(57 days)
The Smith & Nephew Operative Hysteroscope and accessories are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The proposed Smith & Nephew Operative Hysteroscope and Accessories is a reusable surgical device that incorporates a working channel into the needle portion of the hysteroscope. A reusable continuous flow sheath and blunt obturator are offered for atraumatic insertion through the uterine cervix. The needle portion of the hysteroscope has an oval configuration to accommodate adequate fluid flow between the sheath and hysteroscope. The working channel is D-shaped to accommodate the fiber bundles and optical train in the needle. The Smith & Nephew Operative Hysteroscope is compatible with the ETO and autoclave sterilization process. The device accessories can be autoclaved for reuse.
The provided document is a 510(k) summary for the Smith & Nephew Operative Hysteroscope and Accessories. It describes the device and its intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).
The 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) rather than providing detailed performance data from new studies. The critical information required to answer your questions about acceptance criteria and study details is explicitly missing from this type of regulatory document.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document states: "Smith & Nephew's Operative Hysteroscope and accessories is substantially equivalent in design, materials of construction, function and intended use to the Smith & Nephew Images Hysteroscopes and accessories and the Richard Wolf operative Hysteroscopes. The changes in geometry do not introduce any new risks to the proposed device." This indicates that the regulatory approval is based on equivalence to existing devices, not on a new clinical study with new acceptance criteria.
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JAN 1 7 2002
K013870
page 1 of 2
510(k) Summary Smith & Nephew Operative Hysteroscope and Accessories Date Prepared:
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
A. Submitter
Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810
B. Company Contact
Janice Haselton Regulatory Affairs Specialist
C. Device Name
Trade Name: Smith & Nephew Operative Hysteroscope and Accessories Common Name: Hysteroscope Hysteroscopes and Accessories Classification Name:
Predicate Devices D.
Smith & Nephew's Images Hysteroscopes and Accessories K 971188 Richard Wolf's Hysteroscopes Operating Sheath and Insert K 000673
E. Description of Device
The proposed Smith & Nephew Operative Hysteroscope and Accessories is a reusable surgical device that incorporates a working channel into the needle portion of the hysteroscope. A reusable continuous flow sheath and blunt obturator are offered for atraumatic insertion through the uterine cervix.
The needle portion of the hysteroscope has an oval configuration to accommodate adequate fluid flow between the sheath and hysteroscope. The working channel is D-shaped to accommodate the fiber bundles and optical train in the needle.
The Smith & Nephew Operative Hysteroscope is compatible with the ETO and autoclave sterilization process. The device accessories can be autoclaved for reuse.
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K013870
Page of 2
D. Intended Use
The Smith & Nephew Operative Hysteroscope and Accessories are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures
Comparison of Technological Characteristics E.
Smith & Nephew's Operative Hysteroscope and accessories is substantially equivalent in design, materials of construction, function and intended use to the Smith & Nephew Images Hysteroscopes and accessories and the Richard Wolf operative Hysteroscopes. The changes in geometry do not introduce any new risks to the proposed device.
Dominic Haselton
Janice Haselton Regulatory Affairs Specialist
Smith & Nephew Operative Hysteroscope Page 60 of 60
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Ms. Janice Haselton Regulatory Affairs Specialist Smith & Nephew, Inc. 160 Dascomb Road ANDOVER MA 01810
Re: K013870
Trade/Device Name: Smith & Nephew Operative Hysteroscope and Accessories Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: 85 HIH Dated: November 19, 2001 Received: November 21, 2001
Dear Ms. Haselton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616) |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616) |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654) |
| Other | (301) 594-4692) |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Snogdin
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number : KO13870
Device Name : Smith & Nephew Operative Hysteroscope and Accessories
Indications for Use:
The Smith & Nephew Operative Hysteroscope and accessories are used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)
Over-the-Counter _____________________________________________________________________________________________________________________________________________________________
Nancy Brughor
(Division Sign-Of
Division of Reproductive, Abdominét,
and Radiological Devices
510(k) Number K013870
§ 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.