(255 days)
No
The device description focuses on hardware components and basic software functions for image display and capture, with no mention of AI/ML for image analysis or other tasks.
No
Explanation: The device is intended for visualization during diagnostic procedures, not for treating or curing a medical condition.
Yes
The device is described as being "intended for visualization of the cervical canal, uterine cavity, and proximal fallopian tube(s) during diagnostic gynecological procedures," explicitly stating its use in diagnostic procedures.
No
The device description clearly outlines multiple hardware components including an endoscope, catheter, camera module, controller board, LCD display, and LED/fiber optic illumination. While it contains embedded software and a separate PC application, it is fundamentally a hardware device with integrated software.
Based on the provided information, the FemDx FalloView™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for visualization of anatomical structures (cervical canal, uterine cavity, fallopian tubes) during diagnostic gynecological procedures. This is a direct visualization method, not a test performed on samples taken from the body.
- Device Description: The device is an endoscope with a camera and illumination system designed for direct internal viewing. It does not involve the analysis of biological samples (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any process that would involve testing samples in vitro.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The FemDx FalloView™ is a medical device used for direct visualization within the body.
N/A
Intended Use / Indications for Use
The FemDx FalloView™ is intended for visualization of the cervical canal, uterine cavity, and proximal fallopian tube(s) during diagnostic gynecological procedures.
Product codes (comma separated list FDA assigned to the subject device)
MKO, HIH
Device Description
The FemDx FalloView™ is a disposable, hand-held, battery-operated endoscope that contains a 4.7 mm hysteroscopic cannula, a 1.2 mm falloposcopic catheter, and a visualization system. The catheter is integrated inside the cannula center lumen and can be deployed, retracted, or rotated. The cannula includes a lumen and a proximal female luer lock port for saline irrigation. The visualization system includes a camera module positioned at the tip of the catheter, a controller board, an LCD display integrated into the device's handle, and LED/fiber optic illumination. The FemDx FalloView™ contains embedded software designed to display the real time image on the LCD display, control the illumination light level, and capture a screenshot. The captured image can be transmitted to a computer via Bluetooth and then accessed using the FalloView™ Image Viewer, a separate PC based software application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal, uterine cavity, and proximal fallopian tube(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Medical Professionals, Hospitals and Physicians Offices
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 Testing:
A comprehensive series of non-clinical tests were completed including mechanical dimensional and performance, electrical hardware/software performance, optical performance, and safety testing. The FemDx FalloView™ passed all applicable testing in accordance with internal requirements and national and international standards. The results demonstrate that the FemDx FalloView™ satisfies the performance, functional, and safety requirements relative to the product specifications, risk analyses, and Instructions for Use, and does not raise different questions of safety and effectiveness than the predicate device.
The non-clinical tests relied on for a determination of substantial equivalence are listed below:
- "Power on" testing including battery lifetime.
- Image quality comparative testing:
- Field of view, Direction of view ISO 8600-3
- Image color quality
- Image resolution ISO 8600-5
- Depth of field
- Image signal to noise ratio
- Dynamic range
- Image geometric distortion
- Image intensity uniformity
- Flow rate and leakage testing ISO 10555-1
- Dimensional testing:
- Maximum width of insertion portion per ISO 8600-4
- Cannula maximum insertion width ISO 8600-4
- Catheter shaft maximal outer diameter ISO 8600-4
- Mechanical testing for bending (displacement), tensile strength, and torque:
- Catheter insertion force, deployment force, and retraction force
- Cannula and catheter bending force
- Cannula and catheter rotational force
- Mechanical strength:
- Catheter sheath tensile strength
- Catheter stiffness/bending curvature radius
- Catheter torsional strength
- Cannula tensile strength
- Cannula torsional strength
- Visualization and illumination design validation testing including equipment compatibility.
