← Product Code LFL · K150271 # Prime Adaptive Ultrasonic Scalpel System (K150271) _Endoprime, Inc. · LFL · May 29, 2015 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K150271 ## Device Facts - **Applicant:** Endoprime, Inc. - **Product Code:** LFL - **Decision Date:** May 29, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use The Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic surgery in soft tissue where control of hemostasis and thermal spread is desired. The system is indicated for dissection, sealing, transection, otomy creation and transection/coagulation of vessels as indicated for each cutting and coagulation instrument used (consult the instructions for use provided with each instrument). The system can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpels. ## Device Story System comprises G6000 generator, transducer handpiece, and reusable ultrasonic blades. Generator converts electrical energy to mechanical ultrasonic vibration via transducer; blades vibrate to cut tissue and seal vessels (<2mm) through protein coagulation/local heating. Used in OR by surgeons for open/laparoscopic procedures. Generator automatically adapts power output based on tissue load; features footswitch/handswitch activation. Provides audible/visual alarms for system errors or end-of-life components. Benefits include reduced smoke/heat generation compared to electrosurgery/lasers and absence of electrical current flow through patient. Cable disconnect at handpiece allows sterile field component replacement without generator contact. ## Clinical Evidence Bench testing only. System validated for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-1, -4, -5, -10, -11). Cleaning/sterilization validated per AAMI TIR30. No clinical data presented. ## Technological Characteristics Ultrasonic surgical system; generator-driven transducer handpiece with reusable blades. Materials biocompatible per ISO 10993. Connectivity: footswitch/handswitch interface. Power: variable/maximum levels (1-5). Software: EN/IEC 62304 compliant. Sterilization: validated for disassembly, cleaning, and sterilization. Standards: IEC 60601-1, IEC 60601-1-2, IEC 61000 series, ISO 10993 series. ## Predicate Devices - Ultracision® Harmonic Scalpel® ([K002981](/device/K002981.md)) - Ultracision® HARMONIC Scalpel® Hand Piece ([K990430](/device/K990430.md)) - Ultracision Harmonic Scalpel Blade ([K010898](/device/K010898.md)) - Harmonic Scalpel Blades and Shears ([K053056](/device/K053056.md)) ## Reference Devices - Sonopet® Surgical Aspirator ([K010309](/device/K010309.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 29, 2015 EndoPrime Incorporated Mr. Rich Grant Chief Executive Officer 4480 Lake Forest Drive, Suite 414 Cincinnati, Ohio 45242 Re: K150271 Trade/Device Name: Prime™ Adaptive Ultrasonic Scalpel System Regulatory Class: Unclassified Product Code: LFL Dated: May 18, 2015 Received: May 20, 2015 Dear Mr. Grant: 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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 vours. # Jennifer R. Stevenson -S 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}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |-----------------------------------------| | Food and Drug Administration | | Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) Pending K150271 Device Name DrimaTM & dentica - L11 Device Name Prime™ Adaptive Ultrasonic Scalpel System #### Indications for Use (Describe) mentants of oce [Busines] and Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic, and endosection, sealine transation of hemostasis and thermal spread is desired. The system is indicated for dissection, sealing, transection of trention of tremsection/coagulation of vessels as indicated for each uting and on edivert to as substitute of controll and trailsections for use provided with each instrument). The system can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpela | Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* | FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF | |----------------------|-------------|-------------------------------------------| |----------------------|-------------|-------------------------------------------| {3}------------------------------------------------ ## 510(k) Summary | Date Prepared:
Submitter Contact: | May 29, 2015 (REVISED)
Rich Grant, CEO
EndoPrime, Inc.
4480 Lake Forest Drive, Suite 414
Cincinnati, OH 45242
513-769-1916 | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Contact: | Rich Grant
EndoPrime, Inc.
