(486 days)
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No
The summary describes a mechanical surgical holder and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is described as a surgical holder used for manipulation and positioning during laparoscopic procedures, which supports the surgical process rather than directly treating a disease or condition. Its predicate devices are also scope holders, which are instruments used to facilitate surgery, not to provide therapy.
No
The device, a surgical holder for a telescope, is described as being used for "manipulation and positioning" during laparoscopic procedures. This is a functional role for assisting in a surgical procedure, not for diagnosing a condition.
No
The device is described as a "Surgical Holder for Telescope" and its intended use is for "manipulation and positioning of a telescope during laparoscopic procedures," which clearly indicates a physical hardware device.
Based on the provided information, the Olympus SH-1 Surgical Holder for Telescope is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "manipulation and positioning of a telescope during laparoscopic procedures." This describes a surgical tool used in vivo (within the body) to assist with a surgical procedure.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Olympus SH-1 is a mechanical holder used during surgery, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Olympus SH-1 Surgical Holder for Telescope can be utilized for the manipulation and positioning of a telescope during laparoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
510(k) SUMMARY FOR OLYMPUS SH-1 Surgical Holder for Telescope
MAY - 5 1997
| Device Name: | Olympus SH-1 Surgical Holder for Telescope |
|---|---|
| Common/Usual Name: | Telescope Holder |
| Classification Name: | Endoscopes and Accessories |
| Laparoscope and Accessories | |
| Predicate Devices: | Scope Holders manufactured by Aesculap. |
| Andronic, Automated Medical Products, Codman | |
| Computer Motion Inc., Leonard Medical, | |
| Mediflex, and Thompson Medical Products. | |
| Submitted By: | |
| (Contact Person) | Mr. Barry Sands |
| Olympus America Inc. | |
| Endoscope Division | |
| Two Corporate Center Drive | |
| Melville, NY 11747 | |
| (516) 844-5474 |
Summary Preparation Date: December 29, 1995
Statement of Intended Use:
The Olympus SH-1 Surgical Holder for Telescope can be utilized for the manipulation and positioning of a telescope during laparoscopic procedures.
Comparison to Predicate Devices:
The Olympus SH-1 Surgical Holder for Telescope is similar in design, function, and intended use to currently marketed devices for laparoscopic surgery manufactured by Aesculap, Andronic, Automated Medical Products, Codman, Computer Motion Inc., Leonard Medical, Mediflex, and Thompson Medical Products.