(99 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on being identical to comparative devices without mentioning advanced processing.
No
Explanation: The provided information focuses on the device's design, internal components (video imaging system), and mentions predicate and reference devices that appear to be related to imaging or visualization (like cameras), not direct therapeutic intervention. There's no mention of treating, curing, mitigating, or preventing disease, which are hallmarks of a therapeutic device.
No
The provided text does not contain any information about the device's function or "Intended Use / Indications for Use" to determine if it is diagnostic. The "Intended Use / Indications for Use" section is empty, and the "Device Description" only mentions its similarity to comparative devices without detailing their purpose.
Unknown
The summary does not provide enough information to definitively determine if the device is software-only. It mentions a "Video Imaging System" as the input modality and compares the device design to comparative devices, but it doesn't explicitly state whether the device itself is solely software or includes hardware components.
Based on the provided text, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Lack of IVD Indicators: The text does not contain any of the typical characteristics of an IVD. IVDs are used to examine specimens (like blood, urine, tissue) outside the body to diagnose diseases or conditions. The provided information focuses on a "Video Imaging System" and mentions "comparative devices" that are likely imaging systems (based on the predicate and reference devices).
- Focus on Imaging: The description points towards a device that captures video images. This is characteristic of imaging devices used in vivo (within the body) or for external visualization, not for analyzing biological samples.
- Predicate and Reference Devices: The listed predicate and reference devices (K942994 Del Medical Systems MSV-2000, K903339 Medical Dynamics camera, Storz, Olympus, etc.) are all known to be imaging systems, often used in medical procedures or for diagnostic imaging. They are not IVD devices.
- Missing IVD Information: The absence of information about sample types, analytical methods, or performance metrics related to analyzing biological samples further supports that this is not an IVD.
In summary, the information provided strongly suggests that this device is an imaging system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
the intended use the same
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The design of the S-41 and S-41S is virtually identical to the comparative devices, which are listed and displayed in Exhibits 2 and 3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video Imaging System
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
Exhibit 9
510(k) Summary
62020
AUG 30 1996
DMS will provide a 510(k) Summary and allow for the "public" to request this information.
We have taken the terminology from the Reference Manual-"Premarket Notification 510(k): Regulatory Requirements for Medical Devices" (FDA 92-4158).
Summary
Del Medical Systems feels the S-41 and S-41S Video Imaging System are substantially equivalent tothe MSV-2000 marketed byDel Medical Systems under K942924and also to many legally marketed devices already in commerical distribution such as: Storz, Olympus, MP Video, Richard Wolf, Medical Dynamics and Dyonics, just to name a few. Medical Dynamics market's their camera in conjunction with a laparossope under K903339.
The design of the S-41 and S-41S is virtually identical to the comparative devices, which are listed and displayed in Exhibits 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same, DMS feels that thes 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 lead to the safe use of the device in many practitioner's hands.