Rhapsody H-30 Holmium Laser System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 26, 2017 Cook Incorporated Colin Jacob Capital Equipment Specialist, Regulatory Affairs 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402 Re: K172325 Trade/Device Name: Rhapsody H-30 Holmium Laser System 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: July 31, 2017 Received: August 1, 2017 Dear Colin Jacob: 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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. > Sincerely, Jennifer R. Stevenson -53 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K172325 #### Device Name Rhapsody H-30 Holmium Laser System #### Indications for Use (Describe) The Rhapsody H-30 Holmium Laser System is intended for incision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size:20px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |-------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:20px">❍</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the Cook Medical logo, which is white text on a red background. The word "COOK" is in large, bold letters at the top. Below that, the word "MEDICAL" is in smaller letters. Below the logo is the text "510(k) Summary" in a large, bold font. COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM ## Rhapsody H-30 Holmium Laser System (21 CFR § 878.4810) Date Prepared: October 26, 2017 #### Submitted By: | Applicant: | Cook Incorporated | |-----------------------|-------------------------------------------------------------------------------| | Contact: | Colin S. Jacob | | Applicant Address: | Cook Incorporated<br>P.O. Box 489<br>750 Daniels Way<br>Bloomington, IN 47402 | | Contact Phone Number: | (812) 335-3575 x 104965 | | Contact Fax Number: | (812) 332-0281 | #### Device Information: | Trade Name: | Rhapsody H-30 Holmium Laser System | |----------------------------|------------------------------------| | Common Name: | Powered Laser Surgical Instrument | | Classification Name/Panel: | General & Plastic Surgery | | Regulation: | 21 CFR § 878.4810 | | Product Code: | GEX | #### Predicate Devices: - . H-30 Holmium Laser System (K130444) #### Device Description: The Rhapsody H-30 Holmium Laser System is an enclosed, transportable solid-state (i.e., Ho:YAG) laser source unit. The laser system unit produces a beam of coherent nearinfrared light (2100 nm wavelength) upon activation by depressing a footswitch pedal. The beam is directed to the treatment zone by means of a compatible optical delivery system, such as a holmium laser fiber. Components of the unit include a footswitch pedal and rotatable control panel. The system is a reusable, non-sterile device and is supplied in a wooden shipping crate. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is a red rectangle with the word "COOK" in white, sans-serif font. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The bottom left corner of the rectangle is cut off at an angle. COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM #### Indications for Use: The Rhapsody H-30 Holmium Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications. ## Comparison to Predicate Devices: The Rhapsody H-30 Holmium Laser System and the predicate device, H-30 Holmium Laser System (K130444), are substantially equivalent in that these devices have the same intended use and principles of operation. The differences in technological characteristics (i.e., software and minor internal components) do not raise different questions of safety and/or effectiveness when comparing to the predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM # Comparison to Predicate Device | | PRIMARY PREDICATE | SUBJECT DEVICE | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | H-30 Holmium Laser System | Rhapsody H-30 Holmium Laser System | | 510(k) | K130444 | Subject of submission | | Manufacturer | Cook Incorporated | Cook Incorporated | | Regulation | 21 CFR § 878.4810<br>General & Plastic Surgery | IDENTICAL TO PREDICATE | | Product Code | GEX | IDENTICAL TO PREDICATE | | Classification | Powered Laser Surgical Instrument | IDENTICAL TO PREDICATE | | Indications for Use | The H-30 Holmium Laser System is indicated for use in fragmentation of urinary calculi and soft tissue applications. The H-30 Holmium Laser System is indicated for use in urinary procedures where fragmentation of stones and soft tissue incision, hemostasis, vaporization, and ablation are indicated. | The Rhapsody H-30 Holmium Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications. | | Principles of Operation | Generates pulsed laser energy for