(252 days)
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No
The summary mentions "Adaptive Image Processor" but does not explicitly mention AI, ML, or related terms like DNN. There is also no information about training or test sets, which are typically associated with ML models.
No.
The device is described as an "Image Processor," which suggests it is used for diagnostic purposes (e.g., processing medical images for review by a physician) rather than directly treating a condition. Therapeutic devices typically involve some form of intervention or treatment delivery.
No
The Intended Use / Indications for Use section states "Medical Adaptive Image Processor for Medical Applications," which describes a device that processes images rather than diagnosing conditions. The device description also focuses on image processing capabilities. There is no mention of outputting a diagnosis, risk assessment, or disease detection.
Unknown
The summary lacks sufficient detail to definitively determine if the device is software-only. While it mentions "Image Processor," it doesn't explicitly state it's solely software and provides no information about hardware components or dependencies.
Based on the provided information, it is unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The intended use is "Medical Adaptive Image Processor for Medical Applications." This describes a device that processes medical images, which is typically an in vivo (within the body) diagnostic or therapeutic process, not an in vitro (outside the body) diagnostic process.
- Device Description: The description mentions it's an "Image Processor." IVDs typically involve analyzing samples like blood, urine, or tissue outside the body.
- Lack of IVD-Specific Information: The provided text lacks any mention of:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information about a patient's health status based on analysis of biological samples.
In summary, the information strongly suggests this device is involved in processing medical images obtained from within the body, which aligns with the definition of a medical device used for in vivo applications, not an IVD.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
the nD Vision-220, Medical Adaptive Image Processor for Medical Applications
Mentions image processing
Medical Adaptive Image Processor for Medical Applications
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.
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Revised Summary for nD VISION-220
SEP 30 1996
510(K) Summary-(Revision 1)
Del Medical Systems feels the nD Vision-220, Medical Adaptive Image Processor for Medical Applications is substantially equivalent to a marketed devices already in commerical distribution by DigiVision.
The design of the nD Vision-220, Medical Adaptive Image Processor for Medical Applications is virtually identical to the comparative device manufactured and sold by Digivision. Since the design is comparable, technology virtually identical, the specifications similar and the intended use the same, we feel that the devices are substatially equivalent. In addition, the minor differences have no impact on the safe use and/or effectiveness of the device.
Anyone requiring the above information can receive the information by writing to Del Medical Systems at the address listed or by calling Del Medical Systems at (914)-686-3600 or writing Del Medical Systems at One Commerce Park. Valhalla, NY 10595.
27 SEP 96
RECEIVED
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