(83 days)
The TRUCLEAR™ Morcellator System is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
The TRUCLEAR Morcellator System was first introduced in K031787. The method of operation is mechanical resection and suction to cut and remove submucous myomas and endometrial polyps from the uterine lining. The system consists of a control unit, handpiece and footswitch. The system is used in conjunction with disposable hysteroscopic blades.
The provided text describes a 510(k) submission for the TRUCLEAR Morcellator System, which is a medical device for gynecological procedures. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and a detailed analysis of a new device's performance against those criteria.
Therefore, the specific information requested cannot be fully extracted as it pertains to a different type of submission (e.g., a study proving a device meets specific performance criteria, often seen in AI/CADe submissions).
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Cannot be provided directly. The document states: "The TRUCLEAR Morcellator System performance testing has demonstrated that the proposed device is substantially equivalent to the predicate device and the proposed modifications to increase the blade speed range does not raise new questions of safety and efficacy."
- This implies that the "acceptance criteria" were primarily demonstrating equivalence and ensuring that the modification (increased blade speed range) did not negatively impact safety or efficacy, rather than meeting specific quantifiable performance metrics in a new clinical study.
- The "reported device performance" is essentially that it performs equivalently to the predicate and the modification is safe.
2. Sample Size Used for the Test Set and Data Provenance:
- Cannot be provided. The document does not describe a clinical study with a test set of patient samples. Performance testing was likely mechanical/bench testing to demonstrate the safety and equivalence of the increased blade speed.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Cannot be provided. This information is relevant for studies involving human interpretation or annotation (e.g., image-based AI studies), which is not described here.
4. Adjudication Method for the Test Set:
- Cannot be provided. Not applicable due to the nature of the submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size:
- No, an MRMC study was not done. This type of study is common in AI/CADe for comparing human performance with and without AI assistance. This submission is for a mechanical tissue resection system.
6. If a Standalone Performance Study Was Done:
- No, a standalone performance study as typically understood for AI algorithms was not done. The performance testing focused on demonstrating substantial equivalence to the predicate device and the safety/efficacy of the increased blade speed, not a standalone clinical validation against a specific disease outcome in a patient cohort.
7. The Type of Ground Truth Used:
- Not explicitly stated as "ground truth" in the AI sense. For this device, "ground truth" would be related to the functional performance and safety parameters of the device (e.g., cutting efficiency, tissue removal, maintaining sterility, structural integrity). This would likely be assessed through engineering tests, material testing, and potentially simulated tissue models, rather than clinical patient outcomes.
8. The Sample Size for the Training Set:
- Cannot be provided. This concept is not applicable. There is no AI component or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
- Cannot be provided. Not applicable.
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K 110038 page 1 of 2
MAH 3 0 2011
Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA
T 978-749-1000 F 978-749-1443 www.smith-nephew.com
We are smith&nephew
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.
TRUCLEAR Morcellation System
Date Prepared: January 4, 2011
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division l 50 Minuteman Road Andover, MA 01810
B. Company Contact
Janice Haselton Sr. Regulatory Affairs Specialist 978-749-1494 L: F: 978-749-1443 E-mail: Janice.haselton@smith-nephew.com
C. Device Name
| Trade Name: | TRUCLEAR Morcellator System |
|---|---|
| Common Name: | Mechanical Tissue Resection System |
| Classification Name: | Hysteroscopes and Accessories |
D. Predicate Devices
The Smith & Nephew TRUCLEAR Morcellator System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew IUR Morcellation System.
E. Description of Device
The TRUCLEAR Morcellator System was first introduced in K031787. The method of operation is mechanical resection and suction to cut and remove submucous myomas and endometrial polyps from the uterine lining. The system consists of a control unit, handpiece and footswitch. The system is used in conjunction with disposable hysteroscopic blades.
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F. Intended Use
The TRUCLEAR Morcellator System is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
G. Comparison of Technological Characteristics
The TRUCLEAR Morcellator System has the same fundamental technological characteristics as the unmodified predicate device and is substantially equivalent in design, materials and intended use as the unmodified predicate device. The proposed TRUCLEAR Morcellator System has the following similarities as the predicate device cleared in K031787:
- . The same indications for use
- � Utilizes the same operating principle
- . Incorporates the same basic design
- Manufactured under the same Quality System .
There are no significant differences between the proposed and predicate devices that raise new questions of safety or efficacy.
H. Summary Performance Data
The TRUCLEAR Morcellator System performance testing has demonstrated that the proposed device is substantially equivalent to the predicate device and the proposed modifications to increase the blade speed range does not raise new questions of safety and efficacy.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Janice Haselton Senior Regulatory Affairs Specialist Smith & Nephew, Inc. 150 Minuteman Road ANDOVER MA 01810
Re: K110038 MAR 3 0 2511
Trade Name: TRUCLEAR Morcellation System Regulation Number: 21 CFR 8884,1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: March 1, 2011 Received: March 2, 2011
Dear Ms. Haselton:
We have reviewed your Section 510(k) prematket 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 of medical device-related
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adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Huker Lemur MD
Herbert P. Lerner, M.D., Director (Acting) 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): | K110038 |
|---|---|
| --------------------------- | --------- |
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The TRUCLEAR™ Morcellator System is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Tony Whithey | |
|---|---|
| -- | --------------------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological DevicesTRUCLEAR Morcellation System Smith & Nephew Inc., Endoscopy
510(k) Number
KITUDSS
§ 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.