(229 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 performance studies focus on physical characteristics and biological effects, not algorithmic performance.
Yes
The device is described as a "functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting" for various surgical procedures, which directly addresses medical conditions and serves a therapeutic purpose.
No
This device is a surgical instrument designed for cutting, sealing, coagulation, grasping, and dissection of tissue and vessels. It is used for therapeutic purposes, not for diagnosing conditions.
No
The device description explicitly states it is a "functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting" and is a "sterile, single use device," indicating it is a physical hardware instrument, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 surgical procedures. This is an in vivo application.
- Device Description: The device description reinforces its function as a surgical tool for manipulating tissue and vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed for testing biological samples in vitro (in a lab setting). This device is designed for direct interaction with tissue in vivo (within the living organism).
N/A
Intended Use / Indications for Use
The THUNDERBEAT Type S hand instruments are intended to be used with the Ultrasonic Generator (USC-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer (TD-TB400).
Seal & Cut mode:
The THUNDERBEAT Type S hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site 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 Type S hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general 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 Type S 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
GEI, LFL
Device Description
The THUNDERBEAT Type S Hand Instruments is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
The THUNDERBEAT Type S Hand Instruments 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
- Bench Testing:
- Ex-vivo Vessel Burst Pressure: Ex-vivo burst pressure testing of porcine blood vessels (arteries, veins, and tissue bundles) was conducted on both the subject and predicate devices to demonstrate vessel sealing performance.
- Ex-vivo Cutting Performance: Ex-vivo Cutting performance (Cutting time) testing of porcine mesentery was conducted on both the subject and predicate devices to demonstrate cutting performance.
- Max Temperature: Max Temperature testing was conducted on both the subject and predicate devices to demonstrate for the inside/outside temperature at the grasping section.
- Grasping force: Grasping force Testing was conducted on both the subject and predicate devices to demonstrate homogeneousness of grasping force across grasping section.
- Durability of the coating on underside of probe tip: Durability testing was conducted to confirm durability of coating on underside of probe tip after device output.
- Durability against twisting: Durability testing against twisting was conducted on both the subject and predicate devices to demonstrate torque when spark occurs between probe and jaw during activation.
- Animal Testing:
- Chronic Animal Study: Chronic animal study of porcine was conducted on both the subject and predicate devices to confirm seal performance, thermal spread and healing degree including vessels up to 7.0mm in diameter, lymphatics and tissue bundles.
- Acute Animal Study: Acute animal study of porcine was conducted on both the subject and predicate devices to confirm seal performance, thermal spread and degeneration degree including vessels (artery and artery with vein) up to 7.0mm in diameter, lymphatics and tissue bundles.
- Clinical Testing: Clinical testing was not performed.
Key results: The performance, dimensions and materials of the subject device are similar to those of the predicate. To support the proposed design modifications, the performance tests summarized above were conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 17, 2018
Olympus Medical Systems Corp. % Christina Flores Senior Specialist, Regulatory Affairs Gyrus ACMI Inc. 136 Turnpike Road Southborough, Massachusetts 01772
Re: K172610
Trade/Device Name: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, LFL Dated: February 23, 2018 Received: February 26, 2018
Dear Christina Flores:
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, 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 device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, 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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Indications for Use
510(k) Number (if known) K172610
Device Name
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
Indications for Use (Describe)
The THUNDERBEAT Type S hand instruments are intended to be used with the Ultrasonic Generator (USC-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer (TD-TB400).
Seal & Cut mode:
The THUNDERBEAT Type S hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site 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 Type S hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general 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 Type S 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.
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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510(k) Summary Gyrus ACMI, Inc. THUNDERBEAT Type S Hand Instruments
General Information
Regulation Number:
Regulatory Class:
Product Codes:
Review Panel:
| 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
2-248-1 okkonoki
kuroishi-shi aomori, Japan 036-0357
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 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Christina Flores, RAC
Senior Specialist, Regulatory Affairs |
| Date Prepared: | April 16, 2018 |
| Device Description | |
| Classification Name: | Electrosurgical cutting and coagulation
device and accessories |
21 CFR 878.4400
General & Plastic Surgery
Class II,
GEI, LFL
4
Trade Name:
THUNDERBEAT Type S Hand Instruments
| Model Name | Device Name |
|---|---|
| TB-0520FCS | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S |
| TB-0535FCS | THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S |
| TB-0545FCS | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S |
Generic/Common Name:
Ultrasonic and electrosurgical devices
Predicate Devices
Olympus Medical Systems Corp. THUNDERBEAT TB-0520IC/0535PC/0545PC/0535IC/0545IC Hand Instruments K132703
Product Description
The THUNDERBEAT Type S Hand Instruments is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
The THUNDERBEAT Type S Hand Instruments 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.
