(118 days)
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Not Found
No
The document describes a physical medical device for embryo transfer and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an embryo transfer set used for transferring IVF embryos, which is a procedural tool rather than a device intended to treat or cure a disease or condition.
No
Explanation: The device is described as an embryo transfer set used for transferring IVF embryos, not for diagnosing a medical condition.
No
The device description explicitly states the materials used are TFE and 300 Series Stainless Steel, indicating it is a physical device, not software-only.
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 outside of the body (in vitro) to provide information about a person's health.
- Device Function: The description clearly states that the Transmyometrial Embryo Transfer Sets are used for transferring IVF embryos into the endometrial cavity. This is a procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Lack of Diagnostic Activity: The device's purpose is to facilitate a medical procedure (embryo transfer), not to diagnose a condition or provide diagnostic information.
Therefore, this device falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Transmyometrial Embryo Transfer Sets are used for transferring IVF embryo (s) into the endometrial cavity through the myometrium. These devices are sterile and intended for one time use. The Transmyometerial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted disease, a recent uterine perforation. cervical stenosis or other cervical abnormalities which would preclude embryo transfer, a recent cesarcan section, a recent pregnancy (or is currently pregnant), or if a patient currently has an intrauterine device.
Product codes
85 MQF
Device Description
The Transmyometrial Embryo Transfer Set is used for transferring IVF embryo(s) into the endometrial cavity through the myometrial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted discase, a recent uterine perforation, cervical stenosis or other cervical abnormalities which would preclude embryo transfer, a recent cesarean section, a recent pregnanty (or is currently program), or if the patient currently has an intrauterine device. The materials used in this device are TFE and 300 Series Stainless Steel. Both materials are widely used in the medical field and biocompatibility is assured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endometrial cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cook Australia products, Intra-Endometrial Embryo Transfer Set manufactured by Cook Australia
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Jan-26-99 01:08P
2/8/99
510(k) Premarket Notification Tronsinvasmetelal Embryo Transfer Se Cook OB/GYN
.983595
9
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted By:
Brenda Davis Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 October 13, 1998
Device
Trade Name: Proposed Classification Name: Transmyometrial Embryo Transfer Sct Assisted Reproduction Catheters Class II 85 MOF
Predicate Devices:
Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used Cook Australia products as our predicate to illustrate safety and effectivencss. The Transmyometrial Embryo Transfer Set is substantially equivalent to other Transmyometrial Embryo Transfer Sets in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Intra-Endometrial Embryo Transfer Set manufactured by Cook Australia.
Device Description:
The Transmyometrial Embryo Transfer Set is used for transferring IVF embryo(s) into the endometrial cavity through the myometrial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted discase, a recent uterine perforation, cervical stenosis or other cervical abnormalities which would preclude embryo transfer, a recent cesarean section, a recent pregnanty (or is currently program), or if the patient currently has an intrauterine device. The materials used in this device are TFE and 300 Series Stainless Steel. Both materials are widely used in the medical field and biocompatibility is assured.
Substantial Equivalence:
This device will be manufactured according to specified controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for this section 510(k) substantial equivalence.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 8 1999
Brenda Davis Regulatory Affairs Cook Ob/Gyn 1100 West Morgan Street Spencer, Indiana 47460
Re: K983595
Transmyometrial Embryo Transfer Set Dated: December 1, 1998 Received: December 4, 1998 Regulatory Class: II 21 CFR 884.6110/Procode: 85 MQF
Dear Ms. Davis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
**2**
## PREMARKET NOTIFICATION
# INDICATIONS FOR USE STATEMENT
[K983595](https://510k.innolitics.com/search/K983595) 510(k) Number (if known):
Transmyometrial Embryo Transfer Sets Device Name: The Transmyometrial Embryo Transfer Sets are used for Indications for Use: transferring IVF embryo (s) into the endometrial cavity through the myometrium. These devices are sterile and intended for one time use. The Transmyometerial Embryo Transfer Set should not be used on a patient with an active vaginal or intrauterine infection, a sexually transmitted disease, a recent uterine perforation. cervical stenosis or other cervical abnormalities which would preclude embryo transfer, a recent cesarcan section, a recent pregnancy (or is currently pregnant), or if a patient currently has an intrauterine device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number