(129 days)
The THUNDERBEAT hand instruments are intended to be used for open, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect.
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), coasping, 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 coagulation for sterilization procedures, and should not be used for these procedures.
The THUNDERBEAT Type X 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 Type X Hand Instruments are provided as a sterile, single use devices. Type X devices are functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting. These devices have been designed to seal and cut vessels up to and including 7 mm in diameter, tissue bundles, and lymphatics.
The provided document describes the safety and performance testing for the THUNDERBEAT Type X Hand Instruments, comparing them to a predicate device (K132703) to establish substantial equivalence. However, it does not explicitly state specific acceptance criteria in terms of numerical thresholds for performance metrics. Instead, it focuses on demonstrating comparable performance to the predicate device.
Given the information provided, here's an attempt to structure an answer, making assumptions where explicit numerical criteria are missing:
Acceptance Criteria and Study for THUNDERBEAT Type X Hand Instruments
The THUNDERBEAT Type X Hand Instruments demonstrated substantial equivalence to the predicate device (THUNDERBEAT Hand Instruments cleared under K132703) through a series of performance tests. The acceptance criteria were implicitly based on demonstrating performance that is equivalent or superior to the predicate device, or within acceptable safety margins for the intended use. While explicit numerical acceptance criteria are not provided in the document, the studies aimed to show comparable performance in key areas.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Ex-vivo Vessel Burst Pressure: Comparable or superior vessel sealing performance to the predicate device. | Ex-vivo Burst Pressure Testing: Conducted on porcine blood vessels for both subject and predicate devices. The study aimed to demonstrate vessel sealing performance. Specific numerical results or statistical comparisons are not provided in this summary, but the conclusion of substantial equivalence implies comparable performance. |
| Ex-vivo Cutting Performance: Comparable or superior cutting performance (e.g., cutting time) to the predicate device. | Ex-vivo Cutting Performance: Cutting time testing of porcine mesentery conducted on both subject and predicate devices to demonstrate cutting performance. Specific numerical results or statistical comparisons are not provided in this summary, but the conclusion of substantial equivalence implies comparable performance. |
| Chronic Animal Study (Seal Performance & Safety): Comparable or superior seal maintenance rates (up to 7mm vessels, tissue bundles, lymphatics), thermal spread, and healing progression to the predicate device, demonstrating long-term safety and efficacy. | Chronic Animal Study (Porcine): Conducted on both subject and predicate devices to demonstrate seal performance (e.g., seal maintenance rates for vessels up to 7.0mm in diameter, lymphatics, and tissue bundles), thermal spread, and degree of healing progression. Specific numerical results or statistical comparisons for rates, spread, or healing are not provided in this summary, but the conclusion of substantial equivalence implies comparable performance. |
| Acute Animal Study (Seal Performance & Safety): Comparable or superior seal maintenance rates (up to 7mm vessels, tissue bundles, lymphatics), thermal spread, and degree of degeneration to the predicate device, demonstrating immediate safety and efficacy. | Acute Animal Study (Porcine): Conducted on both subject and predicate devices to demonstrate seal performance and safety (e.g., seal maintenance rates for vessels up to 7.0mm in diameter, lymphatics, and tissue bundles), thermal spread, and degree of degeneration. Specific numerical results or statistical comparisons for rates, spread, or degeneration are not provided in this summary, but the conclusion of substantial equivalence implies comparable performance. |
| Biocompatibility: Meet ISO-10993 series requirements. | Biocompatibility Testing: Full biocompatibility testing on all patient contacting surfaces performed in compliance with ISO-10993 series. Implied acceptance: all tests passed. |
| Sterilization & Shelf Life: Compliant with ISO11135:2014 and demonstrate a 3-year shelf life. | Sterilization and Shelf Life: Sterilization tested to comply with ISO11135:2014. Stability evaluation demonstrated a 3-year shelf-life performance. Implied acceptance: compliance achieved and shelf life validated. |
| Compliance to Voluntary Standards: Conformity to relevant IEC and ISO standards (e.g., IEC60601-1, ISO14971). | Compliance to Voluntary Standards: The design of the THUNDERBEAT Type X Hand Instruments complies with IEC60601-1, IEC60601-1-2, IEC60601-2-2, IEC60601-2-18, ISO10993-1, ISO10993-5, ISO10993-7, ISO10993-10, ISO10993-11, ISO11135, ISO14971, ASTM F1980-16. Device-specific guidance from FDA was also considered. Implied acceptance: all listed standards were met. |
2. Sample Sizes and Data Provenance
The document does not explicitly state the exact sample sizes (number of vessels, resections, or animals) for the ex-vivo and in-vivo studies.
- Ex-vivo Vessel Burst Pressure: Porcine blood vessels.
- Ex-vivo Cutting Performance: Porcine mesentery.
- Chronic Animal Study: Porcine animals.
- Acute Animal Study: Porcine animals.
All these studies represent retrospective data collected specifically for the purpose of this submission. The country of origin for the data is implied to be from the manufacturer (Olympus Medical Systems Corp. in Japan, and Aomori Olympus in Japan, with the submitter Gyrus ACMI, Inc. in the US facilitating the submission). However, the specific location where the animal studies were conducted is not mentioned.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a surgical instrument (electrosurgical cutting and coagulation device), not an AI/diagnostic device that requires expert adjudication for ground truth. The "ground truth" for performance is established through objective physical measurements (like burst pressure, cutting time) and biological outcomes in animal models (seal maintenance, thermal spread, healing).
