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K Number
K012220
Device Name
TAO EMBRYO TRANSFER CATHETER SYSTEM
Manufacturer
TTJ BIOMEDICAL, LLC.
Date Cleared
2001-08-27

(42 days)

Product Code
MQF
Regulation Number
884.6110
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
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.
More Information

Not Found

Not Found

No
The provided text describes a physical medical device (catheter system) and its intended use in embryo transfer. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.

No
The device is used for introducing embryos into the uterine cavity, which is part of an assisted reproductive procedure, not for treating a disease or condition.

No
The device is used for introducing embryos into the uterine cavity, which is a therapeutic intervention, not a diagnostic one.

No

The device description explicitly states it consists of physical components: a pellethane outer sleeve and a polyethylene inner catheter.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The Tao embryo transfer catheter system is a medical device used to physically introduce embryos into the uterine cavity. It is a tool used in a medical procedure, not a test performed on a sample.
  • Intended Use: The intended use clearly states it's for "introduction of embryos into the uterine cavity," which is a procedural function, not a diagnostic one.

The device is a surgical/procedural instrument used directly on the patient's body, not a diagnostic test performed on a sample outside the body.

N/A

Intended Use / Indications for Use

Devices are intended for single use, limited exposure (

§ 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).

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
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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 (