(78 days)
No
The summary describes a robotic system for holding and positioning a laparoscope under direct surgeon control, with no mention of AI or ML.
No
The device's function is to hold and position a laparoscope during surgery, which is a supportive rather than a therapeutic action. It does not directly treat or diagnose a disease.
No
The intended use states that the AESOP System's function is to hold and position a laparoscope for use in laparoscopic surgery, which is a treatment procedure, not a diagnostic one.
No
The device description explicitly states it is a "robotic computer-driven system" and its function is to "hold and position a laparoscope," indicating it includes physical hardware components beyond just software.
Based on the provided information, the AESOP System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states its function is to "hold and position a laparoscope" during laparoscopic surgery. This is a surgical tool used in vivo (within the body) during a procedure.
- Device Description: The description reinforces its role as a robotic system for positioning a laparoscope, again, an in vivo function.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting diseases or conditions based on in vitro analysis, or any other typical characteristics of an IVD device.
IVD devices are 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 purely mechanical and supportive during a surgical 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 laparoscope. It is indicated for use in all forms of laparoscopic surgery. A few examples are cholecystecomy, laparoscopic hemia repair, and laparoscopic appendectomy.
Product codes
Not Found
Device Description
The AESOP System is a robotic computer-driven system whose basic function is to hold and position a laparoscope under the direct control of a surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
1) Submitter Information
Computer Motion. Inc. 130-B Cremona Drive Goleta, CA 93117 805-685-3729 Contact: Douglas Bueschel Prepared February 14, 1996
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- Name of Device
Proprietary Name: AESOP System and Accessories Common Name: Automated Endoscopic System for Optimal Positioning Classification Name: Operating Room Table and Accessories
- Name of Device
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Substantially equivalent to AESOP 510(k) K931783
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The AESOP System is a robotic computer-driven system whose basic function is to hold and position a laparoscope under the direct control of a surgeon.
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The intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a laparoscope. It is indicated for use in all forms of laparoscopic surgery. A few examples are cholecystecomy, laparoscopic hemia repair, and laparoscopic appendectomy.
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The AESOP System is comparable to original AESOP System in that it uses the same control methods to position the laparoscope and introduces a new control method of voice control. The control method of voice control is a self-contained speaker dependent speech recognition system. The Voice Control Interface recognizes verbal commands and passes them to the AESOP System to hold and position a laparoscope the same as the Hand or Foot Control of the AESOP System.
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 ●