IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories

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March 13, 2024 IPG Medical Corporation Alexander Wybornov Vice Predisent 225 Cedar Hill Street Marlborough, Massachusetts 01752 Re: K232568 Trade/Device Name: IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories 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 20, 2024 Received: February 20, 2024 Dear Samuel Wade: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devicereporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). {2}------------------------------------------------ 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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Mark J. Antonino -S Mark J. Antonino, M.S. 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232568 #### Device Name IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories #### Indications for Use (Describe) The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indication: urology, lithotripsy, gastroenterological surgery and gynecological surgery. Urology: • Ablation ofBenign Prostatic Hyperplasia (Hypertrophy) [BPH] • Laser Resection of the Prostate (LRP) • Laser Enucleation of the Prostate (LEP) ● Laser Ablation of the Prostate (LAP) ● Transurethral Incision of the Prostate (TUIP) ● Condylomas ● Urethral strictures ● Lesions of External Gentalia ● Bladder Neck Incisions (BNI) ● Ablation and Resection of Bladder Tumors, and Ureteral Tumors . Endoscopic Fragmentation of Urethral, Ureteral, Bladder, and Renal Calculi ● Treatment of distal impacted fragments remaining in the ureters following lithotripsy Lithotripsy and Percutaneous Urinary Indications: ● Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones ● Endoscopic fragmentation of calculi ● Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology: Open and endoscopic gastroentery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: • Appendectomy • Angiodysplasia • Polyps • Colorectal Cancer • Biopsy • Telangiectasias • Gall Bladder Calculi • Telangiectasias of the Osler-Weber-Renu Disease • Biliary/Bile duct Calculi • Vascular Malformation ● Ulcers ● Gastric Ulcers ● Esophagitis ● Duodenal Ulcers ● Esophageal Ulcers ● Non Bleeding Ulcers . Varices . Pancreatits . Colitis . Hemorrhoids . Mallory-Weiss Tear . Cholecystectorny . Gastric Erosions . Benign and Malignant Neoplasm Gynecology: Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue. 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) #### 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." {4}------------------------------------------------ # 510(k) Summary #### Manufacturer Identification: IPG Medical Corporation 225 Cedar Hill Street Marlborough, MA 01752 Phone: 508-506-2800 Establishment Registration #3020221089 Contact Person: Alexander Vybornov (508-506-2718) ## Date Prepared: August 18, 2023 ## Device Identification: | Device Trade Name: | IPG Medical Family of Thulium Fiber Lasers, Surgical<br>Fibers, and Accessories | |------------------------|---------------------------------------------------------------------------------| | Device Common Name: | Laser Instrument for Use in General Surgery | | Classification Name: | Laser Instrument, Surgical, Powered | | Classification Number: | 21 CFR 878.4810 | | Product Code: | GEX | | Device Class: | Class II | | Review Panel: | Gastroenterology / Urology | ## Identification of Predicate Devices: | Trade Name | Manufacturer | 510(k) | |------------------------------------------|-------------------|---------| | SOLTIVE Laser System (primary predicate) | Gyrus, ACMI, Inc. | K211401 | {5}------------------------------------------------ ## Device Description: The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories are portable thulium fiber lasers intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories generates non-ionizing radiation which is transferred to the relevant anatomical treatment site through surgical fibers that serve as the delivery vehicle from the laser energy generator to the treatment site. The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories includes wireless (optional) and wired, three-pedal footswitches for hands-free control. The system can utilize an auxiliary video monitor to display operating parameters. The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories front panel includes a surgical