The Soft-Pass™ Embryo Mock Transfer Catheter Sets are used for mock (simulated) embryo transfer procedures to and in verifying catheter access and positioning in advance of an embryo transfer procedure.

Device Description

The Soft-Pass Embryo Mock Transfer Catheter Sets are used to aid in verifying access and positioning of embryo transfer catheters prior to placing transfer catheters containing embryos into the uterine cavity. These devices consist of a polyethylene guide catheter that is 6.8 Fr in diameter and either 12 or 17.3 cm long, and a polyethylene mock transfer catheter that is 4.4 Fr in diameter and 19.7 or 24.7 cm long. The tip of the mock transfer catheter is closed. The echogenic tip versions of the device also include an echogenic stainless steel band on the distal tip of the mock transfer catheter to aid in tip visualization when using ultrasound. The echogenic tip versions also include a supporting stainless steel cannula in the proximal portion of the mock transfer catheter. Depth markers are also included on both the guide and mock transfer catheters to aid in placement of the device during a mock procedure. These devices are sterilized by ethylene oxide, single-use only, and have a three-year shelf-life.

AI/ML Overview

This device submission (K191015) for the Soft-Pass™ Embryo Mock Transfer Catheter Sets does not include a new study to demonstrate acceptance criteria.

Instead, the submission states that the subject device is identical to the predicate device cleared under K173103, and the changes made in the current submission are solely to clarify the Indications for Use. Therefore, the device relies on the performance data submitted for its predicate device (K173103). The provided document does not contain the details of the study submitted for K173103.

Due to the lack of a new study in this specific document, most of the requested information cannot be extracted. However, based on the provided text, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or device performance data for this submission (K191015) because it relies on the predicate device's data. It asserts that the subject device is identical to the predicate device in terms of material specifications, physical characteristics, and manufacturing features.

Acceptance Criteria (Not explicitly stated in this document)	Reported Device Performance (Implied from predicate equivalence for existing characteristics)
Functional equivalence to predicate device in mock embryo transfer	Identical to predicate device (K173103) in material, physical features, and manufacturing
Sterility	Maintained by Ethylene Oxide (ETO) process; 3-year shelf-life
Integrity of materials	Polyethylene, stainless steel (echogenic tip versions)
Dimensional accuracy (OD, Length)	Identical to predicate device: Transfer catheter (OD 4.4 Fr, Length 19.7-24.7 cm); Guide catheter (OD 6.8 Fr, Length 12-17.3 cm)
Visualization (for echogenic tip)	Echogenic stainless steel band aids in tip visualization with ultrasound

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

Not provided in this document. This information would have been part of the K173103 submission.

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

Not provided in this document. This information would have been part of the K173103 submission. The nature of the device (a physical catheter) suggests that performance testing would likely involve engineering and clinical use validation rather than expert image interpretation, but without the K173103 details, this is speculative.

4. Adjudication method for the test set:

Not provided in this document.

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:

Not applicable. This device is a physical medical instrument (catheter), not an AI/software device that would typically undergo MRMC studies relating to human reader performance or AI assistance.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

Not provided in this document. For a medical device like a catheter, "ground truth" would generally refer to successful mechanical function, material integrity, biocompatibility, and sterility, verified through various physical, chemical, and biological tests, rather than a clinical ground truth like pathology or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set:

Not applicable. This device is a physical instrument, not an AI/machine learning model that requires a training set.

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

Not applicable. This device is a physical instrument, not an AI/machine learning model.

Summary

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May 17, 2019

Cook Incorporated Ian Herrman Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Re: K191015

Trade/Device Name: Soft-Pass™ Embryo Mock Transfer Catheter Sets (Soft-Pass™ Embryo Mock Transfer Catheter Set and Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip) Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: Class II Product Code: MQF Dated: April 16, 2019 Received: April 17, 2019

Dear Ian Herrman:

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.

