(101 days)
Freehand is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use.
A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectomy lymph node dissection hysterectomy gastric banding gastric by pass nephrectomy radical prostatectomy anterior spinal fusion, decompression fixation wedge resection lung biopsy pleural biopsy, internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting where endoscopic visualization is indicated examination of the evacuated cardiac chamber during performance of valve replacement or repair.
Freehand is a modification of Prosurgics EndoAssist. The Freehand is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery where a rigid laparoscope/endoscope is intended for use, and allows the surgeon directly to control movements of a rigid endoscope by head movements. Changes that have been made are to provide simpler control mechanisms that should result in greater reliability, as well as several convenience features. From the surgeon's point of view, the two devices are the same as far as their operation and functions are concerned.
The provided text describes a 510(k) submission for the "Freehand Endoscopic Camera Controller" and states that clinical tests were not necessary because the device uses the same technology as a predicate device. Therefore, there is no study provided that proves the device meets specific acceptance criteria based on clinical performance.
The acceptance criteria and device performance information would typically be derived from such clinical studies. Since no clinical study was performed or presented for K090340, the following points address the questions based on the available non-clinical data and the reasoning for not requiring clinical data.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical: | |
| Electrical safety (IEC 60601-1) | Meets requirements |
| Electromagnetic compatibility (IEC 60601-1-2) | Meets requirements |
| Clinical: | |
| Not applicable (device deemed substantially equivalent to predicate based on existing technology and intended use) | Not applicable |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable for clinical testing.
- Data provenance: Not applicable for clinical testing. The device was deemed substantially equivalent to a predicate based on technical specifications and intended use, not new clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no clinical test set was used to establish ground truth.
4. Adjudication method for the test set
- Not applicable as no clinical test set was used.
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 MRMC or comparative effectiveness study was performed as no clinical tests were deemed necessary. This device is an endoscopic camera controller, not an AI-assisted diagnostic tool for "human readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a robotic camera controller, not an algorithm with standalone performance in a diagnostic context.
7. The type of ground truth used
- Not applicable for clinical validation. For non-clinical validation, ground truth would be defined by the standards of IEC 60601-1 and IEC 60601-1-2, which are engineering and safety standards.
8. The sample size for the training set
- Not applicable. There is no mention of a training set for an algorithm based on clinical data.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the study/non-clinical assessment:
The submission for K090340 (Freehand Endoscopic Camera Controller) did not include a clinical study to prove the device meets acceptance criteria. Instead, the manufacturer argued that clinical tests were unnecessary because the Freehand is a modification of a previously cleared device (Prosurgics EndoAssist, K043284) and uses the same core technology. The changes made were stated to be for "simpler control mechanisms that should result in greater reliability, as well as several convenience features." The safety and efficacy were demonstrated through non-clinical tests showing compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards. The substantial equivalence argument implied that the predicate device's established safety and efficacy extended to the Freehand due to the nature of the modifications.
§ 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.