fiber connection port and a touchscreen with a user interface. The back panel includes electrical and interface cable ports. The Laser Console may be placed on an optional mobile cart. The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories includes: - Laser Console ● - Footswitches, wired or wireless (optional) ● - Surgical Fibers ● - . Accessories: - Power cord O - O Video output cable - Video adapter O - Safety glasses O - Fiber stripper O - Fiber cleaver o - Blast shield O - O Interlock connector - Mobile cart (optional) о The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories on emission wavelengths between 1920 and 1960 nm. The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories can operate at a maximum power output of 60 watts and a maximum frequency output of 2400 Hz with a maximum pulse energy of 6 Joules. The IPG Medical Family of Thulium Fiber Lasers must be operated with the IPG Family of Surgical Fibers. The surgical fibers are flexible optical fibers that deliver the laser energy to the target tissue. The IPG Family of Surgical Fibers are offered in a range of core diameters from 150 microns - 940 microns and include single use, IPG Medical Family of Thulium Fiber Lasers 510(k) Summary Confidential {6}------------------------------------------------ reusable and ball tip options. The surgical fibers are the only patient-contacting components of the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories. #### Indications for Use: The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. Urology: - Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH] - Laser Resection of the Prostrate (LRP) ● - Laser Enucleation of the Prostate (LEP) ● - Laser Ablation of the Prostate (LAP) ● - Transurethral Incision of the Prostate (TUIP) ● - Condylomas - . Urethral strictures - . Lesions of external genitalia - Bladder neck incisions (BNI) ● - Ablation and resection of bladder tumors, urethral tumors, and ureteraltumors ● - Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi ● - Treatment of distal impacted fragments remaining in the ureters following lithotripsy ● Lithotripsy and Percutaneous Urinary Lithotripsy Indications: - Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including . cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones - Endoscopic fragmentation of calculi ● - . Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed. #### Gastroenterology: Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Appendectomy ● - Angiodysplasia ● - Polyps ● - Colorectal cancer ● - Biopsy ● - Telangiectasias - Gall Bladder calculi - Telangiectasias of the Osler-Weber-Renu disease ● - . Biliary/Bile duct calculi - Vascular Malformation ● {7}------------------------------------------------ - Ulcers ● - Gastritis ● - Gastric ulcers . - . Esophagitis - Duodenal ulcers ● - . Esophageal ulcers - Non Bleeding Ulcers ● - . Varices - Pancreatitis - Colitis ● - Hemorrhoids - Mallory-Weiss tear . - Cholecystectomy - Gastric Erosions ● - Benign and Malignant Neoplasm . Gynecology: Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue. ## Comparison to Predicate Devices: The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories is compared to the primary predicate, SOLTIVE Laser System, and the additional predicate, the vela XL Laser System, in the table below. | Feature | IPG Medical Family of Thulium<br>Fiber Lasers, Surgical Fibers and<br>Accessories | SOLTIVE™ Laser System (#K211401)<br>Primary Predicate | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The IPG Medical Family of<br>Thulium Fiber Lasers, Surgical<br>Fibers and Accessories is<br>intended for incision, excision,<br>resection, ablation, coagulation,<br>hemostasis, and vaporization of<br>soft tissue, with or without an<br>endoscope, in the following<br>indications: urology, lithotripsy,<br>gastroenterological surgery and<br>gynecological surgery.<br><br>Urology:<br>• Ablation of Benign<br>Prostatic | The SOLTIVE™ Laser System (SOLTIVE™<br>Pro SuperPulsed Laser, SOLTIVE™<br>Premium SuperPulsed Laser, SOLTIVE™<br>Laser Fibers, and Accessories) is intended for<br>incision, excision, resection, ablation,<br>coagulation, hemostasis, and vaporization of<br>soft tissue, with or without an endoscope,<br>in the following indications: urology,<br>lithotripsy, gastroenterological surgery and<br>gynecological surgery.