(137 days)
No
The device description explicitly states it is "non-powered, and hand-actuated" and there are no mentions of AI, ML, or image processing in the provided text. The performance studies focus on mechanical and usability aspects.
Yes
The device is described as "resect[ing] and remov[ing] tissue, including focal lesions such as endometrial polyps and retained products of conception," which are therapeutic actions.
No
Explanation: The device is intended for the resection and removal of tissue, which is a therapeutic function, not a diagnostic one. While it is used under hysteroscopic visualization, the device itself is for tissue removal, not for diagnosing conditions.
No
The device description clearly states it is a single-use, sterile, non-powered, hand-actuated physical device with mechanical components (rotating outer tube, reciprocating cutting blade, tissue trap, tubes). It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The MyoSure MANUAL Tissue Removal Device is a surgical instrument used in vivo (inside the body) to physically remove tissue from the uterus. It is a therapeutic device, not a diagnostic one.
The description clearly states its intended use is for "hysteroscopically resect and remove tissue" within the uterus. While the removed tissue might be sent for in vitro analysis later (which would involve IVD devices), the MyoSure device itself is not performing that diagnostic function.
N/A
Intended Use / Indications for Use
The MyoSure MANUAL Tissue Removal Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception.
Product codes
HIH
Device Description
The MyoSure MANUAL Tissue Removal Device is a single-use device that is intended for the resection and removal of tissue under hysteroscopic visualization. It is sterile, non-powered, and hand-actuated. It is compatible with the MyoSure hysteroscope and can be used in either an office or an operating room setting. The MyoSure MANUAL Tissue Removal Device is packaged with an accessory inflow tube to facilitate delivery of distention media. The inflow tube contains a bag spike, a tube and a luer connection to the hysteroscope. The MyoSure MANUAL Tissue Removal Device incorporates a rotating outer tube with a side facing cutting window and inner reciprocating cutting blade. A removable in-line tissue trap collects the excised tissue. An Outflow tube transfers and directs the waste fluid into a buttock drape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Hysteroscopic Visualization
Anatomical Site
Intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained gynecologist; office or operating room setting.
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
Testing was conducted with a simulated uterine model that included pieces of chicken breast to simulate the target tissue.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance verification and validation testing of the MyoSure MANUAL Tissue Removal Device evaluated the following:
- Visual Inspection
- Dimensional Measurements
- Outer tube rotation
- Device/Scope/Camera Clearance
- Tissue trap is removable
- Inflow spike to tubing tensile strength
- ¼" Luer to tubing tensile strength
- Trigger force test
- Outer tube/blade tensile test
- Drain tube to connector tensile test
- Tissue trap volume
- Cutting Rate
- Fluid Usage
- Tissue Trap Efficiency
All testing met the acceptance criteria.
Usability and human factors were addressed through Voice of Customer (VOC) studies and design validation. Testing was done to demonstrate that the MyoSure MANUAL Tissue Removal Device meets user needs and intended use. The testing included 15 physicians with a range of experience. Design verification. validation testing and usability testing confirmed that the device performs as intended.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
May 8, 2018
Hologic, Inc. Anne-Marie Keefe Senior Regulatory Affairs Specialist 250 Campus Drive Marlborough, Massachusetts 01752
Re: K173901
Trade/Device Name: MyoSure MANUAL Tissue Removal Device Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH Dated: April 2, 2018 Received: April 3, 2018
Dear Anne-Marie Keefe:
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
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Indications for Use
510(k) Number (if known) K173901
Device Name MyoSure MANUAL Tissue Removal Device
Indications for Use (Describe)
The MyoSure MANUAL Tissue Removal Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and 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) |
Description (i.e. street, company, etc.)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K173901 510(K) SUMMARY
Date: May 7, 2018
510(k) Submitter:
Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Anne-Marie Keefe 508.263.8851 F: 866.523.8663
Establishment Registration Number: 1222780
Trade Name: MyoSure MANUAL Tissue Removal Device
Common/Usual Name: Hysteroscopic Tissue Removal Device
Regulation Name: Hysteroscope and Accessories
Regulation Number: 21.CFR.Reg 884.1690
Product Code: HIH, Hysteroscope and Accessories
Classification: Class II
Panel: Obstetrics/Gynecology
PREDICATE DEVICES
Tradename: MyoSure LITE Tissue Removal Device Submitter/510(k) Holder: Hologic, Inc. 510(k) #: K142029 Product Code: HIH Regulation: 21.CFR.884.1690
The MyoSure LITE Tissue Removal Device has not been subject to a design-related recall.
