	K2016360
200**	3	white	K2016367
270slim*	3	white	K2016361
270slim*	3	white	K2016368
270*	3	blue	K2016362
400*	3	yellow	K2016363
400*	3	yellow	K2016364
600*	3	green	K2016365
1000*	3	red	K2016366

*) SingleFlex Performance

**) GentleFlex Performance

Indications for Use

The indications for use for the subject device is:

The Dornier Thulio Laser is intended for minimally-invasive stone fragmentation, surgical tissue preparation such as cutting, ablation, coagulation and vaporization in the following medical specialties:

Urology

a) Lithotripsy - Endoscopic fragmentation and pulverization of urethral, ureteral, bladder and renal stones

b) Benian Prostatic Hyperplasia (BPH)

c) Urethral Strictures
d) Bladder Neck Incision of the Prostate (BNI)
e) Superficial and invasive bladder, urethral and ureteral tumors

The indications for use for the predicate device is:

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (VersaPulse PowerSuite, Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H, Lumenis Pulse 100H and Lumenis Pulse 120H) are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology: urinary lithotripsy: arthroscopy: discectomy: E.N.T. surgery: pulmonary surgery; qastroenterology surgery; dermatology and plastic surgery and general surgery.

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories are indicated for use in the performance of specific surqical applications as follows:

Urology

Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BN), . holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH)

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K213252 Page 3 of 7

Open and endoscopic urological surgery (ablation, vaporization, excision and coagulation of soft tissue) including treatment of:
- bladder; o
- superficial and invasive bladder, urethral and ureteral tumors: O
- condvlomas: O
- lesions of external genitalia: O
- ureteral and penile hemangioma; o
- ureteral strictures; o
- bladder neck obstructions O
Urinary Lithotripsy including: ●
- endoscopic fragmentation of urinary (urethral, bladder and renal) calculi, including O cvstine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones:
- treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed. o

Arthroscopy

. Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including:
- meniscectomy: o
- plica removal: о
- O ligament and tendon release;
- contouring and sculpting of articular surfaces; O
- debridement of inflamed synovial tissue (synovectomy); O
- loose body debridement; O
- chondromalacia and tears: O
- lateral retinecular release; O
- capsulectomy in the knee; O
- chondroplasty in the knee; o
- chondrornalacia ablation. O
- . Discectornv including:
  - percutaneous vaporization of the L4-5 and LS-Sl lumbar discs of the vertebral spine; open and o arthroscopic spine procedures; foraminotomy.

General Surgerv

Open, laparoscopic, and endoscopic general surgery (vaporization, incision, and coagulation . of soft tissue) including:
- cholecystectomy; o
- O lysis of adhesions;
- appendectomy: O
- biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon; O
- o skin incision:
- tissue dissection; O
- excision of external tumors and lesions; O
- complete or partial resection of internal organs, tumors and lesions; O
- mastectomy: O
- hepatectomy; O
- pancreatectomy; O
- splenectomy; O
- thyroidectomy: O
- parathyroidectomy: O
- O herniorrhaphy;
- tonsillectomy; O
- lymphadenectomy; O
- partial nephrectomy; O
- opilonidal cvstectomy: O
- O resection of lipoma;
- debridement of decubitus ulcer; O
- hemorrhoids; O

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debridement of statis ulcer; O
o biopsy.

ENT Surgery

Endoscopic endonasal/ sinus surgery (ablation, vaporization, and coagulation of soft tissue . and cartilage) including:
- o partial turbinectomy:
- ethmoidectomy; O
- polypectomy: O
- maxillary antrostomy; O
- frontal sinusotomy: O
- sphenoidotomy; O
- dacryocystorhinostomy (DCR); O
- functional endoscopic sinus surgery (FESS). O

Gynecological Surgery

Open and laparoscopic gynecological surgery (ablation, vaporization, excision, and ● coaqulation of soft tissue).

Gastroenterology Surgery

. Open and endoscopic gastroenterology surgery (ablation, vaporization, excision, resection, coagulation and hemostasis, including:
- o gall bladder calculi;
- Biliary /bile duct calculi: O
- benign and malignant neoplasm; O
- polyps; O
- colitis: o
- ulcers: o
- angiodysplasia; O
- hemorrhoids; O
- varices; O
- esophagitis; O
- esophageal ulcer; O
- O Mallorv-Weiss tear:
- gastric ulcer; O
- O duodenal ulcer:
- non-bleeding ulcer; O
- qastric erosions; o
- colorectal cancer; O
- gastritis; O
- bleeding tumors; O
- pancreatitis; O
- O vascular malformations;
- telangiectasia: O
- telangiectasia of the Osler-Weber-Renu disease. O

Pulmonary Surgery

Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and ● coaqulation of soft tissue.

Dermatology and plastic surgery

Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty . and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures, including:
- o scars;
- tattoo removal; O
- vascular lesions; O

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port wine stains; O
O hemangioma;
telangiectasia of the face and leg; O
O rosacea;
corns: O
papilloma: O
basal cell carcinomas; O
lesions of skin and subcutaneous tissue; O
O plantar warts;
periungual and subungual warts; O
debridement of decubitus ulcer: O
O skin tag vaporization.

