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

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary, specifically addressing the acceptance criteria and the study that proves the device meets them:

The document is a 510(k) premarket notification for the "Single Lumen Ovum Aspiration Needles." This is a medical device, and the focus of the regulatory claim is substantial equivalence to a predicate device, not necessarily a demonstration of clinical superiority or a deep dive into AI performance. Therefore, many of the typical AI/ML acceptance criteria and study details you'd expect are not present.

The "acceptance criteria" here largely refer to the performance standards and modifications made to demonstrate that the new device is as safe and effective as the predicate device.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Biocompatibility (ISO 10993-1:2009)	Passed for Cytotoxicity, Sensitization, and Irritation.
- Cytotoxicity (ISO 10993-5:2009)	Passed
- Sensitization (ISO 10993-10:2010)	Passed
- Irritation (ISO 10993-10:2010)	Passed
Mouse Embryo Assay	≥80% development to blastocyst at 72 hours (compared to control group).
Endotoxin testing (USP <85>)	< 20 EU/Device
Mechanical performance testing	Passed for all specific aspects listed below.
- Negative pressure leak test	Passed
- Tensile strength of the tubing to cannula	Passed
- Tensile strength of the tubing to bung	Passed
- Tensile strength of joint between cannula and handle	Passed
- Tensile strength of 4 Fr tubing	Passed
- Tensile strength of the joint between guide needle cannula and hub	Passed
- Needle stiffness	Passed
Stability testing	Passed for all specific aspects listed below after three years of aging.
- Negative pressure leak test after three years of aging	Passed
- Tensile testing of joint between handle and needle cannula after three years of aging	Passed
- Torque testing of joint between guide needle cannula and hub after three years of aging	Passed

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each test set beyond mentioning "device extracts" for the Mouse Embryo Assay. The studies are pre-clinical/design verification and validation studies rather than clinical trials with human participant data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" as relevant to patient data provenance do not directly apply here. These studies are conducted by the manufacturer (William A. Cook Australia Pty Ltd).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of regulatory submission. For a medical device like an ovum aspiration needle, "ground truth" is established through standardized laboratory testing and engineering specifications to confirm physical and biological properties, not expert clinical interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies or other diagnostic assessments involving multiple human readers, which is not the nature of the studies described here.

5. 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

There was no MRMC study conducted. This device is a physical medical instrument (needle) and does not involve AI or human readers in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is not an algorithm or an AI product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance data presented is derived from standardized laboratory testing, engineering specifications, and established biological assays. For example:

Biocompatibility: Conformity to ISO 10993 standards.
Mouse Embryo Assay: Direct observation of embryo development under controlled conditions.
Endotoxin testing: Quantitative measurement against USP <85> limits.
Mechanical testing: Measurements against predefined engineering specifications for strength, leak resistance, and stiffness.

8. The sample size for the training set

This information is not applicable. The device is not an AI/ML system and therefore does not have a "training set" in the computational sense. The design verification and validation tests are performed on representative samples of the manufactured device.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for an AI/ML algorithm.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: +61.7.3841 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:	+61 (7) 3841 1188
Fax:	+61 (7) 3841 3905
E-mail:	Gordana.Pozvek@CookMedical.com

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:

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

Productcodes	Needlegauge	Needlelength(cm)	AspirationLine (cm)	VacuumLine (cm)	FlushingLine(cm)	BevelType
K-OPAA-series	17, 18, 20	35	n/a	n/a	n/a	B
K-DOPU-series	17	28 or 35	60 or 90	n/a	n/a	B
K-OPS-series	16, 17, 19,20, or 21	28, 30, 33,or 35	60 or 90	n/a	n/a	A or B
K-OSN-series	16 or 17	25, 30, 33,or 35	60 or 90	50	n/a	A or B
K-IOPS-series	20	35	60	50	n/a	A
K-UCI-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:

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.

Regulation Number and Section

§ 884.6100 Assisted reproduction needles.

(a)
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.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).