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510(k) Data Aggregation
(66 days)
The Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The Device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open and endoscopic procedures. The Sonicision™ Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to and including 5 mm in diameter.
The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
This is a bundled 510(k) that includes multiple individual component devices, as indicated in the table below.
A functional Sonicision™ Curved Jaw Cordless Ultrasonic Dissection device is assembled by the user within the operating room. The functional device is assembled from the following three components: (1) a sterile, single-use dissector (SCDAxx), (2) a user cleaned and sterilized reusable generator (SCGAA), and (3), a user cleaned and disinfected reusable battery (SCBA). There are four different lengths of sterile single-use dissectors to allow surgeons a range of options to meet the needs of each specific surgical case.
The assembled functional device is a hand-held, battery-powered device used to dissect through tissues and to coagulate vessels up to and including 5 mm in diameter. The clinical intended use is achieved by the surgeon when pressure is applied to tissue placed between the clamping jaw and the exposed portion of the probe while activating ultrasonic energy by pressing a button on the handpiece.
The 510(k) submission includes two accessories. The first is the Battery Insertion Guide (SCBIGA), a reusable, user-sterilized device that facilitates the assembly process.
The second accessory is a custom battery charger (CBCA). The charger is able to charge up to four SCBA batteries at a time. It provides the user with an indication of the charging progress. It also monitors battery health and the number of surgical uses the battery has gone through. It disables batteries that have reached end of life or that are out of specification.
This document is a 510(k) Premarket Notification for a medical device and therefore describes a device comparison study rather than a study aimed at proving a new AI/software-as-a-medical-device (SaMD) meets acceptance criteria. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to define and meet new performance acceptance criteria in the same way an AI/SaMD might.
However, based on the provided text, we can extract information regarding performance testing conducted to support the claim of substantial equivalence. I will frame the response by identifying what would traditionally be acceptance criteria for a new device and then describe the performance testing done in this 510(k) to demonstrate comparable performance to the predicate device.
Device: Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device
Study Purpose: To demonstrate substantial equivalence to the predicate device (Sonicision™ Cordless Ultrasonic Dissection Device family and accessories) by showing comparable performance.
The document does not explicitly state "acceptance criteria" in the traditional sense for a new device's performance benchmarks. Instead, the study aims to show that the proposed device performs comparably to the predicate device. The "acceptance criteria" can be inferred as performance that is not statistically or clinically meaningfully worse than the predicate device for key characteristics.
Here's how the information aligns with your requested format, interpreting "acceptance criteria" as "comparable performance to the predicate":
1. Table of Acceptance Criteria (Inferred as Demonstrating Comparability to Predicate) and Reported Device Performance
| Characteristic (Inferred Acceptance Criteria: Performance Comparable to Predicate) | Predicate Device Performance / Characteristic | Proposed Device (Sonicision Curved Jaw) Performance / Characteristic | Comment / Performance Result |
|---|---|---|---|
| Vessel Coagulation Diameter | Coagulate isolated vessels up to 5 mm in diameter. | Coagulate isolated vessels up to and including 5 mm in diameter. | Minor difference; "up to and including" 5mm. Supported by bench and pre-clinical testing. |
| Ex Vivo Burst Strength | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Blood vessels coagulated by the Sonicision Curved Jaw device had comparable burst strength to the same type of blood vessels coagulated by predicate Sonicision device. | Comparable performance. |
| Ex Vivo Tissue Temperature (Max Blade/Shaft Temp) | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Maximum temperature of the Sonicision Curved Jaw active blade and shaft were comparable to the maximum temperatures of the predicate Sonicision active blade and shaft after multiple activations on mesentery. | Comparable performance. |
| Acute In Vivo Hemostasis Rate | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Achieved comparable rates of hemostasis to the predicate Sonicision device family. | Comparable performance. |
| Acute In Vivo Lateral Thermal Spread | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Achieved comparable lateral thermal spread to the predicate Sonicision device family. | Comparable performance. |
| Chronic In Vivo Hemostasis Duration | (No explicit predicate value). | Vessels (up and including 5 mm) coagulated by the Sonicision Curved Jaw device family maintain hemostasis for at least 21 days. Surgical sites showed an expected healing response. | Meets user needs. |
| Human Factors/Usability | (No explicit predicate value, but implicitly, acceptable usability). | User interfaces and cleaning/sterilization instructions are suitable for intended user populations: OR staff (circulating nurses, surgical scrub nurses/technicians), surgeons (multiple specialties), and central processing technicians. | Validation demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test (e.g., number of vessels tested, number of mesentery activations). It broadly refers to "several bench and animal tests."
- Test Set Sample Size: Not specified quantitatively.
- Data Provenance: The tests are described as "ex vivo burst testing," "ex vivo tissue testing," "acute in vivo testing," and "chronic in vivo testing." This indicates the use of biological tissues (likely from animal models or perhaps excised human tissues, though species not specified) and live animal subjects for the in vivo studies. The country of origin of the data is not specified in the provided text. The studies would be considered prospective as they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The concept of "experts establishing ground truth" as typically seen in AI/SaMD studies (e.g., radiologists labeling images) is not directly applicable here. This is a medical device performance study.
