The Wallace Dual Lumen Oocyte Recovery System in a sterile single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

Device Description

The Wallace Dual Lumen Oocyte Recovery System consists of a dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source.

The Wallace Dual Lumen Oocyte Recovery System consists of a 17 gauge needle that is 33 cm long, and three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.

AI/ML Overview

Based on the provided text, the device in question is the Wallace Dual Lumen Oocyte Recovery System, an ovulation retrieval needle. The document does not describe a study involving an AI/algorithmic device or human readers. Instead, it details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested sections (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set ground truth establishment) are not applicable as they pertain to the evaluation of an AI or algorithm, which is not the subject of this 510(k) summary.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance for the Wallace Dual Lumen Oocyte Recovery System

The device under review is an assisted reproduction needle, not an AI or algorithm. The acceptance criteria and performance data provided relate to the physical and biological characteristics of the device to demonstrate its safety and effectiveness, primarily through comparison to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various non-clinical performance tests and their acceptance criteria (implicitly met as the conclusion states the device passed all testing).

Test Type	Acceptance Criteria	Reported Device Performance
Sterilization Testing	Per ISO 11135:2014; Sterility Assurance Level (SAL) 10^-6	Passed all testing in accordance with internal requirements and applicable standards. Implies SAL 10^-6 was met.
Ethylene Oxide (EtO) Residuals	Per ISO 10993-7: 2008 / (R)2012	Passed all testing in accordance with internal requirements and applicable standards.
Biocompatibility: Cytotoxicity	Per ISO 10993-5: 2009	Passed.
Biocompatibility: Irritation	Per ISO 10993-10: 2010	Passed.
Biocompatibility: Sensitization	Per ISO 10993-10: 2010	Passed.
Stability and Shelf Life (Accelerated Aging)	Two years shelf life (tested at baseline and after 2 years accelerated aging per ASTM F1980-16)	Passed. Device demonstrated stable performance over a two-year shelf life.
Package Integrity (Seal Tensile Strength)	Per ASTM F88/F88M-15	Passed.
Package Integrity (Seal Peel)	Per ASTM F1886/F1866M-16	Passed.
Mouse Embryo Assay (MEA)	≥80% embryos expanded to blastocyst at 96 hours (for one-cell mouse embryos incubated in extracts of the device)	Passed.
Endotoxin	≤20 EU/device (using Gel-Clot Limulus Amoebocyte Lysate (LAL) method per ANSI/AAMI ST72-2011 and USP <85>)	Passed.
Mechanical Performance Testing	Specific criteria not detailed, but tests included: Joint strength tensile testing; Needle point penetration force testing; Needle stiffness; Tubing flow rate; Tubing leak testing	Passed all mechanical performance tests.
Simulated Shipping & Distribution	Per ISTA 3A: 2008; subsequent visual inspection, bubble leak per ASTM F2096-11, and mechanical performance testing (same as above)	Passed. Device and packaging maintained integrity and performance after simulated shipping and distribution conditioning, including visual inspection, bubble leak, and mechanical performance testing.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not explicitly stated for each test (e.g., number of needles tested for mechanical performance, number of packages for integrity). However, the methods refer to standard test procedures (e.g., ISO, ASTM), which typically define sample sizes.
Data Provenance: The document describes non-clinical laboratory testing of the device itself, not human clinical data or imaging data. Therefore, concepts like country of origin or retrospective/prospective are not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not Applicable. This device is a physical medical instrument, not an AI/algorithmic software. "Ground truth" in this context refers to the defined scientific and engineering standards and methods for assessing the device's physical, chemical, and biological properties, which are established by standard organizations (e.g., ISO, ASTM, USP) and verified by qualified laboratory personnel.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical performance testing of a physical device, there is no "adjudication" of expert opinions in the sense of image interpretation. Test results are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/algorithmic device or diagnostic tool. An MRMC study would be irrelevant.

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

Not Applicable. This is a physical medical device. "Standalone performance" in this context refers to the device's ability to meet its specifications independently, which is what the non-clinical performance testing aimed to demonstrate.

7. The Type of Ground Truth Used

Defined Standards and Measurable Performance Metrics: The "ground truth" for this device's performance is based on established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP) for sterility, biocompatibility, mechanical properties, and packaging integrity. Tests evaluate quantitative and qualitative measures directly against these benchmarks (e.g., specific thresholds for endotoxin, percentage of embryo development, strength limits, leak absence).

8. The Sample Size for the Training Set

Not Applicable. This refers to an AI/algorithmic device, not a physical medical instrument. There is no concept of a "training set" for the type of evaluation described.

9. How the Ground Truth for the Training Set was Established

Not Applicable. Again, this is for AI/algorithmic development. The "ground truth" for evaluating this physical device is established through adherence to recognized industrial and medical device testing standards and protocols.

Summary

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May 10, 2019

CooperSurgical, Inc. Christine Kupchick Regulatory Affairs Associate 95 Corporate Drive Trumbull, CT 06611

Re: K182959

Trade/Device Name: Wallace Dual Lumen Oocyte Recovery System Regulation Number: 21 CFR§ 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MQE Dated: April 10, 2019 Received: April 11, 2019

Dear Christine Kupchick:

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. 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 located 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.

