(84 days)
The Guidant Vaso View® Endoscopic Vessel harvesting system is indicated for use 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 patients requiring blunt dissection of tissue including dissection of blood vessels, separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissection along the saphenous vein 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 VasoView System is made up of 6 components including:
-
- Blunt Tip Trocar (BTT) with Syringe,
-
- 5 mm Extended Length Endoscope,
-
- Uniport Plus Dissection Cannula,
-
- VasoView Dissection Cannula,
-
- Uniport BiSector and
-
- Uniport Bipolar Scissors.
These are the exact same devices used for saphenous vein harvesting and have been previously cleared by FDA. Each device is described below.
BTT:
The BTT is a single use device provided sterile. The BTT is used to provide a port of access for insertion of endoscopic instruments into an incision site. 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valve body assembly contains an internal flapper valve and seal to prevent gas leakage when instruments are inserted or withdrawn.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 converters to allow insertion of instruments of different diameters than the main seal and an external one-way valve for gas insufflation. To minimize leakage and secure the port, the distal end of the sleeve has a balloon. A 30cc syringe is provided for inflation/deflation of the balloon.
5mm Extended Length Endoscope:
The 5mm Extended Length Endoscope is a multi-use product supplied non-sterile and must be cleaned and sterilized prior to use. The device is used to visualize endoscopic cavities. It consists of a stainless steel shaft containing optics. The proximal end has an eyepiece, for camera attachment, and a light cable post for light cable connection.
Uniport Plus Dissection Cannula
The Uniport Plus Dissection Cannula is a single use device provided sterile. The Uniport Plus Dissection Cannula is designed to be used in conjunction with the 5mm Extended Length Endoscope. The cannula has a removable conical tip and four lumens to house the endoscopes, vessel cradle/distal lens washer and bipolar instrument for ligation and division of vessel branches. The vessel cradle/distal lens washer is independently controlled by a slider button on the handle of the device for retraction and blunt dissection of tissue as well as washing of the distal tip of the scope. The bipolar instrument is inserted independently into the cannula and can be controlled at the proximal end for blunt dissection.
Dissection System:
The Dissection 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 tunneling, which separates tissue planes, forming a cavity. The cannula tip may also be used for dissection and isolation of structures in the cavity. This tip is clear for endoscopic visualization during tunneling. An elliptical bulb aid tissue separation. A handle is provided to assist with advancement of the cannula.
Uniport BiSector:
The Uniport BiSector is a single use device provided sterile. The Uniport BiSector is a 5mm flexible endoscopic ligating forcep and is intended to be used with the Uniport Dissection Cannula. Bipolar coagulation is achieved using electro surgical energy under endoscopic visualization. Transection is achieved through mechanical actuation of the slide button. This device is intended to be used with the bipolar outputs of compatible generators.
Bipolar Scissors:
The Bipolar Scissors are a single use device provided sterile. The Bipolar Scissors are 5mm cutting and bipolar coagulation scissors and are intended to be used with the Dissection Cannulas. Mechanical cutting and bipolar coagulation is achieved using electrosurgical energy under endoscopic visualization. This device is intended to be used with the bipolar outputs of compatible generators.
Here's an analysis of the provided text regarding the Guidant VasoView Endoscopic Vessel Harvesting System, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative "acceptance criteria" in the traditional sense (e.g., a specific sensitivity or specificity threshold). Instead, it relies on demonstrating substantial equivalence to predicate devices and presenting clinical data to support an indication expansion.
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance |
|---|---|
| Safety: Device does not raise new questions of safety. | The clinical data from over 84 cases demonstrates that the Guidant VasoView Vessel Harvesting System is a "safe approach to endoscopic radial artery harvesting." |
| Effectiveness: Device does not raise new questions of effectiveness, particularly for the expanded indication of radial artery harvesting. | The clinical data from over 84 cases demonstrates that the Guidant VasoView Vessel Harvesting System is an "effective approach to endoscopic radial artery harvesting." |
| Substantial Equivalence: Technological characteristics, intended use, indications, labeling, packaging, and manufacturing processes are equivalent to predicate devices. | The submission explicitly states the device is "substantially equivalent to the predicated devices in intended use, indications, technological characteristics, labeling and packaging materials, and manufacturing processes." It notes that pre-clinical testing information is unchanged from previous 510(k)s. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: "over 84 cases"
- Data Provenance: The document does not explicitly state the country of origin. It does not clarify whether the cases were retrospective or prospective, but the phrasing "results of over 84 cases demonstrate" suggests previously performed procedures that were analyzed (retrospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given 510(k) summary. The document focuses on the outcome of the procedures rather than the assessment by experts to establish a "ground truth" in a diagnostic sense.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary. Given the nature of a surgical device and the focus on safety and effectiveness of the procedure itself, a formal "adjudication method" for a test set ground truth (as seen in AI diagnostics) is not typically applicable in this context.
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
- No, an MRMC comparative effectiveness study was not done.
- This device is a surgical instrument, not an AI diagnostic tool. The concept of "human readers improve with AI" is not relevant to this submission. The study focuses on the safety and effectiveness of the surgical system itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done.
- This device is a surgical instrument used by a surgeon. It is not an AI algorithm. Its performance is intrinsically linked to its use by a human operator.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the safety and efficacy of the endoscopic radial artery harvesting procedure performed using the VasoView system. This would have been established through:
- Clinical Outcomes Data: This would include factors like successful harvesting of the radial artery, complication rates (e.g., vessel damage, nerve injury, infection), patient recovery, and potentially long-term patency of the harvested vessel (though long-term data might not be within the scope of a 510(k) submission focused on a device rather than a full procedure outcome study).
- Surgical Observations: Direct observation of the procedure by experienced surgeons to assess ease of use, visualization, and efficiency.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The VasoView system is a hardware surgical device, not a machine learning algorithm that requires a "training set." The previous 510(k) clearances (K904993, K945975, K960637, K974608, K981700, K992353) for the individual components likely involved various forms of design verification, validation, and potentially clinical experience, but not in the sense of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided as there is no "training set" in the context of an AI algorithm. The device's "ground truth" (its ability to perform its function safely and effectively) would have been established through a combination of:
- Bench testing: Verifying mechanical properties, material compatibility, and functional performance.
- Pre-clinical (animal) studies: Assessing tissue interaction and procedural feasibility.
- Clinical experience and literature: Leveraging existing knowledge and previous clearances of similar devices and the components of the VasoView system for saphenous vein harvesting. The indication expansion to radial artery harvesting then required additional clinical data to specifically demonstrate safety and effectiveness for that new use.
§ 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.