VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

K240307 · Shenzhen Vitavitro Biotech Co., Ltd. · MQF · Aug 16, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K240307
• Device Name: VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
• Applicant: Shenzhen Vitavitro Biotech Co., Ltd.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Aug 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity

Device Story

Sterile, single-use embryo transfer catheter system; includes transfer catheter, guide catheter, and optional obturator. Guide catheter inserted through cervix to provide path; transfer catheter (loaded with embryos) delivered through guide into uterine cavity. Syringe (not included) connects to transfer catheter hub to deliver embryos. Features include depth scales, marker bands, and adjustable positioner (Model ET-A) for depth control. Used by clinicians in IVF procedures to facilitate embryo implantation. Benefits include precise embryo placement within uterine cavity.

Clinical Evidence

Bench testing only. Includes sterilization validation (ISO 11135-1, ISO 10993-7), package integrity (ASTM F1886, F88, F1929), transportation simulation (ASTM D4169), and biocompatibility (ISO 10993-5, -10, -23). Performance testing included Mouse Embryo Assay (MEA) with ≥80% blastocyst development, endotoxin testing (<5 EU/device), and mechanical bench studies (tensile strength, flow rate, leakage, corrosion resistance) conducted before and after accelerated aging (ASTM F1980).

Technological Characteristics

Materials: TPU, stainless steel, ABS, PEBAX, nylon, silicone, PP, LDPE. Sensing/Actuation: Mechanical placement. Energy: None. Dimensions: Transfer catheter 240mm length/0.95mm OD; Guide catheter 172mm length/2.2-2.4mm OD. Connectivity: None. Sterilization: Ethylene oxide. Software: None.

Indications for Use

Indicated for the placement of in vitro fertilized (IVF) embryos into the uterine cavity.

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

• Emtrac; Delphin; Semtrac 2000 Set (K013536)

Submission Summary (Full Text)

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August 16, 2024

Shenzhen VitaVitro Biotech Co., Ltd. Donghai Pan Official Correspondent R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No.16, Shenzhen, Guangdong 518118 China

Re: K240307

Trade/Device Name: VitaVitro Embryo Transfer Catheter (Models ET-S, ET-A, ET-I, ET-IH) Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MQF Dated: July 16, 2024 Received: July 16, 2024

Dear Donghai Pan:

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.

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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 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.

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael T. Bailey -S

For

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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K240307

Device Name

Vita Vitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

Indications for Use (Describe)

VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity

| 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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# 510(k) Summary - K240307

#### I. SUBMITTER

| Applicant: | Shenzhen VitaVitro Biotech Co., Ltd. |
|--------------------|-----------------------------------------------------------------------------------------------------|
| Applicant Address: | R601, Building B, Hai Ke Xing Tech Park<br>Baoshan Road No. 16 Shenzhen 518118 Guangdong,<br>China. |
| Phone: | 86-755-84511813 |
| Fax: | 86-755-85235226 |
| Email: | [e-mail] |
| Contact Person: | Mr. Donghai Pan, International Regulatory Specialist |

August 14, 2024

#### II. DEVICE

Date Prepared:

| Trade Name: | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI,<br>ET-A, ET-I, ET-IH) | |
|--------------------|-------------------------------------------------------------------------------|--|
| Common Name: | Embryo Transfer Catheters | |
| Regulation Name: | Assisted Reproduction Catheters | |
| Regulation Number: | 21 CFR 884.6110 | |
| Regulatory Class: | II | |
| Product Code: | MQF (Catheter, Assisted Reproduction) | |

#### III. PREDICATE DEVICE

Emtrac; Delphin; Semtrac 2000 Set (K013536) manufactured by Gynetics Medical Products Nv.

The predicate device has not been subject to a design-related recall.

#### IV. DEVICE DESCRIPTION

The VitaVitro Embryo Transfer Catheters are sterile (ethylene oxide), single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. They have a three-year shelf-life.

The device includes five catheter models that are composed of a transfer catheter and a guide catheter (some with obturator).

The 172 mm length Guide catheters have OD 2.4 mm for straight (Models ET-SI and ET-S) and OD 2.2 mm for the curved version type (Model ET-A).

The curved version type (Model ET-A) has an additional adjustable positioner which aids in

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positioning the device to the targeted depth within the uterine cavity during a procedure. Both types have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity.

The 240 mm transfer catheter with an OD 0.95 mm is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) is connected to the connector of the transfer catheter and is used to deliver the embryos into the uterine cavity.

The 200 mm obturator with OD 1.3 mm is an optional accessory for the device. It has a rounded/blunt closed tip. The obturator is used to provide additional support (increase rigidity) during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.

#### V. INDICATIONS FOR USE

VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity.

### COMPARISON OF THE INTENDED USE AND TECHNOLOGICAL VI. CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES

The following table compares the VitaVitro Embryo Transfer Catheters to the predicate device.

