(51 days)
- ULTRASONIC BIPOLAR GENERATOR USG-410
The Electrosurgical & Ultrasonic Generator (USC-410) is intended to be used with the THUNDERBEAT Transducer, the SONICBEAT Transducer, the THUNDERBEAT or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
- THUNDERBEAT Open Extended Jaw TB-0920OE
The THUNDERBEAT hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
Seal & Cut mode:
The THUNDERBEAT hand instrument when used in combination with the Seal & Cut mode is indicated for open general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomies (both vaginal assisted and abdominal) 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.
Seal mode:
The THUNDERBEAT hand instrument when used in combination with the Seal mode is indicated for open 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) 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.
The THUNDERBEAT 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.
- THUNDERBEAT Type S Hand Instruments TB-0520FCS/TB-0535FCS/TB-0545FCS
The THUNDERBEAT Type S 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 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), 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 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.
- THUNDERBEAT Open Fine Jaw TB-0009OF
The THUNDERBEAT Open Fine Jaw hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
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, 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, 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.
- THUNDERBEAT Open Fine Jaw Type X TB-0009OFX
The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw Type X 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, parotidectomy, parotidectomy, radical neck dissection, and tonsillectory) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
Seal mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when 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, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The THUNDERBEAT Open Fine Jaw Type X 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.
- SONICBEAT SB-0545PC, 0535PC, 0545IC, 0535IC, 0520IC, 0510IC, SB-0545FC, 0535FC and 0520FC
The SONICBEAT is intended to be used for open, laparoscopic (including single-site surgery), and general surgery to cut (dissect), coagulate, or grasp soft tissue or to ligate (seal and cut) vessels in gynecologic, thoracic, urologic, and endoscopic surgical procedures.
These devices have been designed to seal and cut vessels up to and including 5mm in diameter.
The SONICBEAT has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.
- THUNDERBEAT Transducer TD-TB400
The THUNDERBEAT Transducer (TD-TB400) is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
- SONICBEAT Transducer TD-SB400
The SONICBEAT Transducer (TD-SB400) is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
- SONICBEAT Footswitch Connector MAJ-2412
This product is intended to be used to connect a SONICBEAT footswitch to an Ultrasonic Bipolar Generator and to communicate switch signals.
- POWER CORD US 4.5m MAJ-2387
The power cord has been designed to be used for supplying power to Olympus equipment.
The Electrosurgical & Ultrasonic Generator (USG-410) is intended to be used with the THUNDERBEAT Transducer, the SONICBEAT Transducer, the THUNDERBEAT or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
USG-410 is the successor model of USG-400, with the addition of the function of ESG-400 related to THUNDERBEAT to generate combined ultrasonic and bipolar energy as the dedicated standalone generator. It is intended to be used with the same legacy marketed devices including THUNDERBEAT series and SONICBEAT series which are compatible with the Surgical Tissue Management System (STMS).
The USG-410 can be used with a variety of legally marketed active and miscellaneous accessories including THUNDERBEAT series and SONICBEAT series, transducers, and footswitches. The THUNDERBEAT and SONICBEAT instruments are functional devices capable of vessel sealing and cutting, tissue coagulating and cutting, grasping, dissecting.
The THUNDERBEAT and the SONICBEAT have handswitches. Pressing the handswitches leads to controlling the output. The control signals are sent to the USG-410 via the signal lines in the Transducer cords of the Transducers. Output is also controllable with the Footswitches.
