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510(k) Data Aggregation
(52 days)
LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
The LigaSure Impact™ Curved, Large Jaw. Open Sealer/Divider, Nano-coated (LF4418) is a sterile, single-use, coated, hand-held bipolar vessel sealing device designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, pulmonary arteries/veins, and lymphatics during open general surgical procedures (as indicated). A hand actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting. The proposed devices do not contain software.
The provided text describes a 510(k) premarket notification for a medical device, the LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than to independently prove safety and effectiveness against specific acceptance criteria. Therefore, the document does not contain a typical "acceptance criteria" table with reported device performance metrics in the way one might expect for a de novo device.
Instead, the submission focuses on demonstrating that the new device, which has a non-stick coating added to its jaws, performs comparably to its predicate device (LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider without the nano-coating) across various performance aspects. The "acceptance criteria" here are implicitly that the new device should not introduce new safety or effectiveness concerns and should perform at least as well as the predicate.
Here's an attempt to structure the information based on the provided text, while acknowledging the limitations of a 510(k) submission not explicitly stating quantifiable acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission, explicit quantitative acceptance criteria for each test are not provided in the document. The acceptance criterion is implicitly that the subject device (with nano-coating) should perform comparably to the predicate device (without nano-coating) and not raise new safety or effectiveness questions.
| Category | Acceptance Criteria (Implicit from 510(k) Context) | Reported Device Performance (Subject Device vs. Predicate) |
|---|---|---|
| Biocompatibility | Pass all relevant ISO 10993-1 tests, showing no adverse biological reactions. | The biocompatibility evaluation for the subject device was conducted in accordance with ISO 10993-1, including Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, and Hemolysis tests. Implied: All tests passed, demonstrating acceptable biocompatibility. |
| Electrical Safety | Comply with ANSI AAMI ES 60601-1 and IEC 60601-2-2 standards. | Electrical safety testing was conducted. Implied: The system complies with relevant clauses of ANSI AAMI ES 60601-1 and IEC 60601-2-2. |
| EMC | Comply with IEC 60601-1-2 standard. | EMC testing was conducted. Implied: The system complies with IEC 60601-1-2. |
| Mechanical/Functional | Perform as expected for key mechanical and electrical characteristics (e.g., jaw force, jaw gap, rotation, resistance). | Mechanical, electrical, and functional testing was carried out, including: Jaw force, Jaw gap, Shaft/Jaw Rotation, Device resistance, capacitance, and inductance, Lever latching/unlatching/opening force. Implied: The device performed as expected and comparably to the predicate. |
| Ex-vivo Vessel Burst Pressure | Demonstrate bipolar electrosurgical vessel sealing performance comparable to the predicate device on various vessels. | Ex-vivo burst pressure testing of excised fresh porcine renal, pulmonary arteries, and lymphatics was conducted on both the subject and predicate devices. Implied: Performance was comparable between the subject and predicate devices, demonstrating equivalent vessel sealing performance. |
| Thermal Profile | Exhibit a thermal profile (jaw and shaft) comparable to the predicate device, indicating no new thermal safety concerns. | Bench thermal profile testing using porcine tissue was conducted to evaluate the thermal profile of the jaw and shaft of the subject device in comparison to the predicate. Implied: The thermal profile was comparable, indicating similar thermal safety. |
| Acute Animal Study | Assess acute sealing performance and lateral thermal damage, and demonstrate safety and effectiveness comparable to the predicate. | Two female porcine underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. Evaluation included macroscopic and histological assessment. Reported: These studies demonstrated that the subject devices are as safe and effective as the predicate device. |
| Chronic Animal Study | Assess seal quality over 21 days, demonstrating maintenance of chronic hemostasis. | A chronic study on five animals was conducted to assess seal quality over 21 days. Reported: All animals survived 21 days post-op and all seals maintained chronic hemostasis. (The comparison to the predicate is implicit; the predicate is established as effective, and this study confirms the subject device's long-term effectiveness in an animal model.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly delineate what constitutes a "test set" in the context of device approval, as various tests are performed. However, for the animal studies:
- Acute Animal Study: Two female porcine were used.
- Chronic Animal Study: Five animals (porcine, based on prior mention of porcine tissue) were used.
- Ex-vivo Vessel Burst Pressure and Thermal Profile: "Excised fresh porcine renal, pulmonary arteries, and lymphatics" and "porcine tissue" were used, respectively. The sample size for these ex-vivo/bench tests is not specified.