Comparison of indications for use statements

With respect to urological uses, the IFU statement of the subject device is very similar to that of the predicate. Both devices have similar general purpose laser usages (i.e., cutting, ablation, coaqulation and vaporization), and same specific procedures (laser lithotripsy of urinary tract stones, BPH, urethral strictures, bladder neck incision, and excision of bladder, urethral and ureteral tumors). The subject and predicate device have the same intended use.

Summary of Technological Characteristics

The Thulio laser is substantially equivalent to the Lumenis Pulse 100H/120H (K170121). Both the subject device and the predicate device are single wavelength, solid state lasers intended for use in urological and/or qastroenterological surgical procedures. They are controlled by proprietary software and the units are operated by a footswitch. Further, both units have a similar user interface, a graphic control panel requlates and displays the operating parameters, application modes, time functions, system status and messages to the user. Both the Thulio and the predicate device are solid state lasers that emit a pulsed laser wave with the active laser medium being a YAG-crystal, which is doped with thulium (Tm: YAG) for the Thulio laser and holmium (Ho:YAG) for the predicate device. The primary technological difference between the Thulio laser and the predicate device is the wavelength of the two lasers. Specifically, the Thulio laser operates at 2013 nm while the predicate device operates at 2100 nm. However, this difference does not raise new or different questions of safety or effectiveness as both laser devices are pulsed solid-state lasers designed to perform the same functions, namely cutting, ablation, coagulation and vaporization in urological and gastroenterological procedures. The basic operating principles of the Thulio and the predicate device are also directly comparable tothe predicate device and other medical lasers currently marketed in the U.S. In addition, performance testing has demonstrated that the subject device is as safe and effective as the predicate device.

	Dornier Thulio Laser	The LUMENIS PULSE™ 100H/120H Laser
Type of Laser	Solid-state lasers. Uses YAG crystaldoped with Thulium	Solid-state laser. Uses Holmium-dopedYAG crystal
Wavelength	2013 nm	2100 nm
Output Power	100 W	100 W (100H)120 W (120H)
Pulse Energy	0.1-2.5J	0.2-3.5J (100H)0.2-6J (120H)

A table comparing the key features of the subject and predicate devices is provided below.

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Pulse Duration	150 – 1000 μs	150-600 us (100H)< 1300us 120H
Pulse Frequency	5 – 300 Hz	5-53 Hz (100H)5-80 Hz (120H)
Pre set Mode settings	Yes	Yes
Minimum Fiber Diameter	Compatible with light guides with core diameter: between 200µm and 1000µm	Compatible with light guides with core diameter: between 200µm and 1000µm
Aiming Beam	Green wavelength, 520 nm	Green wavelength, 532 nm
RFID Capable	Yes	Yes

Non-Clinical Performance Data

The subject device was evaluated according to the following recognized consensus standards and FDA Guidance documents:

IEC 60601-1:2012, ed 3.1, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety And Essential Performance
IEC 60601-1-2:2014, ed 4, Medical Electrical Equipment Part 1-2: General Requirements ● for Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.

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. IEC 60601-2-22: 2012, ed 3.1, 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, ed 3.0, Safety of laser products Part 1: Equipment classification and ● requirements
. IEC60601-1-6:2013. ed 3.1. Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
. Software verification and validation testing in accordance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Non-clinical bench testing was performed as well as a detailed literature search to demonstrate he Thulio's equivalence to the predicate and similar devices in regard to their clinical use in urological procedures. The two primary clinical functions tested and reviewed were lithotripsy (dusting performance and retropulsion) and cutting/coagulation functions.

For lithotripsy, the comparison between Dornier Thulio and the Medilas H Solvo 35 Ho:YAG device (reference device) demonstrated that both devices produced similar pressure in almost all investigated settings. The in-vitro experiments demonstrated that both devices have a comparable risk profile for laser lithotripsy in terms of the pressure produced. The study concluded that the Dornier Thulio's dusting performance proved to be comparable to that of the Medilas H Solvo 35 Ho:YAG laser device (reference device) at similar settings. In terms of fragmentation performance, the study concluded that the fragmentation efficiency of Ho:YAG was similar to the Dornier Thulio subject device.

A study on the laser-induced retropulsion force was performed using the Dornier Thulio was compared to the reference Ho:YAG laser Medilas H Solvo 35. With the same laser settings, both laser devices gave comparable values with a slight tendency towards lower retropulsion forces with the Dornier Thulio.

An in-vitro study assessing the tissue cutting and coagulation performance of the Thulio compared to a high power Ho:YAG laser (Dornier Medilas H140). low-power Ho:YAG laser (Dornier Medilas H Solvo 35 Laser). The results of the study concluded that the enucleation performance of the Dornier Thulio was rated comparable to that of the lasers (both high and low power) used in the study.

The results of the non-clinical performance testing demonstrated that the device is as safe and effective for its intended use as the predicate.

Conclusion

The Thulio laser and the predicate devices have the same intended use and similar indications, technological characteristics and principles of operation. The minor technological differences between the Thulio laser and its predicates do not present different questions of safety or effectiveness. Furthermore, performance testing has demonstrated that the subject device is as safe and effective as the predicate device. Thus, the Thulio laser is substantially equivalent to the predicate device.

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.