(136 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, not data processing or algorithmic functions. There is no mention of AI, ML, or related concepts.
No
The device is described as a dual-barrel contrast media syringe used to instill saline and air for diagnostic imaging (Sono HSG) rather than for treating a disease or condition.
No
Explanation: The device is used to instill contrast media for a Sono HSG procedure, which is an imaging technique. It does not perform diagnostic functions itself but rather assists in providing better image quality for a diagnostic procedure.
No
The device description clearly states it is a "dual-barrel contrast media syringe" and describes its physical operation (retraction of plunger, connection to catheter, depression of plunger). The performance studies also focus on physical characteristics like sterilization, package integrity, transportation simulation, biocompatibility, and bench performance (functional/cycle testing, saline-air quantification), all indicative of a hardware device. There is no mention of software components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to instill contrast media into the uterus and fallopian tubes for a Sono HSG procedure. This is a procedure performed on the patient's body using imaging (ultrasound) to visualize anatomical structures.
- Device Description: The device is a syringe designed to deliver a substance (saline and air) into the body.
- Lack of In Vitro Activity: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any analysis or testing of bodily specimens. It is a tool used during a diagnostic imaging procedure performed on the patient.
The device is a medical device used in conjunction with an imaging modality (ultrasound) to aid in the visualization of internal structures, but it is not an IVD.
N/A
Intended Use / Indications for Use
FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
Product codes
LKF
Device Description
FemVue® MINI is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterilization and is intended for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus and fallopian tubes
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)
The following studies have been performed to support substantial equivalence to the predicate device:
- Ethylene Oxide Sterilization Validation testing per:
- ISO 11135:2014
- AAMI TIR 28:2016
- ISO 10993-7: 2008
- Package Integrity testing:
- Visual inspection
- Bubble Leak test per ASTM F2096-11
- Seal Strength testing per ASTM F88/ F88M-23
- Seal Visual Inspection per ASTM F1886/F1886-16
- Transportation Simulation testing per ASTM D4169-22
- Biocompatibility studies conducted in accordance with the 2023 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". Testing included the following assessments:
- Cytotoxicity per ISO 10993-5: 2009
- Sensitization ISO 10993-10: 2021
- Irritation per ISO 10993-10: 2021
- Testing showed the device material to be non-cytotoxic, non-sensitizing, and non- irritating.
- Bench performance studies before and after accelerated aging to the equivalent of 12-months of real-time aging in accordance with ASTM F1980-16 demonstrated that all predetermined acceptance criteria were met in the following tests:
- Visual Inspection
- Functional/Cycle Testing
- Saline-Air Quantification
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
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 22, 2024
Femasys Inc. Carrie Engleman Associate Director of Regulatory 3950 Johns Creek Ct. Suite 100 Suwanee, Georgia 30024
Re: K242002
Trade/Device Name: FemVue MINI Saline-Air Device Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: July 9, 2024 Received: July 9, 2024
Dear Carrie Engleman:
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 Device"
1
(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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-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
2
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,
Monica D. Garcia -S
Monica D. Garcia, 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
FemVue MINI Saline-Air Device
Indications for Use (Describe)
FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
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.
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4
510(k) Summary - K242002
I. SUBMITTER
| Applicant: | Femasys Inc. |
|---|---|
| Applicant Address: | 3950 Johns Creek Court, Suite 100 |
| Suwanee, GA 30024 | |
| Contact Primary: | Carrie Engleman |
| Associate Director, Regulatory | |
| Phone: 770-500-3910 x 138 | |
| Email: Cengleman@femasys.com | |
| Contact Secondary: | Christine Thomas |
| Senior VP, Regulatory and Clinical | |
| Phone: 770-500-3910 x 137 | |
| Email: Cthomas@femasys.com | |
| Date Prepared: | November 20, 2024 |
| II. DEVICE | |
| Trade Name: | FemVue® MINI Saline-Air Device |
| Common Name: | Contrast media syringe |
| Regulation Name: | Obstetric-gynecologic specialized manual instrument |
| Regulation Number: | 21 CFR 884.4530 |
| Regulatory Class: | II |
| Product Code: | LKF (Cannula Manipulator/Injector Uterine) |
III. PREDICATE DEVICE
FemVue® Saline-Air Device (K110288), manufactured by Femasys Inc.
The predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
Fem Vue® MINI is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity.
5
The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterilization and is intended for single-use.
INDICATIONS FOR USE V.