4480 Lake Forest Drive, Suite 414
Cincinnati, OH 45242
513-769-1916 | | Trade Name: | The Prime™ Adaptive Ultrasonic Scalpel System | |-----------------------|-----------------------------------------------| | Common or Usual Name: | Ultrasonic Surgical Instruments | | Product Class: | Class II | | Classification: | Instrument, Ultrasonic Surgical | | Product Codes: | LFL | | Panel Code: | General & Plastic Surgery | | Regulation Standard: | Unclassified | Reason for this Submission: This Traditional 510(k) involves one medical device system compiled of three individual medical device components. No Prior Submissions: There were no prior submissions for the subject device by EndoPrime Inc. ### Indications for Use: The Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic surgery in soft tissue where control of hemostasis and thermal spread is desired. The system is indicated for dissection, sealing, transection, otomy creation and transection/coagulation of vessels as indicated for each cutting and coagulation instrument used (consult the instructions for use provided with each instrument). The system can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpels. ### Device Descriptions: The Prime™ Adaptive Ultrasonic Scalpel System has three major components: Generator (with footswitch), Transducer Handpiece and instruments (or blades). The Prime™ 6000 Generator provides input/output control and operation interface to automatically adapt the {4}------------------------------------------------ ultrasonic power output for the tissue load encountered. The device system is compliant with the following consensus standards: | Performance Standards: | | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1 2005 + CORR. 1
(2006) + CORR. (2007) | International Standard-Medical Electrical Equipment-
General Requirements for Basic Safety and Essential
Performance. | | CAN/CSA-C22.2 No. 60601-1:08 | Medical Electrical Equipment-Part 1-6: General
Requirements for Safety-Collateral Standard; General
Requirements, Tests and Guidance for Alarm Systems in
Medical Electrical Equipment and Medical Electrical
Systems. | | EN 60601-1-2:2007
CISPR 11:2009+A1 | Medical Electrical Equipment-Part 1: General
Requirements for Safety 2. Collateral Standard:
Electromagnetic Compatibility-Requirements and Tests. | | IEC 60601-1-2-18:2009 (Third
Edition) | Medical electrical equipment-Part 2-18: Particular
requirements for the basic safety and essential performance
of endoscopic equipment. | | IEC 61000-4-8:2010 | Medical Electrical Equipment: Part 1-4: General
Requirements for Collateral Standard: Programmable
Electrical Medical Systems. | | IEC 61000-3-2:2006 +A1 +A2 | Electromagnetic compatibility (EMC)-Part 3-2: Limits for
harmonic current emissions (equipment input current ≤ 16
A per phase). | | IEC 61000-3-3:2008 | Electromagnetic compatibility (EMC)-Part 3-3: Limitation
of voltage changes, voltage fluctuations and flicker in
public low-voltage supply systems, for equipment with
rated current ≤ 16 A per phase and not subject to
conditional connection. | | IEC 61000-4-3:2006 + A1:2007 +
A2:2010 | Electromagnetic compatibility (EMC)-Part 4-3: Limits-
Limitation of emission of harmonic currents in low-voltage
power supply systems for equipment with rated current
greater than 16 A. | | IEC 61000-4-4:2004+A1:2010 | Electromagnetic compatibility (EMC). Testing and
measurement techniques. Electrical fast transient/burst
immunity test. | | IEC 61000-4-5:2005 | Electromagnetic compatibility (EMC). Testing and
measurement techniques. Surge immunity test. | | IEC 61000-4-6:2003 | Electromagnetic compatibility (EMC). Testing and
measurement techniques. Immunity to conducted
disturbances, induced by radio-frequency fields. | | IEC 61000-4-11:2004 | Electromagnetic compatibility (EMC). Testing and
measurement techniques. Voltage dips, short interruptions
and voltage variations immunity tests. | | ISO 10993-1:2009/AC2010 | Biocompatibility Evaluation of medical Device Table A.1 | | ISO 10993-5:2009 | Biological evaluation of medical devices--Part 5: Tests for | {5}------------------------------------------------ | | vitro cytotoxicity. | |-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 10993-10:2009 | Biological evaluation of medical devices--Part 10: Test for
irritation and skin sensitivity. | | ISO 10993-11:2009 | Biological evaluation of medical devices--Part 11: Tests
for systemic toxicity. | | ISO 10993-4:2009 | Biological evaluation of medical devices—Part 4: Test for
Hemocompatibility. | | AAMI TIR30:2011 | A compendium of processes, materials, test methods, and
acceptance criteria for cleaning reusable medical devices.
