(148 days)
TRUCLEAR ULTRA PLUS Tissue Removal Device (K132015)
No
The device description focuses on mechanical tissue removal and aspiration, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is used to resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception, which are therapeutic interventions.
No
The device is described as a tissue removal device intended for resecting and removing tissue such as submucous myomas, endometrial polyps, and retained products of conception. Its function is to perform a surgical procedure, not to diagnose a condition.
No
The device description clearly outlines a physical device with mechanical components (stainless steel tubes, plastic housing, cutting edge) and a handpiece that drives the inner tube. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "hysteroscopically resect and remove tissue" from the uterus. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a mechanical tool with a cutting edge and suction for removing tissue. It is used in vivo (within the living body).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform such tests.
The device is a surgical instrument used for tissue removal during a hysteroscopy, which is a medical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The TRUCLEAR Tissue Removal Devices 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 ULTRA Mini Tissue Removal Device is a single use device that hysteroscopically removes intra-uterine tissue. The device consists of a stainless steel inner tube that rotates and reciprocates inside a stainless steel outer tube. The proximal ends of the tubes are enclosed within a plastic housing. The housing is engaged with the TRUCLEAR Handpiece which drives the inner tube of the device. The inner tube has a sharp cutting edge that resects tissue in the cutting window at the distal end of the outer tube. The resected tissue is simultaneously aspirated out of the uterine cavity using suction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Hysteroscopically
Anatomical Site
intrauterine
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)
- Shed Test- A shed test was conducted to determine the relative wear of the blade during use. Results from the testing showed an acceptable level of shedding.
- Cutting Performance Test- A cutting performance test was conducted to demonstrate the durability and robustness of the device to show the ability to function for 20 minutes of activation. Results from the testing demonstrated that the subject devices met the acceptance criteria.
- Resection Rate Test- A resection rate test was conducted to evaluate the performance of the device in terms of an acceptable resection rate. Results from the testing verified that the subject device met the acceptance criteria showing an acceptable resection rate.
- Biocompatibility Testing- Cytotoxicity, sensitization, and irritation testing were conducted along with a chemical analysis of the extract. Results from the testing show the device to be acceptable for biological use.
- Shelf Life Testing- Accelerated age testing along with post-aging performance testing was conducted and justifies the shelf life of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TRUCLEAR ULTRA PLUS Tissue Removal Device (K132015)
Reference Device(s)
TRUCLEAR INCISOR Tissue Removal Device (K132015)
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be emerging from a single form. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2016
Smith & Nephew, Inc. Bradley Heil Regulatory Affairs Manager 150 Minuteman Rd. Andover, MA 01810
K161763 Trade/Device Name: Truclear Ultra Mini Tissue Removal Device Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: Class II Product Code: HIH Dated: November 11, 2016 Received: November 17, 2016
Dear Bradley Heil,
Re:
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,
Benjamin R. Fisher -S
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161763
Device Name
TRUCLEAR ULTRA Mini Tissue Removal Device
Indications for Use (Describe) The TRUCLEAR Tissue Removal Devices are intenderine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial polyps Retained products of conception
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
3
Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.
510(k) Summary K161763
| Submitted by: | Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810 | |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--|
| Date of Summary: | November 18, 2016 | |
| Contact Person and Address: | Bradley Heil
Regulatory Affairs Manager
T 901-216-6884
F 901-566-7831
Bradley.heil@smith-nephew.com | |
| Name of Device: | TRUCLEAR ULTRA MINI Tissue
Removal Device | |
| Common Name: | Hysteroscopic Tissue Removal Device | |
| Device Classification Name and
Reference: | 21 CFR 884.1690 Hysteroscope and Accessories | |
| Device Class: | Class II | |
| Panel Code: | Obstetrics and Gynecology | |
| Product Code: | HIH (Hysteroscope and accessories) | |
| Predicate Device | TRUCLEAR ULTRA PLUS Tissue Removal Device
(K132015)
The predicate device has not been subject to a design
related recall. | |
| Reference Device | TRUCLEAR INCISOR Tissue Removal Device
(K132015) | |
Device Description
Smith & Nephew's TRUCLEAR ULTRA Mini Tissue Removal Device is a single use device that hysteroscopically removes intra-uterine tissue. The device consists of a stainless steel inner tube that rotates and reciprocates inside a stainless steel outer tube. The proximal ends of the tubes are enclosed within a plastic housing. The housing is engaged with the TRUCLEAR Handpiece which drives the inner tube of the device. The inner tube has a sharp cutting edge that resects tissue in the cutting window at the distal end of the outer tube. The resected tissue is simultaneously aspirated out of the uterine cavity using suction.
4
Indications for Use
The TRUCLEAR Tissue Removal Devices 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 indication for use statement for the subject device is identical to the predicate device.
| | TRUCLEAR ULTRA
Mini (Subject Device) | TRUCLEAR ULTRA PLUS Device
(Predicate Device) |
|---------------------------|--------------------------------------------|--------------------------------------------------|
| Principle of
Operation | Mechanical Resection | Mechanical Resection |
| Style of Device | Reciprocating | Reciprocating |
| Scope used | TRUCLEAR 5.0 or 5C
Hysteroscope | TRUCLEAR 8.0 Hysteroscope |
| Outer and inner
shaft | 304 Stainless Steel
440 Stainless steel | 304 Stainless Steel
465 Stainless Steel |
| Coating | Chromium coating | none |
| Inner shaft Lubricant | Silicone | Silicone |
| Sterility | EtO | EtO |
| Single Use | Yes | Yes |
Comparison of Technological Characteristics
Substantial Equivalence Information
The subject device has different technological characteristics compared to the predicate device.
The differences between the subject device and the predicate do not raise different types of safety and effectiveness questions, as these differences have been evaluated in previous 510(k) submissions for hysteroscopic tissue removal devices. The differences in technological characteristics can be evaluated through bench testing. The differences in material can be evaluated through biocompatibility assessment.
Summary of Pre-clinical Testing
To further support a determination of substantial equivalence, non-clinical bench testing was conducted to support the subject device. The specific types of non-clinical testing conducted are listed below.
5
- Shed Test- A shed test was conducted to determine the relative wear of the blade during use. Results from the testing showed an acceptable level of shedding.
- · Cutting Performance Test- A cutting performance test was conducted to demonstrate the durability and robustness of the device to show the ability to function for 20 minutes of activation. Results from the testing demonstrated that the subject devices met the acceptance criteria.
- · Resection Rate Test- A resection rate test was conducted to evaluate the performance of the device in terms of an acceptable resection rate. Results from the testing verified that the subject device met the acceptance criteria showing an acceptable resection rate.
- · Biocompatibility Testing- Cytotoxicity, sensitization, and irritation testing were conducted along with a chemical analysis of the extract. Results from the testing show the device to be acceptable for biological use.
- · Shelf Life Testing- Accelerated age testing along with post-aging performance testing was conducted and justifies the shelf life of the device.
The reference predicate, TRUCLEAR INCISOR, addresses any differences in materials and performance testing between the subject and primary predicate devices. In addition, a risk analysis was conducted to show that any residual risks are outweighed by the medical benefit.
Conclusion
Based on the performance data provided, the subject device is substantially equivalent to the proposed predicate device.