(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.
§ 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.