(263 days)
Not Found
No
The summary describes a surgical hand instrument that uses ultrasonic and electrosurgical energy for cutting, sealing, and coagulation. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical function and energy delivery of the device.
Yes
The device is intended for surgical procedures such as cutting, vessel ligation, coagulation, grasping, and dissection, all of which are interventions to treat or manage a disease or condition.
No
The device description and intended use clearly state that the THUNDERBEAT hand instruments are surgical tools for cutting, sealing, coagulating, grasping, and dissecting tissues and vessels. There is no mention of diagnosing any condition or disease.
No
The device description explicitly states it is a "functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, dissecting" and is provided as "sterile, single use devices." This indicates a physical, hardware-based medical device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The THUNDERBEAT hand instruments are described as surgical tools used for cutting, sealing, coagulation, grasping, and dissection of tissues and vessels within the body during surgical procedures.
- Intended Use: The intended use clearly outlines surgical applications (open, laparoscopic, endoscopic, ENT) and procedures performed directly on the patient's anatomy.
- No Mention of Samples: There is no mention of the device being used to analyze samples taken from the body.
Therefore, the THUNDERBEAT hand instruments are surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomies, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation. grasping is performed. These devices have been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
The THUNDERBEAT hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
THUNDERBEAT TB-0510IC/0520IC
The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have 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 procedures in adults for ligation (sealing and cutting) of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.
Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have 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 procedures in adults for sealing of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.
The THUNDERBEAT hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI, LFL
Device Description
The THUNDERBEAT hand instruments are intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
The THUNDERBEAT hand instruments are provided as sterile, single use devices. These are functional devices capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, dissecting. These instruments have been designed to seal and cut vessels up to and.including 7 mm in diameter, tissue bundles, and lymphatics for open, laparoscopic, open ENT and endoscopic 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, urologic, thoracic, plastic and reconstructive, bowel, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal), ENT
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
Test #A: THUNDERBEAT Ex-vivo Sealing & Cutting Performance Confirmation Test on Blood Vessels
Test #B: THUNDERBEAT Ex-vivo Cutting Performance Confirmation Test on Blood Vessels and Mesentery.
Test #Fa: Sealing performance of the THUNDERBEAT SEAL & CUT mode
Test #Fb: Sealing performance and characteristic of the THUNDERBEAT SEAL & CUT mode during activation
Test #Fc: Sealing performance of the THUNDERBEAT SEAL & CUT mode
Test #H: Comparison of dissecting performance between the THUNDERBEAT vs. Control devices
Test #I/J: A comparison of heating at the grasping section of THUNDERBEAT Hand Instruments vs. Control devices.
Test #P: THUNDERBEAT Ex-vivo Sealing & Cutting and Sealing Performance -Histopathological Confirmation Test on Blood Vessels.
Animal Test
Test Ea: THUNDERBEAT In-vivo Sealing & Cutting and Sealing Performance Confirmation Testing on Porcine Blood Vessels, Lymphatics and Tissue Bundles.
Key results: The performance tests summarized above were conducted to support the proposed indications for use and marketing claims.
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
Traditional 510(k) Notification May 5, 2014
510(k) Summary Gyrus ACMI, Inc. THUNDERBEAT TB-0535PC/0545PC/0510IC/0520IC/0535IC/0545IC
MAY 1 9 2014
General Information
Applicant:
Establishment Registration Number:
Manufacturer:
Establishment Registration Number:
510(k) Submitter:
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Identification
Classification Name:
Regulation Number: Product Code(s): Regulatory Class: Review Panel: Generic/Common Name: Trade Name:
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Phone: (+81) 42-642-2694 Fax: (+81) 42-642-2307
8010047
Aomori Olympus 248-1 Okkonoki 2-chome Kuroishi-shi. Aomori, Japan 036-0367 Phone: (+81) 172-52-8543 Fax: (+81) 172-52-8515
9614641
Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
3003790304
Graham Baillie Manager, Regulatory Affairs
May 5, 2014
Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400 GEI, LFL II. Unclassified General & Plastic Surgery Ultrasonic and electrosurgical devices THUNDERBEAT Hand Instruments
9
1
Traditional 510(k) Notification May 5, 2014
| Model Name | Device Name |
|---|---|
| TB-0545PC | THUNDERBEAT 5mm, 45cm, Pistol Grip |
| TB-0535PC | THUNDERBEAT 5mm, 35cm, Pistol Grip |
| TB-0545IC | THUNDERBEAT 5mm, 45cm, Inline Grip |
| TB-0535IC | THUNDERBEAT 5mm, 35cm, Inline Grip |
| TB-0520IC | THUNDERBEAT 5mm, 20cm, Inline Grip |
| TB-0510IC | THUNDERBEAT 5mm, 10cm, Inline Grip |
Predicate Devices
| Olympus Medical Systems Corp. THUNDERBEAT TB-0535PC, | |
|---|---|
| 0545PC, 0510IC, 0520IC, 0535IC and 0545IC | K111202 |
| Covidien LigaSure Small Jaw | K113572 |
Product Description
The THUNDERBEAT hand instruments are intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
The THUNDERBEAT hand instruments are provided as sterile, single use devices. These are functional devices capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, dissecting. These instruments have been designed to seal and cut vessels up to and.including 7 mm in diameter, tissue bundles, and lymphatics for open, laparoscopic, open ENT and endoscopic procedures in surgery.
