(58 days)
No
The description mentions a "software pressure control algorithm" and "integrated control system," but these are standard terms for automated systems and do not indicate the use of AI or ML. There is no mention of learning, training data, or adaptive capabilities that are characteristic of AI/ML.
Yes
The device is intended for "resection and coagulation of uterine tissue such as intrauterine polyps and myomas," which directly addresses a medical condition, making it a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system facilitates viewing with a hysteroscope during "diagnostic and operative hysteroscopy," indicating its use in diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a Controller with IV Pole and Footswitch, Resecting Device, Fluid Management Accessories (tubing sets), and an optional Fluid Deficit Readout accessory. While software is mentioned as controlling some functions (peristaltic pumps, pressure control algorithm, GUI), the system is fundamentally a combination of hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "resection and coagulation of uterine tissue" and "providing fluid management" during hysteroscopy. This describes a surgical procedure and fluid control, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system with a controller, resecting device, and fluid management accessories. These are all components used during a surgical procedure within the body, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The system's function is to facilitate a surgical procedure and manage the fluid environment during that procedure.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. The Symphion Operative Hysteroscopy System does not fit this definition.
N/A
Intended Use / Indications for Use
The Symphion Operative Hysteroscopy System and accessories are intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device by distending the uterus with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and providing fluid management through either the closed loop recirculation of filtered distension fluid or non-filtered distension fluid.
Product codes
PGT, HIG
Device Description
The Symphion Operative Hysteroscopy System is comprised of the following:
- Controller with IV Pole and Footswitch
- Resecting Device
- Fluid Management Accessories (INFINITY FMA and EXPRESS FMA)
- Fluid Deficit Readout Optional Accessory
The Symphion Operative Hysteroscopy System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of the uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories. The Symphion Controller, with software version 3.0.0 or higher, is designed to be used in either a recirculating (closed-loop) or non-recirculating system configuration. The Fluid Management Accessories are disposable tubing sets and are available in two models, INFINITY FMA and EXPRESS FMA. The FMAs are designed to assist with the delivery, monitoring, and control of the amount of distention media delivered to the uterine cavity when used with the Symphion controller. When the controller is used with the INFINITY FMA, the system components form a closed-loop recirculating system configuration. Alternatively, when the controller is used with EXPRESS FMA, the system components form an open, nonrecirculating, system configuration. The INFINITY FMA is designed to be used in all types of intrauterine pathology whereas the EXPRESS FMA, lower cost alternative, may be more suitable for softer type tissues or in procedures that require a shorter resection time such as polypectomy, visual D&C and similar.
The integrated peristaltic pumps are operated by a software pressure control algorithm, specific to use with either INFINITY FMA or EXPRESS FMA configurations, that measures and controls intra-uterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection when using the Resection Device. The Symphion Controller Graphical User Interface has two options for initial set up depending on which FMA configuration is being used during the procedure. There are fluid control settings which allow the user to toggle infusion ON/OFF and to set the target cavity pressure from 45-125mmHg. Subsequent to the initial setup GUI, all procedure and control settings are identical regardless of which FMA configuration is being used. The system includes an optional Fluid Deficit Readout accessory device which is an independent saline bag measurement scale to present the user with a digital real-time fluid loss/fluid deficit reading during the Symphion procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus / Uterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical and/or Clinical Test Summary:
As a part of the design control process, The Symphion Operative Hysteroscopy System and accessories were subjected to extensive testing at the system, component, and subassembly levels to ensure that the system performs as intended and that the System met its performance specifications.
Biocompatibility: There was no change to the materials that impacted the existing Biocompatibility testing, therefore no additional biocompatibility testing was required to support the device modification. Standards: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2002 and 2010, ISO 10993-11:2006 and 2017, ISO 10993-12:2007 and 2012, ISO 10993-17:2002, ISO 10993-18:2005.
Software Verification: Software Validation was performed in accordance with IEC 62304:2015. All results have been deemed acceptable.
Electrical Equipment Safety: Applicable Electrical Equipment Safety testing has been conducted for the Symphion Fluid Deficit Readout accessory in accordance with IEC 60601-1:2005 +A1:2012 +A2:2020 and IEC 60601-1-2:2014 +A1:2020. All results have been deemed acceptable.
