(64 days)
AMT Esophageal Overtube
No
The description focuses on the mechanical function and material of a surgical access portal, with no mention of AI/ML capabilities or data processing.
No
The device is described as an "instrument access portal" used during endoscopic surgery, which facilitates the surgical procedure by allowing access for instruments, rather than directly treating a condition or disease.
No
Explanation: The device description clearly states its purpose as an "instrument access portal for use during endoscopic surgery," facilitating the use of surgical instruments rather than performing any diagnostic function.
No
The device description clearly describes a physical instrument access portal made of silicone, intended for use during endoscopic surgery. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "an instrument access portal for use during endoscopic surgery." This describes a surgical tool used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a physical device designed to be inserted into an incision site to provide access for surgical instruments. This is a surgical access device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly designed for direct use during a surgical procedure on a patient, which is the domain of medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery.
Product codes
Not Known
Device Description
The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery. It is designed to be substantially equivalent to the presently marketed AMT Esophageal Overtube. The devices' internal flange is inserted into the incision site and allowed to expand freely. Once in place, the internal flange retains the device in place and allows for the access of a variety of surgical instruments.
The shaft is angulated at 30° but can range from 20° to 90°, depending on the specific application. The external flange reduces site contamination and trauma. It also easily defines the access into the region.
The Endoscopic Access Device is injection molded from the same biocompatible Dow Corning silicone (Q7-4840) as the AMT Button (K943392). The Endoscopic Access Device has been developed incorporating all of the safety and effectiveness features for this devices' application. Bench testing and has been performed on the minimum pull out force versus the the strength of the device to ensure mechanical integrity for functional performance (see Exhibit VIa).
The Endoscopic Access Deivce is sold sterile for single use.
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
Not Found
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
Bench testing and has been performed on the minimum pull out force versus the the strength of the device to ensure mechanical integrity for functional performance (see Exhibit VIa).
Key Metrics
Not Found
Predicate Device(s)
AMT Esophageal Overtube
Reference Device(s)
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
EXHIBIT X
510(k) SUMMARY
MAR 2 1 1996
Kathy Feltrin Director of Regulatory Affairs
January 15, 1996
Trade Name: Endoscopic Access Device Common Name: Endoscopic Access Device Not Known Classification name:
The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery. It is designed to be substantially equivalent to the presently marketed AMT Esophageal Overtube. The devices' internal flange is inserted into the incision site and allowed to expand freely. Once in place, the internal flange retains the device in place and allows for the access of a variety of surgical instruments.
The shaft is angulated at 30° but can range from 20° to 90°, depending on the specific application. The external flange reduces site contamination and trauma. It also easily defines the access into the region.
The Endoscopic Access Device is injection molded from the same biocompatible Dow Corning silicone (Q7-4840) as the AMT Button (K943392). The Endoscopic Access Device has been developed incorporating all of the safety and effectiveness features for this devices' application. Bench testing and has been performed on the minimum pull out force versus the the strength of the device to ensure mechanical integrity for functional performance (see Exhibit VIa).
The Endoscopic Access Deivce is sold sterile for single use.