Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
Device Facts
| Record ID | K243373 |
|---|---|
| Device Name | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) |
| Applicant | Vitrolife Sweden AB |
| Product Code | MQF · Obstetrics/Gynecology |
| Decision Date | Jul 23, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6110 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Embryo Transfer Catheter is intended for introduction of in vitro fertilized embryo(s) into the uterine cavity. The stylet is intended to be used with Vitrolife’s Embryo Transfer Catheters to assist in uterine access of the guide during an embryo transfer procedure.
Device Story
Embryo Transfer Catheter (ETC) Assortment consists of sterile, single-use embryo transfer catheters and stylets. Catheters include a guide (outer sheath) for cervical navigation and an inner catheter for embryo delivery. Guides are available in pre-curved (stiff) or straight (malleable) configurations. Inner catheters feature echogenic tips for ultrasound guidance. Stylets are plastic-coated metal wires used to increase guide stiffness. Used in clinical settings by fertility specialists; the physician loads embryos into the catheter, inserts the guide into the uterine cavity, and advances the catheter to deposit embryos. Echogenic markings allow real-time ultrasound visualization to ensure accurate placement. The device facilitates precise embryo delivery, potentially improving implantation success rates.
Clinical Evidence
Bench testing only. Studies included sterilization validation (ISO 11137), packaging integrity (ISO 11607), biocompatibility (ISO 10993-5, -10, -23), endotoxin testing (USP <85>/<161>), and Mouse Embryo Assay (MEA) with ≥80% blastocyst development at 96h. Mechanical performance verified via tensile strength, luer connection (ISO 80369-7), and ultrasound visibility. All tests met acceptance criteria except tip drop, which is mitigated by labeling precautions.
Technological Characteristics
Materials: Polyethylene, Silicone, TPU, Polyamide (PA 12), PEBA, Stainless steel. Sensing: Echogenic markings for ultrasound. Energy: None (manual). Connectivity: None. Sterilization: E-Beam radiation. Form factor: Catheter/guide/stylet assembly. Standards: ISO 11137, ISO 11607, ISO 10993, ISO 80369-7, ASTM F1980, ASTM F1886, ASTM F1929, ASTM F88, ASTM 4169.
Indications for Use
Indicated for the introduction of in vitro fertilized embryos into the uterine cavity during assisted reproduction procedures.
Regulatory Classification
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.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
Predicate Devices
- Kitazato ET Catheters (K162878)
Related Devices
- K161547 — Transem and EchoGen Embryo Transfer Catheters · Origio A/S · Mar 9, 2017
- K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) · Guangzhou Hehong Biotech Co., Ltd. · Feb 12, 2026
- K192540 — Kitazato ET Catheters · Kitazato Corporation · May 1, 2020
- K162878 — Kitazato ET Catheters · Kitazato Corporation · Jul 13, 2017
- K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators · Allwin Medical Devices, Inc. · Jul 1, 2020
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
July 23, 2025
Vitrolife Sweden AB
Ann-Cathrine Ericson
RA Manager
Gustaf Werners gata 2
Gothenburg, 421 32
SWEDEN
Re: K243373
Trade/Device Name: Embryo Transfer Catheter (ETC) Assortment:
EmbryoCath Embryo Transfer Catheter - Pre-curved
230 mm (REF 17500);
EmbryoCath Embryo Transfer Catheter - Straight Malleable
180 mm (REF 17501);
EmbryoCath Embryo Transfer Catheter - Straight Malleable
230 mm (REF 17502);
EmbryoCath Stylet - 180 mm (REF 17510);
EmbryoCath Stylet - 230 mm (REF 17511)
Regulation Number: 21 CFR 884.6110
Regulation Name: Assisted Reproduction Catheters
Regulatory Class: II
Product Code: MQF
Dated: June 13, 2025
Received: June 13, 2025
Dear Ann-Cathrine Ericson:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K243373 - Ann-Cathrine Ericson
Page 2
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" (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 QS 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 (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-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 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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K243373 - Ann-Cathrine Ericson
Page 3
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-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K243373
Device Name
Embryo Transfer Catheter (ETC) Assortment:
EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500);
EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501);
EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502);
EmbryoCath Stylet - 180 mm (REF 17510);
EmbryoCath Stylet - 230 mm (REF 17511)
Indications for Use (Describe)
The Embryo Transfer Catheter is intended for introduction of in vitro fertilized embryo(s) into the uterine cavity.
The stylet is intended to be used with Vitrolife’s Embryo Transfer Catheters to assist in uterine access of the guide during an embryo transfer procedure.
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.