Sterilization: The Fluid Management Accessories are provided sterile and sterilized by irradiation to a sterility assurance level (SAL) of 10-6. Standards: ANSI/AAMI/ISO 11137-2:2013, ANSI/AAMI/ISO 11737-1:2006 (R) 2011, ANSI/AAMI/ISO 11737-2:2009. All results have been deemed acceptable.
Shelf Life Testing: The Fluid Management Accessories are labeled with a 1 year shelf life. Standards: ASTM F1980-07(2011), ASTM F1886/F1886M-09(R)2013.
Packaging and Transit Testing: Fluid Deficit Readout packaging, Controller packaging, and FMA packaging and transit have been verified. Standards: ASTM D4169-22 (2022), ASTM D4169-09 (2009), ASTM D4332-13 (2013).
Performance Testing (Special Controls): Performance tests have been performed for the Fluid Management Accessory and reviewed by FDA in prior submissions (K132695 and K141848), in accordance with Special Controls defined by 884.1710. All results have been deemed acceptable. No new testing was required for mechanical testing (A), pressure testing (B), fluid delivery volume testing (C), flow rate testing (D), simulated use testing (E), filtration testing (F), blood filtration capacity testing (G), tissue collection capacity testing (H), and filtrate characterization and testing (I).
Clinical Testing was not required.
Conclusion: The results of non-clinical performance testing demonstrate that the subject device is as safe and effective as the predicate devices to support a substantial equivalence determination.
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
§ 884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.
(a)
Identification. A closed loop hysteroscopic insufflator with cutter-coagulator is a prescription device configured for hysteroscopic insufflation, resection, and coagulation. It is used to perform diagnostic and surgical procedures (i.e., resection and coagulation). This device type contains a closed-loop recirculating fluid management system for the controlled delivery of filtered distension fluid. This device type also contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterine tissues.(b)
Classification. Class II (special controls). The special control(s) for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Software validation, verification, and hazard analysis must be provided.
(3) Electrical equipment safety, including appropriate thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed.
(4) Device components that are labeled sterile must be validated to a sterility assurance level of 10
−6 .(5) Shelf-life testing that demonstrates the device packaging maintains sterility and the functionality of the device is maintained following simulated shipping and handling must be provided to support the proposed shelf life.
(6) Non-clinical testing data must demonstrate the performance characteristics of the device. Detailed protocols and the test reports must be provided for each test.
(i) The following tests must be performed for the resection portion of the device:
(A) Mechanical testing to assess critical joint strength.
(B) Device electrode temperature testing.
(C) Coagulation depth testing.
(D) Simulated use testing.
(E) Device durability testing.
(ii) The following tests must be performed for the fluid management portion of the device:
(A) Mechanical testing to assess tensile strength of connections.
(B) Pressure testing that demonstrates the following parameters, including accuracy of the pressure displayed; appropriate detection and response to overpressure conditions; activation of a secondary overpressure relief valve at the maximum safe level; and all accessories within the fluid path meet the pressure requirements.
(C) Fluid delivery volume testing that demonstrates that the maximum fluid volume delivered is below a predefined level.
(D) Flow rate testing.
(E) Simulated use testing.
(F) Filtration testing.
(G) Blood filtration capacity testing.
(H) Tissue collection capacity testing.
(I) Filtrate characterization and testing that demonstrates that the continuous reintroduction of filtrate into the uterus does not pose a safety risk.
(7) Clinician labeling must include:
(i) Specific instructions and the clinical training needed for the safe use of the device.
(ii) Appropriate warnings, precautions, and information related to overpressurization.
(iii) Appropriate EMC information.
(iv) An expiration date/shelf life.
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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.
January 17, 2024
Minerva Surgical, Inc. Michelle Becker Director of Regulatory Affairs 4255 Burton Drive Santa Clara, California 95054
Re: K233710
Trade/Device Name: Symphion Operative Hysteroscopy System Regulation Number: 21 CFR 884.1710 Regulation Name: Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator Regulatory Class: Class II Product Code: PGT, HIG Dated: November 9, 2023 Received: November 20, 2023
Dear Michelle Becker:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing
1
Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devicereporting-mdr-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/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-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 Roberts -S
Jason R. Roberts, Ph.D. 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
3
Indications for Use
510(k) Number (if known) K233710
Device Name
Symphion Operative Hysteroscopy System
Indications for Use (Describe)
The Symphion Operative Hysteroscopy System and accessories are intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device by distending the uterus with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and providing fluid management through either the closed loop recirculation of filtered distension fluid or non-filtered distension fluid.
