(25 days)
No
The description focuses on mechanical and software control of a morcellator, with no mention of AI or ML capabilities.
Yes.
The device is intended for hysteroscopic intrauterine procedures to resect and remove tissue, which directly contributes to the treatment of medical conditions.
No
The device is described as a "tissue morcellator" intended for "resecting and removing tissue," which indicates it is a therapeutic or surgical device rather than one designed for diagnosis.
No
The device description clearly outlines multiple hardware components including a control unit, tissue removal device, and foot pedal, in addition to the software controller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps." This describes a surgical procedure performed directly on the patient's body to remove tissue.
- Device Description: The device description details a system for mechanically cutting and removing tissue from the uterus. It involves a motor, a cutter blade, and a vacuum system. This is a surgical instrument.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information about a patient's health. The tissue removed is likely for pathological examination after removal, but the device itself is not performing the diagnostic test.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used to remove tissue from the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Myosure Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
Product codes
HIH
Device Description
The modified Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate Myosure System:
- Myosure Control Unit o
- Myosure Tissue Removal Device 0
- Myosure Foot Pedal 0
The Myosure Control Unit contains an electric motor and software controller that drives the Myosure Tissue Removal Device. The Control Unit motor is activated and deactivated by the Myosure Foot Pedal. The Myosure Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The morcellator's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the Myosure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The Myosure Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 4 mm working channel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained gynecologist
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 (K100559). The 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 O equivalent to that of the predicate device
- cutter durability over time is equivalent for the modified and o predicate Myosure Systems
- heat generation over time is equivalent for the modified and predicate 0 Myosure Systems
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
HOLOGIC, Inc.
PAGE IOF 3
Premarket Notification
న. 510(k) SUMMARY
SEP 10 2012
1. Submitter:
Hologic, Inc. 250 Campus Dr. Marlborough, MA 01752 Telephone: 508.263.8857
Contact: Sarah Fairfield, Sr. Regulatory Affairs Specialist
2. Device:
Trade Name: MyoSure XL Tissue Removal Device (part of the MyoSure Hysteroscopic Tissue Removal System) Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II
3. Predicate Device:
MyoSure™ Hysteroscopic Tissue Removal System (K100559)
4. Device Description:
The modified Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate Myosure System:
- Myosure Control Unit o
- Myosure Tissue Removal Device 0
- Myosure Foot Pedal 0
The Myosure Control Unit contains an electric motor and software controller that drives the Myosure Tissue Removal Device. The Control Unit motor is activated and deactivated by the Myosure Foot Pedal. The Myosure Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The morcellator's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the Myosure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The Myosure Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 4 mm working channel.
1
Premarket Notification
5. Intended Use:
The Myosure Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
6. Comparison of Characteristics:
The modified Myosure Hysteroscopic Tissue Removal System's intended use and indicated use are identical to that of the predicate Myosure Hysteroscopic Tissue Removal System, K100559.
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 modified Myosure Hysteroscopic Tissue Removal System is different from the predicate Myosure Hysteroscopic Tissue Removal System as follows:
- . To target larger uterine pathologies the diameter of the morcellator has been increased
7. 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 (K100559). The 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 O equivalent to that of the predicate device
- cutter durability over time is equivalent for the modified and o predicate Myosure Systems
- heat generation over time is equivalent for the modified and predicate 0 Myosure Systems
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.
2
Premarket Notification
8. Conclusion:
Based on the intended use, descriptive information and performance evaluation provided in this submission, the modified MyoSure Hysteroscopic Tissue Removal System has been shown to be equivalent in technology, method of operation, functional performance and intended use to the predicate MyoSure Hysteroscopic Tissue Removal System.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Sarah Fairfield Senior Regulatory Affairs Specialist Hologic, Inc. 250 Campus Drive MARLBOROUGH MA 01752
SEP 10 2012
Re: K122498
Trade/Device Name: MyoSure XL Tissue Removal Device (part of the MyoSure Hysteroscopic Tissue Removal System)
Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: August 15, 2012 Received: August 16, 2012
Dear Ms. Fairfield:
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 for use sualod in the encreating to 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 I ou may) ateres 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 I tease be advisod that I Dr renation that your device complies with other requirements of the Act that 1 Dr. Has made a colorizantions administered by other Federal agencies. You must of any I outhal battler the requirements, including, but not limited to: registration and listing Comply with an the Free Prequirements and ) == 01 ) == 0 == 0 == 0 == 0 == 0 == 0 == 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0
4
Page 2 -
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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,
Benjamin R. Evanko
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
5
HOLOGIC, Inc.
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Қ ( 2 2 498
Device Name: MyoSure XL Tissue Removal Device (part of the MyoSure Hysteroscopic Tissue Removal System)
Indications For Use:
The Myosure Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
Prescription Use X (Part 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)
Arne W. Zitz
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122498