(242 days)
Not Found
No
The summary describes a surgical hand instrument and its intended uses and performance testing. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is described as a surgical instrument used for cutting, vessel ligation, coagulation, grasping, and dissection during open and ENT procedures, which directly applies therapy to tissues.
No
The device is an electrosurgical and ultrasonic instrument primarily used for cutting, sealing, coagulation, grasping, and dissection of tissues and vessels during surgical procedures. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting" and is provided as a "sterile, single use device." This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for cutting, sealing, coagulating, grasping, and dissecting tissue and vessels within the body during open surgical procedures.
- Device Description: The description reinforces that it's a functional device for performing these actions on tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The performance studies focus on the device's interaction with tissue and vessels, not on analyzing biological samples.
IVDs are used to perform tests on samples taken from the body to provide information about a person's health. This device is a surgical tool used directly on the patient's tissues during a procedure.
N/A
Intended Use / Indications for Use
The THUNDERBEAT Open Fine Jaw hand instrument is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectorny, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.
Seal mode:
The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectomy, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The THUNDERBEAT Open Fine Jaw hand instrument has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.
- 1 It should be extended appropriately depending on the operation situation.
Product codes (comma separated list FDA assigned to the subject device)
GEI, LFL
Device Description
The THUNDERBEAT Open Fine Jaw TB-0009OF is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
The THUNDERBEAT Open Fine Jaw TB-0009OF is provided as a sterile, single use device. It is a functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting. This device has been designed to seal and cut vessels up to and including 7 mm in diameter, tissue bundles, and lymphatics for open, open ENT procedures in surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue bundles, lymphatics, ENT (thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- THUNDERBEAT Open Fine Jaw Ex-vivo Sealing & Cutting and Sealing Performances Confirmation Test on Blood Vessels. Objective: Confirm sealing & cutting and sealing performances of THUNDERBEAT Open Fine Jaw.
- THUNDERBEAT Open Fine Jaw Ex-vivo Sealing & Cutting Performance - Comparative Test on Blood Vessels. Objective: Compare sealing & cutting performance of the THUNDERBEAT Open Fine Jaw with conventional bipolar device.
- THUNDERBEAT Open Fine Jaw Ex-vivo Cutting Performance Comparative Test on Mesentery. Objective: Compare cutting performance of THUNDERBEAT Open Fine Jaw with those of THUNDERBEAT, conventional bipolar and ultrasonic devices.
- Sealing performance and characteristics of the THUNDERBEAT Open Fine Jaw SEAL & CUT mode during activation. Objective: Verify sealing performance and characteristics of THUNDERBEAT Open Fine Jaw during SEAL&CUT mode output compared with a conventional ultrasonic device.
- Cutting performance and characteristics of the THUNDERBEAT Open Fine Jaw SEAL & CUT mode during activation. Objective: Verify characteristics of THUNDERBEAT Open Fine Jaw during SEAL&CUT mode output compared with a conventional ultrasonic device.
- Comparison of grasping and dissection performance between the THUNDERBEAT Open Fine Jaw and the control devices. Objective: Confirm grasping and dissection performance of the THUNDERBEAT Open Fine Jaw by comparison with the control devices.
- THUNDERBEAT Open Fine Jaw Maximum Temperature and Cooling Time of the Grasping Section. Objective: Compare maximum temperature and cooling time of the grasping section of the THUNDERBEAT Open Fine Jaw and the control devices.
- THUNDERBEAT Open Fine Jaw Grasping force distribution verification report on wiper jaw. Objective: Compare subject device to predicate device regarding evenness of grasping force across grasping section.
Animal Testing:
- THUNDERBEAT Open Fine Jaw Performance and Safety Confirmation Test on Blood Vessels, Lymphatics and Tissue Bundle (Acute Animal Testing). Canine and porcine animal models. Objective: Confirm performance of THUNDERBEAT Open Fine Jaw on blood vessels up to 7.0 mm in diameter, lymphatics and tissue bundles, and its safety on blood vessels up to 7.0 mm in diameter and tissue bundles with blood vessels and lymphatics by comparing the seal achievement rate, thermal spread, degree of degeneration and seal achievement with those yielded.
- THUNDERBEAT Open Fine Jaw Performance Confirmation Test on Blood Vessels, Lymphatics and Tissue Bundles (Chronic Animal Testing). Porcine animal models. Objective: Confirm performance of THUNDERBEAT Open Fine Jaw on blood vessels up to 7.0 mm in diameter, lymphatics and tissue bundles by comparing the seal achievement and maintenance rates with those yielded.