| Table 3. Intended use and technological characteristics comparison. | | | |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison Item | Subject Device<br>K240307<br>ET-S, ET-SI,<br>ET-A, ET-I, ET-IH | Predicate Device<br>K013536<br>EMTRAC; DELPHIN;<br>SEMTRAC 2000 SET | Comparison |
| Company/Sponsor | Shenzhen Vita Vitro<br>Biotech Co., Ltd | Gynetics Medical<br>Products Nv | NA |
| Regulation | 884.6110 | 884.6110 | Same |
| Product Code | MQF | MQF | Same |
| Indications for Use | VitaVitro Embryo Transfer<br>Catheter is used to place<br>in vitro fertilized (IVF)<br>embryos into the uterine<br>cavity. | The delphin is to be used<br>for embryo transfer and<br>intra uterine insemination<br>procedures for in vitro<br>fertilization (ivf) and<br>related assisted<br>reproduction technology<br>(art) procedures. | The<br>indications<br>for use for<br>the subject<br>and predicate<br>devices are<br>not identical;<br>however,<br>they have the |
| | | Emtrac catheters are to be<br>used for embryo transfer<br>procedures for in vitro<br>fertilization (ivf) and<br>related assisted<br>reproduction technology<br>(art) procedures.<br><br>Semtrac sets are to be<br>used for embryo transfer<br>procedures for in vitro<br>fertilization (ivf) and<br>related assisted<br>reproduction technology<br>(art) procedures. | same<br>intended use<br>(i.e., transfer<br>of embryos to<br>the uterine<br>cavity). |
| Design Features | Transfer catheter: With<br>insertion depth scale,<br>stainless steel core tube,<br>and Luer lock hub<br><br>Guide: Straight or curved<br>with positioner (Model<br>ET-A only), with insertion<br>depth scale, and Leur lock<br>hub.<br><br>Obturator | Inner catheter (loading<br>catheter), luer lock hub,<br>outer tube (guiding<br>catheter), positioner for<br>depth adjustment,<br>obturator (mandrel) | Different<br>The<br>differences in<br>design<br>features<br>identified do<br>not raise<br>different<br>questions of<br>safety and<br>effectiveness<br>(S&E) |
| Material | Transfer Catheter - TPU,<br>stainless steel, ABS, depth<br>marker ink<br><br>Guide – TPU-LDPE, ABS<br>(straight guide catheter) or<br>PEBAX, nylon, silicone<br>(curved guide catheter),<br>depth marker ink<br><br>Obturator - PP, stainless<br>steel, ABS | Positioner and handle:<br>polyethylene (PP)<br>Transfer catheter:<br>polyethylene (PE)<br>Guide- Polypropylene<br>Stylet: stainless steel | Different<br>The<br>differences in<br>device<br>materials do<br>not raise<br>different<br>questions of<br>S&E. |
| | | | Different |
| Dimension | Length:<br>Transfer catheter – 240 mm<br>Guide catheter – 172 mm<br>Obturator-200 mm<br>O.D.:<br>Transfer catheter – 0.95 mm<br>Guide catheter – 2.4 mm (straight), 2.2 mm (curved)<br>Obturator-1.3 mm | Length:<br>Transfer catheter: 266 mm<br>Guide catheter: 216 mm<br>Obturator: 240 mm<br>Tube O.D.:<br>Guide catheter - 1.60 mm<br>Transfer catheter -1.00 mm<br>Obturator- 1.00 mm | The<br>differences in<br>device<br>dimensions<br>do not raise<br>different<br>questions of<br>S&E. |
| Sterility | Sterilized by ethylene<br>oxide exposure | Sterilized by Gamma<br>irradiation | Different<br>The<br>differences in<br>device<br>sterilization<br>methods do<br>not raise<br>different<br>questions of<br>S&E. |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Mouse Embryo<br>Assay | 1-Cell MEA: ≥ 80%<br>embryos developed to<br>expanded blastocyst at<br>96h | 1-Cell MEA: ≥ 80%<br>embryos developed to<br>blastocyst at 96h | Similar |
| Endotoxin | < 5 EU/device | < 20 EU/device | Different<br>The<br>differences in<br>endotoxin<br>specifications<br>do not raise<br>different<br>questions of<br>S&E. |

Table 3. Intended use and technological characteristics comparison

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The subject and predicate devices have differences in their indications for use statements; however, their intended uses are the same (i.e., transfer of embryos to the uterine cavity). As

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shown in the table above, there are differences in technological characteristics between the subject and predicate devices. However, as stated in the table, 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 of the substantial equivalence to the predicate device:

- Sterilization validation testing: ●
- A ISO 11135-1:2014
- A ISO 10993-7: 2008
- Package integrity testing:
- Visual inspection per ASTM F1886/F1886M-16 A
- > Seal Strength testing per ASTM F88/ F88M-15
- > Dye Penetration test per ASTM F1929-15
- . 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 I: Evaluation and testing within a risk management process. " Testing included the following assessments:
- > Cytotoxicity per ISO 10993-5: 2009
- > Sensitization ISO 10993-10: 2021
- A Irritation per ISO 10993-23: 2021

Testing showed the device material to be non-cytotoxic, non-sensitizing, and non-irritating.

- Endotoxin testing per USP <85> Specification: <5 EU/device ●
- Mouse Embryo Assay (MEA) per the 2021 FDA guidance Mouse Embryo Assay for . Assisted Reproduction Technology Devices. Specification: 1-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 96 hours.
- . Bench performance studies before and after accelerated aging to the equivalent of threeyears of real-time aging in accordance with ASTM F1980-21 demonstrated that all predetermined acceptance criteria were met in the following tests:
- > Appearance
- A Taper/Syringe compatibility
- > Transfer catheter and obturator compatibility with guide catheter
- > Dimensional analysis
- > Distance indication marker location and durability

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K240307 Page 6 of 6

- Dislodgement of positioning ring A
- > Tip drop when held horizontally
- > Bonding strength of device connections/bonds
- > Aspiration and leakage testing of transfer catheter
- > Corrosion resistance of stainless steel tube
- > Tensile/bonding strength test to assess all joints
- > Flow rate of transfer catheter

#### CONCLUSIONS VIII.

The results of the testing described above demonstrate that the VitaVitro Embryo Transfer Catheters are as safe and effective as the predicate device and supports a determination of substantial equivalence.