The IUI Catheter is a balloon catheter for intrauterine insemination. The catheter is placed in the uterus and sperm is intracted through the catheter in less than several minutes. The IUI Catheter is a packaged , sterile, disposable, flexible, plastic catheter with two lumens, one for inflation of the balloon and one for injection of washed sperm. A balloon inflation syringe is provided with the product.

AI/ML Overview

The provided text describes a 510(k) summary for the "IUI Catheter" (K120154). This submission is for a medical device that claims substantial equivalence to a predicate device, not for an AI/ML powered device. As such, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like sensitivity, specificity, F1-score, reader studies, training sets, and ground truth establishment by experts) are not applicable or detailed in this document.

The acceptance criteria and study information provided focus on the physical and functional characteristics of the traditional medical device, particularly in comparison to its predicate.

Here's an analysis of the provided information based on your request, highlighting where information is absent or not applicable due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

The "Equivalence Summary" table on page 2 of the 510(k) document serves as the primary source for acceptance criteria and how the proposed device (IUI Catheter) meets them by demonstrating equivalence to the predicate device.

Acceptance Criterion (Item)	Predicate Device Specification	Proposed Device Performance (Specification)	Comments/Discussion
Components	Mechanical Actuator, Insemination Syringe, Leg Strap, IUI Catheter	Not included (for first three), IUI Catheter	Proposed device does not include Mechanical Actuator, Insemination Syringe, or Leg Strap as they are specific to the predicate's "Slow Release" function, which is not part of the proposed device's "bolus injection" intended use. The IUI Catheter component is identical to the predicate.
Indication for Use	Delivery of approx. 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.	Delivery of washed sperm into the uterus.	Proposed device is for standard IUI use (injection over a shorter period). Considered as "Comparable use for both products."
Use (Insemination Duration)	3-4 hour insemination	< several minutes	Proposed device is identical to predicate, and biocompatibility concerns are reduced due to shorter sperm contact duration compared to the predicate's cleared 4-hour contact. "Acceptance criteria are the same for both proposed and predicate devices."
Endotoxin Testing	< 20EU/device	< 20EU/device	Proposed and predicate devices are the same in terms of endotoxin limits.

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is based on demonstrating substantial equivalence to a legally marketed predicate device (Fertiligent Slow Release IUI Catheter K092579). The core argument is that the proposed "IUI Catheter" component is identical to the predicate's IUI catheter component in design, manufacturing, materials, sterilization, and packaging.

The "Non-clinical/Clinical Testing" listed includes:

Biocompatibility
Endotoxins
HSSA testing
Sterilization validation
Shelf-life
Performance testing

The document states: "Since both the proposed and predicate catheters are identical, we feel that the testing performed on the predicate is sufficient to support the safety and effectiveness of the proposed IUI catheter." This implies that new testing for the proposed device was primarily to confirm these characteristics are met, likely mimicking or referencing the predicate's established performance in these areas. For example, Endotoxin testing is explicitly listed with the same acceptance criterion for both.

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

Not applicable in the context of an AI/ML device's test set. This device is a physical medical instrument. The testing mentioned (biocompatibility, endotoxins, etc.) would involve laboratory samples of the device and biological materials, but not patient data or a "test set" in the sense of AI/ML evaluation.

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

Not applicable. There is no "ground truth" to establish for a test set in the context of an AI/ML algorithm. The equivalence is based on physical and functional characteristics, and regulatory standards for safety and performance (e.g., endotoxin limits, biocompatibility).

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

Not applicable. This concept pertains to human review of AI/ML outputs to establish a ground truth.

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

No. This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

No. This is not an AI/ML algorithm.

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

For the physical device's performance, the "ground truth" would be established by:

Regulatory standards and established test methods for biocompatibility, sterility, endotoxin levels, and physical performance (e.g., balloon inflation, catheter integrity).
Comparison to the predicate device's established safety and effectiveness data, leveraging the identical nature of the core catheter component.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set exists for this type of medical device.

Summary

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510(k) Summary: K120154

MAR 2 1 2012

Applicant/Sponsor:	Catheter Research, Inc.5610 W. 82nd St.Indianapolis, IN 46278
Contact Person:	John Steen317-872-0074 x3517
Date:	12/22/2011
Proprietary Name:	IUI Catheter
Classification Name:	Assisted Reproduction Catheters; CFR 884.6110.Product Code: MQF

Legally Marketed Devices to Which Substantial Equivalence Is Claimed:

Fertiligent Slow Release IUI Catheter K092579

Device Description: The IUI Catheter is a balloon catheter for intrauterine insemination. The catheter is placed in the uterus and sperm is intracted through the catheter in less than several minutes. The IUI Catheter is a packaged , sterile, disposable, flexible, plastic catheter with two lumens, one for inflation of the balloon and one for injection of washed sperm. A balloon inflation syringe is provided with the product.

Intended Use: Delivery of washed sperm into the uterus

The predicate device is intended for the delivery of approximately 1ml of sperm into the uterus over 3 – 4 hours using a controlled release pump,

Summary of Technologies: The IUI Catheter has the identical technologies as the predicate device, IUI catheter component. The IUI Catheter is identioal in materials and function to the predicate. Both devices are assembled in the same environment using the same manufacturing and sterilization process.

Non-clinical/Clinical Testing: Biocompatibility, Endotoxins, HSSA testing, sterilization validation, shelf-life, and performance testing.

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KI 20154
Pg. 2 of 2

Equivalence Summary

Item	Predicate	Proposed	Comments/Discussion
Component	Mechanical Actuator	Not included	Not part of proposed device; required forSlow Release product, not required forbolus injection IUI.
Component	Insemination Syringe	Not included	Not part of proposed device. Required forSlow Release product due to syringe fit inpump; not required for bolus injection IUIas a sperm-compatible syringe is chosenby the andrology lab.
Component	Leg Strap	Not included	Not part of proposed device; required forSlow Release product, not required forbolus injection IUI.
Component	IUI Catheter	IUI Catheter	Identical: No design, manufacturing,material, sterilization, or packagingdifferences.
Indicationfor Use	Delivery of approximately1 ml of sperm into theuterus over 3-4 hoursusing a controlled releasepump.	Delivery of washedsperm into the uterus.	Proposed device is for standard IUI use,where injection is over a shorter period oftime. Comparable use for both products.
Use	3-4 hour insemination	< several minutes	Proposed device is identical to predicateand does not raise any newbiocompatibility concerns. The predicatedevice was cleared for 4 hr sperm contact,whereas the proposed has reduced spermcontact duration, and therefore does notraise any new sperm compatibilityconcerns. Acceptance criteria are thesame for both proposed and predicatedevices.
EndotoxinTesting	< 20EU/device	< 20EU/device	Proposed and predicate devices are thesame.

ﻬﻤﺎ ﺗﺴﺮ

Conclusion: Since both the proposed and predicate catheters are identical, we feel that the testing performed on the predicate is sufficient to support the safety and effectiveness of the proposed IUI catheter.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

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

John A. Steen, Ph.D. President Catheter Research, Inc. 5610 West 82 Street INDIANAPOLIS IN 46278

MAR 2 1 2012

Re: K120154

Trade/Device Name: IUI Catheter Regulation Number: 21 CFR§ 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: MQF Dated: January 13, 2012 Received: January 19, 2012

Dear Dr. Steen:

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

and all 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

510(k) Number (if known): K120154

Device Name: IUI Catheter

Indications For Use:

Delivery of washed sperm into the uterus.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, andUrological Devices
510(k) Number	K120154

Page 1 of 1

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).