(238 days)
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No
The description focuses on a robotic system for holding and positioning an endoscope under direct surgeon control, with no mention of AI/ML terms or capabilities.
No
The device is described as a robotic system that holds and positions endoscopes, assisting the surgeon in visualization during various endoscopic procedures. It does not directly treat or diagnose a disease but rather facilitates a surgical procedure.
No.
The device's function is to hold and position a laparoscope/endoscope for visualization during surgical procedures, not to diagnose medical conditions from imaging or other data.
No
The device description explicitly states it is a "robotic computer-driven system" whose function is to "hold and position a rigid laparoscope/endoscope," indicating the presence of hardware components beyond just software.
Based on the provided information, the AESOP System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is designed to "hold and position a rigid laparoscope/endoscope" for surgical procedures. This is a surgical assist device, not a device used to examine specimens from the human body in vitro (outside the body).
- Device Description: The description reinforces its function as a robotic system for holding and positioning an endoscope under surgeon control.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The AESOP System's function is entirely focused on assisting in surgical visualization and manipulation during a procedure.
N/A
Intended Use / Indications for Use
The intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a rigid laparoscope/endoscope . The AESOP System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a rigid laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy. laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
Product codes
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Device Description
The AESOP System is a robotic computer-driven system whose basic function is to hold and position a laparoscope/endoscope under the direct control of a surgeon.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The users of the AESOP System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
AESOP System 510(k) Summary
In accordance with 21 CFR section 807.92 Computer Motion is submitting the following safety and effectiveness summary.
- Submitter Information
Computer Motion. Inc. 130-B Cremona Drive Goleta, CA 93117 805-685-3729 Contact: Douglas Bueschel Prepared: August 9, 1996
- Name of Device
Proprietary Name: AESOP System and Accessories Common Name: Automated Endoscopic System for Optimal Positioning Classification Name: Laparoscope, General & Plastic Surgery
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Substantially equivalent to AESOP 510(k)'s K931783 and K960655.
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The AESOP System is a robotic computer-driven system whose basic function is to hold and position a laparoscope/endoscope under the direct control of a surgeon.
The intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a rigid laparoscope/endoscope . The AESOP System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a rigid laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy. laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the AESOP System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
- The AESOP System is designed and tested to the following Computer Motion and voluntary standards.
- IEC 601-1 Second Edition 1988 International Standard for Medical Electrical Equipment .
- IEC 601-1 Amendment 1 1991 International Standard for Medical Electrical Equipment ●
- IEC 601-2-18 First Edition 1990 International Standard for Medical Electrical Equipment ●
- UL544 Third Edition ●
- AMMI TIR 12 Design, Testing, and Labeling Reusable Medical Devices for Reprocessing in ● Healthcare Facilities
- EMC Directive European Union 89/336/EEC
- CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92 ●
- . AESOP System Functional Test Requirements
APR -7 1997