(196 days)
Not Found
No
The summary describes a purely mechanical device for embryo transfer and contains no mention of AI, ML, image processing, or data sets for training or testing.
Yes
The device is used to place in vitro fertilized (IVF) embryos into the uterine cavity, which is a therapeutic intervention aimed at achieving pregnancy.
No
This device is used to place in vitro fertilized embryos into the uterine cavity, which is a therapeutic intervention, not a diagnostic one. While some components aid in placement, the primary purpose is delivery, not diagnosis.
No
The device description clearly details physical components like catheters, obturators, and positioners, and the performance studies focus on physical properties and biological interactions, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The VitaVitro Embryo Transfer Catheter is used to physically place in vitro fertilized embryos into the uterine cavity. It is a delivery system for the embryos, not a device that analyzes biological samples to provide diagnostic information.
- Intended Use: The intended use clearly states it is "used to place in vitro fertilized (IVF) embryos into the uterine cavity." This is a procedural device, not a diagnostic one.
- Device Description: The description details the physical components and how they are used to facilitate the transfer of embryos. There is no mention of analyzing biological samples or providing diagnostic results.
- Performance Studies: The performance studies listed focus on the physical and biological compatibility of the device itself (sterilization, packaging, biocompatibility, endotoxin, mouse embryo assay) and its functional performance (flow rate, bonding strength, etc.). These are typical tests for a medical device used in a procedure, not for an IVD.
In summary, the VitaVitro Embryo Transfer Catheter is a medical device used in the process of assisted reproduction, specifically for the physical transfer of embryos. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity
Product codes (comma separated list FDA assigned to the subject device)
MQF
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 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)
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4
510(k) Summary - K240307
I. SUBMITTER
| Applicant: | Shenzhen VitaVitro Biotech Co., Ltd. |
|---|---|
| Applicant Address: | R601, Building B, Hai Ke Xing Tech Park |
| Baoshan 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.
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 | ||
| K240307 | |||
| ET-S, ET-SI, | |||
| ET-A, ET-I, ET-IH | Predicate Device | ||
| K013536 | |||
| EMTRAC; DELPHIN; | |||
| SEMTRAC 2000 SET | Comparison | ||
| Company/Sponsor | Shenzhen Vita Vitro | ||
| Biotech Co., Ltd | Gynetics Medical | ||
| Products Nv | NA | ||
| Regulation | 884.6110 | 884.6110 | Same |
| Product Code | MQF | MQF | Same |
| Indications for Use | VitaVitro Embryo Transfer | ||
| Catheter is used to place | |||
| in vitro fertilized (IVF) | |||
| embryos into the uterine | |||
| cavity. | The delphin is to be used | ||
| for embryo transfer and | |||
| intra uterine insemination | |||
| procedures for in vitro | |||
| fertilization (ivf) and | |||
| related assisted | |||
| reproduction technology | |||
| (art) procedures. | The | ||
| indications | |||
| for use for | |||
| the subject | |||
| and predicate | |||
| devices are | |||
| not identical; | |||
| however, | |||
| they have the | |||
| Emtrac catheters are to be | |||
| used for embryo transfer | |||
| procedures for in vitro | |||
| fertilization (ivf) and | |||
| related assisted | |||
| reproduction technology | |||
| (art) procedures. |
Semtrac sets are to be
used for embryo transfer
procedures for in vitro
fertilization (ivf) and
related assisted
reproduction technology
(art) procedures. | same
intended use
(i.e., transfer
of embryos to
the uterine
cavity). |
| Design Features | Transfer catheter: With
insertion depth scale,
stainless steel core tube,
and Luer lock hub
Guide: Straight or curved
with positioner (Model
ET-A only), with insertion
depth scale, and Leur lock
hub.
Obturator | Inner catheter (loading
catheter), luer lock hub,
outer tube (guiding
catheter), positioner for
depth adjustment,
obturator (mandrel) | Different
The
differences in
design
features
identified do
not raise
different
questions of
safety and
effectiveness
(S&E) |
| Material | Transfer Catheter - TPU,
stainless steel, ABS, depth
marker ink
Guide – TPU-LDPE, ABS
(straight guide catheter) or
PEBAX, nylon, silicone
(curved guide catheter),
depth marker ink
Obturator - PP, stainless
steel, ABS | Positioner and handle:
polyethylene (PP)
Transfer catheter:
polyethylene (PE)
Guide- Polypropylene
Stylet: stainless steel | Different
The
differences in
device
materials do
not raise
different
questions of
S&E. |
| | | | Different |
| Dimension | Length:
Transfer catheter – 240 mm
Guide catheter – 172 mm
Obturator-200 mm
O.D.:
Transfer catheter – 0.95 mm
Guide catheter – 2.4 mm (straight), 2.2 mm (curved)
Obturator-1.3 mm | Length:
Transfer catheter: 266 mm
Guide catheter: 216 mm
Obturator: 240 mm
Tube O.D.:
Guide catheter - 1.60 mm
Transfer catheter -1.00 mm
Obturator- 1.00 mm | The
differences in
device
dimensions
do not raise
different
questions of
S&E. |
| Sterility | Sterilized by ethylene
oxide exposure | Sterilized by Gamma
irradiation | Different
The
differences in
device
sterilization
methods do
not raise
different
questions of
S&E. |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Mouse Embryo
Assay | 1-Cell MEA: ≥ 80%
embryos developed to
expanded blastocyst at
96h | 1-Cell MEA: ≥ 80%
embryos developed to
blastocyst at 96h | Similar |
| Endotoxin | 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 Specification: 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.