(101 days)
The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance
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.
The provided text describes the FemaSeed Intratubal Insemination device and its comparison to a predicate device, along with a summary of non-clinical performance data. However, it does not include detailed acceptance criteria or a study proving the device meets them in the format requested. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It lists various tests performed and their general outcomes (e.g., "all predetermined acceptance criteria were met"), but it doesn't quantify those criteria or the specific performance metrics for each, nor does it describe specific studies with sample sizes, expert involvement, or ground truth establishment for a device performance acceptance criteria table as requested.
Therefore, the following response will extract the available information and highlight the missing details based on your request.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantified acceptance criteria and reported device performance are generally not detailed. The document often states that "predetermined acceptance criteria were met" without specifying what those criteria were. However, some specific acceptance criteria and performance are mentioned:
| Acceptance Criteria Category | Specific Acceptance Criteria (if stated) | Reported Device Performance (if stated) |
|---|---|---|
| Biocompatibility | N/A - Refer to ISO 10993 series | Non-cytotoxic, non-sensitizing, non-irritating |
| Endotoxin | < 20 EU/device | < 20 EU/device |
| Human Sperm Survival Assay (HSSA) | ≥80% of control motility at 24 hours following 30-minute exposure | ≥80% of control motility at 24 hours following 30-minute exposure |
| Mouse Embryo Assay (MEA) | ≥ 80% embryos developed to expanded blastocyst at 72 hours | ≥ 80% embryos developed to expanded blastocyst at 72 hours |
| Mechanical Performance | Predetermined acceptance criteria met | All predetermined acceptance criteria were met |
| Balloon Integrity | Predetermined acceptance criteria met | All predetermined acceptance criteria were met |
| Maximum Burst Pressure | Predetermined acceptance criteria met | All predetermined acceptance criteria were met |
| Maximum Cycles for Stop Lock Clips | Predetermined acceptance criteria met | All predetermined acceptance criteria were met |
| Maximum Extension Force | Predetermined acceptance criteria met | All predetermined acceptance criteria were met |
| Depth of Insertion & Transfer Catheter Advancement | Predetermined acceptance criteria met | All predetermined acceptance criteria were met |
| Aspiration & Delivery | Predetermined acceptance criteria met | All predetermined acceptance criteria were met |
| Minimize Lost Specimen | Predetermined acceptance criteria met | All predetermined acceptance criteria were met |
| Indicate Full Advancement/Retraction | Predetermined acceptance criteria met | All predetermined acceptance criteria were met |
| Guide Catheter Insertion (no kinking, minimize discomfort/injury) | Predetermined acceptance criteria met | All predetermined acceptance criteria were met |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance studies (e.g., sterilization, package integrity, biocompatibility, bench testing). However, it does not specify the sample sizes used for these tests. For instance, for mechanical tests or HSSA/MEA, the number of devices or biological samples tested is not provided. The data provenance is implied to be from laboratory testing performed by or for the device manufacturer (Femasys, Inc.), which is typically considered prospective data generation for regulatory submission. There is no mention of country of origin for any data beyond the general context of U.S. FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies mentioned are non-clinical, benchtop, and biological compatibility tests, which typically do not involve human "experts" establishing a ground truth in the way described (e.g., radiologists interpreting images). The "ground truth" for these tests would be the established scientific and engineering standards and methods against which the device performance is measured (e.g., acceptable cytotoxicity levels, sperm motility percentages, embryo development rates).
4. Adjudication Method for the Test Set
This is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human readers/evaluators where there might be inter-observer variability in assessment. The non-clinical tests described do not involve such a process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned. The studies described are non-clinical hardware performance and biological compatibility tests, not clinical or reader performance studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a "standalone" study in the context of an algorithm or AI without human intervention was not done or mentioned. The device is a physical medical instrument (catheter) used by a healthcare provider.
7. The type of Ground Truth Used
For the biological tests:
- Mouse Embryo Assay (MEA): The ground truth is the biological standard of embryo development (≥ 80% embryos developed to expanded blastocyst at 72 hours).
- Human Sperm Survival Assay (HSSA): The ground truth is the biological standard of sperm motility (≥80% of control motility).