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K243373
Page 1 of 5
Embryo Transfer Catheter (ETC) Assortment
Vitrolife
# 510(k) Summary – K243373
Submitted by:
Vitrolife Sweden AB
Gustaf Werners gata 2
SE-421 32 Västra Frölunda
Sweden
Contact Person:
Ann-Catherine Ericson
Vitrolife Sweden AB
Gustaf Werners gata 2
SE-421 32 Västra Frölunda
Sweden
Phone: +46 31 721 80 00
Fax: +46 31 721 80 90
Email: aericson@vitrolife.com
Date prepared: July 23, 2025
# 1 Device Identification
Trade Name:
Embryo Transfer Catheter (ETC) Assortment:
EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500);
EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501);
EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502);
EmbryoCath Stylet - 180 mm (REF 17510);
EmbryoCath Stylet - 230 mm (REF 17511)
Embryo Transfer Catheters
Common name:
Regulatory Class: II
Regulation number: 21 CFR 884.6110
Regulation name: Assisted Reproduction Catheters
Product code: MQF (Catheter, Assisted Reproduction)
# 2. Predicate Device
Kitazato ET Catheters (K162878) manufactured by Kitazato Corporation.
The predicate device has not been subject to a design-related recall.
# 3. Device Description
Vitrolife’s Embryo Transfer Catheter (ETC) Assortment consists of three embryo transfer catheters (ETCs), one pre-curved variant (Model 17500, 230 mm) and two straight variants (REFs 17501, 17502) in different lengths (180 mm and 230 mm); and two stylets (Stylets) (REFs 17510, 17511) in different lengths (180 mm and 230 mm). ETC and Stylet are sterile, single-use devices used to deliver in vitro fertilized embryos to the uterine cavity.
Embryo Transfer Catheter consists of:
- A guide, also referred as outer sheath. The guide is used to navigate through the cervix canal. The guide has a distance marking, a stopper and a rounded tip to facilitate proper positioning. The guide is available in two different variants:
- Pre-curved - stiff
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K243373
Page 2 of 5
# Vitrolife
Embryo Transfer Catheter (ETC) Assortment
- Straight - soft and malleable
- A catheter, also referred as inner catheter. The catheter is loaded with the embryo(s) in a small volume of transfer medium and inserted through the guide to gently deposit the embryo(s) into the uterine cavity. The transfer catheter is soft, flexible and approximately 50 mm longer than the guide. The tip of the catheter has an echogenic marking to enable ultrasound guidance.
Embryo Transfer Catheter Stylet consists of:
- A plastic-coated metal wire, which is malleable. The stylet is an accessory that can be used together with Vitrolife's guides to make them stiffer.
The 17500 variant includes a stylet. The 17501 and 17502 variants do not include stylets, but the stylet can be purchased separately.
# 4. Indications for Use
The Embryo Transfer Catheter is intended for introduction of in vitro fertilized embryo(s) into the uterine cavity.
The stylet is intended to be used with Vitrolife's Embryo Transfer Catheters to assist in uterine access of the guide during an embryo transfer procedure.
# 5. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices
| Characteristics | Subject Device K243373 | Predicate Device K162878 | Comparison |
| --- | --- | --- | --- |
| Manufacturer | Vitrolife Sweden AB | Kitazato Corporation | N/A |
| Trade name | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) | Kitazato ET Catheters | N/A |
| Indications for use | The Embryo Transfer Catheter is intended for introduction of in vitro fertilized embryo(s) into the uterine cavity.
The Stylet is intended to be used with Vitrolife's Embryo Transfer Catheters to assist in uterine access of the guide | The Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation.
