← Product Code [MQF](/productcode/MQF) · K012220 # TAO EMBRYO TRANSFER CATHETER SYSTEM (K012220) _Ttj Biomedical, LLC · MQF · Aug 27, 2001 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K012220 ## Device Facts - **Applicant:** Ttj Biomedical, LLC - **Product Code:** [MQF](/productcode/MQF.md) - **Decision Date:** Aug 27, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.6110 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **Attributes:** Therapeutic ## Indications for 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 Story Tao Embryo Transfer Catheter System; sterile, single-use device for introducing embryos into uterine cavity. System comprises pellethane outer sleeve and polyethylene inner catheter. Outer sleeve features distal portion with easy-to-shape design and sphere-shaped soft cap at tip. Cap minimizes cervical trauma and reduces potential mucus, blood, or bacterial contamination of inner catheter and embryos. Inner catheter available in end-port or side-port configurations. Used in IVF clinics by trained clinicians. ETO sterilized. Benefits include reduced trauma and contamination during embryo transfer. ## Clinical Evidence No clinical data provided; substantial equivalence based on design, materials, and intended use comparisons. ## Technological Characteristics Materials: pellethane (outer sleeve), polyethylene (inner catheter). Design: two-part system with sphere-shaped soft cap. Sterilization: ETO. Single-use. No electronic or software components. ## Regulatory 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. ## Special Controls *Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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, LLC
2885 Aurora Avenue, Suite 15
Boulder, CO 80303
303-444-5026 303-444-9713 (fax) | | CONTACT: | Richard Jortberg, MS, MAI
Manager, TTJ Biomedical, LLC
2885 Aurora Avenue, Suite 15
Boulder, CO 80303
303-444-5026; 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 {1}------------------------------------------------ ## 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: 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. Predicate devices do not use the proprietary design of the sphere-shaped cap of the outer sleeve. {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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: 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. **Prescription Use** Haneyc. Bordon --- **Source:** [https://fda-staging.innolitics.com/device/K012220](https://fda-staging.innolitics.com/device/K012220) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com