- THUNDERBEAT Open Fine Jaw Safety and Performance Confirmation Test on ENT Procedures (Chronic Animal Testing). Canine animal model. Objective: Confirm safety and performance of THUNDERBEAT Open Fine Jaw when utilized during ENT procedures including thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy.
- THUNDERBEAT Open Fine Jaw Safety and Performance Confirmation Test on ENT Procedures (Acute Animal Testing). Canine animal model. Objective: Confirm safety and performance of THUNDERBEAT Open Fine Jaw when utilized during ENT procedures including thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy. The thermal spread and the acute tissue response of the THUNDERBEAT Open Fine Jaw on the usage in the ENT procedures were evaluated in comparison with the control devices.
Full biocompatibility testing on all patient contacting surfaces has been performed in compliance to the relevant requirements of ISO-10993.
Sterilization has been tested to comply with ISO11135-1: 2007.
Accelerated Aging testing confirmed that the subject device has a three year shelf life.
Clinical testing using the subject device itself was not conducted. A clinical meta-analysis that considered the safety and effectiveness of predicate devices being used in the same procedures proposed for the subject device was conducted.
Key results: Performance tests summarized above demonstrated that the Gyrus ACMI THUNDERBEAT Open Fine Jaw TB-0009OF is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
Olympus Medical Systems Corp. % Mr. Graham Baillie Manager, Regulatory Affairs Gyrus ACMI. Inc. 136 Turnpike Road Southborough, Massachusetts 01772
Re: K151743
Trade/Device Name: Thunderbeat Open Fine Jaw Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, LFL Dated: January 26, 2016 Received: January 27, 2016
Dear Mr. Baillie:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
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/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 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 yours,
Jennifer R. Stevenson -A
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) K151743
Device Name THUNDERBEAT Open Fine Jaw TB-0009OF
Indications for Use (Describe)
The THUNDERBEAT Open Fine Jaw hand instrument is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectorny, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.
Seal mode:
The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectomy, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The THUNDERBEAT Open Fine Jaw hand instrument has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.
- 1 It should be extended appropriately depending on the operation situation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
THUNDERBEAT Open Fine Jaw Hand Instrument Gyrus ACMI, Inc.
Traditional 510(k) Notification Feb 25, 2016
510(k) Summary Gyrus ACMI, Inc. THUNDERBEAT Open Fine Jaw TB-0009OF
General Information
Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Phone: (+81) 42-642-2694 Fax: (+81) 42-642-2307 Establishment Registration Number: 8010047 Manufacturer: Aomori Olympus 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan 036-0367 Phone: (+81) 172-52-8543 Fax: (+81) 172-52-8515 Establishment Registration Number: 9614641 510(k) Submitter: Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104 3003790304 Establishment Registration Number: Contact Person: Graham Baillie Manager, Regulatory Affairs
Date Prepared:
Classification Name:
Regulation Number: Regulatory Class: Product Codes: Review Panel: Trade Name:
Generic/Common Name:
Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400 Class II, GEI, LFL General & Plastic Surgery THUNDERBEAT Open Fine Jaw Hand Instrument Ultrasonic and electrosurgical devices
February 25, 2016
5
THUNDERBEAT Open Fine Jaw Hand Instrument Gyrus ACMI, Inc.
Traditional 510(k) Notification Feb 25, 2016
| Model Name | Device Name |
|---|---|
| TB-0009OF | THUNDERBEAT Open Fine Jaw |
Predicate Devices
| Olympus Medical Systems Corp. THUNDERBEAT TB-0510IC/0520IC | K132703 |
|---|---|
| Covidien LigaSure Small Jaw | K113572 |
| Ethicon Harmonic Focus | K100597 |
Device Description
The THUNDERBEAT Open Fine Jaw TB-0009OF is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
The THUNDERBEAT Open Fine Jaw TB-0009OF is provided as a sterile, single use device. It is a functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting. This device has been designed to seal and cut vessels up to and including 7 mm in diameter, tissue bundles, and lymphatics for open, open ENT procedures in surgery.
Technological Characteristics
The THUNDERBEAT Open Fine Jaw TB-0009OF has two different output modes:
- Seal and Cut mode: Activating the Ultrasonic output (generated by the USG-● 400, Ultrasonic Generator) and the HF Bipolar output (generated by the ESG-400) simultaneously enables sealing and cutting of vessels, tissue bundles, and lymphatics and cutting and coagulation soft tissue.
- Seal mode: Uses only the HF Bipolar (ESG-400) energy output which enables vessel, tissue bundle and lymphatic sealing and hemostasis.
6
Intended Use
The THUNDERBEAT Open Fine Jaw hand instrument is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.
Seal mode:
The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The THUNDERBEAT Open Fine Jaw hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
- 1 It should be extended appropriately depending on the operation situation.