- Endotoxin: The ground truth is the chemical standard of acceptable endotoxin levels (< 20 EU/device).
For mechanical/physical tests:
- The "ground truth" or reference is the predetermined acceptance criteria based on engineering standards, design specifications, and regulatory requirements, ensuring functionality, safety, and compatibility.
For sterilization, package integrity, and biocompatibility:
- The "ground truth" is adherence to recognized international standards and FDA guidance documents (e.g., ISO 11135-1:2014, ASTM F2096-11, ISO 10993 series).
8. The Sample Size for the Training Set
This information is not provided and is not applicable as the device is a physical catheter, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable for the same reason as point 8.
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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.
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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
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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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K231730 Page 1 of 5
510(k) Summary - K231730
I. SUBMITTER
| Applicant: | Femasys Inc. |
|---|---|
| Applicant Address: | 3950 Johns Creek Court, Suite 100Suwanee, GA 30024 |
| Phone: | +770-500-3910 x137 |
| Email: | CThomas@femasys.com |
| Contact Person: | Christine ThomasSr. 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.
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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 FemaSeedIntratubalInsemination isintended to introducewashed sperm or invitro fertilized (IVF)embryos into theuterine ostium viaultrasound guidance. | The intratubaltransfer sets areused to injecteither sperm,gametes orembryos into theuterine ostium ofthe fallopian tubevia ultrasoundguidance. Thedevice is sterileand intended forone time use. | Similar |
| Design Features | The FemaSeedIntratubalInsemination consistsof a polymer curvedtransfer catheter,polymer guidecatheter and aseparate balloon | The IntratubalTransfer Setconsists of apolymer curvedguide catheter,stainless steel,malleableobturator, stainless | Different |
| Comparison Item | Subject Device –K231730 | Predicate Device –K983591 | Comparison |
| inflation syringe. Thetransfer catheterincludes an inflatableballoon. | steel wire guideand a polymertransfer catheter. | ||
| Catheter Assembly | Preassembledcatheters, separatesyringe | Separate catheters,separate stainless-steel obturator | Different |
| Outer and InnerDiameters | Guide catheter 3.8 mmTransfer catheter 1.5 mmThere are two (2) lumens of the transfercatheter:Specimen lumen ID 0.036" +0.000 / -0.003"Balloon inflation lumen ID 0.010" +0.000 / -0.002"The dimension of theballoon when inflated is a minimum of 34F | Guide catheter 1.9 mmTransfer catheter 1 mm | Different |
| Materials | Polymer(Pebax/Pellethane) | PolymerStainless 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 toexpanded blastocystat 72 hours. | Not availablepublicly | Notapplicable |
| Endotoxin | < 20 EU/device | Not availablepublicly | Notapplicable |
| HSSA | ≥80% of controlmotility at 24 hoursfollowing 30-minuteexposure. | Not availablepublicly | Notapplicable |
Table 1. Intended use and technological characteristics comparison
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The subject and predicate devices have similar indications for use statements and have the same intended use. As shown in the table above, the subject and predicate device have some technological characteristics that are the same or similar. However, there are differences in design, materials and shelf-life. 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:
- A ISO 11135-1:2014
- A AAMI TIR 28:2016
- A ISO 10993-7: 2008
- . Package Integrity testing:
- A Visual inspection
- A Bubble Leak test per ASTM F2096-11
- A 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 A
- A Sensitization ISO 10993-10: 2010
- A Irritation per ISO 10993-10: 2010
Testing showed the device material to be non-cytotoxic, non-sensitizing, and nonirritating.
- Endotoxin testing per USP <85> and AAMI/ANSI ST72:2019 ● Specification: < 20 EU/device A
- Bench performance studies before and after accelerated aging to the equivalent of 6-months of real-time aging in accordance with ASTM F1980-16 demonstrated that all predetermined acceptance criteria were met in the following tests:
- A Appearance
- A Dimensional analysis
- A Mechanical performance
- A Device interface compatibility
- Balloon integrity, maximum burst pressure analysis, maximum cycles for stop >
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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.
§ 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).