(300 days)
No
The description focuses on the laser technology, control panel, and footswitch, with no mention of AI, ML, or related concepts. The performance studies compare the device to predicate and reference lasers based on physical effects like pressure, dusting, fragmentation, retropulsion, cutting, and coagulation.
Yes
The device is described as a surgical laser intended for various medical specialties, including minimally-invasive stone fragmentation, surgical tissue preparation (cutting, ablation, coagulation, vaporization), and treatment of conditions like BPH and tumors. These are all therapeutic actions.
No
Explanation: The device description states its purpose is for "minimally-invasive stone fragmentation, surgical tissue preparation such as cutting, ablation, coagulation and vaporization," which are all therapeutic interventions, not diagnostic ones.
No
The device description clearly outlines hardware components including a laser console, footswitch, fiber optic delivery system, and a control panel with a touch screen. It is a physical laser system, not software only.
Based on the provided text, the Dornier Thulio Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes procedures performed on the patient's body (minimally-invasive stone fragmentation, surgical tissue preparation, etc.) within specific medical specialties (Urology). IVD devices are used to examine specimens from the human body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The description details a surgical laser system that delivers energy to the application site via a fiber optic cable. This is consistent with a surgical device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Dornier Thulio Laser is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
GEX
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 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.
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]: 200*, 200**, 270slim*, 270slim*, 270*, 400*, 400*, 600*, 1000*
Packing unit [pcs]: 3 for all listed core diameters
Color code (at sleeve): white, white, white, white, blue, yellow, yellow, green, red
Item number: K2016360, K2016367, K2016361, K2016368, K2016362, K2016363, K2016364, K2016365, K2016366
*) SingleFlex Performance
**) GentleFlex Performance
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethral, ureteral, bladder, renal, prostate.
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)
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.
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
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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.
1
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
2
Indications for Use
510(k) Number (if known) K213252
Device Name Dornier Thulio Laser
Indications for Use (Describe)
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
| 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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3
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 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 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.
4
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)
5
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
6
- 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
7
- 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 crystal | |
| doped with Thulium | Solid-state laser. Uses Holmium-doped | |
| YAG 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.
8
| Pulse Duration | 150 – 1000 μs | 150-600 us (100H)