(26 days)
Not Found
No
The description focuses on mechanical resection and makes no mention of AI or ML.
Yes
The device is used to resect and remove tissue, such as submucous myomas, endometrial polyps, and retained products of conception, from the uterus, which indicates a therapeutic purpose.
No
The device description clearly states its purpose as mechanical resection and removal of tissue within the uterus, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a Tissue Removal Drive System, Tissue Removal Device, and Foot Pedal, indicating it is a hardware-based system.
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 described as a "Hysteroscopic Tissue Removal System" that uses "mechanical resection" to remove tissue. 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 status.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is used to physically remove tissue from the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Myosure Hysteroscopic Tissue Removal System and Myosure 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
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. There have been no major changes in design or materials in the subject Myosure System or its associated tissue removal devices since their market clearance.
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 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 not required because there is no modification to the design of the outer tube of the device. An engineering assessment of the cutting method determined there was no impact to the cutting performance of the device as a result of the change in manufacturing process.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2017
Hologic, Inc. Catherine Sanford Regulatory Affairs Specialist 250 Campus Drive Marlborough, MA 01752
Re: K172566
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: II Product Code: HIH Dated: August 28, 2017 Received: August 30, 2017
Dear Catherine Sanford:
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.
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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 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 (DICE) 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 (DICE) 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
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Indications for Use
510(k) Number (if known) K172566
Device Name
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Indications for Use (Describe)
The Myosure Hysteroscopic Tissue Removal System and Myosure 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)
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510(k) SUMMARY
Date: September 18th, 2017
510(k) Submitter:
Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Attn: Catherine Sanford P: 508.263.8604 F: 508.263.2403
Establishment Registration Number: 1222780
Subject Device:
Trade Name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices Common/Usual Name: Hysteroscope and Accessories Product Code: HIH Classification Name: Hysteroscope and Accessories, 21.CFR.Reg 884.1690 Classification: Class II Panel: Obstetrics/Gynecology
Predicate Device:
Trade Name: Myosure Tissue Removal Device System and Myosure Tissue Removal Devices Submitter / 510(k) Holder: Hologic, Inc. 510(k) #: K152723 Classification code: HIH, Hysteroscope and Accessories, and Regulation: 21.CFR.884.1690 This predicate has not been subject to a design-related recall.
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
- Tissue Removal Device o
- o Foot Pedal
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Hologic. Inc. Special 510(k) Submission September 18th, 2017
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. There have been no major changes in design or materials in the subject Myosure System or its associated tissue removal devices since their market clearance.
Indications for Use:
The Myosure Hysteroscopic Tissue Removal System and Myosure 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 modified Myosure Hysteroscopic Tissue Removal System is different from the predicate Myosure Hysteroscopic Tissue Removal System as follows:
- . The process of manufacturing the outer sheath of the device handpiece has been brought in-house to Hologic Inc.
- . The cutting window of the outer tube is being cut into the tube using a laser rather than the previously used electronic discharge machining (EDM)
- . The process used to clean the outer tube following cutting of the window has been modified to include alkaline cleaning, nitric acid electropolish, and passivation in accordance with ASTM-A967/A967M -13 Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts.
The fundamental scientific technology of the proposed device has not changed relative to the predicate device (K152723):
- . Has the same Indications for Use,
- Has the same mechanism of action and mode of operation, ●
- Is manufactured using the same raw materials,
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Hologic. Inc. Special 510(k) Submission September 18th, 2017
Page 3 of 3
- Is packaged and sterilized using the same process, ●
- Has the same shelf life.
Biocompatibility Testing:
Biocompatibility testing of the modified MyoSure Hysteroscopic Tissue Removal Device outer tubes was conducted to demonstrate that the modified cleaning process does not negatively impact the biocompatibility of the device. Testing was completed using the same methodology as was used in support of the predicate MyoSure Hysteroscopic Tissue Removal System 510(k) submission and in accordance with both AAMI/ISO 10993-1:2009/(R) 2013 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process and the FDA Guidance for Industry and Food and Drug Administration Staff titled Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and dated June 16, 2016. Cytotoxicity, systemic toxicity, intracutaneous reactivity, and maximization sensitization studies were completed in accordance with the standards ISO 10993-5:2009. ISO 10993-11:2006. and ISO 10993-10:2010 respectively. Results from this testing demonstrated that the modified cleaning process does not negatively impact the biocompatibility of the device for the specified use conditions and is therefore substantially equivalent to that of the predicate device.
Performance Testing:
Performance verification testing of the modified Myosure Hysteroscopic Tissue Removal System was not required because there is no modification to the design of the outer tube of the device. An engineering assessment of the cutting method determined there was no impact to the cutting performance of the device as a result of the change in manufacturing process.
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).