(23 days)
The da Vinci Harmonic ACE™ Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Models IS1200, IS2000, and IS3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece. .
The Intuitive Surgical Harmonic™ Curved Shears Instrument is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Models IS1200, IS2000, and IS3000) and a compatible Ethicon Endo-Surgery Generator and Hand Piece.
The Intuitive Surgical Harmonic ACE™ Curved Shears is used to deliver ultrasonic energy to enable transection and coagulation of tissue. The proximal end of the device is a re-usable instrument housing and attaches to the da Vinci Surgical System. The distal end is the Disposable Harmonic ACE™ Insert, which consists of a shaft and grip assembly. The instrument housing and the disposable insert are assembled together, attached to the da Vinci Surgical System and connected to Ethicon's Endo-Surgery Generator using the Hand Piece. When the Harmonic ACE™ Curved Shears is activated, it delivers ultrasonic energy and enables transection and coagulation of tissue. The instrument is available in 5mm and 8mm diameters and in 2 configurations: one for the da Vinci (IS1200) and one for the da Vinci S/Si (IS2000/ IS3000) Surgical Systems, respectively. The same disposable insert is used with all configurations of the instrument.
The Intuitive Surgical Harmonic™ Curved Shears Instrument is used to deliver ultrasonic energy to enable transection and coagulation of tissue. The proximal end of the device is a re-usable instrument housing and attaches to the da Vinci Surgical Systems. The distal end is the Disposable Harmonic™ Curved Shears Insert, which consists of a shaft and grip assembly. The instrument housing and the disposable insert are assembled together, attached to the da Vinci Surgical Systems and connected to Ethicon's Endo-Surgery Generator using the Hand Piece. When the Harmonic ACE™ Curved Shears is activated, it delivers ultrasonic energy and enables transection and coagulation of tissue. The instrument is available in 5mm and 8mm diameters and in 2 configurations: one for the da Vinci (IS1200) and one for the da Vinci S/Si (IS2000/ IS3000) Surgical Systems, respectively. The same disposable insert is used with all configurations of the instrument.
The provided text is a 510(k) summary for a medical device modification, specifically for the da Vinci Harmonic ACE™ Curved Shears and Intuitive Surgical Harmonic™ Curved Shears Instrument. It explicitly states that "Performance testing was not required for this labeling change." The submission is based on the substantial equivalence to predicate devices, noting that the subject devices are "identical in technological characteristics as compared to the predicate device."
Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not applicable to this specific submission.
Here's a breakdown of the information that can be extracted or deduced from the provided text, and where the information is explicitly stated as not applicable or not provided:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. |
Explanation: The documentation explicitly states, "Performance testing was not required for this labeling change." The basis for clearance is solely on substantial equivalence to predicate devices, meaning the modified device shares the same technological characteristics and intended use as devices already on the market. There are no acceptance criteria defined or met through new performance studies in this submission because no new performance studies were conducted.
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No performance test set used.
- Data Provenance: Not applicable. No performance data generated or used from any country or retrospectively/prospectively.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment was required as no new performance data was generated or analyzed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method was used as no test set was analyzed.
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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 (curved shears) used within a robotic surgical system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.
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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 physical surgical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth was established or used for performance testing.
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The sample size for the training set:
- Not applicable. This device is a physical surgical instrument, not an AI/ML algorithm. Therefore, no training set was used.
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How the ground truth for the training set was established:
- Not applicable. As no training set was used, no ground truth needed to be established.
Summary Statement from the Document:
The critical statement that governs all these answers is found under "Performance Data" in the submission: "Performance testing was not required for this labeling change." The basis for clearance is the substantial equivalence to predicate devices based on identical technological characteristics and indications for 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.