(88 days)
Smith & Nephew Images Hysteroscopes and accessories are used to permit viewing of the cervial canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for endoscopic examination and treatment of the cerivcal canal and uterine cavity.
The Images Endoscopes and accessories transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a series of optical lenses and prisms. Hysteroscopic sheaths are used to access and maintain an opening into the uterus for introduction of the endoscope and surgical instruments. Sheaths also allow access for gas or liquid distention of the uterus. Semi-rigid and flexible manual instruments are utilized for examination and treatment of cervical and uterine tissues.
This document is a 510(k) summary for the "Smith & Nephew Images Endoscopes and Accessories for Use in Hysteroscopic Surgical Procedures" (K971188). It describes the device, its intended use, and its substantial equivalence to predicate devices.
Based on the provided text, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria.
The 510(k) submission process focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than proving the de novo performance against a new set of acceptance criteria through a specific study.
Therefore, I cannot extract the requested information (points 1-9) because it is not present in the provided text. The document primarily establishes that the new device is "substantially equivalent in design, materials, function, and intended use" to existing, legally marketed devices.
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JUN 27 1997
Endoscopy Division
Smith & Nenhew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: 508-749-1000 Telefax: 508-749-1599
510(k) Summary Smith & Nenhew. Inc., Endoscopy Division Images Endoscopes and Accessories for Use in Hysteroscopic Surgical Procedures
Substantial Equivalence:
The Smith & Nephew, Inc. Images Endoscopes and accessories for use in hysteroscopic surgical procedures are substantially equivalent in design, materials, function, and intended use to telescopes and accessories offered by Karl Storz Endoscopy and hysteroscopes and accessories offered by Henke-Sass Wolf. Smith & Nephew Semi-rigid and Flexible Manual Instruments are substantially equivalent in design, materials, function, and intended use to hysteroscopic semi-rigid and flexible manual instruments offered by Circon ACMI and Richard Wolfe
Predicate Device:
The predicate devices for this submission are the Karl Storz Endoscopy Telescopes and accessories indicated for use in hysteroscopic surgical procedures, the Hysteroscopes and accessories offered by Henke-Sass Wolf and Semi-rigid and Flexible Manual Instruments offered by Circon ACMI and Richard Wolfe.
Summary of Device Function:
The Images Endoscopes and accessories transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a series of optical lenses and prisms. Hysteroscopic sheaths are used to access and maintain an opening into the uterus for introduction of the endoscope and surgical instruments. Sheaths also allow access for gas or liquid distention of the uterus. Semi-rigid and flexible manual instruments are utilized for examination and treatment of cervical and uterine tissues.
Intended Use of Device:
Smith & Nephew Images Endoscopes are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures,
Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for endoscopic examination and treatment of the cervical canal and uterine cavity.
Comparison of Technological Characteristics of Predicate Device:
The basic technologies, design and function of the Smith & Nephew Semi-rigid and Flexible Manual Instruments and Images Endoscopes and accessories is substantially equivalent in materials, design and function to the Circon ACMI and Richard Wolfe Semi-rigid and Flexible Manual Instruments, the Karl Storz Endoscopy Telescopes and accessories for use in hysteroscopic procedures and to Henke-Sass Wolf Hysteroscopes and accessories. These devices present no new safety or effectiveness concerns.
Elizabeth Ci Ryan
Elizabeth A. Rvan Regulatory Affairs Specialist
mith - Nenhew
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 27 1997
Re: K971188 . . .. Images Hysteroscopes and Accessories . Dated: March 28, 1997 Received: March 31, 1997 Regulatory class: II 21 CFR §884.1690/Product code: 85 HIH
Ms. Deborah Connors Regulatory Affairs Specialist Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810
Dear Ms. Connors:
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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 iis internet address http://www.fda.gov/cdch/dsmamain.html".
Sincerely vours.
h.J. liau Yu
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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K971188 510(k) Number :
Device Name : Smith & Nephew Images Hysteroscopes and accessories
Indications for Use :
Smith & Nephew Images Hysteroscopes and accessories are used to permit viewing of the cervial canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for endoscopic examination and treatment of the cerivcal canal and uterine cavity.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Dater (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ Over-the-Counter ___________ OR Prescription Use (Per 21 CFR 801,109) (Optional Format 1-2-96)
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.