Association for Advancement of Medical Instrumentation,
Arlington, VA. (CRD249). | | EN/ISO 14971:2012 | Risk Management for Medical Device | | EN/IEC 62304:2006 | Medical device software—Software life cycle processes. | #### Prime™ Adaptive Ultrasonic Scalpel System and Blades family of products consist of: Prime™ G6000 Generator provides operation interface display, device condition monitoring and Input/Output control. The generator provides electrical energy output to the transducer, which is controlled by activating the footswitch. The Prime™ G6000 Generator is also validated to operate with hand switched devices and hand switched enabled transducer hand pieces. A built-in, automatic pre-check function verifies proper connection and operation of the system during startup and continuously monitors the system and instruments. Variable and Maximum (or Full) power levels (1 through 5) are displayed on the front panel and can be selected by pressing the VAR or FULL footswitch pedal (or if available the hand switch). The Variable Power setting can be selected throughout the procedure to provide corresponding energy outputs with the interacting instrument. Audible and visual alarms assist with identifying anomalies, error, and failures including generator, instrument or transducer that are at the end of their useful life. A Standby button is available to pause the system to avoid accidental activation when not in use, or conduct manual system checks and diagnostics. Prime™ Ultrasonic Scalpel Reusable Blades vibrate ultrasonically, which enables its cutting ability. The same vibration seals small vessels (< 2mm) with coagulated blood and tissue proteins by producing local heating of tissue. Homeostasis occurs when tissue couples with the blade. The Prime™ Ultrasonic Scalpel Reusable Blades are designed for use with a transducer and a generator system as part of the Prime™ Adaptive Ultrasonic Scalpel System and family of products; these products are compatible with a limited number of other manufacturer's systems. The system instruments can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpels with the advantages of limited heat/smoke generation and the lack of current flow through the patient. The blade instruments are provided with a reusable Torque Wrench to assure proper tightness when attaching the blade to the transducer. The generator will automatically check the tightness to assure proper function. {6}------------------------------------------------ The Prime™ Reusable Transducer Handpiece cooperates with the Prime™ Adaptive Ultrasonic Scalpel Blades as a cutting and coagulation instrument. The Prime™M Reusable Transducer Handpiece is designed to convert electrical energy from the generator to mechanical motion of the instrument blades. When the transducer is used in conjunction with the Prime™ Adaptive Ultrasonic Scalpel System, the transducer provides ultrasonic vibration, which enables cutting ability. Prime™M Adaptive Ultrasonic Scalpel System and Blades family of products is compatible with a limited number of other manufacturer's systems. Prime™ Adaptive Ultrasonic Scalpel System products are compatible with a limited number of other predicate systems. #### Predicate Device(s): K002981-Ultracision® Harmonic Scalpel®, Ethicon Endo-Surgery, Inc. K990430-Ultracision® HARMONIC Scalpel® Hand Piece, Ethicon Endo-Surgery K010898-Ultracision Harmonic Scalpel Blade, Ethicon Endo-Surgery K053056-Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery, Inc. Prime™ Adaptive Ultrasonic Scalpel System blade tips are finished identical to other ultrasonic devices: #### Reference Device: K010309-Sonopet® Surgical Aspirator, Mutoh America CO., LTD. (now Stryker) refinanced for its blue anodized blade tip surface only. ### Technological Characteristics: The Prime™ Adaptive Ultrasonic Scalpel System and Blades technological characteristics are substantially equivalent to the predicated devices including automatically adapting the ultrasonic power output for the tissue load encountered to provide consistent vibration in differing loads and tissue thickness. The predicate device scalpel blades were predicated on reusable scalpel blades and the Prime™ Ultrasonic Scalpel Reusable Blades are designed to function similar to the predicate devices but are provided non-sterile and validated for disassembly, cleaning and sterilization. Another feature of the Prime™ Adaptive Ultrasonic Scalpel System and Blades is the ability to disconnect the cable at the transducer handpiece. This feature allows the surgical scrub technician to quickly replace the transducer handpiece and/or ultrasonic blades without contact with the non-sterile surface of the generator or assistance from others. The cable disconnect was designed as a convenience feature similar to the ability to disconnect at the generator. The Prime™ Ultrasonic Scalpel Reusable Blades are designed similar to the predicate blades but have slightly different end effector designs. The Prime™ Ultrasonic Curved Blades have a compact design to improve access in narrow, delicate anatomy. The Omni™ Ultrasonic Hook Blades are curved for better visibility with a duel hook design to permit easier change of direction without full rotation. These technological improvements will not affect the overall device intended use, performance characteristics, substantial equivalence to the predicate, or raise any new issues regarding safety or efficacy. {7}------------------------------------------------ Conclusion: EndoPrime, Inc. concludes that the Prime™ Adaptive Ultrasonic Scalpel System and Blades family of products, is substantially equivalent to the predicate devices, and raises no new questions of safety or effectiveness. --- **Source:** [https://fda.innolitics.com/device/K150271](https://fda.innolitics.com/device/K150271) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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