The Shepard Intrauterine Insemination Set consists of a 5.4 French polyethylene tubing catheter with a connector cap and a stainless steel inner cannula with a female luer lock adapter (FLLA) hub. The assembled device measures 20 cm in length. A silicone positioner is placed 7 cm from the distal tip. The positioner is adjustable to aid in positioning the device to the targeted depth within the uterine cavity during a procedure. The distal end is curved, with a closed ended tip rounded to a smooth finish. One sideport is located just proximal to the distal tip.

The Soft-Pass™ Coaxial Insemination Catheter is comprised of a guide catheter and an insemination/transfer catheter. The guide catheter is 6.8 French in diameter and measures 12 cm in length. Ink marks are placed on the distal end of the guide catheter to aid in positioning within the cervical canal. The transfer hub has a female luer adaptor to which the preloaded syringe is affixed. The guide catheter hub and transfer hub connect with a friction fit. The transfer catheter is 4.4 French in diameter.

The Insemi-Cath® is 3.5 French in diameter and has a length of 13 cm. It is manufactured from nylon tubing that tapers gradually from 0.195 inches at the proximal end that accepts a standard slip tip syringe and tapers for the remaining 7 cm of the catheter. The distal end is manufactured in both curved and straight configurations. The curved Insemi-Cath® features a silicone positioner placed approximately 7 cm from the distal tip. The positioner is adjustable to aid in positioning the device to the targeted depth within the uterine cavity during a procedure. The distal tip of the catheter is rounded to a smooth finish and designed with an open end.

AI/ML Overview

The provided document is a 510(k) premarket notification for Cook Intrauterine Insemination Catheters (Trade Name: Shepard, Insemi-Cath®, and Soft-Pass™ Coaxial). It outlines the regulatory approval process and includes a "510(k) Summary" which details the device description, indications for use, comparison to predicate devices, and test data to demonstrate substantial equivalence.

Based on the provided text, the device is a medical device (catheter), not an AI/algorithm-based diagnostic device. Therefore, the questions related to acceptance criteria for AI/algorithm performance, human reader studies (MRMC), standalone algorithm performance, expert ground truth establishment, training set size, and data provenance for AI models are not applicable to this document.

The document discusses acceptance criteria and studies relevant to a medical device's physical and biological performance. Here's a breakdown of the applicable information:

Acceptance Criteria and Study for a Medical Catheter Device

1. A table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Special Controls (Lot-to-Lot/Batch)
Human Sperm Survival Assay (HSSA)	≥70% motility after 24 hours	Predetermined acceptance criteria were met on newly manufactured and aged devices.
Endotoxin (LAL) test	< 20 EU/device	Predetermined acceptance criteria were met on newly manufactured devices.
Performance Testing
Catheter Aspiration Test	No air leaking into the syringe through the catheter (predetermined criteria)	All predetermined acceptance criteria were met.
Catheter Leak Test	Fluid path catheter assembly does not leak under predetermined injection pressure (predetermined criteria)	All predetermined acceptance criteria were met.
Tensile Testing (Catheter Hub-shaft)	Tensile strength value greater than predetermined acceptance criterion	Acceptance criterion was met.
Biocompatibility Testing	Conforms to ISO 10993-1:2009	Tests performed: Cytotoxicity, Sensitization, Irritation. Implied that conformity was met.
Shelf Life (Accelerated Aging)	Maintains mechanical and HSSA specifications after three years of aging	Implied that specifications were maintained.
Package Integrity	Pass ASTM F1886-09 (visual), ASTM F2096-11 (bubble leak), and ASTM F88-09 (seal strength)	Implied that package integrity was maintained.

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

The document does not specify specific sample sizes for each test (e.g., number of catheters tested for HSSA, aspiration, or leak tests). It generally states "all predetermined acceptance criteria were met" or "tests were performed."
Data Provenance: The tests are described as being performed to demonstrate the device's performance. The manufacturing entity is Cook Incorporated, based in Bloomington, IN, USA. The testing would presumably be conducted by or for Cook Incorporated. The document does not specify country of origin for test data beyond the company's location. The testing is described as occurring on "newly manufactured" or "aged" devices, implying prospective testing as part of the device's design and manufacturing validation.

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

This is not applicable as the device is a physical medical catheter, not an AI/algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established international standards (e.g., ISO, ASTM, USP) and predefined performance specifications.

4. Adjudication method for the test set:

This is not applicable for the same reasons as above. Performance is measured against objective, quantifiable criteria established by engineering and biological standards, not subjective expert judgment requiring adjudication.

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:

This is not applicable. This type of study relates to the performance of AI algorithms in assisting human interpretation (e.g., radiologists reading images). The submitted device is an Intrauterine Insemination Catheter, which does not involve human readers interpreting data.

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

This is not applicable. The device is a physical catheter, not a standalone algorithm.

7. The type of ground truth used:

The "ground truth" for this medical device's performance is established by objective laboratory measurements and adherence to recognized industry standards (e.g., ISO 10993 for biocompatibility, AAMI/ANSI, USP for endotoxin, ASTM for shelf life and package integrity, and internal engineering specifications for mechanical properties like aspiration, leak, and tensile strength). For the HSSA test, the "ground truth" is defined as living motile sperm, with a quantitative survival rate.

8. The sample size for the training set:

This is not applicable. The device is a manufactured medical product, not an AI model requiring a training set.