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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 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.html; 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 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,

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) K191015

Device Name

Soft-Pass™ Embryo Mock Transfer Catheter Sets (Soft-Pass™ Embryo Mock Transfer Catheter Set and Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip)

Indications for Use (Describe)

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

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510(k) SUMMARY K191015 Soft-Pass™ Embryo Mock Transfer Catheter Sets

Submitted By:	Cook Incorporated
Applicant:	Ian Herrman
Contact:	750 Daniels Way
Applicant Address:	P.O. Box 489
	Bloomington, IN 47402
Contact Phone Number:	(812) 339-2235 x104034
Contact Fax Number:	(812) 332-0281
Date Prepared:	May 15, 2019
Device Information:
Trade Names:	Soft-Pass™ Embryo Mock Transfer Catheter Sets(Soft-Pass™ Embryo Mock Transfer Catheter Set andSoft-Pass™ Embryo Mock Transfer Catheter Set withEchogenic Tip)
Common Name:	Assisted Reproduction Catheter
Regulation Number:	21 CFR §884.6110
Regulation Name:	Assisted Reproduction Catheters
Product Code:	MQF - Catheter, Assisted Reproduction
Device Class:	II

Predicate Device:

K173103 - Pivet and Soft-Pass Embryo Transfer Catheter Sets. Specifically, the Soft-Pass Embryo Mock Transfer Catheter Sets cleared in the predicate submission.

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

Device Description

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ethylene oxide, single-use only, and have a three-year shelf-life. The product number and trade name for the subject device sets are presented in the table below.

Model Number	Trade Name
J-SPPE-681200-MC	Soft-Pass™ Embryo Mock Transfer Catheter Set
J-SPPE-681700-MC	Soft-Pass™ Embryo Mock Transfer Catheter Set
J-SPPE-681210-ET-MC	Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip
J-SPPE-681710-ET-MC	Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip

Indications for Use

The Soft-Pass™ Embryo Mock Transfer Catheter Sets are used for mock (simulated) embryo transfer procedures to aid in verifying catheter access and positioning in advance of an embryo transfer procedure.

Comparison of Intended Use and Technological Characteristics with the Predicate Device:

		Predicate Device	Subject Device
		Pivet and Soft-Pass EmbryoTransfer Catheter Sets	Soft-Pass Embryo MockTransfer Catheter Sets
510(k) Number		K173103 (Specifically, the Soft-PassEmbryo Mock Transfer Catheter Setswith a polyethylene guide catheter, J-SPPE-68XXXX-MC[-ET])	Subject of this submission
Indications for Use		The Embryo Transfer Catheters/Sets areused for transferring IVF embryos intothe uterine cavity.	The Soft-PassTM EmbryoMock Transfer Catheter Setsare used for mock (simulated)embryo transfer procedures toaid in verifying catheteraccess and positioning inadvance of an embryotransfer procedure.
Material Specification
Transfer Catheter		Polyethylene, stainless steel (echogenictip versions only), marker ink	Identical
Guide Catheter		Polyethylene, marker ink	Identical
Physical Characteristics
Hub		Flared hub on the guide catheter	Identical
Dimensional Data
Transfer	OD	4.4 Fr	Identical
Catheter	Length	19.7 cm to 24.7 cm	Identical
Guide	OD	6.8 Fr	Identical
Catheter	Length	12 cm to 17.3 cm	Identical
Physical Features
Transfer		With graduation marks	Identical
		No end-hole	Identical

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	Predicate Device	Subject Device
	Pivet and Soft-Pass EmbryoTransfer Catheter Sets	Soft-Pass Embryo MockTransfer Catheter Sets

Guide	With or without Echotip	Identical
	With graduation marks	Identical
	Without positioner	Identical
	Without Echotip	Identical
	Straight	Identical
Manufacturing Features
Sterilization	ETO	Identical
Packaging	Tyvek Sterile Barrier	Identical
Shelf Life	3 years	Identical

The purpose of this submission is to modify the indications statement for the Soft-Pass Embryo Mock Transfer Catheter Sets to clarify the cleared uses of these devices. As shown in the table above, the subject and predicate devices have different indications for use statements; however, the intended uses of the predicate and subject devices are the same (i.e., catheter used to aid in embryo transfer procedures).

In regards to technological characteristics, the subject Soft-Pass Embryo Mock Transfer Catheter Sets are identical to those cleared under K173103. There are no differences raising different questions of safety or effectiveness.

Performance Data:

The subject device, Soft-Pass Embryo Mock Transfer Catheter Sets, are identical to those cleared under K173103 and have not undergone any design changes since clearance. The changes in indications for use included in this submission did not require additional performance testing. Therefore, the performance testing included in K173103 supports the Soft-Pass Embryo Mock Transfer Catheter Sets included in this submission.

Conclusion:

The Soft-Pass Embryo Mock Transfer Catheter Sets are substantially equivalent to the predicate devices.

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).