(97 days)
The Intuitive Surgical da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 10mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
The da Vinci Single-Site Instruments and Accessories are a set of devices developed by Intuitive Surgical to enable single incision cholecystectomy using the IS3000 da Vinci Si Surgical System.
The da Vinci Single-Site Instruments and Accessories consist of non-wristed, semi-rigid shaft instruments, two fixed-shape curved cannulae, an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator, and a single fascial port (with insufflation tubing and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
The da Vinci Single-Site Instruments and Accessories include instruments to provide grasping, cautery, cutting, clip ligation and suction/irrigation functions.
The provided text describes a 510(k) premarket notification for the Intuitive Surgical da Vinci® Single-Site™ Instruments and Accessories. This notification seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria based on a new, comprehensive clinical study with predefined performance metrics.
Therefore, many of the requested elements of the response, such as a table of "acceptance criteria" and "reported device performance," the sample size for a test set, the number and qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or provided in this document.
The document focuses on demonstrating substantial equivalence through design modifications, technological characteristics comparison, and performance testing (bench and animal) rather than a human-in-the-loop clinical trial or a study designed to meet specific quantitative performance criteria against a clinical "ground truth."
Here's a breakdown of the information that can be extracted, with an explanation for the elements that are not applicable:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the context of this 510(k) summary. This submission is for demonstrating "substantial equivalence" to a predicate device, not for establishing new performance criteria in a clinical setting against a definitive clinical outcome. The performance data presented are for demonstrating that the modified device functions as intended and is equivalent to the predicate, focusing on design inputs and safety.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The performance testing included "bench and animal" studies. The sample sizes for these tests (e.g., number of animals, number of bench tests) are not detailed in this summary. Data provenance (country of origin, retrospective/prospective) is also not specified.
3. 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. Since this is not a study requiring human expert evaluation to establish a "ground truth" for a diagnostic or AI-assisted task, no information on experts for ground truth establishment is provided. The evaluation was primarily engineering-focused (mechanical, electrical, simulated use in animals).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As no expert ground truth establishment is described, no adjudication method is relevant.
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 conducted as this device is a surgical instrument system, not an AI diagnostic tool requiring "readers" or evaluation of "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical instrument system, not an algorithm, so "standalone algorithm performance" is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. The "ground truth" for this submission revolves around engineering specifications and functional performance. The device's "truth" is whether it performs its intended mechanical and electrical functions safely and effectively, as demonstrated via bench and animal testing. This is not a clinical "ground truth" like pathology or outcomes data.
8. The sample size for the training set
- Not applicable. This is a hardware device submission, not an AI or machine learning application, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of the Study and Device Performance as described in the provided text:
Device: Intuitive Surgical da Vinci® Single-Site™ Instruments and Accessories
Predicate Device: The original Intuitive Surgical da Vinci® Single-Site™ Instruments and Accessories (cleared under K112208 on December 8, 2011).
Purpose of Submission (K120215): To demonstrate substantial equivalence of a modified version of the device to its predicate. Modifications include simplifying the back-end drive mechanism, minor design and dimensional changes to the distal grip, and moving from machined to molded components.
Table of Acceptance Criteria and Reported Device Performance (based on the context of this 510k):
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: The modified device should have the same intended use as the predicate. | The modified Intuitive Surgical da Vinci Single-Site Instruments and Accessories are equivalent to the predicate devices in terms of their intended use. |
| Indications For Use Equivalence: The modified device should have the same indications for use as the predicate. | The modified Intuitive Surgical da Vinci Single-Site Instruments and Accessories are equivalent to the predicate devices in terms of their indications for use. Specific indication: "endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 10mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port." (From section Indications For Use:) |
| Technological Characteristics Equivalence (Safety & Effectiveness): Modifications should not raise new safety or effectiveness questions and should align with the predicate's performance. | The modified Intuitive Surgical da Vinci Single-Site Instruments and Accessories are equivalent to the predicate devices in terms of their technological characteristics. Performance testing (bench and animal) was conducted to demonstrate that the modified devices are substantially equivalent to the predicate devices, and that the design outputs meet the design inputs. The results of the testing did not raise any new safety or effectiveness questions. The tests conducted consisted of dimensional measurements, mechanical and functional verification, electrical safety, and simulated use in an an animal model. |
| Safety and Effectiveness: Overall safety and effectiveness compared to the predicate. | Based on the Intended Use, indications for use, technological characteristics and performance data, the modified Intuitive Surgical da Vinci Single-Site Instruments and Accessories are equivalent to the predicate devices in terms of safety and effectiveness. Limitation added by FDA: "The safety and effectiveness of this device for use in the performance of general laparoscopic abdominal surgery procedures have not been established. This device is only intended to be used for single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and the da Vinci Si Surgical System (IS3000)." |
Study Details:
- Type of Study: Performance testing (bench and animal) for substantial equivalence to a predicate device.
- Sample Sizes: Not specified.
- Data Provenance: Not specified (presumably conducted by Intuitive Surgical, Inc. in the US).
- Ground Truth Establishment: For this type of device, "ground truth" is established by engineering specifications, functional requirements, and safety standards, confirmed through controlled bench tests and simulated use in animal models. No human expert consensus on clinical outcomes or pathology is mentioned as this is a device modification submission, not a new clinical efficacy claim.
- Training Set/MRMC/Standalone AI: Not applicable as this is not an AI/ML device.
In essence, the "study" was a series of engineering and animal tests designed to confirm that design changes did not negatively impact the performance, safety, and effectiveness of the device when compared to the previously cleared predicate, thus maintaining substantial equivalence.
§ 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.