7
Traditional 510(k) Notification Feb 25, 2016
Comparison of Technological Characteristics
The subject and predicate devices have similar technology, priciples of operation, performance, dimensions and materials. A side-by-side comparison of the marketed and proposed devices is provided below.
| Feature | Proposed
THUNDERBEAT Open
Fine Jaw
TB-0009OF | Predicate
THUNDERBEAT
TB-0510IC/0520IC
(K132073) | Predicate
LigaSure
Small Jaw
K113572 | Predicate
Harmonic
Focus
K100597 | | | |
|------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------|----------------------------------|-------------------------|---------|
| Instrument
working length | 9cm | 10, 20cm | Unknown | 9cm | | | |
| Shaft rotation | No rotation | 360 degrees | No rotation | No rotation | | | |
| Output mode | Seal and
Cut mode
Combined
output
(Ultrasonic
and HF
Bipolar) | Seal and
Cut mode
Combined
output
(Ultrasonic
and HF
Bipolar) | Seal mode
(HF
Bipolar) | HF
Bipolar | Ultrasonic | | |
| Ultrasonic
output | Ultrasonic
Output
Frequency | 47kHz | Not
activated | 47kHz | Not
activated | Not
activated | 55kHz |
| | Probe
Amplitude | 64μm | Not
activated | 80μm | Not
activated | Not
activated | Unknown |
| HF Bipolar
output | Activated | Activated | Activated | Activated | Not
activated | | |
| Tissue or vessel
cutting
mechanism | ultrasonic
vibration | No
cutting | ultrasonic
vibration | No
cutting | A
mechanical blade
deploys | Ultrasonic
vibration | |
| Shaft Diameter | No shaft | No shaft | 5.5mm | 5.5mm | No shaft | No shaft | |
| Handle | hemostat-style body | Inline Grip with shaft
body | hemostat-style body | hemostat-style body | | | |
8
Compliance to Voluntary Standards
The design of the THUNDERBEAT Open Fine Jaw TB-0009OF complies with the following standards:
- IEC60601-1: 2005+A1 Medical electrical equipment - Part1: General ● Requirements for basic safety and essential performance
- . IEC60601-1-2 Edition 3: 2007-03 Medical electrical equipment - Part 1-2; General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirement and tests
- AAMI ANSI IEC60601-2-2:2009 Medical electrical equipment. Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- ISO10993-1: Forth Edition 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- AAMI ANSI ISO10993-5: 2009/(R) 2014 Biological evaluation of medical . devices - Part5: Tests for in vitro cytotoxicity
- ISO10993-7 Second Edition: 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- AAMI ANSI ISO10993-10: 2010 Biological evaluation of medical devices. ● Tests for irritation and sensitization
- . ISO10993-11 Second Edition: 2006-08-15 Biological evaluation of medical devices. Tests for systemic toxicity
- ISO11135-1:2007 Sterilization of health-care products - ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO14971 Second Edition: 2007-03-01 - Medical devices - Application of risk management to medical devices
- ASTM F1980-07(Reapproved 2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical devices
9
Traditional 510(k) Notification
Feb 25, 2016
THUNDERBEAT Open Fine Jaw Hand Instrument Gyrus ACMI, Inc.
Summary of Non-clinical Testing
Full biocompatibility testing on all patient contacting surfaces has been performed in compliance to the relevant requirements of ISO-10993.
Sterilization has been tested to comply with ISO11135-1: 2007. Accelerated Aging testing confirmed that the subject device has a three year shelf life.
