(143 days)
The Saphena Medical OnePass Endoscopic Vessel Harvesting System is in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.
The OnePass™ Endoscopic Vessel Harvesting System attaches to existing laparoscopic endoscopes (e.g. 7mm) to provide a means to endoscopically harvest vessels for use in arterial bypass graft procedures. Endoscopic Vessel Harvesting is a procedure that has been in use for approximately 15 years. The OnePass™ device differs in that it provides for single device entry into the body cavity without the need for additional instruments. Also, the distal end effector design allows for excellent visibility and quick thermal ligation of vessel trunks while minimizing trauma to the target vessel.
The provided text describes a 510(k) submission for the OnePass™ Endoscopic Vessel Harvesting System. The focus of the submission is to demonstrate substantial equivalence to a predicate device, not to establish performance against specific acceptance criteria through a standalone clinical study. Therefore, direct answers to many of the requested points are not available in this document.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance:
The document focuses on demonstrating substantial equivalence to an existing predicate device rather than fulfilling specific, quantifiable acceptance criteria for a novel device performance claim. The reported device performance is defined by its ability to be "as safe and effective and performs at least as safely and effectively as the predicate device."
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Safe and Effective as Predicate Device | "Performance testing demonstrates that the device is as safe and effective and performs at least as safely and effectively as the predicate device stated in this summary." |
| Functional Specification Met | "Non-clinical testing of the subject device has shown that it meets its functional specification..." |
| Performs According to Intended Use | "...and performs according to the prescribed intended use." |
| Equivalent Intended Use to Predicate | "As described in this submission, the intended use of the OnePass™ Endoscopic Vessel Harvesting System is equal to the predicate device." |
| Similar Technological Characteristics to Predicate | "Further, the subject and predicate device have similar technological characteristics." |
| Equivalent in terms of Intended Use, Principles of Operations, Technology, Design, Materials and Performance to Predicate | "The OnePass™ Endoscopic Vessel Harvesting System is equivalent to the predicate device in terms of intended use, principles of operations, technology, design, materials and performance." |
| No new issues of safety or effectiveness raised by noted differences | "The noted difference between the OnePass™ Endoscopic Vessel Harvesting and predicate device does not raise new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document describes non-clinical performance data, which includes:
- Design Verification Testing (dimensional verification, tensile/compressive strength, durability)
- Compatibility Testing with standard 7mm scope
- Electrical Safety and Electromagnetic Testing
- Packaging and Shipping Testing
- Sterility Testing
- Biocompatibility Testing
- Simulated animal testing use evaluation
These tests are typically laboratory-based and do not involve human subjects or clinical data in the traditional sense of a "test set" like in an AI/diagnostic algorithm study. Therefore, information on sample size for a "test set" (human cases) and data provenance (country, retrospective/prospective) is not applicable in this context. The "simulated animal testing use evaluation" implies some form of animal study, but no details on sample size or specific outcomes are provided beyond its inclusion in the non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since this is a submission for a surgical device demonstrating substantial equivalence via non-clinical performance and animal testing, there is no mention of experts used to establish ground truth for a clinical test set, as such a set was not used in the described studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As no clinical test set with human data and expert ground truth establishment is described, an adjudication method is not applicable and not mentioned.
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:
This device is an electrosurgical cutting and coagulation device, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is a physical surgical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable and not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical and simulated animal testing, the "ground truth" would be established through engineering specifications, validated test methods, and potentially pathological examination or physiological endpoints in the animal models, rather than expert consensus on human data or pathology from real clinical cases. The specific types of "ground truth" for each non-clinical test (e.g., tensile strength values, sterility test results, biocompatibility standards compliance) are implied but not explicitly detailed as "ground truth types" in the provided summary.
8. The sample size for the training set:
As this is a physical device and not an AI algorithm, the concept of a "training set" in the context of data for model development is not applicable and not mentioned. The device's design and manufacturing processes are based on engineering principles and regulatory standards, not statistical training data.
9. How the ground truth for the training set was established:
Since there is no "training set" as defined for an AI algorithm, this question is not applicable. The "ground truth" for the device's design and functionality would be established through engineering design specifications, material properties, and manufacturing standards.
§ 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.