Here's a breakdown of the acceptance criteria and study information for the Olympus ULTRASONIC BIPOLAR GENERATOR USG-410, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes general performance testing but does not provide specific numerical acceptance criteria (e.g., "burst pressure must be > X mmHg") or detailed quantitative performance reports for each criterion. Instead, it states that the device was tested to "demonstrate vessel sealing performance," "compare surface temperatures," and "demonstrate seal performance and safety."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | |
| Ex-vivo Vessel Burst Pressure | Conducted on both subject and predicate devices to demonstrate vessel sealing performance. (No specific numerical results provided, but the conclusion states "equivalent performance" to the predicate for sealing). |
| Ex-vivo Max Temperature of Jaw | Tested on both subject and predicate devices to compare surface temperatures. (No specific numerical results provided, but the conclusion states "equivalent performance" to the predicate for thermal spread). |
| Cutting and Sealing (General) | Bench tested and verified/validated to meet design specifications and user requirements. |
| Modified Sealing Algorithm | Verified. |
| Compatibility with Accessories | Confirmed with listed accessories (THUNDERBEAT series and SONICBEAT series, transducers, and footswitches). |
| Animal Testing | |
| Seal Performance (Chronic) | Chronic animal study (porcine subjects) conducted on both subject and predicate devices to demonstrate seal performance (e.g., seal maintenance rates including vessels up to 7.0mm, lymphatics, and tissue bundles), thermal spread, and degree of healing progression. (No specific numerical results provided, but the conclusion states "equivalent performance" to the predicate for sealing performance and thermal spread). |
| Seal Performance (Acute) | Acute animal study (porcine subjects) conducted on both subject and predicate devices to demonstrate seal performance and safety (e.g., seal maintenance rates including vessels up to 7.0mm, lymphatics, and tissue bundles), thermal spread, and degree of degeneration. (No specific numerical results provided, but the conclusion states "equivalent performance" to the predicate for sealing performance and thermal spread, and "no new concerns or modified existing risks regarding safety and effectiveness"). |
| Other Testing | |
| Biocompatibility | For patient-contacting accessories, successfully established previously for predicate devices according to ISO 10993. No changes impacted established biocompatibility. (USG-410 does not have patient contact). |
| Electrical Safety & EMC | Confirmed compliance with relevant requirements (IEC60601-1, IEC60601-2-2, IEC60601-1-2). |
| Software V&V | Performed and documented in compliance with FDA guidance. |
| Risk Analysis | Conducted per ISO 14971, identified and performed design verification tests and acceptance criteria. Human factors validation performed confirming no unacceptable user-related residual risk. |
2. Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: The document does not specify a numerical sample size for the ex-vivo burst pressure or jaw temperature tests. It states "both the subject and predicate devices" were tested, implying comparative analysis but not the number of samples.
- Animal Testing: The document mentions "porcine subjects" for both chronic and acute animal studies. It does not provide the specific number of animals used.
- Data Provenance: The ex-vivo and animal studies are preclinical, conducted to directly compare the subject device (USG-410) with the predicate device (Surgical Tissue Management System - STMS, composed of USG-400 and ESG-400). The location where these studies were conducted is not explicitly stated, but the manufacturer is based in Japan.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Bench Testing: Not applicable. These are physical tests measuring objective parameters.
- Animal Testing: The document does not specify the number or qualifications of experts (e.g., veterinary surgeons, pathologists) involved in establishing ground truth for the animal studies (e.g., assessing seal maintenance rates, thermal spread, healing progression). These assessments would typically be done by qualified personnel in a preclinical study setting.
4. Adjudication Method for the Test Set:
- Not applicable. The tests described are primarily objective measurement and observation comparisons, not involving human interpretation of data that would require an adjudication method like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument, not an AI diagnostic tool primarily reliant on human interpretation of images, which is where MRMC studies are typically applied.
6. Standalone Performance:
- The device, a surgical generator, inherently operates in a standalone manner in terms of its electrosurgical and ultrasonic energy delivery. However, the performance studies described are focused on its tissue effects in conjunction with compatible accessories (THUNDERBEAT and SONICBEAT instruments) and in comparison to a predicate device, rather than an isolated "algorithm only" performance. The document verifies the "modified sealing algorithm" as part of the overall bench testing, indicating its standalone functionality within the device.
7. Type of Ground Truth Used:
- Bench Testing: Mechanical and thermal measurements; direct observation of tissue effects (e.g., seal performance on ex-vivo vessels).
- Animal Testing: Physiological and histological assessments from animal models (e.g., in-vivo seal maintenance rates, thermal spread, healing progression, degeneration). These observations and measurements form the ground truth for comparing the device's efficacy and safety against the predicate.
8. Sample Size for the Training Set:
- The document describes a medical device (surgical generator) and its accessories, not an AI software where a distinct "training set" would be used for machine learning. The "modified sealing algorithm" was verified, implying it was developed and tested internally, but no information about a "training set" in the context of machine learning is provided as it's not relevant to this type of device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a "training set" in the context of machine learning for this device. The "modified sealing algorithm" verification would rely on engineering specifications, physical models, and potentially iterative testing to refine its performance.
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