delivery to the surgical site via silica core laser fibers | IDENTICAL TO PREDICATE | | Fundamental Scientific Technology | Solid-state, holmium yttrium aluminum garnet (Ho:YAG), pulsed laser operating at 2100 nanometers | IDENTICAL TO PREDICATE | | | PRIMARY PREDICATE | SUBJECT DEVICE | | | H-30 Holmium Laser System | Rhapsody H-30 Holmium Laser System | | Technological Characteristics | | | | Laser Wavelength | 2100 nm | IDENTICAL TO PREDICATE | | Maximum Output | 30 W | IDENTICAL TO PREDICATE | | Repetition Rate | 5 to 20 Hz | IDENTICAL TO PREDICATE | | Visible Aiming Beam | Variable Intensity <3 mW,<br>532 nm | IDENTICAL TO PREDICATE | | Laser Activation | Foot switch | IDENTICAL TO PREDICATE | | Minimum Energy | 0.5 J at 5 Hz | IDENTICAL TO PREDICATE | | Maximum Energy | 3.5 J at 5 Hz | IDENTICAL TO PREDICATE | | Electrical Pulse Width | Short: 350 to 800 μs<br>Long: 800 to 1200 μs | IDENTICAL TO PREDICATE | | Input Voltage | 115 & 230 V (full power) | IDENTICAL TO PREDICATE | | Fiber Communication | 1) Detects a resistor embedded within the fiber to identify<br>the size of the attached fiber and limit the laser energy to<br>the fiber's maximum allowable power output.<br>2) Communicates with a printed circuit board (two-way<br>communication) embedded within the laser fiber to<br>display extra information onscreen, or recording use<br>information for the laser system and the fiber such as<br>power setting, number of pulses, and error codes. | IDENTICAL TO PREDICATE | | Max Flash-lamp Voltage | 700 V | IDENTICAL TO PREDICATE | | Blast Shield | User accessible | IDENTICAL TO PREDICATE | | Water Reservoir | Plastic | IDENTICAL TO PREDICATE | | Filter | De-ionized cartridge & strainer | IDENTICAL TO PREDICATE | | Enclosure | Metal with cabinet & flat top | IDENTICAL TO PREDICATE | | Control Panel | Rotatable | IDENTICAL TO PREDICATE | | Water Pump | Fixed | Fixed with slightly different orientation | | Firmware | 1.5 version | 1.6 version | | Fan Shrouds | None | Present | | Ferrite | None | Present | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, uppercase letters, and above the word "MEDICAL" which is also in white, uppercase letters. COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM # Comparison to Predicate Devices (continued) {7}------------------------------------------------ Image /page/7/Picture/0 description: The image features the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font, set against a red square. Below the word "COOK", there is a smaller red rectangle containing the word "MEDICAL" in white, sans-serif font. The overall design is simple and clean, with a focus on the company name and its association with the medical field. COOK INCORPORATED WW.COOKMEDICA ### Performance Data: The subject device, Rhapsody H-30 Holmium Laser System, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below: | | | Table 2.0-2: Rhapsody H-30 Holmium Laser System Testing Summary | | |--|--|-----------------------------------------------------------------|--| | | | | | | Test Report | Result | |------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Test # RT20110616 | Testing must demonstrate that LCK 1.6 firmware performs as<br>intended. Test results met predetermined criteria. | | H-30 Litho family: Software Verification and<br>Validation | | | Test # 28110456-001 | Test article must demonstrate to comply with IEC 60601-1 | | IEC 60601-1 Medical electrical equipment<br>Part 1: General requirements for basic safety<br>and essential performance | Medical electrical equipment Part 1: General requirements for<br>basic safety and essential performance. Test results met<br>predetermined criteria. | | Test # 031714_502_PR #95252 | Test articles must demonstrate acceptable output energy within ±<br>10% of the factory setting and each system must fire for a<br>minimum of 30 minutes at maximum output energy of 2.5J@<br>12Hz on short pulse width. Test results met predetermined<br>criteria. | | Evaluation of Rhapsody H-30 - Addition of<br>Fan Shroud, Optimization of Cooling Lines<br>and Alignment Procedure | | ### Conclusion: For these tests, all pre-determined acceptance criteria were met. The results of these tests show that the Rhapsody H-30 Holmium Laser System meets the design input requirements based on the intended use. Furthermore, these results support the conclusion that the differences between the subject device, Rhapsody H-30 Holmium Laser System, and the predicate device, H-30 Holmium Laser System, do not raise new questions of safety or effectiveness and support a determination of substantial equivalence.