(97 days)
Not Found
Not Found
No
The device description explicitly states the technology is "virtually identical" to predicate devices, and there are no mentions of AI, ML, or related concepts.
No.
The document describes the S-357 device as comparable to video imaging devices from companies like Circon/ACMI, Storz, Stryker, Smith & Nephew, and Olympus. These companies are known for producing endoscopy and surgical imaging equipment, which are primarily diagnostic or provide visualization during procedures, rather than offering therapeutic treatment. The description focuses on design, technology, specifications, and intended use being "the same as those above listed devices," none of which inherently imply a therapeutic function.
No
The document states that the intended use of the S-357 is the same as the listed predicate devices, which are primarily optical viewing instruments (e.g., Circon/ACMI, Storz, Stryker, Smith & Nephew, Olympus are known for endoscopes and related surgical instruments). While some endoscopes can be used for diagnostic purposes, the provided text does not explicitly state that the S-357 or its comparative devices are diagnostic in nature. Without information on the "intended use/indications for use", and based on the provided text's focus on "safe use and/or effectiveness" and "video imaging", it appears to be a general viewing or imaging device, not specifically a diagnostic one.
Unknown
The summary lacks sufficient detail about the device's components and functionality to definitively determine if it is software-only. While it mentions comparison to other devices and video imaging input, it doesn't explicitly state whether it includes hardware or is purely software.
Based on the provided information, it is not possible to definitively determine if this device is an IVD (In Vitro Diagnostic).
Here's why:
- The "Intended Use / Indications for Use" section is "Not Found". This is the most crucial section for determining if a device is an IVD. IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Without the intended use, we cannot assess if it fits this definition.
- The "Device Description" mentions comparison to other devices but doesn't explicitly state their nature. While it says the design, technology, and intended use are the same as the listed reference devices, it doesn't tell us what those reference devices are used for. The listed reference devices (Circon/ACMI, Storz, Stryker, Smith & Nephew, Olympus) are manufacturers of a wide range of medical devices, including both IVDs and non-IVDs.
- The input modality is "Video Imaging". While video imaging can be used in some IVD systems (e.g., for analyzing microscopic images of specimens), it is also used in many non-IVD medical devices (e.g., endoscopes, surgical cameras).
In summary, the information provided is insufficient to classify the S-357 as an IVD. We would need to know the specific intended use of the device to make that determination.
N/A
Intended Use / Indications for Use
The design of the S-357 is virtually identical to the comparative device as slisted in the above paragraph.. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same as those above listed devices, DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The design of the S-357 is virtually identical to the comparative device as slisted in the above paragraph.
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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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).
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
Revised Summary for S-357
510(k)
Summary-(Revision 1)
OCT 15 1996 K962684
Del Medical Systems feels the S-357 Video Imaging System is substantially equivalent to the many marketed devices already in commercial distribution. The legally marketed devices already in commerical distribution are: Circon/ACMI, Storz, Stryker, Smith & Nephew and Olympus, just to name a few.
The design of the S-357 is virtually identical to the comparative device as slisted in the above paragraph.. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same as those above listed devices, DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.
For information purposes and completeness, Del Medical Systems has also incorporated other legally marketed devices in this filing to illustrate the wide, general use of similar other devices. This wide use has led to the safe use of the device in many practitioner's hands.