Intended Use: Single use, limited exposure (<24 hours), mucosal membrane surface contact, embryo transfer procedures. The Tao embryo transfer catheter system is intended for use for the introduction of embryos into the uterine cavity. The procedure should be completed by an individual with requisite experience and education in the process of IVF and embryo transfers, and the procedure should be completed in a facility suited for IVF and embryo transfers. The catheter system consists of a single use, ETO sterilized inner catheter and outer sleeve.

Device Description

The Tao Embryo Transfer Catheter system consists of two devices which are used for introducing embryos into the uterine cavity. This sterile, single use embryo transfer system consists of a pellethane outer sleeve and a polyethelene inner catheter. The outer sleeve has a distal portion which has an easy-to-shape design. At the tip, the outer sleeve is protected by a sphere-shaped soft cap. The revolutionary design of the cap not only significantly minimizes trauma when passing the cervix, but it also minimizes possible mucus, blood and bacterial contamination of the inner catheter and embryos. The inner catheter has two different designs, with one having an end-port and the other a side-port.

AI/ML Overview

This document describes the 510(k) submission for the Tao Embryo Transfer Catheter System. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant regulations, rather than presenting a study with specific performance metrics against pre-defined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove its fulfillment cannot be extracted from the provided text.

Here is an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the given document. The document focuses on demonstrating substantial equivalence based on indications for use, materials, and physical construction, rather than specific performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No test set or associated sample size is mentioned. The submission is a 510(k) for substantial equivalence, not a clinical trial report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as no test set requiring expert ground truth is described.

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

This information is not applicable as no test set requiring adjudication is described.

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 information is not applicable. The device is a physical embryo transfer catheter system, not an AI-assisted diagnostic or decision support tool. An MRMC study is not relevant in this context.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

This information is not provided as no specific "ground truth" for performance evaluation is mentioned. The basis for approval is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set:

This information is not applicable as the device is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

Summary of what the document does provide regarding "acceptance criteria" (implicitly):

While not framed as explicit "acceptance criteria" with performance metrics, the document implies that the "acceptance criteria" for this 510(k) submission are met by demonstrating:

Conformance with 21 CFR 884.6110 Assisted Reproduction Catheters: This is a regulatory standard that the device must meet.
Substantial equivalence to legally marketed predicate devices: This involves comparing the new device's indications for use, materials, and physical construction to existing, approved devices. The differences in proprietary design (sphere-shaped cap) are noted, but the overall similarity is asserted.
Safety and Efficacy: Although not explicitly detailed with performance data, the implication of substantial equivalence is that the device is as safe and effective as its predicates. The safety aspects are mainly addressed through materials (pellethane, polyethelene) and sterilization (ETO).

In essence, for this 510(k) submission, the "acceptance criteria" are regulatory compliance and demonstrable substantial equivalence to predicates, rather than specific quantitative performance targets from a clinical study.

Summary

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510(K) Tao Embryo Transfer Catheter System

AUG 2 7 2001

Chapter 5 TRADITIONAL 510(K) SUMMARY Tao Embryo Transfer Catheter System

APPLICATION DATE:	May 22, 2001
APPLICANT:	TTJ Biomedical, LLC2885 Aurora Avenue, Suite 15Boulder, CO 80303303-444-5026 303-444-9713 (fax)
CONTACT:	Richard Jortberg, MS, MAIManager, TTJ Biomedical, LLC2885 Aurora Avenue, Suite 15Boulder, CO 80303303-444-5026; 303-444-9713 (fax)REJ@RJAssociatesInc.Com
TRADE NAME:	Tao Embryo Transfer Catheter System
COMMON NAME:	Embryo Transfer Catheter
CLASSIFICATION NAME:	Assisted Reproduction Catheter
DEVICE CLASS:	Class II
REGISTRATION NUMBER:	To be registered upon completion of 510(K)review process
REGULATION NUMBER:	21 CFR 884.6110
PRODUCT CODE (PROCODE):	85 MOF
510(K) TYPE:	Traditional

K012220
page 1 of 2

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TRADITIONAL 510(K) SUMMARY (Continued) Tao Embryo Transfer Catheter System

SUBSTANTIAL EQUIVALENCE / PREDICATE DEVICES:

The Tao Embryo Transfer Catheter system is substantially equivalent to applicable published requirements due to conformance with descriptions from CFR 884.6110 Assisted Reproduction Catheters as described in the Final Rule in the Federal Register, Vol. 63, No. 175, September 10, 1998, page 48436. In addition, the Tao catheter is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act. Finally, due to similarity with respect to indications for use, materials and physical construction to predicate devices, the Tao catheter meets the requirement for section 510(K) substantial equivalence.

INDICATIONS FOR USE:

Devices are intended for single use, limited exposure (<24 hours), mucosal membrane surface contact, embryo transfer procedures. The sterile Tao Embryo Transfer Catheter system is intended for use for the introduction of embryos into the uterine cavity. The procedure should be completed by an individual with requisite experience and education in the process of IVF and embryo transfers, and the procedure should be completed in a facility suited for IVF and embryo transfers. The catheter system consists of a single use, ETO sterilized inner catheter and outer sleeve.

DEVICE DESCRIPTION/ TECHNICAL CHARACTERISTICS:

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/3 description: The image shows a partial view of the Department of Health logo. The logo features a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH" is partially visible, running vertically along the left side of the image.

AUG 2 7 2001

Mr. Richard Jortberg, MS, MAI Manager, TTJ Biomedical, LLC TTJ Biomedical, LLC 2885 Aurora Avenue, Suite 15 BOULDER CO 80303

Re: K012220

Tao Embryo Transfer Catheter System (IVF Reproduction Transfer Catheter) Dated: May 22, 2001 Received: July 16, 2001-Regulatory Class: II 21 CFR 884.6110/Procode: 85 MQF

Dear Mr. Jortberg:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your Section 516(x) hourselves or use stated in the enclosure) to legally marketed predicate devices device is substantially equivacile for the morelies to the Medical Device Amendments, or to devices of the Medical of the May 2014 at 11:44 am marketed in meets as commerce provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act .
therefore, market the device, subject to the general therefore, market the device, subject on the general or no noversion, and increasing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Prematice Approval), it may be subject of Erderel Results of to such additional controls. Existing major reaulttions affecting your device can be found in the Code of Federal Regulations, to such additional comitrois. Existure high regulations areomes compliance with the Current Good Manufacturing I I tic Z , Patis 800 to 693. A Subsantany quartation (QS) for Medical Devices: General regulation (21 CFR Part Practice requirements, as set tour in the Quality Dystem Aconnistration (FDA) will verify such assumptions. Failure ozon and the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to conting your device in the Federal Register. Please note: this response to your premarket notification submission does not concenting your device in alle I oderal not sections 531 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of I his letter will allow your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro If you desire specific at 10 years contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, advolume of your convertion promation" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours.

Nancij broydon
U.S.A.

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Chapter 4 STATEMENT OF INDICATIONS FOR USE:

Ver/ 3 - 4/24/96 Applicant: TTJ Biomedical, LLC KOL2220 510(k) Number (if known): Device Name: Tao Embryo Transfer Catheter System Indications For Use:

Prescription Use

Haneyc. Bordon

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).