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

This is not applicable for the same reasons as above.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 21, 2017

Cook Incorporated Naomi Funkhouser. MBA Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Re: K172321

Trade/Device Name: Shepard, Insemi-Cath®, and Soft-Pass™ Coaxial - Cook Intrauterine Insemination Catheters Regulation Number: 21 CFR& 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: II Product Code: MQF Dated: November 27, 2017 Received: November 28, 2017

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.

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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,

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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Indications for Use

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

510(k) Number (if known)

K172321

Device Name

Shepard, Insemi-Cath®, and Soft-Pass™ Coaxial - Cook Intrauterine Insemination Catheters

Indications for Use (Describe)

Intrauterine Insemination Catheters are used for the introduction of washed spermatozoa into the uterine cavity.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, smaller letters on a red background.

COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

age I of 4

510(k) Summary - K172321

Shepard. Insemi-Cath®, and Soft-Pass™ Coaxial Cook Intrauterine Insemination Catheters

Date Prepared: December 20, 2017

Submitted By:

Applicant: Contact: Applicant Address:

Contact Phone Number: Contact Fax Number:

Device Information:

Trade Name:

Common Name: Classification Name: Classification Number: Product Code: Device Class: Classification Panel:

Cook Incorporated Naomi Funkhouser. Rohini Patel 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 x104371 (812) 332-0281

Shepard, Insemi-Cath®, and Soft-Pass™ Coaxial -Cook Intrauterine Insemination Catheters Intrauterine Insemination Catheters Assisted Reproduction Catheters 884.6110 MQF - Catheter, Assisted Reproduction Class II Obstetrics/Gynecology

Predicate Devices:

Shepard IUI Catheter, K890301 ●
Coaxial Catheter Set, K902694
Insemi-Cath II, K954398

The predicate devices have not been subject to a design-related recall.

Device Description:

Shepard Intrauterine Insemination Set

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The distal end is curved, with a closed ended tip rounded to a smooth finish. One sideport is located just proximal to the distal tip.

Soft-Pass™ Coaxial Insemination Catheter

Insemi-Cath®

Indications for Use:

Intrauterine Insemination Catheters are used for the introduction of washed spermatozoa into the uterine cavity.

Comparison to Predicate Devices:

The subject Shepard IUI set as compared to the predicate device. Shepard IUI Set (K890301), has the same intended use, and is similar in terms of principles of operation, basic technological characteristics, and design. The dimensions of the device are within the range of the predicate, and with a minor design modification to include a winged FLLA. The hub material of the predicate device was not specified, and the subject device hub material is Polycarbonate.

The subject Soft-Pass™ Coaxial Insemination Catheter as compared to the predicate device, Coaxial Catheter Set (K902694), has the same intended use, and is similar in terms of principles of operation, and basic technological characteristics. The Soft-Pass™

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transfer and guide catheter material was changed to Polyethylene and the hub material to HDPE. The hub design was modified to include a friction fit connection, the silicone positioner was removed, and ink marks were placed on the distal end of the guide catheter, rather than the proximal end of transfer catheter. Finally, the guide catheter size and length dimensions were modified to better function with the Soft-Pass™ insemination catheter.

The Insemi-Cath® is identical to the predicate device the Insemi-Cath® II (K902694). The curved version of the subject device has an added silicone positioner.

Special Controls:

The IUI catheters are subject to special controls and must pass HSSA and endotoxin testing. The testing is conducted on a lot-to-lot (batch) basis.

I Human Sperm Survival Assay (HSSA), ≥70% motility after 24 hours.
. Endotoxin - (LAL) test per AAMI/ANSI ST72:2011/(R) 2016 and USP <85>. < 20 EU/device

The predetermined acceptance criteria were met for these special controls on newly manufactured (HSSA, endotoxin) and aged (HSSA only) devices.

Test Data:

The following tests were performed to demonstrate that the minor modifications to the subject IUI catheters have met applicable design and performance requirements to support a determination of substantial equivalence.

. Catheter Aspiration Test - Testing ensures there is no air leaking into the syringe through the catheter. All predetermined acceptance criteria were met.
. Catheter Leak Test - Testing ensures that fluid path catheter assembly does not leak under a predetermined injection pressure. All predetermined acceptance criteria were met.
. Tensile Testing (Catheter Hub- shaft) - Testing demonstrated that the tensile strength value was greater than the predetermined acceptance criterion. Acceptance criterion was met.

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Image /page/6/Picture/0 description: The image is a logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, sans-serif font in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font.

K172321
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Biocompatibility Testing shows that the subject device sets conform to the . biocompatibility requirements of ISO 10993-1:2009. The following tests were performed:
- Cytotoxicity per ISO 10993-5:2009 o
- Sensitization per ISO 10993-10:2010 o
- Irritation per ISO 10993-10:2010 о
Shelf life - accelerated aging per ASTM F1980-16 to demonstrate that the subject device maintains the mechanical and HSSA specifications after three years of aging.
. Package integrity - per ASTM F1886-09 (visual inspection), ASTM F2096-11 (bubble leak), and ASTM F88-09 (seal strength)

Conclusion:

The results of the performance testing support a determination of substantial equivalence of the subject device to the predicate devices, and do not raise any new questions of the safety or effectiveness.

Regulation Number and Section

§ 884.6110 Assisted reproduction catheters.

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