| Test
| Code | Title | Objective |
|---|---|---|
| #A1 | THUNDERBEAT Open Fine | |
| Jaw Ex-vivo Sealing & Cutting | ||
| and Sealing Performances | ||
| Confirmation Test on Blood | ||
| Vessels | This test was designed to confirm the | |
| sealing & cutting and sealing performances | ||
| of THUNDERBEAT Open Fine Jaw | ||
| #A2 | THUNDERBEAT Open Fine | |
| Jaw Ex-vivo Sealing & Cutting | ||
| Performance - Comparative Test | ||
| on Blood Vessels | This test was designed to compare the | |
| sealing & cutting performance of the | ||
| THUNDERBEAT Open Fine Jaw with the | ||
| conventional bipolar device | ||
| #B1 | THUNDERBEAT Open Fine | |
| Jaw Ex-vivo Cutting | ||
| Performance Comparative Test | ||
| on Mesentery. | This test was designed to compare the | |
| cutting performance of THUNDERBEAT | ||
| Open Fine Jaw with those of | ||
| THUNDERBEAT, conventional bipolar and | ||
| ultrasonic devices | ||
| #Fb1 | Sealing performance and | |
| characteristics of the | ||
| THUNDERBEAT Open Fine | ||
| Jaw SEAL & CUT mode during | ||
| activation. | This test was designed to verify the sealing | |
| performance and characteristics of | ||
| THUNDERBEAT Open Fine Jaw during | ||
| SEAL&CUT mode output compared with a | ||
| conventional ultrasonic device | ||
| #Fb2 | Cutting performance and | |
| characteristics of the | ||
| THUNDERBEAT Open Fine | ||
| Jaw SEAL & CUT mode during | ||
| activation. | This test was designed to verify the | |
| characteristics of THUNDERBEAT Open | ||
| Fine Jaw during SEAL&CUT mode output | ||
| compared with a conventional ultrasonic | ||
| device | ||
| #H | Comparison of grasping and | |
| dissection performance between | ||
| the THUNDERBEAT Open | ||
| Fine Jaw and the control | ||
| devices. | This test was designed to confirm grasping | |
| and dissection performance of the | ||
| THUNDERBEAT Open Fine Jaw by | ||
| comparison with the control devices | ||
| #I/J | THUNDERBEAT Open Fine | |
| Jaw Maximum Temperature and | ||
| Cooling Time of the Grasping | ||
| Section. | This test was designed to compare | |
| maximum temperature and cooling time of | ||
| the grasping section of the | ||
| THUNDERBEAT Open Fine Jaw and the | ||
| control devices | ||
| #L | THUNDERBEAT Open Fine | |
| Jaw Grasping force distribution | ||
| verification report on wiper jaw | The purpose of this test is to compare | |
| subject device to predicate device regarding | ||
| evenness of grasping force across grasping | ||
| section. | ||
| Test | Title | Objective |
| Code | ||
| #D | THUNDERBEAT Open Fine | |
| Jaw Performance and Safety | ||
| Confirmation Test on Blood | ||
| Vessels, Lymphatics and Tissue | ||
| Bundle (Acute Animal Testing) | This test was designed to confirm the | |
| performance of THUNDERBEAT Open | ||
| Fine Jaw on blood vessels up to 7.0 mm in | ||
| diameter, lymphatics and tissue bundles, | ||
| and its safety on blood vessels up to 7.0 mm | ||
| in diameter and tissue bundles with blood | ||
| vessels and lymphatics by comparing the | ||
| seal achievement rate, thermal spread, | ||
| degree of degeneration and seal | ||
| achievement with those yielded | ||
| #Ca | THUNDERBEAT Open Fine | |
| Jaw Performance Confirmation | ||
| Test on Blood Vessels, | ||
| Lymphatics and Tissue Bundles | ||
| (Chronic Animal Testing) | This test was designed to confirm the | |
| performance of THUNDERBEAT Open | ||
| Fine Jaw on blood vessels up to 7.0 mm in | ||
| diameter, lymphatics and tissue bundles by | ||
| comparing the seal achievement and | ||
| maintenance rates with those yielded | ||
| #G | THUNDERBEAT Open Fine | |
| Jaw Safety and Performance | ||
| Confirmation Test on ENT | ||
| Procedures (Chronic Animal | ||
| Testing) | This test was designed to confirm the safety | |
| and performance of THUNDERBEAT | ||
| Open Fine Jaw when utilized during ENT | ||
| procedures including thyroidectomy, | ||
| parathyroidectomy, parotidectomy, and | ||
| tonsillectomy | ||
| #M | THUNDERBEAT Open Fine | |
| Jaw Safety and Performance | ||
| Confirmation Test on ENT | ||
| Procedures (Acute Animal | ||
| Testing) | This test was designed to confirm the safety | |
| and performance of THUNDERBEAT | ||
| Open Fine Jaw when utilized during ENT | ||
| procedures including thyroidectomy, | ||
| parathyroidectomy, parotidectomy, and | ||
| tonsillectomy. The thermal spread and the | ||
| acute tissue response of the | ||
| THUNDERBEAT Open Fine Jaw on the | ||
| usage in the ENT procedures were | ||
| evaluated in comparison with the control | ||
| devices |
Bench Testing
10
Animal Testing:
Canine animal model was used for performance testing M and G, and porcine animal models were used for performance testing Ca and D.
Summary of Clinical Testing
Clinical testing using the subject device itself was not conducted. Therefore, a clinical meta-analysis that considered the safety and effectiveness of predicate devices being used in the same procedures proposed for the subject device was conducted.
Conclusion:
Performance tests summarized above demonstrated that the Gyrus ACMI THUNDERBEAT Open Fine Jaw TB-0009OF is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.