(77 days)
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No
The description focuses on the mechanical function and design of a surgical clip applier and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No
The device is described as an instrument for ligating and marking vessels and tubular structures during endoscopic surgery, which is an interventional surgical tool, not a device directly applying therapy.
No
The device is intended for "ligating and marking vessels and tubular structures" in endoscopic surgery, which describes a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly outlines a physical, reusable stainless steel instrument with mechanical components (control levers, clip magazine attachment) designed for surgical procedures. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in endoscopic surgery for ligating and marking vessels and tubular structures." This describes a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a reusable surgical instrument used to apply clips during surgery. This is consistent with a surgical device, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The devices presented in this submission are intended for use in endoscopic surgery for ligating and marking vessels and tubular structures.
Product codes
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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.
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
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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
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.
Key Metrics
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Predicate Device(s)
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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
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
Page 1 of 2
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.
1
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.