(30 days)
No
The summary describes a rigid hysteroscope with an optical fiber bundle and a working channel. There is no mention of AI, ML, image processing, or any software-based analysis of the visual data. The performance studies are focused on physical characteristics and flow/visualization time, not algorithmic performance.
No
The device is described as an operative hysteroscope used for viewing the cervical canal and uterine cavity for diagnostic and surgical procedures, and is modified from a previously cleared device. Its function is to permit viewing and provide space for instrumentation, not explicitly to deliver a therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures." The term "diagnostic" directly indicates its use for diagnosis.
No
The device description clearly outlines a rigid hysteroscope with physical components like an optical fiber bundle, working channel, and slanted distal tip, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures." This describes a device used for direct visualization and intervention within the body, not for testing samples in vitro (outside the body).
- Device Description: The description details a rigid hysteroscope with an optical fiber bundle and a working channel. This is a surgical instrument used for internal examination and procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body. The device facilitates visual inspection and surgical procedures directly within the patient.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Smith & Nephew TRUCLEAR Operative Hysteroscope 5C and Sheath 5C are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Product codes
HIH
Device Description
The subject TRUCLEAR Operative Hysteroscope 5C and TRUCLEAR Sheath 5C are modifications to the TRUCLEAR Operative Hysteroscope 5.0 and TRUCLEAR Sheath 5.6 previously cleared in K112134. The TRUCLEAR Operative Hysteroscope 5C is a rigid hysteroscope with a slanted distal tip 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 inflowchannel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal and the uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
office based, hospital and ambulatory surgical centers
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)
To further support a determination of substantial equivalence, non-clinical bench testing was conducted to support the proposed hysteroscope and sheath. Test results demonstrated that the proposed devices are substantially equivalent to the previously cleared predicate devices listed above. The specific types of non-clinical testing conducted are listed below.
- Dimensional Inspection testing was conducted to show that all devices met drawing dimensions and that all scopes could be assembled with all sheaths.
- Flow and Visualization testing was also performed on the proposed devices. All devices showed an average time to attain clear vision was 14.2 seconds.
- Insertion Force testing of the proposed devices showed an average 29% reduction in insertion force compared to the predicate devices.
- Packaging/Ship Testing with visual inspection and functional testing showed that product will not be damaged during shipping and will function properly post-shipping
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/1 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 three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2015
Smith & Nephew, Inc. Bradley Heil Regulatory Affairs Manager 150 Minuteman Road Andover, MA 01810
Re: K152143
Trade/Device Name: TRUCLEAR Operative Hysteroscope 5C and Sheath 5C. Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: July 31, 2015 Received: August 3, 2015
Dear Bradley Heil,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152143
Device Name
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
Indications for Use (Describe)
The Smith & Nephew TRUCLEAR Operative Hysteroscope 5C and Sheath 5C are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitted by: | Smith & Nephew, Inc.
150 Minuteman Rd
Andover, MA 01810 |
|----------------------------------------------|--------------------------------------------------------------------------------|
| Date of Summary: | September 1, 2015 |
| Contact Person and Address: | Bradley Heil
Regulatory Affairs Manager
T 901-399-6339
F 901-566-7831 |
| Name of Device: | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C |
| Common Name: | Hysteroscope and Accessories |
| Device Classification Name and
Reference: | Class II
21 CFR 884.1690 Hysteroscope and Accessories |
| Panel Code: | Obstetrics and Gynecological |
| Product Code: | HIH |
| Table 1: Substantially Equivalent Predicates to the TRUCLEAR Operative Hysteroscop |
|---|
| 5C & Sheath 5C |
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|----------------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | TRUCLEAR Operative
Hysteroscope 5.0 and Sheath
5.6 | K112134 | 11-22-2011 |
Device Description
The subject TRUCLEAR Operative Hysteroscope 5C and TRUCLEAR Sheath 5C are modifications to the TRUCLEAR Operative Hysteroscope 5.0 and TRUCLEAR Sheath 5.6 previously cleared in K112134. The TRUCLEAR Operative Hysteroscope 5C is a rigid hysteroscope with a slanted distal tip 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 inflowchannel.
4
Intended Use
The Smith & Nephew TRUCLEAR Operative Hysteroscope 5C and Sheath 5C are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Technological Characteristics
Device comparisons described in this premarket notification, including the proposed changes of a slanted distal tip, a change in outer diameter, and the movement of the outflow holes, demonstrate that the proposed hysteroscope and sheath are substantially equivalent to the legally marketed predicate devices (listed above in Table 1) with regard to intended use, indications for use, and performance characteristics.
Summary of Pre-Clinical Testing
To further support a determination of substantial equivalence, non-clinical bench testing was conducted to support the proposed hysteroscope and sheath. Test results demonstrated that the proposed devices are substantially equivalent to the previously cleared predicate devices listed above. The specific types of non-clinical testing conducted are listed below.
- . Dimensional Inspection testing was conducted to show that all devices met drawing dimensions and that all scopes could be assembled with all sheaths.
- Flow and Visualization testing was also performed on the proposed devices. All devices showed an average time to attain clear vision was 14.2 seconds.
- Insertion Force testing of the proposed devices showed an average 29% reduction in ● insertion force compared to the predicate devices.
- Packaging/Ship Testing with visual inspection and functional testing showed that . product will not be damaged during shipping and will function properly post-shipping
Conclusion
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for TRUCLEAR Operative Hysteroscope 5C and Sheath 5C. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the predicate operative hysteroscope/sheath listed above in Table 1.