<br><br>Urology:<br>• Ablation of Benign Prostatic<br>Hyperplasia (Hypertrophy) [BPH]<br>• Laser Resection of the | | Hyperplasia (Hypertrophy) [BPH] | | | | Laser Resection of the Prostate (LRP) Laser Enucleation of the Prostate (LEP) Laser Ablation of the Prostate (LAP) Transurethral Incision of the Prostate (TUIP) Condylomas Urethral Strictures Lesions of External Genitalia Bladder Neck Incisions (BNI) Ablation and Resection of Bladder Tumors, Urethral Tumors, and Ureteral Tumors Endoscopic Fragmentation of Urethral, Ureteral, Bladder, and Renal Calculi Treatment of Distal Impacted Fragments remaining in the Ureters following Lithotripsy Lithotripsy and Percutaneous Urinary Lithotripsy Indications: Endoscopic Fragmentation of Urethral, Ureteral, Bladder, and Renal Calculi including Cystine, Calcium Oxalate, Monohydrate and Calcium Oxalate Dihydrate Stones Endoscopic Fragmentation of Calculi | Prostrate (LRP) Laser Enucleation of the Prostate (LEP) Laser Ablation of the Prostate (LAP) Transurethral Incision of the Prostate (TUIP) Condylomas Urethral strictures Lesions of external genitalia Bladder neck incisions (BNI) Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi Treatment of distal impacted fragments remaining in the ureters following lithotripsy. Lithotripsy and Percutaneous Urinary Lithotripsy Indications: Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones Endoscopic fragmentation of calculi Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology: Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: Appendectomy Angiodysplasia Polyps Colorectal cancer Biopsy | | | Feature | IPG Medical Family of Thulium<br>Fiber Lasers,<br>Surgical Fibers and<br>Accessories | SOLTIVETM Laser System (#K211401)<br>Primary Predicate | | | Treatment of Distal<br>Impacted Fragments of<br>Steinstrasse when Guide<br>Wire cannot be Passed <b>Gastroenterology:</b> Open and<br>endoscopic gastroenterology<br>surgery (incision, excision,<br>resection, ablation, vaporization,<br>coagulation and hemostasis)<br>including: Appendectomy Angiodysplasia Polyps Colorectal cancer Biopsy Telangiectasias Gall Bladder Calculi Telangiectasias of the Osler-<br>Weber- Renu Disease Biliary/Bile Duct Calculi Vascular Malformation Ulcers Gastritis Gastric Ulcers Esophagitis Duodenal Ulcers Esophageal Ulcers Non Bleeding Ulcers Varices Pancreatitis Colitis Hemorrhoids Mallory-Weiss Tear Cholecystectomy Gastric Erosions Benign and Malignant<br>Neoplasm <b>Gynecology:</b> | Telangiectasias Gall Bladder calculi Telangiectasias of the Osler-Weber-<br>Renu disease Biliary/Bile duct calculi Vascular Malformation Ulcers Gastritis Gastric ulcers Esophagitis Duodenal ulcers Esophageal ulcers Non Bleeding Ulcers Varices Pancreatitis Colitis Haemorrhoids Mallory-Weiss tear Cholecystectomy Gastric Erosions Benign and Malignant Neoplasm <b>Gynecology:</b> Open and laparoscopic<br>gynecological surgery (incision, excision,<br>resection, ablation, vaporization, coagulation<br>and hemostasis) of soft tissue. | | Feature | IPG Medical Family of Thulium<br>Fiber Lasers,<br>Surgical Fibers and Accessories | SOLTIVETM Laser System (#K211401)<br>Primary Predicate | | | Open and laparoscopic<br>gynecological surgery (incision,<br>excision, resection, ablation,<br>vaporization, coagulation and<br>hemostasis) of soft tissue. | | | Feature | IPG Medical Family of Thulium<br>Fiber Lasers,<br>Surgical Fibers and Accessories | SOLTIVETM Laser System (#K211401)<br>Primary Predicate | | | | | | | | | | Laser Type | Thulium | Thulium | | Laser Class | Class 4 | Class 4 | | Laser<br>Emission Mode | Pulsed and CW | Pulsed | | Average Power | 2 - 60 W adjustable | 2 - 60 W adjustable | | Peak Optical Power | 125 W to 500 W | 125 W to 500 W | | Repetition Rate | Up to 2400 Hz | Up to 2400 Hz | | Operating Temp<br>Range | 15 – 30 deg C | 15 – 30 deg C | | Cooling | Air cooled | Air cooled | | Beam Delivery | Flexible Optical Fiber | Flexible Optical Fiber | | Control Panel | 10" LCD Color<br>Touchscreen | 7" and 12.1" LCD Color Touchscreen<br>Displays | | Electrical | 100-240V ≈ 1200VA<br>50/60 Hz | 100-240V ≈ 1200VA<br>50/60 Hz | | Weight | <40 kg | <40 kg | | Dimensions | 43 x 29 x 62 cm | 30 x 37 x 56 cm | | Feature | IPG Medical Family of Thulium<br>Fiber Lasers,<br>Surgical Fibers and Accessories | SOLTIVETM Laser System (#K211401)<br>Primary Predicate | | (HxWxD) | | | | Fiber Sizes | 150, 200, 365, 550, 940 μm…