(114 days)
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.
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 ultrasonic power output for the tissue load encountered.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is an FDA 510(k) clearance letter for the Prime™ Adaptive Ultrasonic Scalpel System, focusing on its substantial equivalence to predicate devices and adherence to various performance and safety standards.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily details:
- Device Name: Prime™ Adaptive Ultrasonic Scalpel System
- Indications for Use: Cutting and coagulation in open, laparoscopic, and endoscopic surgery where control of hemostasis and thermal spread is desired. Used for dissection, sealing, transection, and vessel coagulation. Can be an adjunct or substitute for electrosurgery, lasers, or steel scalpels.
- Key Components: Generator (Prime™ 6000), Transducer Handpiece, and Instruments/Blades.
- Technological Characteristics: Automatically adapts ultrasonic power output to tissue load, consistent vibration, non-sterile reusable blades validated for cleaning/sterilization, and a cable disconnect feature at the transducer handpiece for convenience.
- Predicate Devices: Ultracision® Harmonic Scalpel® series from Ethicon Endo-Surgery, Inc.
- Reference Device: Sonopet® Surgical Aspirator for its blue anodized blade tip surface.
- Standards Met: A comprehensive list of IEC, ISO, AAMI, CAN/CSA, and EN standards related to electrical safety, electromagnetic compatibility, biocompatibility, risk management, and software life cycle processes. These are general safety and performance standards for medical devices, not specific clinical performance criteria or results.
The document asserts "no new questions of safety or effectiveness" and concludes substantial equivalence, which is the basis for 510(k) clearance, rather than presenting a detailed clinical study demonstrating meeting specific performance criteria.
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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.
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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
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| 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
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510(k) Summary
| Date Prepared:Submitter Contact: | May 29, 2015 (REVISED)Rich Grant, CEOEndoPrime, Inc.4480 Lake Forest Drive, Suite 414Cincinnati, OH 45242513-769-1916 |
|---|---|
| Regulatory Contact: | Rich GrantEndoPrime, Inc.4480 Lake Forest Drive, Suite 414Cincinnati, OH 45242513-769-1916 |
| 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
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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 EssentialPerformance. |
| CAN/CSA-C22.2 No. 60601-1:08 | Medical Electrical Equipment-Part 1-6: GeneralRequirements for Safety-Collateral Standard; GeneralRequirements, Tests and Guidance for Alarm Systems inMedical Electrical Equipment and Medical ElectricalSystems. |
| EN 60601-1-2:2007CISPR 11:2009+A1 | Medical Electrical Equipment-Part 1: GeneralRequirements for Safety 2. Collateral Standard:Electromagnetic Compatibility-Requirements and Tests. |
| IEC 60601-1-2-18:2009 (ThirdEdition) | Medical electrical equipment-Part 2-18: Particularrequirements for the basic safety and essential performanceof endoscopic equipment. |
| IEC 61000-4-8:2010 | Medical Electrical Equipment: Part 1-4: GeneralRequirements for Collateral Standard: ProgrammableElectrical Medical Systems. |
| IEC 61000-3-2:2006 +A1 +A2 | Electromagnetic compatibility (EMC)-Part 3-2: Limits forharmonic current emissions (equipment input current ≤ 16A per phase). |
| IEC 61000-3-3:2008 | Electromagnetic compatibility (EMC)-Part 3-3: Limitationof voltage changes, voltage fluctuations and flicker inpublic low-voltage supply systems, for equipment withrated current ≤ 16 A per phase and not subject toconditional 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-voltagepower supply systems for equipment with rated currentgreater than 16 A. |
| IEC 61000-4-4:2004+A1:2010 | Electromagnetic compatibility (EMC). Testing andmeasurement techniques. Electrical fast transient/burstimmunity test. |
| IEC 61000-4-5:2005 | Electromagnetic compatibility (EMC). Testing andmeasurement techniques. Surge immunity test. |
| IEC 61000-4-6:2003 | Electromagnetic compatibility (EMC). Testing andmeasurement techniques. Immunity to conducteddisturbances, induced by radio-frequency fields. |
| IEC 61000-4-11:2004 | Electromagnetic compatibility (EMC). Testing andmeasurement techniques. Voltage dips, short interruptionsand 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 |
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| vitro cytotoxicity. | |
|---|---|
| ISO 10993-10:2009 | Biological evaluation of medical devices--Part 10: Test forirritation and skin sensitivity. |
| ISO 10993-11:2009 | Biological evaluation of medical devices--Part 11: Testsfor systemic toxicity. |
| ISO 10993-4:2009 | Biological evaluation of medical devices—Part 4: Test forHemocompatibility. |
| AAMI TIR30:2011 | A compendium of processes, materials, test methods, andacceptance 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.
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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.
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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.
N/A