Fem Vue® MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
COMPARISON OF THE INTENDED USE AND TECHNOLOGICAL VI. CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES
The intended use and key technological characteristics of the subject and predicate device are compared in the table below.
| Comparison
Item | FemVue® MINI Saline-Air Device
Subject Device | FemVue® Saline-Air Device
Predicate Device | Comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) | K242002 | K110288 | N/A |
| Regulation
Number | 884.4530 | 884.4530 | Same |
| Device Class | Class II | Class II | Same |
| Product Code | LKF | LKF | Same |
| Device
Classification
Name | Cannula, Manipulator/Injector, Uterine | Cannula, Manipulator/Injector, Uterine | Same |
| Regulation
Description | Obstetric-gynecologic specialized
manual instrument | Obstetric-gynecologic specialized
manual instrument | Same |
| Regulation
Medical
Specialty | Obstetrics/Gynecology | Obstetrics/Gynecology | Same |
| Indications for
Use | FemVue MINI is intended to instill a
consistent alternating pattern of saline
and air as a continuous stream of
contrast media into the uterus and
fallopian tubes to be used in
conjunction with an intrauterine
catheter for performance of sono-
hysterosalpingogram (Sono HSG). | The FemVue Saline-Air Device instills
a consistent alternating pattern of saline
and air as a continuous stream of
contrast media into the uterus and
fallopian tubes to be used in
conjunction with an intrauterine
catheter for performance of sono-
hysterosalpingogram (Sono HSG). | Same |
| Design
Features | Dual-barrel contrast media syringe that
can be connected to an intrauterine
catheter. | Dual-barrel contrast media syringe that
can be connected to an intrauterine
catheter. | Same |
| Principle of
Operation | Sterile dual-barrel contrast media
syringe that is connected to an
intrauterine catheter to instill saline-air
contrast medium as part of a sono- | Sterile dual-barrel contrast media
syringe that is connected to an
intrauterine catheter to instill saline-air
contrast medium as part of a sono- | Same |
Table 1. Intended use and technological characteristics comparison.
6
| Comparison
Item | FemVue® MINI Saline-Air Device
Subject Device | FemVue® Saline-Air Device
Predicate Device | Comparison |
|------------------------------|--------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | hysterosalpingogram (Sono HSG)
procedure. | hysterosalpingogram (Sono HSG)
procedure. | |
| Prescription
Only | Yes | Yes | Same |
| Target Patient
Population | Patient undergoing Sono HSG
procedure. | Patient undergoing Sono HSG
procedure. | Same |
| Shelf Life | 12 months | 60 months | Different.
The
differences
do not raise
different
questions of
safety and
effectiveness. |
| Syringe | 5 mL | 10 mL | Different.
The different
size of the
syringes does
not raise
different
questions of
safety and
effectiveness. |
The subject and predicate device have the same intended use - to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media through a connected intrauterine catheter into the uterus and fallopian tubes for performance of sonohysterosalpingogram (Sono HSG) procedure. The subject and predicate device have the same principle of operation (dual-barrel syringe device that delivers saline and air contrast through an intrauterine catheter). However, minor modifications have been made to the device dimensions and the materials to reduce the overall size of the FemVue MINI device in comparison to the predicate device. These differences do not raise different questions of safety and effectiveness.
SUMMARY OF NON-CLINICAL PERFORMANCE DATA VII.
The following studies have been performed to support substantial equivalence to the predicate device:
· Ethylene Oxide Sterilization Validation testing per:
-ISO 11135:2014 -AAMI TIR 28:2016 -ISO 10993-7: 2008
7
-
· Package Integrity testing:
-Visual inspection -Bubble Leak test per ASTM F2096-11 -Seal Strength testing per ASTM F88/ F88M-23 -Seal Visual Inspection per ASTM F1886/F1886-16 -
· Transportation Simulation testing per ASTM D4169-22
-
· Biocompatibility studies conducted in accordance with the 2023 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". Testing included the following assessments:
-Cytotoxicity per ISO 10993-5: 2009 -Sensitization ISO 10993-10: 2021 -Irritation per ISO 10993-10: 2021
Testing showed the device material to be non-cytotoxic, non-sensitizing, and non- irritating.
- · Bench performance studies before and after accelerated aging to the equivalent of 12-months of real-time aging in accordance with ASTM F1980-16 demonstrated that all predetermined acceptance criteria were met in the following tests:
-Visual Inspection -Functional/Cycle Testing -Saline-Air Quantification
VIII. CONCLUSIONS
The results of the testing demonstrate that the Fem Vue MINI Saline-Air Device are as safe and effective as the predicate device and supports a determination of substantial equivalence.