(196 days)
Not Found
Not Found
No
The device description focuses on the physical components and materials of a traditional laparoscope, with no mention of software, image processing, or AI/ML capabilities.
No
A laparoscope is an imaging device used to view internal body structures, not to treat them. Its function described is for illumination and viewing during surgery.
No
A laparoscope is a surgical instrument used to visualize internal organs during minimally invasive surgery; it does not diagnose conditions.
No
The device description clearly details physical components made of stainless steel, brass, aluminum, optical glass, optical fibers, and acetal plastic, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro use: The description clearly states the device is a laparoscope, which is used in vivo (within the body) for surgical procedures.
- No mention of analyzing samples from the body: IVDs are designed to examine samples taken from the human body (like blood, urine, tissue) to provide diagnostic information. This device is for direct visualization during surgery.
- Intended Use/Indications for Use is "Not Found": While this section is missing, the device description itself points to a surgical instrument, not a diagnostic test.
The description focuses on the physical components and function of a surgical laparoscope used for visualization during surgery. This is consistent with a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The outer tube of the Surgical Image Laparoscope are fabricated from 304 stainless steel. The block and light adapter are made from plated brass and the I.D. ring from anodized aluminum. The distal end tip of the laparoscope that is inserted into the body through a small incision during surgery is fabricated from optical glass which may be coated with an anti-reflective coating. The optic tube which fits within the outer tube is fabricated from stainless steel. The distal fiber which transmits light from the light source through the fiber cone, around the optic tube, and on to the surgical area is fabricated from optical fibers and sealed at the distal end with adhesive. The eye shield or camera connection adapter is made from acetal plastic or an FDA accepted equivalent. All surfaces of the Surgical Image's Laparoscope are smooth and polished or bead blasted. The end of the instrument that is inserted into the human body through an incision is blunt or rounded with no sharp edges.
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
qualified professional trained technician / 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.
The Surgical Image Laboratories Laparoscope is equivalent in materials, intended use, safety and effectiveness to the Dyonics 8000 Laparoscope. [No K/DEN number provided]
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
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
Image /page/0/Picture/0 description: The image shows a logo with a circular graphic on the left and text on the right. The graphic contains the letters 'STI' in a stylized font, enclosed within a circle with horizontal lines. To the right of the graphic, the text reads 'SURGI' on the top line and 'LABOR' on the bottom line, both in a bold, sans-serif font.