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) |
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Image /page/4/Picture/1 description: The image shows the logo for Minerva, The Uterine Health Company. The word "minerva" is written in a light gray sans-serif font, with a stylized "V" in purple and blue. Below the logo is the tagline "The Uterine Health Company" in a smaller, light gray font.
Administrative Information
| Subject Device | |
|---|---|
| Trade Name | Symphion Operative Hysteroscopy System |
| Common Name | Symphion Operative Hysteroscopy System |
| 510(k) # | K233710 |
| 510(k) Applicant | Minerva Surgical, Inc. |
| 4255 Burton Drive | |
| Santa Clara, CA 95054 | |
| Applicant Contact | Michelle Becker |
| Phone: 978-760-1704 | |
| Date Prepared | January 16, 2024 |
| Legal Manufacturer | Minerva Surgical, Inc |
| 4255 Burton Drive | |
| Santa Clara, CA 95054 | |
| Classification # | 21 CFR 884.1710 |
| Device Classification Name | Closed loop hysteroscopic insufflator with cutter-coagulator |
| Product Code | PGT (Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With |
| Cutter-Coagulator, Endoscopic, Bipolar) | |
| HIG (Hysteroscopic insufflator) | |
| Classification | Class II (controller with IV pole and footswitch, recirculating tubing set, |
| resecting device, and Fluid Deficit Readout Accessory) | |
| Class I (non-recirculating tubing set) |
Legally Marketed Predicate Devices
| Predicate (Primary) | Predicate (Secondary) | |
|---|---|---|
| Trade Name | IOGYN System | Fluent ® Fluid Management System |
| 510(k) # | K141848 (originally cleared through DeNovo | |
| K132695) | K180825 | |
| 510(k) Applicant | IOGYN, Inc | |
| 20195 Stevens Creek Blvd, Suite 120 | ||
| Cupertino, CA 95014 | HOLOGIC, INC. | |
| 250 Campus Drive | ||
| Marlborough, MA 01752 USA | ||
| Legal Manufacturer | Minerva Surgical, Inc | |
| 4255 Burton Drive | ||
| Santa Clara, CA 95054 | HOLOGIC, INC. | |
| 250 Campus Drive | ||
| Marlborough, MA 01752 USA |
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Image /page/5/Picture/1 description: The image shows the logo for Minerva, a uterine health company. The logo features the company name in a modern, sans-serif font, with the letters in a light gray color. To the right of the name is a stylized, abstract symbol in shades of purple and blue, resembling a stylized flower or leaf. Below the company name is the tagline "The Uterine Health Company" in a smaller, light gray font.
The predicate devices have not been subject to a design-related recall.
Device Description Summary
The Symphion Operative Hysteroscopy System is comprised of the following:
- Controller with IV Pole and Footswitch
- · Resecting Device
- Fluid Management Accessories (INFINITY FMA and EXPRESS FMA)
- · Fluid Deficit Readout Optional Accessory
The Symphion Operative Hysteroscopy System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of the uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories. The Symphion Controller, with software version 3.0.0 or higher, is designed to be used in either a recirculating (closed-loop) or non-recirculating system configuration. The Fluid Manaqement Accessories are disposable tubing sets and are available in two models, INFINITY FMA and EXPRESS FMA. The FMAs are designed to assist with the delivery, monitoring, and control of the amount of distention media delivered to the uterine cavity when used with the Symphion controller. When the controller is used with the INFINITY FMA, the system components form a closed-loop recirculating system configuration. Alternatively, when the controller is used with EXPRESS FMA, the system components form an open, nonrecirculating, system configuration. The INFINITY FMA is designed to be used in all types of intrauterine pathology whereas the EXPRESS FMA, lower cost alternative, may be more suitable for softer type tissues or in procedures that require a shorter resection time such as polypectomy, visual D&C and similar.
The integrated peristaltic pumps are operated by a software pressure control algorithm, specific to use with either INFINITY FMA or EXPRESS FMA configurations, that measures and controls intra-uterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection when using the Resection Device. The Symphion Controller Graphical User Interface has two options for initial set up depending on which FMA configuration is being used during the procedure. There are fluid control settings which allow the user to toggle infusion ON/OFF and to set the target cavity pressure from 45-125mmHg. Subsequent to the initial setup GUI, all procedure and control settings are identical
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Image /page/6/Picture/1 description: The image shows the logo for Minerva, The Uterine Health Company. The word "minerva" is written in a light gray sans-serif font, with a stylized "V" in purple and blue. Below the logo is the tagline "The Uterine Health Company" in a smaller, light gray sans-serif font.
regardless of which FMA configuration is being used. The system includes an optional Fluid Deficit Readout accessory device which is an independent saline bag measurement scale to present the user with a digital real-time fluid loss/fluid deficit reading during the Symphion procedure.
