(52 days)
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.
§ 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.