Transem and EchoGen Embryo Transfer Catheters

K161547 · Origio A/S · MQF · Mar 9, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K161547
• Device Name: Transem and EchoGen Embryo Transfer Catheters
• Applicant: Origio A/S
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Mar 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Transem and EchoGen™ are embryo transfer catheters used in clinical settings by fertility specialists. Devices feature angled or spherical tips; EchoGen™ variants include metallic marker bands for ultrasound visibility. Stylets are provided to assist insertion by maintaining catheter rigidity when cervical passage is difficult. Catheters are inserted into the uterine cavity to deliver embryos. Ultrasound guidance allows the physician to visualize the catheter tip during placement. The device facilitates the transfer process, potentially improving success rates in infertility treatment. All components are single-use and sterile.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10), sterilization validation (ISO 11137-2), shelf-life (ISO 11607-1, ASTM F1980-07), and performance characteristics. Performance metrics included Mouse Embryo Assay (≥80% blastocyst rate at 96 hr), endotoxin levels (≤ 1.25 EU/device), air resistance, tensile strength, and ultrasound visibility. No clinical data presented.

Technological Characteristics

Materials: stainless steel, thermoplastic elastomers, polyethylene, polypropylene, ink. Dimensions: 24/25 cm working lengths; spherical/angled tips. Echogenic principle: metallic marker band. Sterilization: irradiation (SAL 10^-6). Single-use. Packaging: blister pack. Shelf life: 1.3 years.

Indications for Use

Indicated for patients undergoing embryo transfer into the uterine cavity for infertility treatment. Stylets indicated for use when cervical passage is impeded.

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

• Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter (K033084)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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)

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# Transem and EchoGen™ Embryo Transfer Catheters 510(k) Summary (K161547)

#### SUBMITTER l .

| Name: | ORIGIO a/s |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Address: | Knardrupvej 2<br>2760 Måløv<br>Denmark |
| Contact Person: | Tove Kjær<br>Director, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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.

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#### 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<br>(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.

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### 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<br>with angled or spherical tips for embryo<br>transfer into the uterine cavity in the<br>treatment of infertility. | Embryo Replacement Catheters are<br>sterile, single-use devices for ultrasound<br>guided introduction of embryos into the<br>uterine cavity following in vitro<br>fertilization. |
| | The Transem Stylets are intended to assist<br>the insertion of the Transem or EchoGen™<br>catheters where the passage through the<br>cervix is impeded. | Trial transfer catheters are sterile, single-<br>use devices for determining whether the<br>cervix is passable for a Wallace embryo<br>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<br>elastomers, polyethylene,<br>polypropylene) | Plastics (types not publicly<br>available) |
| | Ink | Ink |
| Dimensions** | | |
| - Working lengths | 24/25 cm | 18/23 cm |
| - Forming of tip | Spherical/Angled | Straight/Angled |

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| - | 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<85>)
- 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.

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#### 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.