(50 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical accessories for endoscopic procedures, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device components are accessories for urological procedures (e.g., sheaths, dilators, syringes, scissors) that facilitate examination or access, but they do not directly provide therapy. They are instrumental in diagnostic and procedural steps rather than being therapeutic interventions themselves.
No
The device description focuses on tools for surgical access, tissue manipulation, and fluid management within urological procedures, with one component specified as a "cystoscope diagnostic adapter" which, while connected to a cystoscope (a diagnostic imaging device), serves as a bridge or provides passage for instruments rather than performing diagnosis itself. The primary function of the listed devices appears to be aiding endoscopic procedures, not making a diagnosis.
No
The device description explicitly lists physical components made of materials like stainless steel, brass, plastic, PTFE, aluminum oxide, and silicone. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that these devices are used during urological procedures to examine and access the urethra and bladder, provide irrigation and suction, and facilitate the passage of other instruments. They are used in vivo (within the living body) for direct examination and manipulation.
- Lack of Sample Analysis: There is no mention of these devices being used to analyze samples taken from the body. Their function is entirely procedural and involves direct interaction with the patient's anatomy.
- Regulatory Classification: The text references regulatory classifications like 21 CFR §876.1500 (endoscope and accessories) and 21 CFR §876.5520 (urethral dilator), which fall under the category of medical devices used in surgical or diagnostic procedures, not IVDs.
Therefore, these devices are classified as medical devices used for surgical and diagnostic procedures, not as in vitro diagnostics.
N/A
Intended Use / Indications for Use
Continuous-Flow Inner and Outer Sheaths The intended use for the continuous-flow inner and outer sheaths is in urological procedures to endoscopically examine and allow access to the urethra and bladder and also provide simultaneous suction and irrigation for the resectoscope. The surgeon performs the procedure through the urethra. The sheaths are devices that allow for a less traumatic passage for cystoscopes, resectoscopes, and various instrumentation. 2 Fixed Stopcock and 2-Way-Tap Outer Sheaths The intended use for these devices is in urological procedures to endoscopically examine and allow access to the urethra and bladder. The surgeon performs the examination through the urethra. The sheaths are devices that allow for a less traumatic passage for cystoscopes and various instruments and also allow for simultaneous suction and irrigation.
Obturators: The intended use for the obturators is in urological procedures to endoscopically examine and allow access to the urethra and bladder. The obturator is inserted into the sheath and its blunt end protrudes from the distal end. It protects the tissue when the sheath is entered into the area under examination.
Cystoscope Diagnostic Adapters The intended use for the cysotocope diagnostic adapter is in urological procedures to bridge the cystoscope to the cystoscope sheath. In versions with operating channels, it also provides passage for instruments.
Dilator, Urethral Meatus: The intended use for the dilator is in urological procedures. It is inserted into the urethra and is intended to dilate the penis for insertion of a catheter or instrumentation.
Urological Syringe and Evacuator with Adapter The intended use for the urological syringe and evacuator with adapter is in urological procedures. The syringe is connected directly to the sheath and is used for manual suction of the bladder. The evacuator is used to remove loose debris (tissue) from the bladder. It is also connected directly to the sheath.
Single Action scissors The intended use for the single action scissors is in urological and gastroenterological procedures to endoscopically cut tissue and/or sutures.
Luer Lock Connectors: The intended use for the luer lock connectors is in urological procedures. The luer is connected directly to the sheath suction and irrigation port and is used to connect catheters and suction and irrigation tubes to sheaths. They provide an adaption, extension, or stopcock.
Product codes
Not Found
Device Description
The COMEG Endoscopy devices that we intend to market include the following resectoscope accessories (Tier 1 devices): sheaths; obturators; cystoscope diagnostic adapters; dilator, urethral meatus; urological syringe and evacuator with adaptor; cystoscope (single action) scissors; and, luer lock connectors.
Resectoscope accessories are described in endoscope and accessories 21 CFR §876.1500 and dilators are described in urethral dilator 21 CFR §876.5520. The materials used to fabricate these devices include stainless steel, brass chrome plated, plastic (polyvinylchoride (PVC) and Tecapeek), PTFE, aluminum oxide, and silicone. The stainless steel of which these devices are fabricated is ASTM type 304 which meets the ASTM specification F899-84 Standards for Stainless Steel Billet, Bar and Wire for Surgical Instruments and is biocompatible with human tissue.
These devices can be reused and instructions for cleaning and sterilization will be provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder, penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the word "COMEG" in a bold, sans-serif font, with the letters in white against a black background. Below the word "COMEG" is the word "Endoscopy" in a smaller, serif font. The word "Endoscopy" is also in white.
