(122 days)
Not Found
No
The summary describes a mechanical device for introducing an endoscope and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is an introducer kit designed to aid in the insertion of an endoscope, which is an accessory to a diagnostic procedure, not a therapeutic intervention itself.
No
The device is described as an "endoscope introducer kit," which facilitates the insertion of an endoscope. Its function is to provide an open channel for an endoscope. It does not perform any diagnostic function itself, such as detecting or measuring a condition or disease. The endoscope that it helps introduce may be used for diagnostic purposes, but the introducer kit itself is a surgical/procedural accessory.
No
The device description clearly outlines physical components (internal dilator, external sheath, luer fittings, hemostasis valve, guidewire lumen), indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Mitsubishi Endoscope Introducer Kit is a surgical tool used during a procedure (laparoscopic choledochoscopy) to facilitate the insertion of an endoscope into the body. It does not analyze or test any bodily specimens.
The device description and intended use clearly indicate it's an instrument for surgical access, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Mitsubishi Endoscope Introducer Kit is intended to provide an open channel to allow insertion of a small diameter endoscope during laparoscopic choledochoscopy.
Product codes
78FED
Device Description
The Mitsubishi Endoscope Introducer Kit consists of an internal dilator (with luer fitting to accommodate a hemostasis valve) contained within an external sheath (with attached hemostasis valve and luer fitting). The dilator may be straight or curved and has a lumen to allow passage of a flexible guidewire.
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
Not Found
Key Metrics
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
K955717
510(k) Summary: #K95_
Endoscope Introducer Kit
| 1) | Name of Submitter: | Mitsubishi Cable America, Inc. |
|---|---|---|
| Address: | 520 Madison Avenue | |
| New York, NY 10022 | ||
| Telephone: | (212) 888-2270 | |
| Contact Person: | Dr. Ronald J. Ehmsen | |
| (714) 771-7656 | ||
| Date Submitted: | December 15, 1995 | |
| 2) | Name of Device: | Endoscope Introducer Kit |
| Proprietary/Trade Name: | (Not yet determined) | |
| Common/Usual Name: | Endoscope Introducer Sheath | |
| Classification: | Class II | |
| Classification Name: | Sheath, For Endoscope (78FED) |
3) Name of Predicate or Legally Marketed Device:
The Mitsubishi Endoscope Introducer Kit is substantially equivalent to the "Candela Introducer Sheath System" that was approved by FDA for marketing on August 16, 1991, under 510(k) No. K912443.
Description of Device: 4)
The Mitsubishi Endoscope Introducer Kit consists of an internal dilator (with luer fitting to accommodate a hemostasis valve) contained within an external sheath (with attached hemostasis valve and luer fitting). The dilator may be straight or curved and has a lumen to allow passage of a flexible guidewire.
ನ) Intended Use of Device:
The Mitsubishi Endoscope Introducer Kit is intended to provide an open channel to allow insertion of a small diameter endoscope during laparoscopic choledochoscopy.
1
510(k) Summary: #K95 Mitsubishi Cable America, Inc. Endoscope Introducer Kit December 15, 1995 Page 2
6) Comparison of Technological Characteristics:
The Mitsubishi Endoscope Introducer Kit is substantially equivalent to the predicate or legally marketed Candela Introducer Sheath System. Mitsubishi's devices employ the same design considerations, materials of construction and operating principles. The Mitsubishi devices also employ lengths, diameters, and smoothly finished contours similar to those of the predicate devices and can be sterilized. Any differences between the Mitsubishi and Candela devices do not raise new questions regarding safety or effectiveness. None of the devices actively delivers any form of energy to the target under observation.
$\mathcal{J}$
1 The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.