(77 days)
The devices presented in this submission are intended for use in endoscopic surgery for ligating and marking vessels and tubular structures.
Aesculap's Endoscopic Clip Appliers (PL506R, PL508R) are reusable stainless steel instruments 10mm in diameter and ranging in length from 260mm to 370mm. They are designed for use with a disposable clip magazine which attaches to the shaft of the clip applier. The clip magazine cartridge holds 8 titanium clips which can be applied one at a time. The instrument handle has a control lever for supplying the clips and a separate control lever for closing the clips. The design enables the surgeon to apply several clips without the need for withdrawing and reinserting the clip applier each time.
Like Aesculap's Modular Endoscopic Instruments, these clip appliers can be disassembled for cleaning, disinfection and sterilization. The handle can be removed, allowing the shaft of the instrument to be disassembled into three separate pieces.
The provided text describes a 510(k) summary for Aesculap Endoscopic Clip Appliers. This document is for a medical device (surgical instrument) and does not contain information about an AI/ML algorithm or a study involving acceptance criteria and device performance in the context of diagnostic or prognostic AI.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to predicate devices, discussing device description, intended use, and manufacturing standards (ISO, German Din Standards), which are typical for traditional medical devices rather than AI-powered systems.
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K9624-93
Image /page/0/Picture/1 description: The image shows the logo for AESCULAP. The logo consists of a square with a white circle inside, containing a black medical symbol. To the right of the square is the word "AESCULAP" in large, bold, black letters. There is a small registered trademark symbol next to the "P" in AESCULAP.
SEP 11 1986
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510(k) Summary of Safety and Effectiveness
(in Accordance with SMDA of 1990)
Aesculap Endoscopic Clip Appliers June 25, 1996
Aesculap®, Inc. Submitted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Mary Ellen Holden Phone: (415) 876-7000 x348 (415) 589-3007 FAX:
Product Name
| Trade Name: | Endoscopic Clip Appliers |
|---|---|
| Common Name | Endoscopic Instruments |
| Classification Name: | Endoscope and Accessories |
Predicate Device
Aesculap's Endoscopic Clip Appliers with disposable clip magazine represents a modification to existing devices. The modified devices are compared to their predecessors, which were previously cleared in Aesculap's 510(k)'s. The modified Endoscopic Clip Appliers with disposable clip magazine are also compared to endoscopic clip appliers and implantable clips by Baxter. Ethicon. Horizon Surgical, and U.S. Surgical.
Device Description
Aesculap's Endoscopic Clip Appliers (PL506R, PL508R) are reusable stainless steel instruments 10mm in diameter and ranging in length from 260mm to 370mm. They are designed for use with a disposable clip magazine which attaches to the shaft of the clip applier. The clip magazine cartridge holds 8 titanium clips which can be applied one at a time. The instrument handle has a control lever for supplying the clips and a separate control lever for closing the clips. The design enables the surgeon to apply several clips without the need for withdrawing and reinserting the clip applier each time.
Like Aesculap's Modular Endoscopic Instruments, these clip appliers can be disassembled for cleaning, disinfection and sterilization. The handle can be removed, allowing the shaft of the instrument to be disassembled into three separate pieces.
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510(k) Summary of Safety and Effectiveness
(in Accordance with SMDA of 1990)
Aesculap Endoscopic Clip Appliers
Intended Use
The devices presented in this submission are intended for use in endoscopic surgery for ligating and marking vessels and tubular structures.
Summary of Technological Characteristic
Aesculap's Endoscopic Clip Appliers represent no change in technological characteristics, only modifications to instrument design.
Performance Data
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the Endocopic Clip Appliers and disposable clip magazine will be manufactruered in accordance with ISO and German Din Standards. Furthermore, Aesculap AG has received ISO 9001 certification.
Substantial Equivalence
Aesculap believes that the Endoscopic Clip Appliers presented in this submission are substantially equivalent in design, function, and intended use to the presented devices from Baxter, Ethicon, Horizon Surgical, and U.S. Surgical.
§ 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.