Comparison of Technological Characteristics
The THUNDERBEAT Type S Hand Instruments have the same intended use and fundamental scientific technological characteristics as the predicate THUNDERBEAT Hand Instruments cleared under K132703. The subject and predicate devices activate combined HF Bipolar (FineCoag) output and Ultrasonic output [Seal & Cut mode] simultaneously while grasping vessels, tissue bundles and lymphatics between the Probe and the Grasping section.
The THUNDERBEAT Type S Hand Instruments, like the predicate THUNDERBEAT, also activates the HF Bipolar (HardCoag) output [Seal mode]. Those outputs can be used for sealing and cutting/sealing of vessels, tissue bundles and lymphatics and or coagulating and cutting/coagulating tissues. The hand switches provided on the grip handle enable those output operations.
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The differences between the THUNDERBEAT Type S and the predicate THUNDERBEAT include the following:
- Grasper shape difference in upper jaw .
- Coating on underside of probe tip
- . Front actuation grip on handle
Material
Full biocompatibility testing on all patient contacting surfaces has been performed in compliance to the relevant requirements of ISO-10993 series.
Indications for use
The THUNDERBEAT Type S 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 Type S 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 Type S 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 Type S 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.
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Compliance to Voluntary Standards
The design of the THUNDERBEAT Type S Hand Instruments comply with the following standards:
IEC60601-1: 2005+A1:2012 IEC60601-1-2: 2001+A1, 2007 IEC60601-2-2:2009 IEC60601-2-18:2009 ISO10993-1:2009 ISO10993-5: 2009 ISO10993-7: 2008 ISO10993-10: 2010 ISO10993-11: 2006 ISO11135:2014 ISO14971:2007 ASTM F1980-16
Device-specific guidance
- Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery - Guidance for Industry and Food and Drug Administration Staff, 08/15/2016
- Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery - Guidance for Industry and Food and Drug Administration Staff, 08/15/2016
Summary of Sterilization and Shelf Life Discussion
The sterilization has been tested to comply with ISO11135:2014. Accelerated Aging testing confirmed that the subject device has a three-year shelf life.
Summary of Performance Testing
The following performance testing was conducted in support of the substantial equivalence determination.
| Item | Contents |
|---|---|
| Ex-vivo Vessel Burst | |
| Pressure | Ex-vivo burst pressure testing of porcine blood vessels (arteries, veins, and tissue bundles) was conducted on both the subject and predicate devices to demonstrate vessel sealing performance. |
| Ex-vivo Cutting | |
| Performance | Ex-vivo Cutting performance (Cutting time) testing of porcine mesentery was conducted on both the subject and predicate devices to demonstrate cutting performance. |
1. Bench Testing
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| Item | Contents |
|---|---|
| Max Temperature | Max Temperature testing was conducted on both the subject and predicate devices to demonstrate for the inside/outside temperature at the grasping section. |
| Grasping force | Grasping force Testing was conducted on both the subject and predicate devices to demonstrate homogeneousness of grasping force across grasping section. |
| Durability of the coating on underside of probe tip | Durability testing was conducted to confirm durability of coating on underside of probe tip after device output. |
| Durability against twisting | Durability testing against twisting was conducted on both the subject and predicate devices to demonstrate torque when spark occurs between probe and jaw during activation. |
2. Animal Testing
| Item | Contents |
|---|---|
| Chronic Animal Study | Chronic animal study of porcine was conducted on both the subject and predicate devices to confirm seal performance, thermal spread and healing degree including vessels up to 7.0mm in diameter, lymphatics and tissue bundles. |
| Acute Animal Study | Acute animal study of porcine was conducted on both the subject and predicate devices to confirm seal performance, thermal spread and degeneration degree including vessels (artery and artery with vein) up to 7.0mm in diameter, lymphatics and tissue bundles. |
- Clinical Testing
Clinical testing was not performed.
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Substantial Equivalence
The subject and predicate devices have the same fundamental technology and indications for use. The performance, dimensions and materials of the subject device are similar to those of the predicate. Compared to the predicate device (K132703), the subject device has a different shape in the Grasping section, a coating of insulating material has been added to the underside of the probe, and the handle is now a frontactuated grip. To support the proposed design modifications, the performance tests summarized above were conducted.
Conclusion:
In summary, the THUNDERBEAT Type S Hand Instruments are substantially equivalent to the predicate devices and present no new questions of safety or efficacy.