(84 days)
K-902197/B, K912859/A
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description is limited to a basic electronic video laparoscope.
No.
The 'Intended Use / Indications for Use' section is listed as 'Not Found', and the 'Device Description' only names the device as 'S-52 Electronic Video Laparossope' without specifying a therapeutic purpose. While it's used by a "trained physician," there's no information to suggest it performs therapy rather than diagnosis or visualization. Its listed predicates are also 'EVL-R' devices, which are typically for visualization.
No
The device is described as an "Electronic Video Laparoscope" and lists predicate devices that are also imaging scopes. There is no information to suggest it processes or analyzes data for diagnosis; it appears to be an imaging tool used by a physician.
No
The device description explicitly states "The S-52 Electronic Video Laparossope," which is a hardware device. The predicate devices also include hardware components (laparoscopes and CCD devices).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: This crucial section for identifying an IVD is "Not Found". IVDs typically have intended uses related to diagnosing diseases or conditions based on in vitro examination of specimens from the human body.
- Device Description: The description "The S-52 Electronic Video Laparossope" points to a surgical instrument used for minimally invasive procedures, not a device for analyzing biological samples.
- Input Imaging Modality: "Not Found" further suggests it's not an imaging device used for in vitro analysis.
- Anatomical Site: "Not Found" is less definitive, but IVDs often specify the type of specimen (e.g., blood, urine).
- Intended User / Care Setting: "trained physician" and the nature of a laparoscope indicate use in a clinical setting for surgical procedures, not laboratory analysis.
- Predicate Devices: The listed predicate devices (EVL-R, Smith & Nephew distal end CCD devices, Welch Allyn distal end CCD devices) are all types of endoscopes or related imaging devices used in surgical or diagnostic procedures on the body, not for in vitro analysis of samples.
In summary, all the available information points to the S-52 Electronic Video Laparossope being a surgical instrument used for visualization during procedures performed directly on a patient, which is not the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The design of the S-52 is virtually identical to the Smith & Nephew device and comparative to the Fujinon device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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.
K-902197/B, K912859/A
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-52 SIG K Summary (Revision 1)
SED 30 1906
Del Medical Systems feels the S-52 Electronic Video Laparossope is substantially equivalent tothe EVL-R marketed by Pujinon under K-902197/B and K912859/A in terms of technology and intended use. DMS also feels that the device is similiar to the device marketed by Smith and Nepherw in terms of technology, shape, size and composition and intended use.
The design of the S-52 is virtually identical to the Smith & Nephew device and comparative to the Fujinon device. Since the design is comparable, technology virtually identical, the specifications, apart from, the flexible vs rigid issue, which makes no difference when operated by a trained physician the devices are very similar, and the intended use the same. DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.
The wide use of the same or very similar instruments has lead to the device in many practitioner's hands.
Confirmation of Substantial Equivalence Determination made by Del Medical Systems. The device is virtually identical to the devices in commercial distribution, such as the Fujion filed under EVL-F- K902197/B and K912859/A, which the FDA has reviewed and sent Fujinon the appropriate paperwork, allowing for the marketing of this product. We also cite Smith & Nephew and Welch Allyn as makers/marketers of "distal end CCD devices"(Charged-coupled Device Laparoscopes) as other devices of comparison. Each of the predicate devices has the same intended use.
RECEIVED
27 SEP 96
IIIII
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