Device Intended Use/Indications for Use
The Symphion Operative Hysteroscopy System and accessories are intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device by distending the uterus with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and providing fluid management through either the closed loop recirculation of filtered distension fluid or non-recirculating/non-filtered distension fluid.
Indications for Use Comparison
The Subject Device has the same general Intended Use/Indications for Use as the predicate devices.
| Attribute | Subject Device | Predicate (Primary) | Predicate (Secondary) | Equivalent |
|---|---|---|---|---|
| Trade Name | Symphion Operative | |||
| Hysteroscopy System | IOGYN System | Fluent® Fluid Management | ||
| System | NA | |||
| Intended | ||||
| Use/Indications for Use | The Symphion Operative | |||
| Hysteroscopy System is | ||||
| intended for resection and | ||||
| coagulation of uterine | ||||
| tissue such as intrauterine | ||||
| polyps and myomas using a | ||||
| bipolar resecting device by | ||||
| distending the uterus with | ||||
| saline to facilitate viewing | ||||
| with a hysteroscope during | ||||
| diagnostic and operative | ||||
| hysteroscopy and providing | ||||
| fluid management through | ||||
| either the closed loop | ||||
| recirculation of filtered | ||||
| distension fluid or non- | ||||
| recirculating/non-filtered | The Symphion System is | |||
| intended to distend the | ||||
| uterus by filling it with saline | ||||
| to facilitate viewing with a | ||||
| hysteroscope during | ||||
| diagnostic and operative | ||||
| hysteroscopy and provide | ||||
| fluid management through | ||||
| the closed loop recirculation | ||||
| of filtered distension fluid. It | ||||
| is also intended for resection | ||||
| and coagulation of uterine | ||||
| tissue such as intrauterine | ||||
| polyps and myomas using a | ||||
| bipolar resecting device. | The Fluent Fluid | |||
| Management System is | ||||
| intended to provide liquid | ||||
| distension of the uterus | ||||
| during diagnostic and | ||||
| operative hysteroscopy, and | ||||
| to monitor the volume | ||||
| differential between the | ||||
| irrigation fluid flowing into | ||||
| and out of the uterus. The | ||||
| Fluent Fluid Management | ||||
| System is designed to be | ||||
| used in operating room, | ||||
| ambulatory surgical center, | ||||
| and physician's office | ||||
| environments. The | YES |
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Image /page/7/Picture/1 description: The image shows the logo for Minerva, The Uterine Health Company. The word "minerva" is written in a light gray sans-serif font, with a stylized purple and blue "V" shape replacing the "V" in the name. Below the name, the words "The Uterine Health Company" are written in a smaller, light gray sans-serif font.
| | distension fluid. | gynecologist should be
trained in diagnostic and
therapeutic hysteroscopy,
resection, and removal of
gynecological tissue. | |
| -- | ------------------- | ---------------------------------------------------------------------------------------------------------------------------------------- | -- |
|---|
Although there are minor differences in how intended use/indications for use are written, the general indication remains the same across the subject device and its predicates. The subject device is a modified version of the primary predicate (Symphion System, closed loop). The modifications include the ability for the user to select a recirculating or nonrecirculating model of the Fluid Management Accessory based on the needs of the patient and dictated by pathology as well as the use of an optional Fluid Deficit Readout accessory.
The intended use/indications use is identical with the primary predicate in all aspects with the exception of the addition of fluid management through a non-recirculating/non-filtered mechanism. The Intended Use/ Indications for Use of secondary predicate (Fluent) does not specify the Fluid management configuration in detail, closed-loop vs non-recirculating. However, the Fluent Fluid Management System is designed with a non-recirculating/ non-filtered fluid management system. The Intended Use of the Subject Device does not specifically mention the optional Fluid Deficit Readout accessory as the Secondary Predicate does describe fluid volume differential monitoring feature. This is due to the fact the Fluid Deficit Readout is an optional accessory to the Symphion Operative Hysteroscopy System, shares the intended use of its parent device, and does not require its own Intended Use.
