The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes are 970 microns (um) outer diameter borosilicate glass tubing that is bent and tapered. The Embryo Biopsy Pipette is tapered to a flat, smooth tip inner diameter of 30 um and 35 um. It is intended to be used for blastomere or trophectoderm aspiration. The Polar Body Biopsy Pipette is tapered to an inner diameter of 20 um and beveled to a spike to assist in piercing through the zona pellucida to biopsy the polar body. The Testicular Sperm Extraction Pipette is tapered to a flat angle with an inner diameter of 6.5 um. These pipettes are intended to extract sperm cells from biopsied testicular tissue. The device is supplied gamma sterilized and is intended for one-time use.

AI/ML Overview

The document describes three medical devices: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, and Testicular Sperm Extraction Pipette. The acceptance criteria and the studies performed to demonstrate equivalence are detailed as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criterion	Reported Device Performance
MEA (Mouse Embryo Assay)	≥80% 1-cell stage embryos must develop to blastocyst within 96 hours.	The predetermined acceptance criterion was met.
LAL (Limulus Amebocyte Lysate)	< 20 EU/device	The predetermined acceptance criterion was met.
Functionality Study (Embryo Biopsy Pipettes)	Glass pipettes fitted to a micromanipulator, micro-injector, and Micro-injector holder are capable of aspirating fluid without breaking or leaking.	The predetermined acceptance criterion was met.
Shelf Life	Maintain sterility and functional performance characteristics over the proposed shelf life.	The results of accelerated and real-time aging studies demonstrate this.
Sterilization Validation	Performed in accordance with FDA recognized standards.	Sterilization validation was performed in accordance with FDA recognized standards.

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

The document does not explicitly state the sample sizes for each specific test (MEA, LAL, Functionality). It mentions "lot release" for MEA and LAL testing, implying that samples are taken from each manufacturing lot. The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The tests performed are laboratory-based and do not involve human expert adjudication for establishing ground truth in a clinical sense.

4. Adjudication Method

Not applicable, as the tests performed are laboratory-based and do not require expert adjudication in the context of clinical interpretation or diagnostic performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes performance testing for the physical and biological characteristics of the pipettes, not diagnostic efficacy involving human readers.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. The devices are physical microtools used in assisted reproduction procedures, not AI algorithms.

7. Type of Ground Truth Used

The ground truth used for these tests is based on objective, quantifiable biological and physical criteria:

MEA: Successful development of mouse embryos to the blastocyst stage.
LAL: Presence of endotoxins measured in Endotoxin Units.
Functionality Study: Observable physical performance of the pipettes (aspirating fluid without breaking or leaking).
Shelf Life: Maintenance of sterility and functional characteristics over time.
Sterilization Validation: Adherence to FDA recognized standards.

8. Sample Size for the Training Set

Not applicable. These are physical medical devices, not AI/ML algorithms that require training sets.

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

Not applicable, as there is no training set for these physical devices.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2016

Cook Incorporated Naomi Funkhouser Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47404

Re: K151018

Trade/Device Name: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted Reproduction Microtools Regulatory Class: Class II Product Code: MOH Dated: December 10, 2015 Received: December 11, 2015

Dear Naomi Funkhouser,

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 yours.

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Jeffrey W. Cooper -S 2016.01.08 11:19:22 -05'00'

For

Beniamin 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

510(k) Number (if known) K151018

Device Name Embryo Biopsy Pipette Polar Body Biopsy Pipette Testicular Sperm Extraction Pipette

Indications for Use (Describe)

The Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection.

The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection.

The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied tessue.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

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K151018

5.0 510(k) Summary

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, and Testicular Sperm Extraction Pipette 510(k) Summary 21 CFR §884.6130 Date Prepared: January 8, 2016

Submitted By:

Applicant:	Cook Incorporated
Address:	750 Daniels WayP.O. Box 489Bloomington, IN 47402
Phone Number:	(812) 335-3575 x104371
Fax Number:	(812) 332-0281
Contact:	Naomi Funkhouser
Contact Address:	Cook Incorporated750 Daniels WayP.O. Box 489Bloomington, IN 47402
Contact Phone Number:	(812)335-3575 x104371
Contact Fax Number:	812-332-0281
Device Information:
Trade names:	Embryo Biopsy Pipette
	Polar Body Biopsy Pipette
	Testicular Sperm Extraction Pipette
Common name:	Microtools, Assisted Reproduction (Pipettes)
Classification Name:	Assisted Reproduction Microtools
Regulation:	21 CFR §884.6130
Product Code:	MQH

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Predicate Devices:

The predicate device for the Embryo Biopsy and the Polar Body Biopsy is as follows:

Cook's Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) (K033904) .
The predicate device for the Sperm Extraction Pipettes is as follows:
Cook's Intracytoplasmic Sperm Injection (ICSI), Micro-Injection Pipettes, Holding ● Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes (K033903)

Device Description:

Intended Use:

The Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection.

The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection.

The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied testicular tissue.

Comparison to Predicates:

The Embryo Biopsy Pipette and the Polar Body Pipette have the same intended use as K033904 - aspiration of embryo tissues/cells for genetic diagnosis.

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The Testicular Sperm Extraction Pipette has the same intended us as K033903 - to manipulate sperm during ART procedures.

The proposed devices have the same technological characteristics (design material, comparable dimensions) as the predicate devices.

Performance Testing:

The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes were subjected to testing as to assure validation of design and performance as listed below. In addition, the Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes undergo MEA and LAL testing for each lot manufactured.

1. MEA Testing The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes underwent lot release Mouse Embryo Assay testing. The acceptance criterion was that ≥80% 1 cell stage embryos must develop to blastocyst within 96 hours. The predetermined acceptance criterion was met.
1. LAL Testing The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes were lot-release tested using the Limulus Amebocyte Lysate (LAL) test. The devices must demonstrate < 20 EU/device. The predetermined acceptance criterion was met.
1. Functionality Study The Embryo Biopsy Pipettes were tested to show evidence that glass pipettes fitted to a micromanipulator, micro-injector, and Micro-injector holder are capable of aspirating fluid without breaking or leaking. The predetermined acceptance criterion was met.
1. Shelf Life The results of accelerated and real-time aging studies demonstrate that the subject devices maintain their sterility and functional performance characteristics over their proposed shelf life.
1. Sterilization Validation Sterilization validation was performed in accordance with FDA recognized standards.

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Conclusion:

The results of these tests support a conclusion that the Embryo Biopsy Aspiration, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 884.6130 Assisted reproduction microtools.

(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.