(118 days)
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No
The description focuses on the mechanical and optical design of a rigid hysteroscope and does not mention any AI or ML components or functionalities.
No
The device is described as permitting viewing and performing diagnostic and surgical procedures, indicating it is an operative tool rather than a device intended to treat or cure a disease or condition itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures."
No
The device description clearly states it is a rigid hysteroscope with an optical fiber bundle and a working channel, indicating it is a physical hardware device.
No, 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. They are used outside of the body (in vitro) to provide information about a person's health.
- Device Function: The Smith & Nephew TRUCLEAR Operative Hysteroscope is a surgical instrument used to view and perform procedures directly within the cervical canal and uterine cavity. It is used inside the body (in vivo) for direct visualization and intervention.
The description clearly states its purpose is for "viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures." This is a direct visualization and surgical tool, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Smith & Nephew TRUCLEAR Operative Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HIH
Device Description
Smith & Nephew's TRUCLEAR Operative Hyteroscope is a rigid hysteroscope that is intended for use in office based, hospital and ambulatory surgical centers. The operative hysteroscope incorporates an optical fiber bundle design in order to reduce the overall diameter of the needle portion of the hysteroscope and still provide adequate space in the working channel for instrumentation. The Smith & Nephew TRUCLEAR Operative Hysteroscope internal design consists of a "D" shaped working channel into the needle portion of the hysteroscope. The working channel also acts as an inflow-channel.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical canal and uterine cavity
Indicated Patient Age Range
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Intended User / Care Setting
office based, hospital and ambulatory surgical centers
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Optical performance tests included brightness, vignetting, resolution, near and far focus, image run out, depth of field and image distortion testing. Performance tests included sheath force testing and working channel instrument compatibility testing. Optical and performance testing demonstrated that the Smith & Nephew TRUCLEAR Operative performed comparably under similar conditions. Additionally, the Smith & Nephew TRUCLEAR Operative Hysteroscope complies with applicable portions of IEC 60601-2-18 and IEC 60601 electrical standards and has successfully passed cleaning and sterilization validations per AAMI TIR 30 and AAMI TIR 12. All materials have been demonstrated to meet biocompatibility requirements according to FDA General Program Memorandum #G95-1, Use of International Standards ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". In conclusion, the optical and performance testing demonstrates that the proposed device is as safe, effective and performs as well as or better than the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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.
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We are smith&nephew
Endoscopy Smith & Nenhew Inc 150 Minuteman Road Andover, MA 01810 USA
T 978 749 1000 F 978 740 1500 www.smith-nephew.com
NOV 2 2 2011
SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based. Smith & Nephew TRUCLEAR Operative Hysteroscope Date Prepared: July 15, 2011
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road. Andover MA. 01810
B. Company Contact
Janice Haselton Sr. Regulatory Affairs Specialist T 978-749-1494 F 978-749-1443
C. Device Name
| Trade Name: | Smith & Nephew TRUCLEAR Operative Hysteroscope |
|---|---|
| Common Name: | Hysteroscope |
| Classification Name: | Hysteroscope and Accessories per CFR §884.1690 |
D. Predicate Device
The predicate device is the Smith & Nephew Operative Hysteroscope cleared in K013870.
E. Description of Device
Smith & Nephew's TRUCLEAR Operative Hyteroscope is a rigid hysteroscope that is intended for use in office based, hospital and ambulatory surgical centers. The operative hysteroscope incorporates an optical fiber bundle design in order to reduce the overall diameter of the needle portion of the hysteroscope and still provide adequate space in the working channel for instrumentation. The Smith & Nephew TRUCLEAR Operative Hysteroscope internal design consists of a "D" shaped working channel into the needle portion of the hysteroscope. The working channel also acts as an inflow-channel.
F. Intended Use
The Smith & Nephew TRUCLEAR Operative Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
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