- The Subject Device, Primary Predicate, and Secondary Predicate are all designed and intended for distension of the uterus through an integrated Fluid Management System.
- The Subject Device and Primary Predicate are designed and intended for resection and coagulation of uterine tissue.
- The Subject Device and its Secondary Predicate both have the ability to monitor fluid for potential absorption.
Therefore, it is concluded the Subject Device's Intended Use/ Indications for Use are similar to the Predicates and does not raise different questions of safety or effectiveness.
Technological Comparison
| Attribute | Subject Device | Predicate (Primary) | Predicate (Secondary) | Equivalent |
|---|---|---|---|---|
| Trade Name | Symphion Operative | |||
| Hysteroscopy System | IOGYN System | Fluent® Fluid Management | ||
| System | NA | |||
| 510(k) # | K233710 | K141848 (originally cleared | ||
| through DeNovo K132695) | K180825 | NA |
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Image /page/8/Picture/1 description: The image shows the logo for Minerva, The Uterine Health Company. The word "minerva" is written in a light gray sans-serif font, with a stylized "V" in purple and blue. Below the logo is the company's tagline, "The Uterine Health Company", also in light gray.
| 510(k) | Applicant | NA | ||
|---|---|---|---|---|
| Minerva Surgical, Inc. 4255 Burton Drive Santa Clara, CA 95054 | IOGYN, Inc 20195 Stevens Creek Blvd, Suite 120 Cupertino, CA 95014 | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 USA | ||
| Controller | ||||
| Specifications | Mode of Operation: | |||
| Intermittent. Duty Cycle: | ||||
| 30 seconds ON 10 seconds | ||||
| OFF | ||||
| Input: 100-240VAC, 50-60Hz, 700VA | ||||
| Output (Resect): 275W ±20%, 275VMAX, 148 kHz, 200 Ω load | ||||
| Output (Coag): 110W ±20%, 200VMAX, 148 kHz, 200 Ω load | ||||
| Operating Conditions: 60°F to 80°F (16°C to 27°C), 30% to 75% Relative Humidity non-condensing | Identical | YES | ||
| Energy | ||||
| Delivered | Bi-Polar Radiofrequency | Identical | YES | |
| Hysteroscopic | ||||
| Fluid Pumps | Peristaltic type, one each Infusion and Aspiration | Identical | YES | |
| Controller User | ||||
| Interface | Digital Touchscreen with both set up steps and procedural controls | Identical | YES | |
| Operating | ||||
| Modes | Diagnostic, Resection | Identical | YES | |
| Intra-Operative | ||||
| Pressure | ||||
| Control | Direct Intra-uterine Pressure measurement | Identical | YES | |
| Pressure | ||||
| Control Limits | 45 - 125mmHg | Identical | YES | |
| Default | ||||
| Intrauterine | ||||
| Pressure | ||||
| Setting | 45 mmHg | Identical | YES | |
| Infusion Flow | ||||
| Rate | Variable- Infusion flow rate is modulated by the software to control pressure in accordance | Identical | YES | |
| with the pressure control | ||||
| specification | ||||
| Maximum | ||||
| Intrauterine | ||||
| Pressure | 125mmHg | Identical | YES | |
| Key Safety | ||||
| Features | ||||
| (overpressure | ||||
| protection and | ||||
| Venting | ||||
| Mechanism) | The system is designed | |||
| with both software and | ||||
| hardware overpressure | ||||
| protection in addition to a | ||||
| system warning if/when | ||||
| the pressure set point is | ||||
| increased above | ||||
| 100mmHg. | Identical | YES | ||
| Visualization- | ||||
| Recirculation | ||||
| Mode | Resection activation not | |||
| required. Footswitch | ||||
| actuated recirculation to | ||||
| clear field | Identical | YES | ||
| Saline Bag | ||||
| Capacity | One 3 liter saline bag | |||
| Maximum | Identical | YES | ||
| Resection | ||||
| Device (RD) | ||||
| Shaft diameter | 3.6mm (~11Fr) | Identical | YES | |
| RD Shaft | ||||
| Working Length | 37cm | Identical | YES | |
| RD Electrode | ||||
| Reciprocation | Handpiece motor driven | |||
| actuation | Identical | YES | ||
| RD | ||||
| Reciprocation | ||||
| Type and Travel | Axial, 18mm | Identical | YES | |