- Cannula and catheter insertion testing within a uterus and fallopian tube model
- Illumination testing within a uterus and fallopian tube model
- LED illumination light level testing
- Thermal safety testing
- Photobiological safety IEC 62471
- Packaging testing ISO 11607-1:
- Simulated shipping conditions ASTM D4169
- Climatic conditioning ASTM D4332
- Package and seal integrity visual inspection ASTM F1886/F1186M
- Bubble leak ASTM F2096
- Aseptic opening ISO 11607-1
- Seal strength ASTM F88/F88M
- Seal width ASTM F2203
- Biocompatibility ISO 10993-1:
- Cytotoxicity ISO 10993-5
- Sensitization ISO 10993-10
- Irritation ISO 10993-10
- Sterilization ISO 11135
- EO and ECH residual testing ISO 10993-7
- Software verification and validation IEC 62304
- Electrical safety IEC 60601-1
- Electromagnetic compatibility IEC 60601-1-2 (EMC and Immunity)
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.
Conceptus Fallopian Tube Catheterization with Microendoscopy (FTCM) System (K962587)
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.
LiNA Medical ApS LINA Opera Scope (K171113), Cook Incorporated Rösch-Thurmond Fallopian Tube Catheterization Set and Fallopian Tube Catheterization Set (K171604), Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) (K213171)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 17, 2023
FemDx Medsystems, Inc. % Sevrina Ciucci Regulatory Consultant Regulatory Consulting Services LLC 2336 Walsh Avenue, Suite A Santa Clara, CA 95051
Re: K221965
Trade/Device Name: FemDx FalloView™ Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: MKO, HIH Dated: February 16, 2023 Received: February 17, 2023
Dear Sevrina Ciucci:
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.
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.
1
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 and Part 809); 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-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 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 mediation-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 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
2
Indications for Use
510(k) Number (if known) K221965
Device Name FemDx FalloView™
Indications for Use (Describe)
The FemDx FalloView™ is intended for visualization of the cervical canal, uterine cavity, and proximal fallopian ube(s) during diagnostic gynecological procedures.
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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3
510(k) Summary
| Date Prepared: | March 15, 2023 |
|---|---|
| Submitter: | FemDx Medsystems, Inc. |
| 2336 Walsh Avenue, Suite A | |
| Santa Clara, CA 95051 | |
| Contact Person: | Xi Francis, CEO |
| Email: Ashlee@femdxmedical.com | |
| Trade/Device Name: | FemDx FalloView™ |
| Common Name: | Falloposcope, Hysteroscope |
| Classification Regulation: | 21 CFR §884.1690, Hysteroscope and accessories |
| Product Codes: | MKO, HIH |
| Device Classification: | Class II |
| Classification Panel: | Obstetrics/Gynecology |
| Primary Predicate: | Conceptus Fallopian Tube Catheterization with Microendoscopy (FTCM) |
| System (K962587) | |
| Reference Devices: | LiNA Medical ApS LINA Opera Scope (K171113) |
| Cook Incorporated Rösch-Thurmond Fallopian Tube Catheterization Set and | |
| Fallopian Tube Catheterization Set (K171604) | |
| Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta | |
| Disposable Cystoscope (Coral) (K213171) |
Device Description
The FemDx FalloView™ is a disposable, hand-held, battery-operated endoscope that contains a 4.7 mm hysteroscopic cannula, a 1.2 mm falloposcopic catheter, and a visualization system. The catheter is integrated inside the cannula center lumen and can be deployed, retracted, or rotated. The cannula includes a lumen and a proximal female luer lock port for saline irrigation. The visualization system includes a camera module positioned at the tip of the catheter, a controller board, an LCD display integrated into the device's handle, and LED/fiber optic illumination. The FemDx FalloView™ contains embedded software designed to display the real time image on the LCD display, control the illumination light level, and capture a screenshot. The captured image can be transmitted to a computer via Bluetooth and then accessed using the FalloView™ Image Viewer, a separate PC based software application.
4
Indications for Use
The FemDx FalloView™ is intended for visualization of the cervical canal, uterine cavity, and proximal fallopian tube(s) during diagnostic gynecological procedures.
