(279 days)
Not Found
No
The summary describes a mechanical catheter and stylet system for embryo transfer. There is no mention of AI, ML, or any software component that would suggest the use of such technologies. The performance studies focus on biocompatibility, sterilization, shelf-life, and basic bench testing of physical and performance characteristics.
Yes
The device is used for embryo transfer into the uterine cavity in the treatment of infertility, which falls under therapeutic intervention.
No
The device is an embryo transfer catheter used for treatment (delivery of embryos), not for diagnosis. While some variants are visible under ultrasound, this is to aid in guided therapy, not to produce diagnostic images.
No
The device description clearly indicates physical catheters and stylets, which are hardware components. The performance studies also focus on physical properties and biocompatibility of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Transem and EchoGen™ are catheters used for embryo transfer into the uterine cavity. This is a surgical or procedural device used to physically deliver something into the body.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a tool for a medical procedure.
The information provided about the device's intended use, description, and testing all point to it being a medical device used in a clinical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Transem and EchoGen™ are catheters with angled or spherical tips for embryo transfer into the uterine cavity in the treatment of infertility.
The Transem Stylets are intended to assist the insertion of the Transem or EchoGen™ catheters where the passage through the cervix is impeded.
Product codes (comma separated list FDA assigned to the subject device)
MQF
Device Description
The Transem and EchoGen™ are Embryo Transfer Catheters with various angled or spherical tips and various lengths. The EchoGen™ variants are designed to be visible under ultrasound imaging. Stylets to aid in the insertion of the embryo catheters are also available. The product variants covered in this 510(k) include the following:
Trade name: Transem, Catheter type: Angled tip, Code: TSET25SA, Description: Transem Angled 25 cm
Trade name: Transem, Catheter type: Angled tip, Code: TSET25SAO, Description: Transem Angled O* 25 cm
Trade name: Transem, Catheter type: Spherical tip, Code: TSET24SAS, Description: Transem Spherical 24 cm
Trade name: Transem, Catheter type: Spherical tip, Code: TSET24SASO, Description: Transem Spherical O* 24 cm
Trade name: Transem, Catheter type: Stylets, Code: TSS1520, Description: Transem Stylet 15 cm
Trade name: Transem, Catheter type: Stylets, Code: TSS1823, Description: Transem Stylet 18 cm
Trade name: Transem, Catheter type: Stylets, Code: TSS2025, Description: Transem Stylet 20 cm
Trade name: EchoGen™, Catheter type: Angled tip, Code: TSET25SAEG, Description: EchoGen™ Angled 25 cm
Trade name: EchoGen™, Catheter type: Angled tip, Code: TSET25SAOEG, Description: EchoGen™ Angled O* 25 cm
Trade name: EchoGen™, Catheter type: Spherical tip, Code: TSET24SASEG, Description: EchoGen™ Spherical 24 cm
Trade name: EchoGen™, Catheter type: Spherical tip, Code: TSET24SASOEG, Description: EchoGen™ Spherical O* 24 cm
*includes obturator
Key specifications for the Transem and EchoGen™ Embryo Transfer Catheters are listed in the table below.
Aspect: Packaging type, Subject Device: Blister pack
Aspect: Sterility assurance level, Subject Device: SAL 10-6
Aspect: Sterilization method, Subject Device: Irradiation
Aspect: Reprocessing, Subject Device: Single use
Aspect: Shelf life, Subject Device: 1.3 years
Aspect: Endotoxins, Subject Device: =80% blastocyst rate at 96 hr (1-cell test)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound imaging
Anatomical Site
uterine cavity, cervix
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)
Biocompatibility testing: Transem and EchoGen™ were tested for cytotoxicity according to ISO 10993-5:2009, sensitization according to ISO 10993-10:2010 and vaginal irritation according to ISO 10993-10:2010. The results showed the device is not cytotoxic, not sensitizing and a non-irritant.
Sterilization and Shelf-life: The sterilization of Transem and EchoGen™ has been validated according to ISO 11137-2:2006. The shelf-life has been established through real-time and accelerated testing according to standards ISO 11607-1:2006 and ASTM F1980-07. The following parameters were assessed during shelf life testing:
- Air resistance
- Tensile strength
- Dimensional characteristics
- Sterility
- Endotoxin (Limulus Amebocyte Lysate test per USP)
- Mouse Embryo Assay (MEA)
- Package integrity (peel strength, visual inspection for damage, label integrity, and contamination)
Bench Testing: Bench testing included the physical properties of Transem and EchoGen™ (air resistance, tensile strength, dimensional verification), performance characteristics (sterility, endotoxin and embryotoxicity [MEA]), and echogenic marker assessments (mounting accuracy, pull force to remove), flow restriction, and ultrasound visibility assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2017
ORIGIO a/s Tove Kjaer Director, Corporate Regulatory Affairs Knardrupvej 2 Maaloev, 2760 Denmark
Re: K161547
Trade/Device Name: Transem and EchoGen™ Embryo Transfer Catheters Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MOF Dated: February 10, 2017 Received: February 13, 2017
Dear Tove Kjaer:
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. 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.