DEVICE DESCRIPTION
The MyoSure MANUAL Tissue Removal Device is a single-use device that is intended for the resection and removal of tissue under hysteroscopic visualization. It is sterile, non-powered, and hand-actuated. It is compatible with the MyoSure hysteroscope and can be used in either an office or an operating room setting.
The MyoSure MANUAL Tissue Removal Device is packaged with an accessory inflow tube to facilitate delivery of distention media. The inflow tube contains a bag spike, a tube and a luer connection to the hysteroscope.
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The MyoSure MANUAL Tissue Removal Device incorporates a rotating outer tube with a side facing cutting window and inner reciprocating cutting blade. A removable in-line tissue trap collects the excised tissue. An Outflow tube transfers and directs the waste fluid into a buttock drape.
INDICATIONS FOR USE:
The MyoSure MANUAL Tissue Removal Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception.
The MyoSure MANUAL Tissue Removal Device indications for use are similar to the predicate MyoSure LITE device. The primary difference between the subject MyoSure MANUAL Tissue Removal Device and the predicate MyoSure LITE is as follows:
- Resection and removal of tissue for the MyoSure MANUAL device includes focal lesions such . as endometrial polyps and retained products of conception. Resection and removal of tissue for the MyoSure LITE includes submucous myomas. Both the MyoSure MANUAL and MyoSure LITE devices are intended for removal of endometrial polyps and retained products of conception.
The MyoSure MANUAL Tissue Removal Device intended use is identical to the predicate MyoSure LITE device.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
Primary specifications including morcellator dimensions (including OD, cutting window and cutting depth) cutting blade configuration, fluid distention media, visualization and access route to targeted tissue are identical to the predicate MyoSure LITE device.
The mode of operation including method of use and mechanism of action, material composition, and aspiration pressure are similar to the predicate MyoSure LITE device.
The primary difference between the subject MyoSure MANUAL Tissue Removal Device and the predicate MyoSure LITE is as follows:
- . The MyoSure MANUAL Tissue Removal Device is a hand actuated device while the predicate MyoSure LITE is motor actuated.
- . The MyoSure MANUAL Tissue Removal Device consists of a rotatable outer sheath while the MyoSure LITE consists of a stationary outer sheath.
- The MyoSure MANUAL Tissue Removal Device contains an Inflow Tube Assembly ● while the MyoSure LITE is not packaged with this assembly.
- . The MyoSure LITE requires an external vacuum source while the MyoSure MANUAL Tissue Removal Device does not.
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The differences in technological characteristics do not raise different questions of safety and effectiveness.
PERFORMANCE TESTING
Performance verification and validation testing of the MyoSure MANUAL Tissue Removal Device evaluated the following:
- Visual Inspection ●
- Dimensional Measurements ●
- Outer tube rotation
- Device/Scope/Camera Clearance
- Tissue trap is removable
- Inflow spike to tubing tensile strength
- ¼" Luer to tubing tensile strength ●
- Trigger force test ●
- Outer tube/blade tensile test
- Drain tube to connector tensile test
- Tissue trap volume ●
- Cutting Rate ●
- Fluid Usage ●
- . Tissue Trap Efficiency
All testing met the acceptance criteria.
Usability and human factors were addressed through Voice of Customer (VOC) studies and design validation. Testing was done to demonstrate that the MyoSure MANUAL Tissue Removal Device meets user needs and intended use. The testing included 15 physicians with a range of experience. Testing was conducted with a simulated uterine model that included pieces of chicken breast to simulate the target tissue. Design verification. validation testing and usability testing confirmed that the device performs as intended.
CONCLUSION
Based on the intended use, descriptive information and performance provided in this submission, the MyoSure MANUAL Tissue Removal Device has been shown to be substantially equivalent to the predicate MyoSure LITE Tissue Removal Device.