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 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.

AI/ML Overview

The provided text describes the VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) and its substantial equivalence to a predicate device. However, this document does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance as initially requested in the prompt.

The document details the non-clinical performance data for a medical device (a catheter), not a software or AI-driven diagnostic device. Therefore, the specific questions related to AI/algorithm performance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training/test set sample sizes are not applicable to the information provided.

The "acceptance criteria" discussed in the document are related to the physical and biological performance of the catheter, such as sterilization, biocompatibility, and functional integrity.

Here's an attempt to answer the questions based only on the provided text, recognizing that it does not align with the implied context of AI/algorithm performance:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from text)	Reported Device Performance (from text)
Mouse Embryo Assay (MEA): 1-Cell MEA: ≥ 80% embryos developed to expanded blastocyst at 96 hours.	MEA: All predetermined acceptance criteria were met (implies ≥ 80% embryos developed to expanded blastocyst at 96 hours, though not explicitly stated with a specific percentage).
Endotoxin: < 5 EU/device	Endotoxin: < 5 EU/device (per USP <85>)
Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating (per ISO 10993 series)	Biocompatibility: Device material found to be non-cytotoxic, non-sensitizing, and non-irritating.
Sterilization: Sterile (ethylene oxide)	Sterilization: ISO 11135-1:2014 & ISO 10993-7:2008 standards met.
Package Integrity: Passes ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F1929-15	Package Integrity: All predetermined acceptance criteria were met.
Transportation Simulation: Per ASTM D4169-22	Transportation Simulation: All predetermined acceptance criteria were met.
Bench Performance (after accelerated aging): All predetermined acceptance criteria met for: Appearance, Taper/Syringe compatibility, Transfer catheter and obturator compatibility with guide catheter, Dimensional analysis, Distance indication marker location and durability, Dislodgement of positioning ring, 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	Bench Performance: All predetermined acceptance criteria were met in the listed tests after accelerated aging.

Regarding the other questions, the provided text does not contain the requested information as it pertains to an embryo transfer catheter and not an AI-powered device:

Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are lab tests on physical device properties and biological interaction (MEA).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on established laboratory standards and measurements, not expert human interpretation of medical images or data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the listed tests is based on scientific and engineering standards (e.g., ISO for biocompatibility and sterilization, ASTM for mechanical properties, USP for endotoxin), and biological assay results (MEA).
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

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,

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

{3}------------------------------------------------

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)

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary - K240307

I. SUBMITTER

Applicant:	Shenzhen VitaVitro Biotech Co., Ltd.
Applicant Address:	R601, Building B, Hai Ke Xing Tech ParkBaoshan Road No. 16 Shenzhen 518118 Guangdong,China.
Phone:	86-755-84511813
Fax:	86-755-85235226
Email:	pandh@vitavitro.com
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,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

{5}------------------------------------------------

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.

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 DeviceK240307ET-S, ET-SI,ET-A, ET-I, ET-IH	Predicate DeviceK013536EMTRAC; DELPHIN;SEMTRAC 2000 SET	Comparison
Company/Sponsor	Shenzhen Vita VitroBiotech Co., Ltd	Gynetics MedicalProducts Nv	NA
Regulation	884.6110	884.6110	Same
Product Code	MQF	MQF	Same
Indications for Use	VitaVitro Embryo TransferCatheter is used to placein vitro fertilized (IVF)embryos into the uterinecavity.	The delphin is to be usedfor embryo transfer andintra uterine inseminationprocedures for in vitrofertilization (ivf) andrelated assistedreproduction technology(art) procedures.	Theindicationsfor use forthe subjectand predicatedevices arenot identical;however,they have the
		Emtrac catheters are to beused for embryo transferprocedures for in vitrofertilization (ivf) andrelated assistedreproduction technology(art) procedures.Semtrac sets are to beused for embryo transferprocedures for in vitrofertilization (ivf) andrelated assistedreproduction technology(art) procedures.	sameintended use(i.e., transferof embryos tothe uterinecavity).
Design Features	Transfer catheter: Withinsertion depth scale,stainless steel core tube,and Luer lock hubGuide: Straight or curvedwith positioner (ModelET-A only), with insertiondepth scale, and Leur lockhub.Obturator	Inner catheter (loadingcatheter), luer lock hub,outer tube (guidingcatheter), positioner fordepth adjustment,obturator (mandrel)	DifferentThedifferences indesignfeaturesidentified donot raisedifferentquestions ofsafety andeffectiveness(S&E)
Material	Transfer Catheter - TPU,stainless steel, ABS, depthmarker inkGuide – TPU-LDPE, ABS(straight guide catheter) orPEBAX, nylon, silicone(curved guide catheter),depth marker inkObturator - PP, stainlesssteel, ABS	Positioner and handle:polyethylene (PP)Transfer catheter:polyethylene (PE)Guide- PolypropyleneStylet: stainless steel	DifferentThedifferences indevicematerials donot raisedifferentquestions ofS&E.
			Different
Dimension	Length:Transfer catheter – 240 mmGuide catheter – 172 mmObturator-200 mmO.D.:Transfer catheter – 0.95 mmGuide catheter – 2.4 mm (straight), 2.2 mm (curved)Obturator-1.3 mm	Length:Transfer catheter: 266 mmGuide catheter: 216 mmObturator: 240 mmTube O.D.:Guide catheter - 1.60 mmTransfer catheter -1.00 mmObturator- 1.00 mm	Thedifferences indevicedimensionsdo not raisedifferentquestions ofS&E.
Sterility	Sterilized by ethyleneoxide exposure	Sterilized by Gammairradiation	DifferentThedifferences indevicesterilizationmethods donot raisedifferentquestions ofS&E.
Single-Use	Yes	Yes	Same
Shelf Life	3 years	3 years	Same
Mouse EmbryoAssay	1-Cell MEA: ≥ 80%embryos developed toexpanded blastocyst at96h	1-Cell MEA: ≥ 80%embryos developed toblastocyst at 96h	Similar
Endotoxin	< 5 EU/device	< 20 EU/device	DifferentThedifferences inendotoxinspecificationsdo not raisedifferentquestions ofS&E.

Table 3. Intended use and technological characteristics comparison

{6}------------------------------------------------

{7}------------------------------------------------

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

{8}------------------------------------------------

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

{9}------------------------------------------------

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.

Regulation Number and Section

§ 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).