| RD Electrode | ||||
| size | 2.6mm | Identical | YES | |
| RD Coagulation | Single point, spot | |||
| coagulation | Identical | YES | ||
| Aspiration | Aspiration channel for | |||
| Tissue/chip removal | Identical | YES | ||
| Optics | Endoscopic visualization | |||
| through the use of the | ||||
| IOGYN Hysteroscope | ||||
| (K123330) | Identical | YES | ||
| Hysteroscopic | ||||
| Fluid | Recirculating and non- | |||
| recirculating tubing sets | Recirculating tubing set | Non-recirculating tubing set | YES | |
| Circulation | ||||
| Configuration | ||||
| Fluid Filtration | Infinity FMA only: | |||
| Molecular filter | Identical | YES | ||
| Tissue | ||||
| collection | Included - Tissue catch | |||
| (pore size 100 | ||||
| micrometer) | Identical | YES | ||
| Pressure Sensor | Direct sensing, Dual | |||
| Pressure Sensor | ||||
| configuration | Identical | YES | ||
| Overall FMA | ||||
| Tubing Length | 3 meters | Identical | YES | |
| Tubing Set | ||||
| Infusion Tubing | ||||
| Size | OD: 5/16" ID: 3/16" | Identical | YES | |
| Tubing Set | ||||
| Aspiration | ||||
| Tubing Size | OD: 5/16" ID: 3/16" | Identical | YES | |
| Fluid Deficit | ||||
| Readout | ||||
| Methodology | Real-time, weight based | |||
| measurement | Identical | YES | ||
| Fluid Deficit | ||||
| Accuracy | +/- 50mL | Identical | YES | |
| Maximum | ||||
| Allowable Fluid | ||||
| Deficit Alert | ||||
| Limit function | Automatic, 2450mL | |||
| maximum | Automatic, 2500mL | |||
| maximum | YES | |||
| Fluid Deficit | ||||
| Alert Limit | ||||
| Range | 50mL - 2450mL | 100mL - 2500mL | YES | |
| Fluid Deficit | ||||
| Alert Limit | ||||
| Adjustment | ||||
| Interval | 50mL (single button press) | |||
| 100mL (button press w/ | ||||
| hold) | 50mL | YES | ||
| FMA (Fluid | ||||
| Pathway) | ||||
| Materials | ABS, PVC, Nylon, | |||
| Polycarbonate, | ||||
| Polypropylene, Acrylic | ||||
| copolymer, Cyanoacrylate, | ||||
| Viton, Stainless Steel, | ||||
| Silicone, AdvantPure | ||||
| AdvantaFlex, High Density | Identical | YES | ||
| Polyethylene (HDPE), | ||||
| PureWeld, Ethylene | ||||
| Propylene Diene Monomer | ||||
| (EPDM), Polysulfone, | ||||
| Biresin | ||||
| Sterility | Disposable tubing sets and Identical | |||
| resecting devices are | ||||
| provided sterile (106 SAL) | YES | |||
| Sterilization | ||||
| Method | Irradiation | Identical | YES |
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Image /page/9/Picture/1 description: The image shows the logo for Minerva, The Uterine Health Company. The word "minerva" is written in a light gray sans-serif font, with a stylized "v" in purple and blue. Below the logo is the company's tagline, "The Uterine Health Company", also in light gray.
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Image /page/10/Picture/1 description: The image shows the logo for Minerva, "The Uterine Health Company". The word "minerva" is written in gray, with the "v" in purple and blue. The tagline is written in gray below the company name.
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Image /page/11/Picture/1 description: The image shows the Minerva Surgical company logo. The word "minerva" is written in gray lowercase letters, with a stylized purple and blue "V" shape above the "a". Below the word "minerva" is the text "The Uterine Health Company" in gray. The logo is simple and modern, with a focus on the company's name and mission.
Non-Clinical and/or Clinical Test Summary
As a part of the design control process, The Symphion Operative Hysteroscopy System and accessories were subjected to extensive testing at the system, component, and subassembly levels to ensure that the system performs as intended and that the System met its performance specifications.
Biocompatibility
There was no change to the materials that impacted the existing Biocompatibility testing, therefore no additional biocompatibility testing was required to support the device modification.
- . ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
- ISO 10993-10:2002 and 2010, Biological evaluation of medical devices Part 10: Tests ● for skin sensitization
- . ISO 10993-11:2006 and 2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . ISO 10993-12:2007 and 2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- . ISO 10993-17:2002, Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
- ISO 10993-18:2005, Biological evaluation of medical devices Part 18: Chemical . characterization of medical device materials within a risk management process.
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Image /page/12/Picture/1 description: The image shows the logo for Minerva, The Uterine Health Company. The word "minerva" is written in a light gray sans-serif font, with the "v" in purple and blue. Below the word "minerva" is the text "The Uterine Health Company" in a smaller, light gray sans-serif font.
Software Verification
Software Validation was performed in accordance with the following standards.
- IEC 62304:2015, Medical device software Software life cycle processes . All results have been deemed acceptable.
Electrical Equipment Safety
The proposed modifications do not impact the applicable Electrical Equipment Safety testing previously conducted for the Symphion Controller.
Applicable Electrical Equipment Safety testing has been conducted for the Symphion Fluid Deficit Readout accessory in accordance with the following standards:
- . IEC 60601-1:2005 +A1:2012 +A2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 +A1:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
All results have been deemed acceptable.
Sterilization
The Fluid Manaqement Accessories are provided sterile. Fluid Management Accessories are sterilized by irradiation. Sterilization was previously completed to a sterility assurance level (SAL) of 10-6 per the following standards:
- . ANSI/AAMI/ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- . ANSI/AAMI/ISO 11737-1:2006 (R) 2011, Sterilization of health care products -Microbiological methods - Part 1: Determination of a population of microorganisms on product
- . ANSI/AAMI/ISO 11737-2:2009, Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
All results have been deemed acceptable.
Shelf Life Testing
The is no change in the device packaging for the controller and the fluid management system. The Fluid Management Accessories are labeled with a 1 year shelf life. Shelf Life has been verified in accordance with the following standards:
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Image /page/13/Picture/1 description: The image shows the logo for Minerva, a uterine health company. The logo features the company name in a modern, sans-serif font, with the "V" in "Minerva" stylized as two overlapping leaves in shades of purple and blue. Below the company name is the tagline "The Uterine Health Company" in a smaller font.
- . ASTM F1980-07(2011), Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- . ASTM F1886/F1886M-09(R)2013, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
Packaging and Transit Testing
Fluid Deficit Readout packaging and transit has been verified in accordance with the following standards:
- . ASTM D4169-22 (2022), Performance Testing of Shipping Containers and Systems Controller packaging and transit has been verified in accordance with the following standards:
- ASTM D4169-09 (2009), Performance Testing of Shipping Containers and Systems ●
- ASTM D4332-13 (2013), Conditioning Containers, Packages, or Packaging Components . for Testing
FMA packaging and transit testing has been validated in accordance with the following standards:
- . ASTM D4169-09 (2009), Performance Testing of Shipping Containers and Systems
- ASTM D4332-13 (2013), Conditioning Containers, Packages, or Packaging Components ● for Testing
Performance Testing (Special Controls)
Performance tests have been performed for the Fluid Management Accessory and reviewed by FDA in prior submissions (K132695 and K141848), in accordance with Special Controls defined by 884.1710. All results have been deemed acceptable. The related specifications have not been affected by the proposed modification of the device and therefore no new testing is required for the following:
(A) Mechanical testing to assess tensile strength of connections.
(B) Pressure testing that demonstrates the following parameters, including accuracy of the pressure displayed; appropriate detection and response to overpressure conditions; activation of a secondary overpressure relief valve at the maximum safe level; and all accessories within the fluid path meet the pressure requirements.
(C) Fluid delivery volume testing that demonstrates that the maximum fluid volume delivered is below a predefined level.
(D) Flow rate testing.
- (E) Simulated use testing.
- (F) Filtration testing.
- (G) Blood filtration capacity testing.
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Image /page/14/Picture/1 description: The image shows the logo for Minerva, a uterine health company. The logo consists of the word "minerva" in gray lowercase letters, with a stylized purple and blue leaf-like design above the "v". Below the word "minerva" is the tagline "The Uterine Health Company" in a smaller gray font. The logo is simple and modern, and the colors are calming and professional.
(H) Tissue collection capacity testing.
(I) Filtrate characterization and testing that demonstrates that the continuous reintroduction of filtrate into the uterus does not pose a safety risk.
Clinical Testing was not required.
Conclusion
The results of non-clinical performance testing demonstrate that the subject device is as safe and effective as the predicate devices to support a substantial equivalence determination.