Substantial Equivalence Discussion
The FemDx FalloView™ is substantially equivalent to Conceptus Fallopian Tube Catheterization with Microendoscopy (FTCM) System (K962587). Table 1 compares the FemDx FalloView™ to the predicate device. The different technological characteristics exist in other previously cleared FDA devices of the same type and do not raise different questions of safety and effectiveness than the predicate device.
| Predicate Device | Subject Device | |
|---|---|---|
| Characteristic | Conceptus FTCM System | FemDx FalloView™ |
| K962587 | K221965 | |
| Device Classification | II | II |
| Classification Name | Falloposcope | Falloposcope, Hysteroscope and Accessories |
| Regulation Number | 884.1690 | 884.1690 |
| Product Code | MKO | MKO, HIH |
| Indications for Use | The Conceptus FTCM System is intended for | |
| use in selective catheterization / cannulation | ||
| of the fallopian tubes in order to evaluate | ||
| proximal tubal occlusion or patency under | ||
| direct visualization. | The FemDx FalloView is intended for | |
| visualization of the cervical canal, uterine | ||
| cavity, and proximal fallopian tube(s) during | ||
| diagnostic gynecological procedures. | ||
| Components | Soft Seal Cervical Catheter, Soft Torque | |
| Uterine Catheter (including Mandrel and | ||
| Accessory Valve), and/or Articulating Tip | ||
| Hysteroscope, Variable Softness Catheter, | ||
| Guidewires (Robust Guidewire, Traveler | ||
| Guidewire, Supple Guidewire, and Pirouette | ||
| Guidewire), and a Microendoscope with | ||
| Eyepiece | •Handle with LCD display unit, battery pull | |
| tab, and control button to turn device on and | ||
| off. | ||
| •Cannula with stainless -steel hypo-tube that | ||
| forms the inner lumen of the cannula that | ||
| houses the catheter. The distal tip | ||
| incorporates a low intensity LED to illuminate | ||
| the uterus. | ||
| •Catheter with a CMOS-chip endoscope that | ||
| maintains an image of the tissue in contact | ||
| with its surface. Contains an LED and camera | ||
| connected to the controller board. | ||
| Intended User | Trained Medical Professionals | Trained Medical Professionals |
| Site of Use | Hospitals and Physicians Offices | Hospitals and Physicians Offices |
| Anatomical Use | Proximal Fallopian Tube(s) | Cervical Canal, Uterine Cavity, and Proximal |
| Fallopian Tube(s) | ||
| Cannula Working | ||
| Length | Unknown | 250 mm |
| Cannula Outer | ||
| Diameter | Unknown | 4.7 mm |
| Predicate Device | Subject Device | |
| Characteristic | Conceptus FTCM System | FemDx FalloView™ |
| K962587 | K221965 | |
| Cannula Tip Design | Soft Torque Uterine Catheter: curved tip | Rounded polymer tip with angled distal portion (10 mm approx. 15°) |
| Cannula Lumens | Soft Seal Cervical Catheter: dual lumen | |
| Soft Torque Uterine Catheter and Variable | ||
| Softness Catheter: single lumen | Three lumens | |
| Inflow / Outflow Design | Inflow: Inflow occurs through a port on the | |
| Variable Softness catheter | ||
| Outflow: No outflow | Inflow: Inflow occurs through a port on the proximal side of the cannula. | |
| Outflow: No outflow | ||
| Inflow Pressure Limit | Unknown, use a syringe, or irrigation tube | 75 mmHg |
| Catheter Working Length | Unknown | 108 mm (extension beyond cannula tip) |
| Catheter Outer Tip Diameter | Variable Softness Catheter: 1.2 to 1.3 mm | |
| according to Surrey et.al.1996Error! Bookmark not | ||
| defined. | 1.2 mm | |
| Catheter Tip Design | Unknown | Rounded polymer |
| Imaging Technology | Microendoscope: fiberscope with optical fiber | |
| bundle for pixels | CMOS Camera Module | |
| LCD Display Size | Not applicable, use eyepiece or external video | |
| system for display | 3.5 inches (diagonal) | |
