Single Lumen Ovum Aspiration Needles

K171625 · Willian A. Cook Australia Pty, Ltd. · MQE · Jan 12, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K171625
• Device Name: Single Lumen Ovum Aspiration Needles
• Applicant: Willian A. Cook Australia Pty, Ltd.
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Jan 12, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.6100
• Device Class: Class 2

Indications for Use

The Single Lumen Ovum Aspiration Needles are used for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

Device Story

Single Lumen Ovum Aspiration Needles are sterile, single-use devices used for oocyte retrieval. The device consists of a stainless-steel needle with an echogenic tip for ultrasound visualization, a manipulating handle, and FEP or PTFE tubing connected to a silicone stopper. The stopper fits into a 14mL test tube, which serves as a collection reservoir. The device is connected to an external vacuum pump to provide aspiration suction. Used in clinical settings by physicians during assisted reproductive procedures, the needle is guided transvaginally or laparoscopically into ovarian follicles. The aspiration process allows for the collection of oocytes for further laboratory processing. The device facilitates oocyte retrieval, which is a critical step in assisted reproduction, potentially benefiting patients by enabling fertilization procedures.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10), Mouse Embryo Assay (≥80% development to blastocyst at 72 hours), endotoxin testing (USP <85>, <20 EU/Device), and mechanical performance testing (leak, tensile strength, needle stiffness). Stability testing confirmed performance after three years of aging.

Technological Characteristics

Stainless-steel needle (16-21 gauge, 25-35 cm length) with echogenic tip. Tubing materials: FEP and PTFE. Stopper: Silicone. Connectivity: Luer lock to vacuum pump. Sterile, single-use. Mechanical operation via external vacuum source. No software or electronic components.

Indications for Use

Indicated for patients undergoing Assisted Reproductive procedures requiring laparoscopic or ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles.

Regulatory Classification

Identification

Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

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

• Ovum Pick-Up Aspiration Needles (K983593)

Submission Summary (Full Text)

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January 12, 2018

Willian A. Cook Australia Pty. Ltd. Gordana Pozvek, Ph.D. Senior Regulatory Affairs Specialist 95 Brandl Street Eight Mile Plains, Queensland 4113 Australia

Re: K171625

Trade/Device Name: Single Lumen Ovum Aspiration Needles Regulation Number: 21 CFR§ 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MOE Dated: December 12, 2017 Received: December 15, 2017

Dear Gordana Pozvek:

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 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Charles Viviano -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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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171625

#### Device Name Single Lumen Ovum Aspiration Needles

Indications for Use (Describe)

The Single Lumen Ovum Aspiration Needles are used for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

| 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.

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K171625 Page 1 of 4

Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with a registered trademark symbol to the right of the word. Below the word "COOK" is the word "MEDICAL" in white. The background of the logo is a solid red color.

WILLIAM A. COOK AUSTRALIA PTY. LTD. BRISBANE TECHNOLOGY PARK, EIGHT MILE PLAINS BRISBANE, QLD 4113, AUSTRALIA HONE: 1800.777.222 FAX: [phone] WWW.COOKMEDICA

# 510(k) Summary - K171625

#### SUBMITTED BY:

William A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains OLD 4113 Australia

| Contact Person: | Gordana Pozvek Ph.D. |
|-----------------|--------------------------------|
| Tel: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

#### Date Prepared: January 11, 2018

#### DEVICE IDENTIFICATION:

| Trade Name: | Single Lumen Ovum Aspiration Needles |
|-------------------|-----------------------------------------------|
| Common Name: | Oocyte Retrieval Needles |
| Regulation No: | 21 CFR 884.6100, Assisted Reproduction Needle |
| Regulatory Class: | II |
| Product Code: | MQE - Needle, Assisted Reproduction |

#### PREDICATE DEVICE:

Ovum Pick-Up Aspiration Needles (K983593)

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

## DEVICE DESCRIPTION:

Single Lumen Ovum Aspiration Needles consist of a stainless-steel needle with a manipulating handle which may be connected to a fluorinated ethylene-propylene (FEP) or polytetrafluorethylene (PTFE) tube, which in turn is connected to a Silicone stopper (bung). The stopper has a Luer lock fitting directly to the stopper or connected to a length of tube to allow connection to a vacuum pump which provides aspiration suction. The stopper is placed in a 14mL test tube which acts as a collection reservoir. Needles are available in 16 to 21 gauge sizes and lengths from 25 to 35 cm. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound.

