(52 days)
No
The description focuses on mechanical resection and does not mention any AI/ML components or functionalities.
Yes
The device is described as a "Tissue Removal System" intended to "resect and remove tissue" such as "submucous myomas," "endometrial polyps," and "retained products of conception." This indicates it is used to treat or alleviate a medical condition by removing problematic tissue.
No
The device is described as "resect and remove tissue" and "uses mechanical resection to remove endometrial polyps, submucous myomas, and retained products of conception". This clearly indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly lists hardware components (Tissue Removal Drive System, Tissue Removal Device (TRD), Foot Pedal) and describes mechanical resection, indicating it is a hardware-based system with potentially integrated software/firmware.
Based on the provided information, the MyoSure Tissue Removal System and Tissue Removal Devices are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to resect and remove tissue from the uterus during a hysteroscopic procedure. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device description details a mechanical system for cutting and removing tissue. It does not describe any components or processes for analyzing biological samples outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue samples, or any other biological specimens in vitro (in a lab setting). The device's function is purely mechanical tissue removal.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MyoSure system's purpose is therapeutic/interventional, not diagnostic.
N/A
Intended Use / Indications for Use
The MyoSure Tissue Removal System and 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
The Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the sponsor's previously cleared device:
- Tissue Removal Drive System
- Tissue Removal Device (TRD)
- Foot Pedal
The Myosure Hysteroscopic Tissue Removal System uses mechanical resection to remove endometrial polyps, submucous myomas, and retained products of conception 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.
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)
Performance verification testing of the modified Myosure Hysteroscopic Tissue Removal System was completed using the same methodology as was used in support of the predicate Myosure System 510(k) submission. The Myosure Tissue Removal Devices and modified Control Units were used to cut beef tongue tissue; each device was tested for a 30 minute duration test interval. Testing evaluated cutting functionality and heat generation over the test interval for the modified Myosure System. Test results for the predicate and modified Myosure Hysteroscopic Tissue Removal Systems were then compared. Results from this testing demonstrated that:
- the modified Myosure System's tissue cutting performance is equivalent to that of the predicate device.
- cutter durability over time is equivalent for the modified and predicate Myosure Systems .
- heat generation over time is equivalent for the modified and predicate Myosure Systems and meets IEC 60601-1 thermal safety requirements.
The modified device software/firmware was assessed per the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. Verification/validation testing of the modified Myosure System was completed and confirmed that the modified Myosure System meets the same functional and performance specifications as the predicate Myosure System.
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.
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 13, 2015
Hologic, Inc Catherine Eaton Regulatory Affairs Specialist 250 Campus Drive Marlborough, MA 01752
Re: K152723
Trade/Device Name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH Dated: October 29, 2015 Received: October 30, 2015
Dear Catherine Eaton,
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 device
1
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 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,
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
Indications for Use
510(k) Number (if known) K152723
Device Name
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Indications for Use (Describe)
The MyoSure Tissue Removal System and 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
| 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)
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."
3
Hologic, Inc. Special 510(k) Submission November 12th, 2015
510(k) SUMMARY
Date: November 12th, 2015
510(k) Submitter:
Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Attn: Catherine Eaton P: 508.263.8604 F: 508.263.2403
Establishment Registration Number: 1222780
Trade Name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Common/Usual Name: Hysteroscope and Accessories, 21.CFR.Reg 884.1690
Product Code: HIH
Classification: Class II
Panel: Obstetrics/Gynecology
Predicate Device:
Trade name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices Submitter / 510(k) Holder: Hologic, Inc. 510(k) #: K142029 Classification code: HIH and Regulation: 21.CFR.884.1690
DEVICE DESCRIPTION
The Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the sponsor's previously cleared device:
- Tissue Removal Drive System O
- o Tissue Removal Device (TRD)
- o Foot Pedal
4
Hologic. Inc. Special 510(k) Submission November 12th, 2015
The Myosure Hysteroscopic Tissue Removal System uses mechanical resection to remove endometrial polyps, submucous myomas, and retained products of conception 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.
Indications for Use:
The Myosure Hysteroscopic Tissue Removal System and 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
Comparison of Characteristics:
The principles of operation and primary functional specifications of the modified Myosure Hysteroscopic Tissue Removal System are identical to those of the predicate Myosure Hysteroscopic Tissue Removal System. The primary change to the Myosure Hysteroscopic Tissue Removal System is the modification of the Myosure Tissue Removal Device (TRD) used with the system (to be named Myosure Reach TRD). The MyoSure Reach TRD will be part of the family of the MyoSure TRDs utilized with the Myosure Hysteroscopic Tissue Removal System.
The modified Myosure Hysteroscopic Tissue Removal System is different from the predicate Myosure Hysteroscopic Tissue Removal System as follows:
- Cutting window has been shifted farther down the distal end of the morcellator.
- . The tolerance within the firmware has been tightened to coincide with the dimensional change made by shifting the window farther down the distal tip
- The helix within the TRD has been modified to improve manufacturability and optimize ● the bidirectional movement of the motor.
The differences between the subject device and predicate do not raise any new types of safety and effectiveness questions. The difference in cutting window placement and helix design were evaluated by performance bench testing
5
Hologic. Inc. Special 510(k) Submission November 12th, 2015
The fundamental scientific technology of the proposed device has not changed relative to the predicate device (K142029):
- Has the same mechanism of action and mode of operation, .
- Is manufactured using the same materials, ●
- Is packaged and sterilized using the same process,
- Has the same shelf life.
Performance Testing:
Performance verification testing of the modified Myosure Hysteroscopic Tissue Removal System was completed using the same methodology as was used in support of the predicate Myosure System 510(k) submission. The Myosure Tissue Removal Devices and modified Control Units were used to cut beef tongue tissue; each device was tested for a 30 minute duration test interval. Testing evaluated cutting functionality and heat generation over the test interval for the modified Myosure System. Test results for the predicate and modified Myosure Hysteroscopic Tissue Removal Systems were then compared. Results from this testing demonstrated that:
- . the modified Myosure System's tissue cutting performance is equivalent to that of the predicate device.
- cutter durability over time is equivalent for the modified and predicate Myosure Systems .
- heat generation over time is equivalent for the modified and predicate Myosure Systems ● and meets IEC 60601-1 thermal safety requirements.
The modified device software/firmware was assessed per the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. Verification/validation testing of the modified Myosure System was completed and confirmed that the modified Myosure System meets the same functional and performance specifications as the predicate Myosure System.
Conclusion:
The proposed Myosure Tissue Removal System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs. The proposed Myosure Tissue Removal System is substantially equivalent to the legally marketed predicate device (Hologic's Myosure Tissue Removal Device System and Tissue Removal Devices).