- For Human Factors and Usability validation, the text mentions "Extensive human factors evaluation with operating room nurses and surgical technicians, surgeons, and central processing." While these are experts in their fields, their role is to evaluate usability rather than to establish a 'ground truth' in the diagnostic sense. The number of such participants is not specified.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1 consensus) are typically used for establishing ground truth in diagnostic studies (like image interpretation by multiple readers). This type of adjudication is not relevant to the performance tests conducted for this ultrasonic dissection device (e.g., burst strength, temperature measurement, hemostasis rates).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for AI applications where multiple human readers interpret patient cases, often with and without AI assistance, to measure diagnostic performance change. This document describes performance testing of a surgical device, not a diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is a surgical instrument operated by a human, not an AI algorithm performing a task without human intervention. The performance tests ("ex vivo," "in vivo") are of the device's physical performance in the hands of users or under simulated conditions, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" for this type of device performance study is established through highly controlled experimental measurements and observations:
- Quantitative Measurements: Burst strength, temperature, hemostasis rates, lateral thermal spread. These are direct physical measurements and observable outcomes from the bench and animal studies.
- Qualitative Observations: Healing responses in chronic in vivo testing, user feedback on usability. These are assessed based on established biological and usability criteria.
- The comparison is primarily against the performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a medical device performance study, not an AI/Machine Learning study involving training data sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied in this 510(k) submission.
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The iDrive Intelligent Power Unit with iConsole, when used with:
a) compatible Intelligent Surgical Instrument Linear Staplers , have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
b) compatible Intelligent Delivery Systems (iStraight, iFlex, iCurve) and Right Angle or Power Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.
c) compatible Intelligent Delivery Systems and Circular Stapler Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
d) compatible Vascular Intelligent Surgical Instruments or Intelligent Delivery Systems with Vascular Digital Loading Units®, has applications for general and endoscopic surgery including multiple open and minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for resection, transection, and/or creation of anastomoses. They can be used with staple line buttressing material such as bovine pericardium.
The iDrive with iConsole is used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments in order to resect tissue, transect tissue and create anastomoses between structures. The iDrive was previously cleared to market via K073001 and was subsequently cleared to market with additional vascular indications via K073148. The iDrive is a handpiece with integrated controls that operate the attached Intelligent Delivery Systems and Intelligent Surgical Instruments.
Here's an analysis of the provided text regarding the acceptance criteria and study for the iDrive Intelligent Power Unit with iConsole:
Unfortunately, the provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification summary, which focuses on establishing substantial equivalence to predicate devices rather than reporting on performance studies against defined criteria.
Here's a breakdown of what is and is not available in the given input, organized according to your requested points:
Acceptance Criteria and Study for iDrive Intelligent Power Unit with iConsole
| Information Type | Detail |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not available. The document does not describe specific quantitative or qualitative acceptance criteria for the device's performance, nor does it report on any specific performance metrics from a study against such criteria. The focus is on demonstrating that the modified device functions identically to the predicate devices. |
| 2. Sample size and data provenance (test set) | Not available. There is no mention of a specific test set or any associated data provenance (country of origin, retrospective/prospective). The document primarily discusses the device's design and its intended use, along with a comparison to predicate devices, but not a performance study. |
| 3. Number/qualifications of experts (ground truth for test set) | Not available. Since no specific test set or performance evaluation against a ground truth is described, there is no mention of experts establishing ground truth or their qualifications. |
| 4. Adjudication method (test set) | Not available. Without a described test set or performance evaluation, there is no adjudication method detailed. |
| 5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study | Not available. The document describes a "device modification" to the iDrive where components become detachable from the handpiece, and states that the device "functions identically" to its predicates. It does not mention any MRMC study, human-in-the-loop performance, or AI assistance. The device appears to be a mechanical surgical stapler system, not an AI-assisted diagnostic or prognostic tool. |
| 6. Standalone (algorithm only) performance study | Not applicable/Not available. This device is a mechanical surgical instrument, not an algorithm. Therefore, a standalone algorithm-only performance study would not be relevant, and none is described. |
| 7. Type of ground truth used | Not available. No ground truth for performance evaluation is described, as the document focuses on substantial equivalence for a modified device rather than de novo performance testing. |
| 8. Sample size for training set | Not applicable/Not available. As the device is a mechanical surgical instrument and not an AI/algorithmic system, there would be no "training set" in the context of machine learning. The document describes a modification to an existing device, and the evaluation relies on comparison to predicate devices. |
| 9. How ground truth for training set was established | Not applicable/Not available. See point 8. |
Summary of the Provided Document:
The provided document is a 510(k) premarket notification for the iDrive Intelligent Power Unit with iConsole. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices (K073001, K073148, K071708).
The "study" in this context is the comparison made to the predicate devices. The document states:
- "The iDrive with iConsole, when used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments, functions identically to the predicate devices..." (Page 2, Section 5 - Device Modification)
- "The iDrive with iConsole is used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments and functions identically to the predicate devices. The electronics, power configuration, and internal gearing & transmission are common to both predicate and subject devices. Both the predicate and subject devices are powered mechanically by rotational energy. In both the predicate and the subject device, a clamp shaft drives a clamp screw, which causes the anvil to close and compress tissue. The same is true for firing." (Page 3, Section 7 - Comparison to Predicate Devices)
This means the "proof" that the device meets acceptance criteria (implied to be "performs as safely and effectively as the predicate devices") is based on a technical comparison and functional assessment showing that the modifications (making the instruments detachable) do not change the fundamental operation, electronics, power configuration, or tissue manipulation mechanism that were validated in the predicate devices. This is a common approach for 510(k) submissions for device modifications.
No new clinical or performance studies with specific acceptance criteria, test sets, or ground truth establishment are detailed in this 510(k) summary.
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