| Image Resolution | Unknown | 40,000 pixels |
| Pixel size 1.75 um | ||
| Illumination Light Source | External light source. | |
| Fiber optics in hysteroscope and | ||
| microendoscope extend the light energy. | LED at tip of the cannula and internal LED | |
| with fiber optics that extends to the tip of the | ||
| catheter. | ||
| Light at 20 mm from target. Range high to low level [LUX] | Not applicable | 378 - 192 LUX |
| Image Transmission | Not applicable | Transits images from CMOS camera module |
| to integrated LCD display. | ||
| Energy Source | Not applicable | Handpiece: 9V battery, regulated to 3.3V |
| internally | ||
| Sterilization | Unknown | Ethylene Oxide (EO) |
| Image Saving Software | Not applicable | Yes |
Table 1: Substantial Equivalence Table
5
Non-Clinical Testing
To demonstrate safety and effectiveness of the FemDx FalloView™ and show substantial equivalence to the predicate device, a comprehensive series of non-clinical tests were completed including mechanical dimensional and performance, electrical hardware/software performance, optical performance, and safety testing in accordance with FDA's guidance, "Hysteroscopes and Gynecological Laparoscopes Submission
6
Guidance for a 510(k)". The FemDx FalloView™ passed all applicable testing in accordance with internal requirements and national and international standards. The results demonstrate that the FemDx FalloView™ satisfies the performance, functional, and safety requirements relative to the product specifications, risk analyses, and Instructions for Use, and does not raise different questions of safety and effectiveness than the predicate device.
The non-clinical tests relied on for a determination of substantial equivalence are listed below.
- . "Power on" testing including battery lifetime.
- . Image quality comparative testing
- Field of view, Direction of view ISO 8600-3 O
- Image color quality о
- Image resolution ISO 8600-5 O
- O Depth of field
- Image signal to noise ratio O
- Dynamic range O
- Image geometric distortion O
- Image intensity uniformity O
- Flow rate and leakage testing ISO 10555-1 ●
- Dimensional testing ●
- Maximum width of insertion portion per ISO 8600-4 O
- Cannula maximum insertion width ISO 8600-4 O
- Catheter shaft maximal outer diameter ISO 8600-4 O
- Mechanical testing for bending (displacement), tensile strength, and torque ●
- Catheter insertion force, deployment force, and retraction force O
- O Cannula and catheter bending force
- Cannula and catheter rotational force O
- Mechanical strength ●
- Catheter sheath tensile strength o
- Catheter stiffness/bending curvature radius O
- Catheter torsional strength o
- Cannula tensile strength O
- Cannula torsional strength O
- Visualization and illumination design validation testing including equipment compatibility.
- Cannula and catheter insertion testing within a uterus and fallopian tube model O
- Illumination testing within a uterus and fallopian tube model O
- LED illumination light level testing
- Thermal safety testing
- . Photobiological safety IEC 62471
- Packaging testing ISO 11607-1
- Simulated shipping conditions ASTM D4169 o
- Climatic conditioning ASTM D4332 O
7
- Package and seal integrity visual inspection ASTM F1886/F1186M O
- O Bubble leak ASTM F2096
- O Aseptic opening ISO 11607-1
- Seal strength ASTM F88/F88M O
- Seal width ASTM F2203 O
- Biocompatibility ISO 10993-1
- Cytotoxicity ISO 10993-5 O
- o Sensitization ISO 10993-10
- o Irritation ISO 10993-10
- Sterilization ISO 11135 ●
- . EO and ECH residual testing ISO 10993-7
- . Software verification and validation IEC 62304
- . Electrical safety IEC 60601-1
- Electromagnetic compatibility IEC 60601-1-2 (EMC and Immunity)
Conclusion
The FemDx FalloView™ is substantially equivalent to the predicate device.