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The Single Lumen Ovum Aspiration Needles are sterile and single-use devices.

| Product<br>codes | Needle<br>gauge | Needle<br>length<br>(cm) | Aspiration<br>Line (cm) | Vacuum<br>Line (cm) | Flushing<br>Line<br>(cm) | Bevel<br>Type |
|-------------------|--------------------------|--------------------------|-------------------------|---------------------|--------------------------|---------------|
| K-OPAA-<br>series | 17, 18, 20 | 35 | n/a | n/a | n/a | B |
| K-DOPU-<br>series | 17 | 28 or 35 | 60 or 90 | n/a | n/a | B |
| K-OPS-<br>series | 16, 17, 19,<br>20, or 21 | 28, 30, 33,<br>or 35 | 60 or 90 | n/a | n/a | A or B |
| K-OSN-<br>series | 16 or 17 | 25, 30, 33,<br>or 35 | 60 or 90 | 50 | n/a | A or B |
| K-IOPS-<br>series | 20 | 35 | 60 | 50 | n/a | A |
| K-UCI-<br>series | 16 or 17 | 30 or 35 | 60 | n/a | 60 | A |

The following needle series are included in this 510(k):

### INDICATIONS FOR USE:

The Single Lumen Ovum Aspiration Needles are used for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

#### COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

Single Lumen Ovum Aspiration Needles have similar Indications for Use as the predicate device (K983593). The intended use of the subject device is the same as the predicate device.

The Single Lumen Ovum Aspiration Needles are a modification of the Ovum Pick-up Aspiration Needles (K983593). The modifications are:

- The indications for use statement has been modified from the predicate device to include transvaginal ultrasound and laparoscopic approaches, both of which were specifically stated within cleared labeling for the legally marketed device. This modification to the Indication for Use statement does not impact safety and effectiveness of the device.
- Addition of a 21-gauge variant to the K-OPS Series needles. This modification provides a smaller gauge needle option. The 21-gauge variant has a 4 Fr aspiration tubing.

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- Addition of a 17 gauge, 30 cm guide needle. This modification provides a guide needle size suitable for the 20-gauge K-IOPS variant.
- The aspiration and flushing tubing has changed from Tetrafluoroethylene (NRT [TFE]) to Fluorinated Ethylene Propylene (NRT-FEP) and Polytetrafluoroethylene (NRT-PTFE).

The modifications listed above do not raise different questions of safety and effectiveness as compared to the predicate device.

### PERFORMANCE DATA:

To support the modifications to the subject device, the following design verification and validation activities were performed and summarized:

- Biocompatibility per ISO 10993-1:2009 ●
- o Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) o
- o Irritation (ISO 10993-10:2010)
- Mouse Embryo Assay Two cell mouse embryos were exposed to device extracts ● and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocysts stage within 72 hours were assessed in comparison with the control group. The acceptance criteria for this test is ≥80% development to blastocyst at 72 hours.
- Endotoxin testing per USP <85> (< 20 EU/Device)
- Mechanical performance testing
- Negative pressure leak test o
- Tensile strength of the tubing to cannula O
- Tensile strength of the tubing to bung O
- Tensile strength of joint between cannula and handle O
- Tensile strength of 4 Fr tubing O
- Tensile strength of the joint between guide needle cannula and hub o
- o Needle stiffness
- Stability testing ●
- Negative pressure leak test after three years of aging O
- Tensile testing of joint between handle and needle cannula after three years of O aging
- Torque testing of joint between guide needle cannula and hub after three o vears of aging

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# CONCLUSION:

The results of the testing provided demonstrated that the Single Lumen Ovum Aspiration Needle is as safe and effective as the predicate device and supports a determination of substantial equivalence.