Kitazato ET Catheters are provided in various configurations (Type 1 through Type 5), which | The indications for use statements subject and predicate devices are not identical; however, they have the same intended use (i.e., transfer of embryos into the uterine cavity). |
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K243373
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# Vitrolife
Embryo Transfer Catheter (ETC) Assortment
| | during an embryo transfer procedure. | consist of the following components: • Transfer Catheter, for delivery of embryos into the uterine cavity; • Guide Catheter, to guide the insertion of the Transfer Catheter and reinforce it during use: • Trial Catheter, used to confirm the curvature of the cervix and if the cervix is passable; • Stylet Sheath, used to increase the strength of the Guide Catheter during insertion. | |
| --- | --- | --- | --- |
| Device Components | Embryo transfer catheter, guide and stylet | Transfer catheter, guide catheter, trial catheter, and a stylet sheath | Different. The differences in device components do not raise different questions of safety and effectiveness (S&E). |
| Materials | Straight Guide: Polyethylene (PE), Silicone Pre-curved Guide: Thermoplastic polyurethane (TPU), Silicone Catheter: Thermoplastic polyurethane (TPU), Polyamide (PA 12) Stylet: Stainless steel, Polyamide (PA 12) Luer Connector: PEBA | Catheter/Trial shaft: Polyurethane Guide: Fluoric resin Outer Stiffener: Stainless steel Luer Connector: ABS | Different. The differences in device materials do not raise different questions of S&E. |
| Markings | Distance markings on embryo transfer catheter and guide. | Depth marks on catheter and guide. | Same |
| Ultrasound visibility | Yes – Echogenic marking | Yes – Echo line for Type3 and Type4. | Same |
| Single use | Yes | Yes | Same |
| Dimension | Length: Catheter: 20 cm, 25 cm Guide: 13 cm, 18 cm Stylet: 15 cm, 20 cm OD: Catheter: 1.45 mm Guide: 2.35 mm Stylet: 1.2 mm | Length: Catheter: 18 cm, 23 cm Guide: 14 cm, 19 cm OD: Catheter: 1.55 mm (4.7 Fr) Guide: Unknown Stylet: Unknown | Different. The differences in device dimension do not raise different questions of S&E. |
| Sterilization | Sterilized by E-Beam radiation | Sterilized by ethylene oxide (ETO) | Different. The differences in device |
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K243373
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Embryo Transfer Catheter (ETC) Assortment
| | | | sterilization methods do not raise different questions of S&E. |
| --- | --- | --- | --- |
| Shelf-life | 3 months | 3 years | Different. The differences in shelf-life duration do not raise different questions of S&E |
| Mouse Embryo Assay (MEA) | One-cell MEA: ≥80% embryos developed to expanded blastocyst at 96h | One-cell MEA: ≥80% embryos developed to expanded blastocyst at 96h | Same |
| Bacterial Endotoxin Assay (BEA) | <20 EU/device | <20 EU/device | Same |
The subject and predicate device have differences in their indications for use statements; however, their intended uses are the same (i.e., transfer of embryos to the uterine cavity). There are different technological characteristics, including differences in device components, materials, dimension, sterilization method, and shelf-life. The different technological characteristics do not raise different questions of safety and effectiveness.
# 6. Summary of Non-Clinical Performance Testing
The following studies have been performed to support substantial equivalence to the predicate device
Sterilization validation performed according to ISO 11137-1:2006/(R)2015 and ISO 11137-2:2013.
Packaging integrity testing according to ISO 11607-1:2019 and ISO 11607-2:2019
- Visual inspection per ASTM F1886/F1886M-16
- Dye penetration per ASTM F1929-15
- Seal strength per ASTM F88/F88M-23
Transportation simulation testing per ASTM 4169-22 and package integrity testing
Biocompatibility evaluation 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
- Sensitization per ISO 10993-10
- Irritation per ISO 10993-23
Testing showed the device material to be non-cytotoxic, non-sensitizing, and non-irritating.
Endotoxin testing (BEA) performed according to USP <85> and USP <161> with acceptance criteria < 20 EU/device.
Mouse embryo assay (MEA) performed per the 2021 FDA guidance document Mouse Embryo Assay for Assisted Reproduction Technology Devices with specification: One-Cell MEA: ≥80% embryos developed to expanded blastocysts within 96 hours.
Bench performance assessed before and after accelerated aging to the equivalent of three months of real-time aging in accordance with ASTM F1980-21:
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K243373
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Embryo Transfer Catheter (ETC) Assortment
- Visual inspection of device, packaging and labels
- Dimensional verification
- Compatibility testing with catheter, guide, and stylet
- Useable length verification of assembled guide and catheter
- Echogenic marking verification by ultrasound
- Verification of Luer lock connection per ISO 80369-7:2021
- Aspiration, flush, leak and flowrate tests of catheter per EN 1618
- Distance marking location and durability
- Curvature verification of Pre-curved guide
- Dislodgement force of positioning stopper
- Tensile strength testing of catheter
- Echogenic marking visibility test of catheter
- Tip drop angle of simulated loaded catheter when held horizontally
All test articles met the predetermined acceptance criteria in the tests, except for "tip drop when held horizontally." The device labeling includes a precaution "Due to the soft nature of the catheter, when loaded, the catheter may bend. Ensure the tip of the catheter is properly aligned with the guide before inserting it into the guide during the embryo transfer procedure" to mitigate embryo loss risks.
## 7. Conclusion
The results of the performance testing described above demonstrate that the EmbryoCath Embryo Transfer Catheters (REFs 17500, 17501, 17502) and EmbryoCath Stylets (REFs 17510, 17511) are as safe and effective as the predicate device and supports a determination of substantial equivalence.
