(15 days)
The Vaso View™ Dissection/Vessel Harvesting System has applications in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/ vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
The VasoView™ Dissection/Vessel Harvesting System is a single-use device provided sterile. It is designed to be used in conjunction with a 5mm Extended Length Endoscope. The cannula has a tapered tip for tissue separation. Initial tissue separation is performed under endoscopic visualization with the clear tapered tip. The elliptical bulb aids tissue separation, and insufflation holds open the cavity created. The cannula tip may also be used for dissection and isolation of structures in the cavity. This tip is clear to allow for endoscopic visualization during tunneling. A handle is provided to assist with advancement of the cannula. The device is configured to accept a 5mm endoscope through the inner lumen of the cannula. The Origin BTT Port is used to provide a port of access for insertion of endoscopic instruments into an extremity or extraperitoneal space. The device consists of a valve body assembly with a balloon on the sleeve. The valve body assembly contains an internal flapper valve and seal to prevent gas leakage when instruments are inserted or withdrawn. It also includes built-in converter doors to allow insertion of instruments of different diameters than the main seal. The external distal end of the sleeve has a balloon. A 30cc syringe is provided for inflation/deflation of the balloon.
The provided text describes a "Special 510(k): Device Modification" for the Guidant Corporation/ORIGIN VasoView™ Dissection/Vessel Harvesting System (K981700). This type of submission is for modifications to a previously cleared device. Therefore, the focus is on demonstrating that the modified device remains substantially equivalent to the original predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the same way a de novo device might.
Based on the provided document, here's what can be inferred and stated regarding acceptance criteria and supporting studies:
- A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials in patient contact are cleared for biocompatibility. | Parts are "currently being used in existing ORIGIN products, and therefore have been cleared for biocompatibility (safety) and effectiveness." |
| Substantial Equivalence | Device maintains identical function, identical technological characteristics, and similar materials to the predicate device. | The device "shares the identical function, technological characteristics and similar materials as the predicate device (VasoView™ Balloon Dissection Cannula previously cleared product)." |
| Intended Use | Intended use remains consistent with the predicate device. | Intended use is "identical in intended use" to the predicate. |
Explanation: For a 510(k) submission, especially a "Special 510(k) for Device Modification," the primary "acceptance criterion" is often demonstrating substantial equivalence to a legally marketed predicate device. This means showing that the modified device is as safe and effective as the predicate, either by having the same technological characteristics and intended use, or by having different technological characteristics that do not raise new questions of safety or effectiveness and are supported by appropriate data.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail a specific "test set" or clinical study with a sample size for this modification. The assessment is based on the comparison to the predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The document does not describe a clinical study requiring expert ground truth establishment for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The document does not describe a clinical study requiring adjudication.
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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 device is a surgical instrument, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a surgical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device, against which the modified device is compared. The assessment relies on material compatibility and functional similarity to the cleared predicate.
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The sample size for the training set:
Not applicable. The document does not describe a machine learning or AI device that would require a training set.
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How the ground truth for the training set was established:
Not applicable.
Summary of the Study/Evidence:
The "study" presented here is a demonstration of substantial equivalence through a comparison of device characteristics.
- Evidence Type: Benchmarking against an existing, cleared predicate device (ORIGIN System VasoView™ Balloon Dissection System, K964171).
- Key Arguments for Equivalence:
- Identical Intended Use: Both devices are used for minimally invasive vessel harvesting and tissue separation in specified anatomical regions.
- Identical Function: The modified device performs the same core functions of tissue separation, cavity creation, and endoscopic visualization.
- Identical Technological Characteristics: The core design and mechanism of action are the same.
- Similar Materials: The patient contact materials (Polycarbonate, Loctite™ adhesive) are the same as those used in existing cleared ORIGIN products, implying pre-established biocompatibility.
Conclusion from the document: The FDA found the device "substantially equivalent" to the predicate, permitting its marketing based on the comparison provided in the 510(k) submission and the established safety and effectiveness of the predicate device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.