4. Adjudication Method for Test Set
Not applicable. As noted above, this device does not involve human interpretation of outputs that would require an adjudication method like 2+1 or 3+1. Performance is measured objectively.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a surgical instrument. MRMC studies are typically used for diagnostic or imaging AI devices to assess the impact on human reader performance.
6. Standalone Performance
The "standalone performance" of the device is precisely what the ex-vivo and in-vivo animal studies evaluated. These tests assess the direct performance of the instrument on biological tissue without human-in-the-loop performance considerations (beyond the operator performing the procedure as intended). The performance metrics described in Section 1 above (burst pressure, cutting time, seal maintenance, thermal spread, healing, degeneration) represent the standalone performance of the device.
7. Type of Ground Truth Used
The ground truth for the performance studies was based on:
- Objective physiological measurements: Ex-vivo burst pressure of vessels, ex-vivo cutting time.
- Pathological and observational outcomes in animal models: Seal maintenance rates, thermal spread, degree of healing progression, degree of degeneration observed in porcine tissue. These would typically be assessed by veterinary pathologists or trained researchers.
- Biocompatibility testing: Standardized laboratory tests adhering to ISO 10993.
- Sterilization and stability testing: Standardized laboratory tests adhering to ISO 11135 and other stability protocols.
8. Sample Size for the Training Set
Not applicable. This is a medical device (surgical instrument), not an AI/machine learning model, so there is no "training set." The performance testing described (bench and animal studies) serves as the validation set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 12, 2018
Olympus Medical Systems Corp. % Graham Baillie RA Manager Gyrus ACMI Inc. 136 Turnpike Road Southborough, Massachusetts 01772
Re: K180575
Trade/Device Name: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, LFL Dated: February 28, 2018 Received: March 5, 2018
Dear Graham 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
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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 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.
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 comprehensive regulatory information about medical devices and radiation-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,
Binita S. Ashar -S
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) K180575
Device Name
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X
Indications for Use (Describe)
The THUNDERBEAT hand instruments are intended to be used for open, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect.
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), coasping, 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 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 X Hand Instruments
General Information
| Applicant: | OLYMPUS MEDICAL SYSTEMSCORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo,Japan 192-8507Phone: (+81) 42-642-2694Fax: (+81) 42-642-2307 |
|---|---|
| Establishment Registration Number: | 8010047 |
| Manufacturer: | Aomori Olympus2-248-1 okkonokikuroishi-shi aomori, Japan 036-0357Phone: (+81) 172-52-8543Fax: (+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: | Graham A.L. Baillie MSManager, Regulatory Affairs |
| Date Prepared: | February 28, 2018 |
| Device Description |
Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Regulatory Class: Class II, Product Codes: GEI, LFL Review Panel: General & Plastic Surgery
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Trade Name:
THUNDERBEAT Type X Hand Instruments
| Model Name | Device Name |
|---|---|
| TB-0520FCX | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X |
| TB-0535FCX | THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X |
| TB-0545FCX | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X |
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 X 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 Type X Hand Instruments are provided as a sterile, single use devices. Type X devices are functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting. These devices have 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 X 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 X 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 X and the predicate THUNDERBEAT include the following:
- Grasper shape difference in upper jaw
- . Coating on underside of probe tip
- Addition of a cover to the outside of the electrode .
- . 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 hand instruments are intended to be used for open, laparoscopic, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect.
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.
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Compliance to Voluntary Standards
The design of the THUNDERBEAT Type X Hand Instruments complies 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. The result of stability evaluation demonstrated that the THUNDERBEAT Type X has 3 years shelf-life performance.
Summary of Performance Testing
The following performance testing was conducted in support of the substantial equivalence determination.
| TestCode | Item | Contents |
|---|---|---|
| #A | Ex-vivo Vessel BurstPressure | Ex-vivo burst pressure testing of porcine bloodvessels was conducted on both the subject andpredicate devices to demonstrate vessel sealingperformance. |
1. Bench Testing
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| TestCode | Item | Contents |
|---|---|---|
| #B | Ex-vivo CuttingPerformance | Ex-vivo Cutting performance (Cutting time)testing of porcine mesentery was conducted onboth the subject and predicate devices todemonstrate cutting performance. |
-
- Animal Test
| TestCode | Item | Contents |
|---|---|---|
| #C | Chronic Animal Study | Chronic animal study of porcine was conducted onboth the subject and predicate devices todemonstrate seal performance (ex. sealmaintenance rates include vessels up to 7.0mm indiameter and lymphatics and tissue bundles,thermal spread, degree of healing progression ). |
| #D | Acute Animal Study | Acute animal study of porcine was conducted onboth the subject and predicate devices todemonstrate seal performance and safety (ex. sealmaintenance rates include vessels up to 7.0mm indiameter and lymphatics and tissue bundles,thermal spread, degree of degeneration). |
- Clinical Testing
Clinical testing was not performed.
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 X Hand Instruments are substantially equivalent to the predicate devices and present no new questions of safety or efficacy.
§ 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.