(88 days)
Not Found
No
The device description focuses on mechanical resection and control via a foot pedal, with no mention of AI or ML capabilities. The performance studies are bench and laboratory tests evaluating mechanical function and safety, not algorithmic performance.
Yes
The device is indicated for intrauterine use 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" used to "resect and remove tissue." Its function is therapeutic (tissue removal), not diagnostic (identifying or characterizing a condition).
No
The device description clearly outlines physical components such as a hand-held device, drive shaft, motorized control unit, foot pedal, and vacuum tubing, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 is a mechanical tissue removal tool used during a surgical procedure. It physically cuts and removes tissue.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue biopsies) to provide information about a person's health. This device does not perform any diagnostic testing on a sample.
The device is a surgical instrument used for therapeutic purposes (removing abnormal tissue), not for diagnosing a condition based on analyzing a sample outside the body.
N/A
Intended Use / Indications for Use
The Reprocessed MyoSure Tissue Removal Device (Model # 10-401/10-403) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
The Reprocessed MyoSure REACH Tissue Removal Device (Model # 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure LITE Tissue Removal Device (Model # 30-401LITE) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure XL Tissue Removal Device (Model # 50-501XL/50-503XL) is indicated for intrauterine use by trained gyneologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure XL Tissue Removal Device for Fluent (Model # 50-601XL/50-603XL) is indicated for intrauterine use by trained gynecologically resect and remove tissue such as: submucous myomas. endometrial polyps, and retain products of conception.
Product codes (comma separated list FDA assigned to the subject device)
HIH
Device Description
The Reprocessed MyoSure Tissue Removal Devices are sterile, disposable, hand-held tissue removal devices that are used to hysteroscopically remove intrauterine tissue. The devices are connected via a 6-foot (1.8-meter) flexible drive shaft to a motorized control unit. A foot pedal allows the user to control the cutting action of the tissue removal device by turning the motor in the control unit on and off. The proximal end of the 10-foot (3-meter) vacuum tubing is connected to a collection canister. The devices use mechanical resection by drawing the tissue through the cutting window under suction, while the inner blade simultaneously rotates and reciprocates to cut the tissue.
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)
Bench and laboratory testing were conducted to demonstrate performance (safety and effectiveness) of the Reprocessed MyoSure Tissue Removal Device. This included the following tests: Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Materials Mediated Pyrogenicity, Chemical Characterization), Validation of Reprocessing, Sterilization and Shelf Life, Electrical Safety, and Functional Performance (Shaft deflection, Leak decay, Drive cable plug insertion, Shaft insertion force, Torque, Linearity, Revolutions Per Minute, Reciprocation, Wear particulate, Bend, Tissue cutting and removal performance, Reliability testing, Device functional attribute tests, Equipment compatibility). The results of the evaluations demonstrate that the Reprocessed MyoSure Tissue Removal Devices effectively cut and resect tissue in accordance with the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 25, 2020
Stryker Sustainability Solutions Scott English Senior Staff Regulatory Affairs Specialist 1810 W. Drake Drive Tempe, AZ 85283
Re: K201756
Trade/Device Name: Reprocessed MyoSure Tissue Removal Device (10-401/10-403), Reprocessed MyoSure REACH Tissue Removal Device (10-401FC/10-403FC), Reprocessed MyoSure LITE Tissue Removal Device (30-401LITE/30-403LITE), Reprocessed MyoSure XL Tissue Removal Device (50-501XL/50-503XL), Reprocessed MyoSure XL Tissue Removal Device for Fluent (50-601XL/50-603XL) Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: June 27, 2020 Received: June 29, 2020
Dear Scott English:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jason R. Roberts, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K201756
Device Name
Reprocessed MyoSure Tissue Removal Device (10-401/10-403). Reprocessed MyoSure REACH Tissue Removal Device (10-401FC/10-403FC), Reprocessed MyoSure LITE Tissue Removal Device (30-401LITE), Reprocessed MyoSure XL Tissue Removal Device (50-501XL), Reprocessed MyoSure XL Tissue Removal Device for Fluent (50-603XL)
Indications for Use (Describe)
The Reprocessed MyoSure Tissue Removal Device (Model # 10-401/10-403) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
The Reprocessed MyoSure REACH Tissue Removal Device (Model # 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure LITE Tissue Removal Device (Model # 30-401LITE) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure XL Tissue Removal Device (Model # 50-501XL/50-503XL) is indicated for intrauterine use by trained gyneologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure XL Tissue Removal Device for Fluent (Model # 50-601XL/50-603XL) is indicated for intrauterine use by trained gynecologically resect and remove tissue such as: submucous myomas. endometrial polyps, and retain 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."