K970764
P192 APR 22 1997
SUMMARY OF SAFETY AND EFFECTIVENESS FOR RESECTOSCOPE ACCESSORIES
$807.92 (a)(1)
Contact Person:
Peter Duffy Vice President
Date of Summary Preparation: February 26, 1997
$807.92 (a)(2)
| Trade Name: | COMEG Endoscopy Resectoscope Accessories | |
|---|---|---|
| Common Name: | Endoscope and accessories | 13790 E. RICE PLACE |
| AURORA, CO 80015 | ||
| PHONE (303) 617-7901 | ||
| FAX (303) 617-7929 | ||
| (800) 647-6883 | ||
| Classification Name: | Endoscope and accessories (21 CFR §876.1500) | |
| Urethral dilator (21 CFR §876.5520) |
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Karl Storz resectoscope accessories and Circon ACMI Sheaths
$807.92 (a)(4)
Description of Device. The COMEGEndoscopy devices that we intend to market include the following resectoscope accessories (Tier 1 devices): sheaths; obturators; cystoscope diagnostic adapters; dilator, urethral meatus; urological syringe and evacuator with adaptor; cystoscope (single action) scissors; and, luer lock connectors.
Resectoscope accessories are described in endoscope and accessories 21 CFR §876.1500 and dilators are described in urethral dilator 21 CFR §876.5520. The materials used to fabricate these devices include stainless steel, brass chrome plated, plastic (polyvinylchoride (PVC) and Tecapeek), PTFE, aluminum oxide, and silicone. The stainless steel of which these devices are fabricated is ASTM type 304 which meets the ASTM specification F899-84 Standards for Stainless Steel Billet, Bar and Wire for Surgical Instruments and isbiocompatible with human tissue.
These devices can be reused and instructions for cleaning and sterilization will be provided. $807.92 (a)(5)
Image /page/0/Picture/15 description: The image shows a close-up of a protractor with degree markings. The protractor displays degree values of 98, 102, and 106. A crosshair is positioned over the protractor, likely used for precise angle measurement or alignment.
1
Intended Use:
2000
Endoscopy
Continuous-Flow Inner and Outer Sheaths The intended use for the continuous-flow inner and outer sheaths is in urological procedures to endoscopically examine and allow access to the urethra and bladder and also provide simultaneous suction and irrigation for the resectoscope. The surgeon performs the procedure through the urethra. The sheaths are devices that allow for a less traumatic passage for cystoscopes, resectoscopes, and various instrumentation. 2 Fixed Stopcock and 2-Way-Tap Outer Sheaths The intended use for these devices is in urological procedures to endoscopically examine and allow access to the urethra and bladder. The surgeon performs the examination through the urethra. The sheaths are devices that allow for a less traumatic passage for cystoscopes and various instruments and also allow for simultaneous suction and irrigation.
970764
P2012
Obturators: The intended use for the obturators is in urological procedures to endoscopically examine and allow access to the urethra and bladder. The obturator is inserted into the sheath and its blunt end protrudes from the distal end. It protects the tissue when the sheath is entered into the area under examination.
Cystoscope Diagnostic Adapters The intended use for the cysotocope diagnostic adapter is in urological procedures to bridge the cystoscope to the cystoscope sheath. In versions with operating channels, it also provides passage for instruments.
Dilator, Urethral Meatus: The intended use for the dilator is in urological procedures. It is inserted into the urethra and is intended to dilate the penis for insertion of a catheter or instrumentation.
Urological Syringe and Evacuator with Adapter The intended use for the urological syringe and evacuator with adapter is in urological procedures. The syringe is connected directly to the sheath and is used for manual suction of the bladder. The evacuator is used to remove loose debris (tissue) from the bladder. It is also connected directly to the sheath.
Single Action scissors The intended use for the single action scissors is in urological and gastroenterological procedures to endoscopically cut tissue and/or sutures.
Luer Lock Connectors: The intended use for the luer lock connectors is in urological procedures. The luer is connected directly to the sheath suction and irrigation port and is used to connect catheters and suction and irrigation tubes to sheaths. They provide an adaption, extension, or stopcock.
$807.92 (a)(6)
Comparison of Technical Characteristics:
The subject devices are similar to devices marketed by Karl Storz and Circon ACML The predicate device for the "Quick-Connection" feature is the Circon ACMI inner and outer sheaths. The intended uses are the same for the subject devices and the competitors' products. The materials used to fabricate both the COMEG and the Karl Storz devices and the operational principles and mode of action are similar as well.