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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.

for

Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182959

Device Name

Wallace Dual Lumen Oocyte Recovery System

Indications for Use (Describe)

The Wallace Dual Lumen Oocyte Recovery System in a sterile single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

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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510(k) Summary K182959

Submitter Information:

CooperSurgical Inc. 95 Corporate Drive Trumbull, CT 06611

Contact:

Name:	Christine Kupchick
Telephone:	203-601-5200 Ext. 3370
Fax:	203-601-9870
E-mail:	Christine.Kupchick@coopersurgical.com

Date Prepared: May 9, 2019

Device Identification:

Trade Name:	Wallace Dual Lumen Oocyte Recovery System
Common Name:	Oocyte Retrieval Needle
Regulation Number:	21 CFR 884.6100
Regulation Name:	Assisted Reproduction Needles
Product Code:	MQE (Needle, Assisted Reproduction)
Regulatory Class:	Class II

Predicate Device Information

Wallace Dual Lumen Oocyte Retrieval Sets (K031622).

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

Device Description

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Indications for Use

The Wallace Dual Lumen Oocyte Recovery System is a sterile, single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

Substantial Equivalence Discussion

Table 1: Substantial Equivalence Comparison

Attribute	Wallace Dual Lumen OocyteRecovery System - Subject Device	Wallace Dual Lumen OocyteRetrieval Sets -Predicate Device
Manufacturer	CooperSurgical, Inc.	Smiths Medical
510(k) Number	K182959	K031622
Indications forUse	The Wallace Dual Lumen OocyteRecovery System is a sterile, single-use device for ultrasonic-guidedtransvaginal collection of oocytesfrom the ovarian follicles.	The Wallace Dual Lumen OocyteRetrieval Sets are sterile, single-usedevices for ultrasonic-guidedtransvaginal collection of oocytesfrom the ovarian follicles.
Needle	33cm dual lumen needle; 17g	33cm dual lumen needle; 16g and17g sizes
Needle Hub	Molded with friction fit needlebosses and solvent bonded flushingside connector	Molded with glued needle bossesand solvent bonded flushing tube
Tubing Sets	Aspiration: 500, 750, and 950mmFlushing: 700mmVacuum: 500mm	Aspiration: 600, 750, and 950mmFlushing: 600, 750, 950mmVacuum: 500mm
Device Materials	Stainless steel, methacrylatebutadiene styrene (MBS), silicone,polyurethane, polycarbonate, Nylon,and acrylonitrile butadiene styrene(ABS)	Stainless steel, MBS, silicone,polyurethane, fluorinated ethylenepropylene (FEP), and ABS
Sterilization	Ethylene oxide; SAL 10-6	Ethylene oxide; SAL 10-6
Number of Uses	Single-use; disposable	Single-use; disposable
Shelf Life	Two years	Two years

The Wallace Dual Lumen Oocyte Recovery System and the predicate device (K031622) have identical Indications for Use statements; therefore, their intended uses are the same.

The subject and predicate device have different technological characteristics. The Wallace Dual Lumen Oocyte Recovery System is a modification of the Wallace Dual Lumen Oocyte Retrieval Sets (K031622). The modifications include:

Dimensional differences including needle gauges offered and tubing lengths provided.
Differences in device materials.
Differences in the design of needle hubs and connectors. ●

The technological differences identified do not raise different questions of safety and effectiveness as compared to the predicate.

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Non-Clinical Performance Testing

As part of demonstrating substantial equivalence to the predicate, the following tests were performed. The Wallace Dual Lumen Oocyte Retrieval System passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device:

. Sterilization testing per ISO 11135:2014
. Ethylene oxide and ethylene chlorohydrin residual testing per ISO 10993-7: 2008 / (R)2012
. Biocompatibility Testing:
- O Cytotoxicity per ISO 10993-5: 2009
- Irritation per ISO 10993-10: 2010 O
- Sensitization per ISO 10993-10: 2010 O
Stability and Shelf Life ●
- The following tests were completed at baseline and after two-years of accelerated aging O per ASTM F1980-16:
  - I Package integrity testing
    - . Seal tensile strength per ASTM F88/F88M-15
    - . Seal peel per ASTM F1886/F1866M-16
  - . Mouse embryo assay (MEA) - One-cell mouse embryos were incubated in extracts of the subject device and cultured at 37°C. The percent of embryos developed to the expanded blastocyst stage within 96-hours was assessed in comparison to the control group. The acceptance criterion for the 1-Cell MEA was ≥80% embryos expanded to blastocyst at 96 hours.
  - l Endotoxin - Evaluation performed using the Gel-Clot Limulus Amoebocyte Lysate (LAL) method per ANSI/AAMI ST72-2011 and USP <85>. The acceptance criterion was ≤20 EU/device.
  - l Mechanical performance testing:
    - Joint strength tensile testing
    - Needle point penetration force testing
    - Needle stiffness ●
    - Tubing flow rate ●
    - Tubing leak testing

Simulated shipping and distribution testing per ISTA 3A: 2008 ●

o The following tests were completed after simulated shipping and distribution conditioning:
- l Visual inspection
- Bubble leak per ASTM F2096-11
- l Mechanical performance testing (see above)

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Conclusion

The results of the testing described above demonstrate that the Wallace Dual Lumen Recovery System 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).