3
510(k) SUMMARY
Submitter:
Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283
Contact:
Scott English Senior Staff Regulatory Affairs Specialist 480-763-5333 (o) 480-763-5310 (f) scott.english@stryker.com
Date of Preparation: June 27, 2020
Name of Device:
| Trade/Proprietary Name | Model Number |
|---|---|
| Reprocessed MyoSure Tissue Removal Device | 10-401/10-403 |
| Reprocessed MyoSure REACH Tissue Removal Device | 10-401FC/10-403FC |
| Reprocessed MyoSure LITE Tissue Removal Device | 30-401LITE/30-403LITE |
| Reprocessed MyoSure XL Tissue Removal Device | 50-501XL/50-503XL |
| Reprocessed MyoSure XL Tissue Removal Device for Fluent | 50-601XL/50-603XL |
Common Name: Hysteroscope and Accessories
Classification Information: Hysteroscope and Accessories (21 CFR § 884.1690, HIH, Class II)
Predicate Devices:
| Model
Number | 510(k)
Number | 510(k) Title | Original
Manufacturer |
|--------------------------|------------------|-----------------------------------------------------------------------------------|--------------------------|
| 10-401
10-403 | K172566 | MyoSure Hysteroscopic Tissue Removal System
and MyoSure Tissue Removal Devices | Hologic, Inc. |
| 10-401FC
10-403FC | K152723 | MyoSure Hysteroscopic Tissue Removal System
and MyoSure Tissue Removal Devices | Hologic, Inc. |
| 30-401LITE
30-403LITE | K172566 | MyoSure Hysteroscopic Tissue Removal System
and MyoSure Tissue Removal Devices | Hologic, Inc. |
| 50-501XL
50-503XL | K172566 | MyoSure Hysteroscopic Tissue Removal System
and MyoSure Tissue Removal Devices | Hologic, Inc. |
| 50-601XL
50-603XL | K181974 | MyoSure XL Tissue Removal Device for Fluent | Hologic, Inc. |
The predicate devices have not been subject to a design-related recall.
Device Description:
The Reprocessed MyoSure Tissue Removal Devices are sterile, disposable, hand-held tissue
4
removal devices that are used to hysteroscopically remove intrauterine tissue. The devices are connected via a 6-foot (1.8-meter) flexible drive shaft to a motorized control unit. A foot pedal allows the user to control the cutting action of the tissue removal device by turning the motor in the control unit on and off. The proximal end of the 10-foot (3-meter) vacuum tubing is connected to a collection canister. The devices use mechanical resection by drawing the tissue through the cutting window under suction, while the inner blade simultaneously rotates and reciprocates to cut the tissue.
