(56 days)
Optical Biopsy Forceps - The intended use is in urological procedures to endoscopically remove tissue for evaluation.
Urological Visual Obturators - The intended use 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. The visual obturator has a cystoscope directly inserted in the center of the obturators to allow for visualization while entering the subject.
Optical Stone Crushing Forceps - The intended use for the optical stone crushing forceps is in urological procedures to endoscopically remove, manipulate, crush, or grasp calculi (i.e. stones) and other foreign objects.
Endoscopes and accessories are described in 21 CFR 8876.1500. The COMEG Endoscopy devices that we intend to market include Optical Biopsy Forceps, Urological Visual Obturators, and Optical Stone Crushing Forceps. The stainless steel of which the 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. The devices can be reused and instructions for cleaning and sterilization will be provided.
The provided document is a 510(k) premarket notification for COMEG Endoscopy devices, specifically Optical Biopsy Forceps, Urological Visual Obturators, and Optical Stone Crushing Forceps. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving efficacy or meeting specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study design, sample sizes, expert involvement, ground truth establishment, or clinical effectiveness.
The document states:
- "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 subject devices are similar to devices marketed by Karl Storz. ... The intended uses are the same for the subject devices and the competitor's product. 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."
This indicates that the FDA's clearance was based on a comparison to existing devices rather than a de novo study to establish performance against specific acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the word "Endoscopy" in a simple, sans-serif font. The letters are evenly spaced and appear to be printed in black ink on a white background. The word is presented in a straightforward manner, with no additional design elements or embellishments.
1971202 0102
SUMMARY OF SAFETY AND EFFECTIVENESS FOR COMEG OPTICAL BIOPSY FORCEPS, UROLOGICAL VISUAL OBTURATORS, OPTICAL STONE CRUSHING FORCEPS
$807.92 (a)(1)
Contact Person:
Peter Duffy Vice President
Date of Summary Preparation: March 28, 1997
$807.92 (a)(2)
Trade Name
COMEG Optical Biopsy Forceps COMEG Urological Visual Obturators COMEG Optical Stone Crushing Forceps
Endoscopes and accessories Common Name:
Classification Name: Endoscope and accessories (21 CFR §876.1500)
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Karl Storz Short Jaw Biopsy Forceps, Visual Obturators for Cystoscopes - Urethroscopes, Kidney Stone Crusher
$807.92 (a)(4)
Description of Device:
Endoscopes and accessories are described in 21 CFR 8876.1500. The COMEG Endoscopy devices that we intend to market include Optical Biopsy Forceps, Urological Visual Obturators, and Optical Stone Crushing Forceps. The stainless steel of which the 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. The devices can be reused and instructions for cleaning and sterilization will be provided.
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Endoscopy
Intended Use:
K 971202
p<92
Optical Biopsy Forceps - The intended use is in urological procedures to endoscopically remove tissue for evaluation.
Urological Visual Obturators - The intended use 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. The visual obturator has a cystoscope directly inserted in the center of the obturators to allow for visualization while entering the subject.
Optical Stone Crushing Forceps - The intended use for the optical stone crushing forceps is in urological procedures to endoscopically remove, manipulate, crush, or grasp calculi (i.e. stones) and other foreign objects.
$807.92 (a)(6)
Comparison of Technical Characteristics:
The subject devices are similar to devices marketed by Karl Storz. The "Quick-Connection" feature is also used in COMEG Resectoscope accessories (K970764). The intended uses are the same for the subject devices and the competitor's product. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 1997
Mr. Peter Duffy Vice President COMEG Endoscopy 13790 East Rice Place Aurora, Colorado 80015 Re: K971202
COMEG Optional Stone Crushing Forceps, Visual . Obturators, and Optical Biopsy Forceps Dated: March 28, 1997 Received: April 1. 1997 Regulatory Class: II 21 CFR 876.1500/Procode: 78 KOG
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, market the device, 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 (Special Controls) or class III (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 the Electronic Product 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 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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,
Lillian Yin, Ph.D.
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
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Indications for Use
510(k) Number (if known)
Device Name: COMEG Optical Biopsy Forceps, Urological Visual Obturators, Optical Stone Crushing Forceps
Indications for Use:
Optical Biopsy Forceps - The intended use is in urological procedures to endoscopically remove tissue for evaluation.
Urological Visual Obturators - The intended use 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. The visual obturator has a cystoscope directly inserted in the center of the obturators to allow for visualization while entering the subject.
Optical Stone Crushing Forceps - The intended use for the optical stone crushing forceps is in urological procedures to endoscopically remove, manipulate, crush, or grasp calculi (i.e. stones) and other foreign objects.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) ાર
Over-the-Counter Use
Robert R. Settling
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
§ 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.