1
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161547
Device Name
Transem and EchoGen™ Embryo Transfer Catheters
Indications for Use (Describe)
The Transem and EchoGen™ are catheters with angled or spherical tips for embryo transfer into the uterine cavity in the treatment of infertility.
The Transem Stylets are intended to assist the insertion of the Transem or EchoGen™ catheters where the passage through the cervix is impeded.
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.
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 Druq 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."
3
Image /page/3/Picture/1 description: The image shows the word "origio" in a stylized purple font. The letters are rounded and connected, giving the word a modern and fluid appearance. The background is plain white, which makes the purple letters stand out.
Transem and EchoGen™ Embryo Transfer Catheters 510(k) Summary (K161547)
SUBMITTER l .
| Name: | ORIGIO a/s |
|---|---|
| Address: | Knardrupvej 2 |
| 2760 Måløv | |
| Denmark | |
| Contact Person: | Tove Kjær |
| Director, Corporate Regulatory Affairs | |
| Telephone: +45 4679 0220 | |
| Fax: +45 4679 0300 | |
| Email: tkjaer@origio.com | |
| Date of Preparation | March 8, 2017 |
ll. SUBJECT DEVICE
| Name of Device: | Transem and EchoGen™ Embryo Transfer Catheters |
|---|---|
| Common or Usual Name: | Embryo Transfer Catheters, Stylets |
| Classification Number: | 21 CFR 884.6110 |
| Classification Name: | Assisted Reproduction Catheters |
| Regulatory Class: | II |
| Product Code: | MQF (Catheters, Assisted Reproduction) |
| Included model numbers: | TSET25SA, TSET25SAO, TSET24SAS, TSET24SASO, TSS1520, TSS1823, TSS2025, TSET25SAEG, TSET25SAOEG, TSET24SASEG, TSET24SASOEG |
PREDICATE DEVICE III.
| Trade Name: | Wallace (Sure View) Embryo Replacement Catheter and |
|---|---|
| Trial Transfer Catheter | |
| Manufacturer: | Portex, Ltd. |
| 510(k): | K033084 |
The predicate device was subject to a design-related recall in 2013. However, the recall status for the predicate device is completed, and the predicate device is currently marketed.
4
DEVICE DESCRIPTION IV.
The Transem and EchoGen™ are Embryo Transfer Catheters with various angled or spherical tips and various lengths. The EchoGen™ variants are designed to be visible under ultrasound imaging. Stylets to aid in the insertion of the embryo catheters are also available. The product variants covered in this 510(k) include the following:
| Trade name | Catheter type | Code | Description |
|---|---|---|---|
| Transem | Angled tip | TSET25SA | Transem Angled 25 cm |
| TSET25SAO | Transem Angled O* 25 cm | ||
| Spherical tip | TSET24SAS | Transem Spherical 24 cm | |
| TSET24SASO | Transem Spherical O* 24 cm | ||
| Stylets | TSS1520 | Transem Stylet 15 cm | |
| TSS1823 | Transem Stylet 18 cm | ||
| TSS2025 | Transem Stylet 20 cm | ||
| EchoGen™ | Angled tip | TSET25SAEG | EchoGen™ Angled 25 cm |
| TSET25SAOEG | EchoGen™ Angled O* 25 cm | ||
| Spherical tip | TSET24SASEG | EchoGen™ Spherical 24 cm | |
| TSET24SASOEG | EchoGen™ Spherical O* 24 cm |
*includes obturator
Key specifications for the Transem and EchoGen™ Embryo Transfer Catheters are listed in the table below.
| Aspect | Subject Device |
|---|---|
| Packaging type | Blister pack |
| Sterility assurance level | SAL 10-6 |
| Sterilization method | Irradiation |
| Reprocessing | Single use |
| Shelf life | 1.3 years |
| Endotoxins | ≤ 1.25 EU/device |
| Mouse Embryo Assay | ≥80% blastocyst rate at 96 hr |
| (1-cell test) |
V. INDICATIONS FOR USE
The Transem and EchoGen™ are catheters with angled or spherical tips for embryo transfer into the uterine cavity in the treatment of infertility.
The Transem Stylets are intended to assist the insertion of the Transem or EchoGen™ catheters where the passage through the cervix is impeded.
5
Image /page/5/Picture/1 description: The image shows the word "origio" in a stylized, purple font. The letters are rounded and connected, giving the word a flowing appearance. The overall design is modern and minimalist.