| Device Specifications | |||||
|---|---|---|---|---|---|
| Model | Outer | ||||
| Diameter | Working | ||||
| Length | Window | ||||
| Length | Window | ||||
| Depth | Window | ||||
| Size | |||||
| Reprocessed MyoSure | 3 mm | 32 cm | 14.0 mm | 1.8 mm | 54 mm3 |
| Reprocessed MyoSure REACH | 3 mm | 32 cm | 14.0 mm | 1.8 mm | 54 mm3 |
| Reprocessed MyoSure LITE | 3 mm | 32 cm | 10.2 mm | 1.5 mm | 31 mm3 |
| Reprocessed MyoSure XL | 4 mm | 32 cm | 14.0 mm | 2.4 mm | 98 mm3 |
| Reprocessed MyoSure XL-Fluent | 4 mm | 32 cm | 14.0 mm | 2.4 mm | 98 mm3 |
Indication for Use:
The Reprocessed MyoSure Tissue Removal Device (Model # 10-401/10-403) is indicated for intrauterine use by trained qynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
The Reprocessed MyoSure REACH Tissue Removal Device (Model # 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure LITE Tissue Removal Device (Model # 30-401LITE/30-403LITE) is indicated for intrauterine use by trained qynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure XL Tissue Removal Device (Model # 50-501XL/50-503XL) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure XL Tissue Removal Device for Fluent (Model # 50-601XL/50-603XL) is indicated for intrauterine use by trained qynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The indications for use are the same as the predicate devices.
Comparison of Technological Characteristics:
5
The principles of operation and primary functional specifications of the Reprocessed MyoSure Tissue Removal Devices are identical to those of the predicate MyoSure Tissue Removal Devices. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. The only differences between the Reprocessed MyoSure Tissue Removal Devices and the predicate devices MyoSure Tissue Removal Devices is that devices are reprocessed, and some device components are replaced with equivalent components during the reprocessing operation.
The differences in technological characteristics do not raise different questions of safety and effectiveness.
Performance Data:
Bench and laboratory testing were conducted to demonstrate performance (safety and effectiveness) of the Reprocessed MyoSure Tissue Removal Device. This included the following tests:
Biocompatibility
The biocompatibility evaluation for the Reprocessed MyoSure Tissue Removal Devices was conducted in accordance with FDA Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" dated June 16, 2016, and International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Manaqement Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity ●
- Sensitization
- Irritation
- Systemic Toxicity
- Materials Mediated Pyrogenicity ●
- Chemical Characterization .
The Reprocessed MyoSure Tissue Removal Devices are considered surface contacting, applied to breached surfaces for a duration of less than 24 hours.
Validation of Reprocessing
The reprocessing validation was derived from the recommendations of AAMI/TIR 30:2011, "A Compendium of Processes, Materials. Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices"; ASTM D7225-13:2013, "Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors: AAMI/TIR 12:2010: Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers"; AAMI/ANSI ST35:2003, "Safe handling and biological decontamination of medical devices in health care facilities and in non-clinical settings"; ISO/TS 15883-5, "Washer-disinfectors – Part 5: Test soils and methods for demonstrating cleaning efficacy", and ASTM F3208-18, "Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices."
Sterilization and Shelf Life
6
Sterility of the Reprocessed MyoSure Tissue Removal Devices was assessed in accordance with ANSI/AAMI/ISO 11135-1:2014, "Sterilization of Health Care Products - Ethylene oxide -Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices."
Shelf Life verification testing included assessment of package integrity and device functional performance following aging.
Electrical Safety
Electrical safety testing was conducted on the Reprocessed MyoSure Tissue Removal Devices. The devices comply with the IEC 60601-1 standard for safety.
Functional Performance
- Shaft deflection ●
- Leak decay ●
- Drive cable plug insertion
- Shaft insertion force ●
- Torque ●
- Linearity ●
- . Revolutions Per Minute
- Reciprocation ●
- Wear particulate ●
- Bend
- Tissue cutting and removal performance
- Reliability testing
- Device functional attribute tests ●
- . Equipment compatibility
The bench testing involved evaluation of the devices' performance and ability to cut and resect tissue. The results of the evaluations demonstrate that the Reprocessed MyoSure Tissue Removal Devices effectively cut and resect tissue in accordance with the intended use.
Conclusion:
The results of bench testing and laboratory evaluations demonstrate that the Reprocessed MyoSure Tissue Removal Devices are at least as safe and effective and perform as well as the identified legally marketed predicate devices as described herein.