- Data Provenance: The origin of the animal and tissue data is preclinical testing (animal and ex-vivo studies). The document does not specify the country of origin, but it is typically conducted by or for the manufacturer, Covidien, based in Boulder, Colorado, USA. The data is prospective with respect to the tests conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish "ground truth" for the preclinical test results.
For the animal studies, "macroscopic and histological evaluation" was performed. This implies assessment by veterinary pathologists or similar experts, but their number and specific qualifications are not mentioned. In a 510(k) submission for a device of this nature, the ground truth for performance characteristics (like burst pressure, thermal damage, hemostasis) is typically established through objective measurements and accepted scientific and histopathological evaluation methodologies rather than subjective expert consensus, as might be the case for image-based diagnostic AI.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test set. This type of adjudication is typically relevant for studies involving human interpretation (e.g., medical image reading), which is not the primary focus of the performance tests for this electrosurgical device. The evaluation of test results (e.g., burst pressure measurements, histological findings) is based on objective criteria and standard scientific/pathological assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an electrosurgical instrument, not a diagnostic imaging device that involves human interpretation of medical cases. Comparative effectiveness was demonstrated through preclinical performance testing between the subject device and the predicate device. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to this device. The LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated is a physical electrosurgical instrument operated by a human surgeon; it does not contain an algorithm or AI that operates in a "standalone" or "human-in-the-loop" fashion. The device description explicitly states: "The proposed devices do not contain software."
7. The Type of Ground Truth Used
The "ground truth" for the various performance tests was established through:
- Objective Measurements: For electrical safety, EMC, mechanical/functional tests (e.g., jaw force, resistance), and ex-vivo burst pressure.
- Biological/Pathological Evaluation: For biocompatibility tests (e.g., cytotoxicity, sensitization), thermal profile assessment (using porcine tissue), and animal study outcomes (macroscopic and histological evaluation of tissue for sealing performance, lateral thermal damage, and chronic hemostasis).
There is no pathology used in the sense of diagnosing a disease from a biopsy, but rather in the sense of macroscopic and microscopic evaluation of tissue changes as a result of the device's action. Outcomes data in the animal studies included survival and maintenance of chronic hemostasis.
8. The Sample Size for the Training Set
This question is not applicable to this device. As noted previously, the device does not contain software or AI components that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable to this device, as there is no training set.
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LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER
The LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LigaSure Impact LF4318 is intended to be used with the ForceTriad™ energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies. Nissen fundoplication, colectorny, adhesiolysis, oophorectorny, etc. The LigaSure Impact LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7mm and tissue bundles.
The LigaSure™ system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
The LigaSure Impact™, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol grip style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10 foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device-specific recognition by the generator.
The provided text is a 510(k) summary for a medical device (LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider) and does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically assessed for AI/software devices.
Instead, it describes the performance testing undertaken to demonstrate substantial equivalence to predicate devices, which is the regulatory pathway for this type of medical device. Therefore, I cannot extract the information required by your prompt as it pertains to AI/software acceptance criteria and studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size).
However, I can extract the information provided about the device's performance testing for its 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of numeric acceptance criteria and corresponding performance metrics in the way your prompt expects for AI/software. Instead, the performance is described qualitatively in the "Performance" section:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Testing | Involved safety and performance testing in accordance with IEC 60601-1 and IEC 60601-2-2. |
| Verification/Comparative Testing | Performed against predicate devices. |
| Bench Testing | Evaluation of the device's performance and ability to seal and divide vessels up to 7mm. |
| Pre-clinical Testing | Performed both acute and chronic testing. Evaluated thermal spread and ability to achieve hemostasis of tissue and vessels in a variety of simulated clinical settings. Confirmed that the LF4318 is as safe and effective as the predicate devices and operated as intended. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified quantitatively. The text only mentions "extensive functional, bench and pre-clinical testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for this kind of hardware device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a surgical instrument, not an AI/software device requiring expert-established ground truth on a dataset. Performance was evaluated through engineering tests and pre-clinical studies.
4. Adjudication method for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a hardware surgical instrument, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
For this device, "ground truth" would be established through physical measurements (e.g., sealing strength, thermal spread, hemostasis) and direct observation in pre-clinical studies, rather than expert labels on data.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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