(114 days)
No
The description mentions the generator "automatically adapt[ing] the ultrasonic power output for the tissue load encountered," which is a form of adaptive control, not necessarily AI/ML. There are no explicit mentions of AI, ML, or related terms, nor are there descriptions of training or test sets typically associated with AI/ML development.
Yes
This device is a cutting and coagulation system used in surgery to control hemostasis and thermal spread, which are therapeutic actions.
No
Explanation: The device is described as a "cutting and coagulation system" used for surgical procedures like dissection, sealing, and transection. Its function is to perform surgical actions on tissue, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly lists hardware components: Generator (with footswitch), Transducer Handpiece, and instruments (or blades). This indicates it is a hardware-based system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Function: The Prime™ Adaptive Ultrasonic Scalpel System is a surgical tool used directly on soft tissue within the body during open and laparoscopic surgery. It cuts and coagulates tissue.
- Intended Use: The intended use clearly describes its application in surgical procedures on living tissue, not on specimens in a lab.
The information provided about the device's function, intended use, and components all point to it being a surgical instrument, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
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.
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 (
N/A
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.
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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"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 |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
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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 (