(101 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, not AI/ML algorithms. There is no mention of AI, ML, or related concepts.
No.
The device is described as a delivery system for sperm or IVF embryos into the uterine ostium. It facilitates reproduction but does not treat a disease or condition, which is the primary function of a therapeutic device.
No
The device is intended to introduce washed sperm or IVF embryos into the uterine ostium. This is a therapeutic or delivery function, not a diagnostic one. While it uses ultrasound guidance, the ultrasound itself is the diagnostic tool for placement, not the device itself which performs the delivery.
No
The device description clearly outlines physical components (catheter, syringe, balloon) and the performance studies focus on the physical properties and biological interactions of these components, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Function: The FemaSeed Intratubal Insemination device is a delivery system. Its purpose is to physically introduce washed sperm or IVF embryos into the uterine ostium. It does not perform any diagnostic testing on a sample.
- Intended Use: The intended use clearly states it's for "introducing washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium". This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details the physical components and how they are used to deliver the samples. There is no mention of analyzing a sample or providing diagnostic information.
The device is a medical device used in an assisted reproductive technology procedure, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance.
Product codes
MQF
Device Description
The FemaSeed Intratubal Insemination consists of polymer curved transfer catheter with balloon, polymer guide catheter and separate balloon inflation syringe. The balloon inflation syringe is a 3 mL syringe fitted with clips that allow for the piston to lock in place to maintain balloon inflation. When the clips are pinched, the piston releases, deflating the balloon. The device is intended to deliver washed sperm or in vitro fertilized embryos into the uterine ostium via ultrasound guidance by a licensed healthcare provider specifically trained in women's health.
Prior to insertion, the slider is moved back until the curved transfer catheter is fully retracted and contained within guide catheter. The preassembled guide catheter is then passed transvaginally through the cervix to the fundus, under ultrasound guidance. Once in position, the preloaded transfer catheter is advanced approximately 2 cm into the uterine ostium and the balloon is inflated with the provided syringe. The balloon location in the uterine ostium is confirmed using ultrasound. The samples are then instilled into the uterine ostium of the fallopian tube, followed by deflating the balloon and discarding the device. The recommended volume for loading washed sperm should not exceed 1 mL and 50-100 µL when loading embryos.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
uterine ostium, fallopian tube
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare provider specifically trained in women's health.
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
The following studies have been performed to support substantial equivalence to the predicate device:
- Ethylene Oxide Sterilization Validation testing per:
- ISO 11135-1:2014
- 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-15
- Transportation Simulation testing per ASTM D4169-14
- Biocompatibility studies conducted in accordance with the 2020 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: 2010
- Irritation per ISO 10993-10: 2010
Testing showed the device material to be non-cytotoxic, non-sensitizing, and non-irritating.
- Endotoxin testing per USP and AAMI/ANSI ST72:2019
- Specification:
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
0
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.
September 22, 2023
Femasys, Inc. Christine Thomas SVP. Regulatory & Clinical Affairs 3950 Johns Creek Court. Suite 100 Suwanee, GA 30024
Re: K231730
Trade/Device Name: FemaSeed Intratubal Insemination Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MQF Dated: August 18, 2023 Received: August 22, 2023
Dear Christine Thomas:
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); 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 (QS) 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,
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
2
Indications for Use
510(k) Number (if known) K231730
Device Name FemaSeed Intratubal Insemination
Indications for Use (Describe)
The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K231730 Page 1 of 5
510(k) Summary - K231730
I. SUBMITTER
| Applicant: | Femasys Inc. |
|---|---|
| Applicant Address: | 3950 Johns Creek Court, Suite 100 |
| Suwanee, GA 30024 | |
| Phone: | +770-500-3910 x137 |
| Email: | CThomas@femasys.com |
| Contact Person: | Christine Thomas |
| Sr. VP, Regulatory & Clinical Affairs | |
| Date Prepared: | September 21, 2023 |
II. DEVICE
| Trade Name: | FemaSeed Intratubal Insemination |
|---|---|
| Common Name: | Transfer Catheter |
| Regulation Name: | Assisted Reproduction Catheters |
| Regulation Number: | 21 CFR 884.6110 |
| Regulatory Class: | II |
| Product Code: | MQF (Catheter, Assisted Reproduction) |
III. PREDICATE DEVICE
K983591 Intratubal Transfer Sets, currently legally marketed as Echosight Jansen-Anderson Intratubal Transfer Set.
The predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The FemaSeed Intratubal Insemination consists of polymer curved transfer catheter with balloon, polymer guide catheter and separate balloon inflation syringe. The balloon inflation syringe is a 3 mL syringe fitted with clips that allow for the piston to lock in place to maintain balloon inflation. When the clips are pinched, the piston releases, deflating the balloon. The device is intended to deliver washed sperm or in vitro fertilized embryos into the uterine ostium via ultrasound guidance by a licensed healthcare provider specifically trained in women's health.
Prior to insertion, the slider is moved back until the curved transfer catheter is fully retracted and contained within guide catheter. The preassembled guide catheter is then passed transvaginally through the cervix to the fundus, under ultrasound guidance.
4
Once in position, the preloaded transfer catheter is advanced approximately 2 cm into the uterine ostium and the balloon is inflated with the provided syringe. The balloon location in the uterine ostium is confirmed using ultrasound. The samples are then instilled into the uterine ostium of the fallopian tube, followed by deflating the balloon and discarding the device. The recommended volume for loading washed sperm should not exceed 1 mL and 50-100 µL when loading embryos.
V. INDICATIONS FOR USE
The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance.
VI. COMPARISON OF THE INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES
The following table compares the FemaSeed Intratubal Insemination Transfer Catheters to the predicate device.
| Comparison Item | Subject Device –
K231730 | Predicate Device
– K983591 | Comparison |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Classification | 21 CFR 884.6110 | 21 CFR 884.6110 | Same |
| Product code | MQF | MQF | Same |
| Indications for Use | The FemaSeed
Intratubal
Insemination is
intended to introduce
washed sperm or in
vitro fertilized (IVF)
embryos into the
uterine ostium via
ultrasound guidance. | The intratubal
transfer sets are
used to inject
either sperm,
gametes or
embryos into the
uterine ostium of
the fallopian tube
via ultrasound
guidance. The
device is sterile
and intended for
one time use. | Similar |
| Design Features | The FemaSeed
Intratubal
Insemination consists
of a polymer curved
transfer catheter,
polymer guide
catheter and a
separate balloon | The Intratubal
Transfer Set
consists of a
polymer curved
guide catheter,
stainless steel,
malleable
obturator, stainless | Different |
| Comparison Item | Subject Device –
K231730 | Predicate Device –
K983591 | Comparison |
| | inflation syringe. The
transfer catheter
includes an inflatable
balloon. | steel wire guide
and a polymer
transfer catheter. | |
| Catheter Assembly | Preassembled
catheters, separate
syringe | Separate catheters,
separate stainless-
steel obturator | Different |
| Outer and Inner
Diameters | Guide catheter 3.8 mm
Transfer catheter 1.5 mm
There are two (2) lumens of the transfer
catheter:
Specimen lumen ID 0.036" +0.000 / -0.003"Balloon inflation lumen ID 0.010" +0.000 / -0.002"The dimension of the
balloon when inflated is a minimum of 34F | Guide catheter 1.9 mm
Transfer catheter 1 mm | Different |
| Materials | Polymer
(Pebax/Pellethane) | Polymer
Stainless steel | Different |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
| Single Use | Yes | Yes | Same |
| Shelf Life | 6-months | 36-months | Different |
| Mouse Embryo Assay | 2-Cell MEA: ≥ 80%
embryos developed to
expanded blastocyst
at 72 hours. | Not available
publicly | Not
applicable |
| Endotoxin | and AAMI/ANSI ST72:2019 ● Specification:
7
lock clips to maintain balloon inflation
- Maximum extension force for transfer and guide catheters A
-
Depth of insertion and transfer catheter advancement testing
- Aspiration and delivery testing >
-
Minimize lost specimen during aspiration and delivery
-
Indicate when transfer catheter is fully advanced or retracted
-
Guide catheter insertion without kinking and minimize patient discomfort or risk of injury
-
Human Sperm Survival Assay (HSSA) demonstrating ≥80% of control motility at 24 hours following 30-minute exposure.
-
Mouse Embryo Assay (MEA) per the 2021 FDA guidance Mouse Embryo Assay for Assisted Reproduction Technology Devices: Specification - 2-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 72 hours.
VIII. CONCLUSIONS
The results of the testing described above demonstrate that the FemaSeed Intratubal Insemination transfer catheters are as safe and effective as the predicate device and supports a determination of substantial equivalence.