Technological Characteristics
The THUNDERBEAT activates combined HF Bipolar (FineCoag) output and Ultrasonic output [Sea] and Cut model simultaneously while grasping a tissue or a vessel between the Probe and the Grasping section.
The THUNDERBEAT also performs the HF Bipolar (HardCoag) output [Seal mode]. Those outputs lead to sealing and cutting/sealing of vessels or coagulating and cutting soft tissue.
The hand switches provided on the grip handle enable those output operations. However, the technological features of the subject devices are identical to the predicate (K111202) such as the shaft length, shaft rotation, and shaft diameter.
Material
The patient contacting materials are well established and identical to the predicate devices cleared under K111202. Full biocompatibility testing on all patient contacting surfaces has been performed in compliance to the relevant requirements of ISO-10993.
2
Traditional 510(k) Notification May 5, 2014
Intended Uses
The purpose of this submission is to demonstrate equivalence to predicate devices and to expand the Indication for Use for the existing (subject) TB-0535PC/0545PC/0535IC/05451C/0510IC/05201C. The additional indications appear as bolded text under the Intended Use section below.
THUNDERBEAT TB-0535PC/0545PC/0535IC/0545IC
The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation. grasping is performed. These devices have been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
The THUNDERBEAT hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
3
Page 4 of 6
THUNDERBEAT TB-0510IC/0520IC
The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have 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 procedures in adults for ligation (sealing and cutting) of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.
Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have 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 procedures in adults for sealing of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.
The THUNDERBEAT hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
4
ditional 510(k) Notification lav 5. 2014
Compliance to Voluntary Standards
The design of the THUNDERBEAT TB-0535PC. 0545PC. 0510IC. 0520IC. 0535IC and 0545IC complies with the following standards:
AAMI/ ANSI60601-1: 2005/(R)2012 and CI:2009/(R)2012 IEC60601-1-1:2000 IEC60601-2-2:2009 IEC60601-1-2:2007 IEC60601-2-18: 2009 ISO10993-1:2009 ISO11135-1:2007 ISO14971:2007
Summary of Sterilization and Shelf Life Discussion
The sterilization had been tested to comply with ISO11135-1: 2007.
Real Time Aging testing confirmed that the subject devices have a three year shelf life.
Summary of Performance Testing
The following performance testing was conducted.
- Bench Testing
Test #A: THUNDERBEAT Ex-vivo Sealing & Cutting Performance Confirmation Test on Blood Vessels
Test #B: THUNDERBEAT Ex-vivo Cutting Performance Confirmation Test on Blood Vessels and Mesentery.
Test #Fa: Sealing performance of the THUNDERBEAT SEAL & CUT mode
Test #Fb: Sealing performance and characteristic of the THUNDERBEAT SEAL & CUT mode during activation
Test #Fc: Sealing performance of the THUNDERBEAT SEAL & CUT mode
Test #H: Comparison of dissecting performance between the THUNDERBEAT vs. Control devices
Test #I/J: A comparison of heating at the grasping section of THUNDERBEAT Hand Instruments vs. Control devices.
13
5
Traditional 510(k) Notification May 5, 2014
Test #P: THUNDERBEAT Ex-vivo Sealing & Cutting and Sealing Performance -Histopathological Confirmation Test on Blood Vessels.
- Animal Test
Test Ea: THUNDERBEAT In-vivo Sealing & Cutting and Sealing Performance Confirmation Testing on Porcine Blood Vessels, Lymphatics and Tissue Bundles.
Substantial Equivalence
The subject devices have identical technology, performance, dimensions and materials. The differences between the predicate and the subject devices are expanded indications for use and additional marketing claims. To support the proposed indications for use and marketing claims, the performance tests summarized above were conducted.
Conclusion:
In summary, the Gyrus ACMI THUNDERBEAT TB-0535PC, 0545PC, 0510IC, 05201C, 0535IC and 0545IC handpieces are substantially equivalent to the predicate devices and present no new questions of safety or efficacy.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WObb-Golle Silver Spring, MD 20993-0002
May 19, 2014
OLYMPUS MEDICAL SYSTEMS CORPORATION % Mr. Graham Baillie Gyrus ACMI Incorporated 136 Turnpike Road Southborough, Massachusetts 01772
Rc: K132703
Trade/Device Name: Thunderbeat Regulation Number: 21 CFR 878.4400 Regulation Name; Electrosurgical, Cutting & Coagulation and Accessories Regulatory Class: Class II Product Code: GEI, LFL Dated: April 16, 2014 Received: April 18, 2014
· 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
7
Page 2 - Mr. Graham Baillie
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510{k} Number (if known) K132703
Device Name
THUNDERBEAT TB-0535PC/0545PC/0510IC/0520IC/05351C/05451C
Indications for Use (Describe) THUNDERBEAT TB-0535PC/0545PC/0535IC/05451C
The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication,
adhesiolysis, oophorectorny, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
The THUNDERBEAT hand instruments have not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.
THUNDERBEAT TB-0510IC/0520IC
The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including wologic, thoracic, laboropio (including mage on resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cuting), coagulation, grasping, and dissection is performed. These devices have 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 procedures in adults for ligation (sealing and cutting) of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.
Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open,
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
9
laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication,
adhesiolysis, oophorectorny, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coasing is performed. These devices have 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 procedures in adults for sealing of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.
The THUNDERBEAT hand instruments have not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR FOR FOR FOR FOR FOR
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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