(165 days)
Not Found
No
The description focuses on mechanical resection and does not mention any AI/ML components or functionalities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
This device is designed for mechanical resection and removal of tissue, which is a surgical procedure rather than a therapeutic treatment in itself.
No
The device is described as a "TRUCLEAR Morcellator System" that uses "mechanical resection to remove endometrial polyps and submucous myomas hysteroscopically from the uterus." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a "TRUCLEAR Morcellator System and TRUCLEAR Morcellators" which are mechanical devices used for tissue resection, indicating a hardware component. The submission is for modifications to the indications for use of this existing hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The TRUCLEAR System and Morcellators are described as devices for intrauterine use to resect and remove tissue directly from the uterus. This is a surgical procedure performed inside the body.
- Intended Use: The intended use is to remove tissue like submucous myomas, endometrial polyps, and retained products of conception through hysteroscopy. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a surgical tool used for tissue removal within the body, which falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TRUCLEAR System and TRUCLEAR Morcellators are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception
Product codes
HIH
Device Description
Smith & Nephew's TRUCLEAR Morcellator System and TRUCLEAR Morcellators use mechanical resection to remove endometrial polyps and submucous myomas hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue. There have been no major changes in design or materials in the subject TRUCLEAR Morcellator System or its associated morcellators since their market clearance.
Subject of this premarket notification is modifications to the indications for use for the Smith & Nephew, Inc. TRUCLEAR Morcellator System and its associated morcellators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrauterine, uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained gynecologists
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)
Clinical literature showcasing the use of the TRUCLEAR Morcellator System and Morcellators support the use of TRUCLEAR for the proposed additional indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110038, K103389, K041774, K031787
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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K132015 Page 1 of 2
510(k) Summary Smith & Nephew, Inc. TRUCLEAR Morcellator System and TRUCLEAR Morcellators
Smith & Nephew, Inc.
| 150 Minuteman Road | ||
|---|---|---|
| Andover, MA 01810 | ||
| Date of Summary: | December 11, 2013 | |
| Contact Person and Address: | Bradley Heil, Regulatory Affairs Specialist | |
| T (901) 399-6339 | ||
| F (901) 566-7831 | ||
| Name of Device(s): | Smith & Nephew, Inc. TRUCLEAR Morcellator System | |
| Common Name: | Hysteroscopes and Accessories | |
| Device Classification Name and | 21 CFR 884.1690 Hysteroscopes and Accessories- Class | |
| Reference: | = | |
| Device Class: | Class II | |
| Panel Code: | Obstetrics and Gynecological | |
| Product Code: | HIH | |
Predicate Devices
Submitted by:
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | TRUCLEAR Morcellator System | K110038 | 03/30/2011 |
| Smith & Nephew, Inc. | TRUCLEAR Incisor Plus Blade 2.9 | K103389 | 03/25/2011 |
| Smith & Nephew, Inc. | IUR Reciprocating Morcellator | K041774 | 10/07/2004 |
| Smith & Nephew, Inc. | IUR Morcellation System | K031787 | 12/02/2003 |
Device Description
Smith & Nephew's TRUCLEAR Morcellator System and TRUCLEAR Morcellators use mechanical resection to remove endometrial polyps and submucous myomas hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue. There have been no major changes in design or materials in the subject TRUCLEAR Morcellator System or its associated morcellators since their market clearance.
Subject of this premarket notification is modifications to the indications for use for the Smith & Nephew, Inc. TRUCLEAR Morcellator System and its associated morcellators.
1
Intended Use
The TRUCLEAR System and TRUCLEAR Morcellators are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception
The predicate devices listed above are 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 new proposed indications reword the general indication and specifically list retained products of conception.
Technological Characteristics
There have been no major changes in design or materials in the subject TRUCLEAR Morcellator System or its associated morcellators since their market clearance. As such, the technological characteristics of the TRUCLEAR Morcellator System or its associated morcellators have not changed.
Performance Data
Clinical literature showcasing the use of the TRUCLEAR Morcellator System and Morcellators support the use of TRUCLEAR for the proposed additional indications.
Conclusion
This Traditional 510(k) Premarket Notification is being submitted to modify the indications for use for the Smith & Nephew, Inc. TRUCLEAR Morcellator System and associated morcellators. Based on the similarities to the predicate components and published articles supporting the additional indications, the devices are substantially equivalent to their predicates.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2014
Smith & Nephew, Inc. Bradley Heil Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810
Re: K132015
Trade/Device Name: TRUCLEAR Morcellator System and TRUECLEAR Morcellators Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated (Date on orig SE ltr): November 15, 2013 Received (Date on orig SE ltr): November 18, 2013
Dear Bradley Heil,
This letter corrects our substantially equivalent letter of December 13, 2013.
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. Iisting 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.
3
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 device-related 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indications for Use Statement
510(k) Number: K132015
Device Name: TRUCLEAR Morcellator System and TRUCLEAR Morcellators
Indications for Use:
The TRUCLEAR System and TRUCLEAR Morcellators are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801.109)
AND/OR
Over-the-Counter Use _ (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S 2014.01.29 15:28:15-05'00'
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