INTENDED USE AND TECHNOLOGY COMPARISON WITH THE PREDICATE VI. DEVICE
Intended Use
The indication for use statements for the subject and predicate devices are shown in the table below.
| Aspect | Subject Device (K161547) | Predicate Device (K033084) |
|---|---|---|
| Indications for use | The Transem and EchoGen™ are catheters | |
| with angled or spherical tips for embryo | ||
| transfer into the uterine cavity in the | ||
| treatment of infertility. | Embryo Replacement Catheters are | |
| sterile, single-use devices for ultrasound | ||
| guided introduction of embryos into the | ||
| uterine cavity following in vitro | ||
| fertilization. | ||
| The Transem Stylets are intended to assist | ||
| the insertion of the Transem or EchoGen™ | ||
| catheters where the passage through the | ||
| cervix is impeded. | Trial transfer catheters are sterile, single- | |
| use devices for determining whether the | ||
| cervix is passable for a Wallace embryo | ||
| replacement catheter. |
The subject and predicate devices have the same intended use - transfering embryos into the uterine cavity during in vitro fertilization procedures. The subject device includes the Transem Stylet, which is intended to assist insertion of the catheters by maintaining rigidity of the device. While the use of a stylet is not included in the predicate device Indications for Use statement, the inclusion of the stylet does not represent a new intended use for the device. The predicate device indication includes a trial transfer catheter, used to determine whether the cervix is passable. The subject device does not contain a trial catheter; however, the lack of a trial catheter does not change the intended use of the subject device.
Technology
In the following tables, the technological features and performance specification of the subject device are compared to the predicate device.
| Aspect | Subject Device (K161547) | Predicate Device (K033084) |
|---|---|---|
| Materials | Stainless steel | Stainless steel |
| Plastics (thermoplastic | ||
| elastomers, polyethylene, | ||
| polypropylene) | Plastics (types not publicly | |
| available) | ||
| Ink | Ink | |
| Dimensions** | ||
| - Working lengths | 24/25 cm | 18/23 cm |
| - Forming of tip | Spherical/Angled | Straight/Angled |
6
Image /page/6/Picture/1 description: The image shows the word "origio" in a stylized, purple font. The letters are rounded and connected, giving the word a flowing appearance. The dot of the "i" is replaced with a small, curved shape, adding a unique design element to the logo.
| - | Bulb tip | Yes* | No |
|---|---|---|---|
| - | Inner catheter I.D. | 0.50*/0.77 mm | 0.76 mm |
| - | Inner catheter O.D. | 1.00*/1.47 mm | 1.50 mm |
| - | Outer catheter O.D. | 2.15*/2.65 mm | 2.30 mm |
| Stylet | 15/18/20 cm | Not present | |
| Other characteristics | |||
| - | Echogenic tip | Yes (EchoGen™ models) | Yes (Sureview & Surepro models) |
| - | Echogenic principle | Metallic marker band | Extruded air bubbles |
*: Models with spherical tips
**: The only difference between the Transem and EchoGen™ catheters is the inclusion of an echogenic marker. Therefore, the dimensions listed for the subject device apply to both the Transem and EchoGen™ catheters.
The technological characteristics of the subject device are different - the subject device has different material components, dimensions, echogenic marker materials, and includes a stylet to help maintain rigidity during insertion. However, different types of safety or effectiveness questions are not raised by these differences in technological characteristics.
VII. PERFORMANCE DATA
Biocompatibility testing
Transem and EchoGen™ were tested for cytotoxicity according to ISO 10993-5:2009, sensitization according to ISO 10993-10:2010 and vaginal irritation according to ISO 10993-10:2010. The results showed the device is not cytotoxic, not sensitizing and a non-irritant.
Sterilization and Shelf-life
The sterilization of Transem and EchoGen™ has been validated according to ISO 11137-2:2006. The shelf-life has been established through real-time and accelerated testing according to standards ISO 11607-1:2006 and ASTM F1980-07. The following parameters were assessed during shelf life testing:
- Air resistance
- Tensile strength
- Dimensional characteristics
- Sterility
- Endotoxin (Limulus Amebocyte Lysate test per USP)
- Mouse Embryo Assay (MEA)
- Package integrity (peel strength, visual inspection for damage, label integrity, and contamination)
Bench Testing
Bench testing included the physical properties of Transem and EchoGen™ (air resistance, tensile strength, dimensional verification), performance characteristics (sterility, endotoxin and embryotoxicity [MEA]), and echogenic marker assessments (mounting accuracy, pull force to remove), flow restriction, and ultrasound visibility assessment.
7
Image /page/7/Picture/1 description: The image shows the word "origio" in a stylized, sans-serif font. The letters are a deep purple color. The letters are connected to each other, creating a continuous line. The logo has a modern and minimalist design.
conclusions VIII.
The results of the testing described above demonstrate that the Transem and EchoGen™ Embryo Transfer Catheters are as safe and effective as the predicate device and supports a determination of substantial equivalence.