(84 days)
Not Found
Not Found
No
The description focuses on mechanical and electrical components for surgical procedures, with no mention of AI or ML for image analysis, decision support, or automated control.
Yes
The devices are intended for use in urological procedures to remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra, which are therapeutic actions.
No
The devices described (resectoscopes, urethrotomes, electrodes, etc.) are intended for therapeutic purposes such as removing, cutting, coagulating, and transecting tissue. While visualization (cystoscope for visualization, visually finding the location of stricture) is mentioned as part of the procedure, it is explicitly for guiding the surgical intervention and not for making a diagnosis. The primary function is active tissue manipulation for treatment.
No
The device description explicitly details physical components made of materials like stainless steel, plastic, brass, silicone, teflon, ultem, tungsten, and silver, and describes their mechanical functions in surgical procedures. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This testing is performed outside of the body.
- Device Function: The described devices (resectoscopes, working elements, urethrotomes, electrodes, etc.) are surgical instruments used directly within the body during urological procedures. Their purpose is to physically manipulate, cut, coagulate, or remove tissue.
- Intended Use: The intended use clearly states that these devices are used in urological procedures to perform actions on tissue within the bladder, prostate, and urethra. They are not used to analyze samples taken from these areas.
The description focuses on the mechanical and electrical functions of the instruments for surgical intervention, not on diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current.
Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths.
The intended use for the urethrotomes is in urological procedures to endoscopically cut and/or transect tissue (strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome will be extracted, cutting the affected area.
Electrodes are intended to be used endoscopically in conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable.
Product codes (comma separated list FDA assigned to the subject device)
FJL, FDC, EZO, FAS
Device Description
The COMEG devices that we intend to market include the following endoscopic electrosurgical instruments and accessories: resectoscope and laser-resectoscope working elements; Albarran deflectors; urethrotomes (urethrotome bridges, obturators, and knives); high frequency cable; and, electrodes. A "Quick-Connection" feature is used to attach the device to the sheath or working element.
Endoscopic electrosurgical instruments and accessories are described in endoscope and accessories 21 CFR 8876.1500, urethrotomes are described in 21 CFR §876.4770, and endoscope ESU unit and accessories are described in 21 CFR §876.4300.
The Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current.
These devices are composed of stainless steel chrome plated, plastic, and brass chrome plated. The high frequency cable is composed of silicone.
Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths.
These devices are composed of stainless steel chrome plated and brass chrome plated.
The intended use for the urethrotomes is in urological procedures to endoscopically cut and/or transect tissue (strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome will be extracted, cutting the affected area.
These devices are composed of stainless steel chrome plated, plastic, and brass chrome plated. The complete working unit is comprised of each of the models below plus a cystoscope.
The electrodes are intended to be used endoscopically in conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable.
These electrodes are composed of stainless steel, teflon, silicone, ultem (black plastic), tungsten, and silver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, prostate, urethra
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.
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.
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/ 97/881 AUG 12 1997
E n d o s c o p y
pg 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS FOR RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS. ALBARRAN DEFLECTORS, URETHROTOMES, AND ELECTRODES
$807.92 (a)(1)
Contact Person: Peter Duffy Vice President
May 16, 1997 Date of Summary Preparation:
$807.92 (a)(2)
Trade Name: COMEG Endoscopy Resectoscope and Laser-Resectoscope Albarran Deflectors. Urethrotomes. Working Elements. and Electrodes Common Name: Endoscopes and accessories Classification Name: Endoscope and accessories (21 CFR $876.1500) Urethrotome (21 CFR §876.4770) Endoscope ESU unit and accessories (21 CFR $876.4300)
§807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Karl Storz and Circon ACMI
$807.92 (a)(4)
The COMEG devices that we intend to market Description of Device: the following endoscopic electrosurgical instruments and accessories: include resectoscope and laser-resectoscope working elements; Albarran deflectors; urethrotomes (urethrotome bridges, obturators, and knives); high frequency cable; and, electrodes. A "Quick-Connection" feature is used to attach the device to the sheath or working element.
Endoscopic electrosurgical instruments and accessories are described in endoscope and accessories 21 CFR 8876.1500, urethrotomes are described in 21 CFR §876.4770, and endoscope ESU unit and accessories are described in 21 CFR §876.4300.
The Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the
1
K971881 Pg 2 of 2
back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current.
These devices are composed of stainless steel chrome plated, plastic, and brass chrome plated. The high frequency cable is composed of silicone.
Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths.
These devices are composed of stainless steel chrome plated and brass chrome plated.
The intended use for the urethrotomes is in urological procedures to endoscopically cut and/or transect tissue (strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome will be extracted, cutting the affected area.
These devices are composed of stainless steel chrome plated, plastic, and brass chrome plated. The complete working unit is comprised of each of the models below plus a cystoscope.
The electrodes are intended to be used endoscopically in conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable.
These electrodes are composed of stainless steel, teflon, silicone, ultem (black plastic), tungsten, and silver.
8807.92 (a)(5) Intended Use:
See Device Description above.
$807.92 (a)(6)
Endosco
Comparison of Technical Characteristics:
The subject devices are similar to devices marketed by Karl Storz and Circon ACMI. The predicate device for the Quick-Connection feature is Circon ACMI. The intended uses for the subject devices 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.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its head and wings.
Food and Drug
9200 Corporate
Rockville MD 2
AUG 1 2 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Duffy Vice President COMEG Endoscopy 13790 E. Rice Place Aurora, Colorado 80015
Re: K971881 COMEG Resectoscope and Laser-Resectoscope Working Elements, Urethrotomes (bridges, obturator, and knives), and Electrodes Dated: May 16, 1997 Received: May 20, 1997 Regulatory Class: II 21 CFR §876.1500, 876.4770, and 876.4300 Product Code: FJL, FDC, EZO, and FAS
Dear Mr. Duffy
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitr diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
H.D.Liau Yin
Lillian Yin, Ph.D. Director. Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "COMEG" in a bold, sans-serif font, with each letter in white against a black background. Below the word "COMEG", the word "Endoscopy" is written in a smaller, serif font. The word "Endoscopy" is also in white against a black background. The image appears to be a logo or branding for a medical company specializing in endoscopy.
Indications for Use
510(k) Number (if known) Device Name: Endoscopic electrosurgical instruments and accessories
Indications for Use:
Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current.
Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths.
Urethrotomes are intended to be used in urological procedures to endoscopically cut and or transect tissue(strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome knife will be extended an the entire urethrotome will be extracted cutting the affected area.
Electrodes are intended to be used endoscopically im conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | K | OR |
|---|---|---|
| (Per 21 CFR 801.109) | ||
| (Division Sign-Off) | Dmed VAP | |
| Division of Reproductive, Abdominal, ENT, | ||
| and Radiological Devices | ||
| 510(k) Number | K971881 |
-5-Over-the-Counter Use