(69 days)
Not Found
Not Found
No
The summary describes a physical medical device (catheter) and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used to place embryos into the uterine cavity, which is a medical intervention aimed at treating infertility.
No
The device description indicates its use for placing embryos into the uterine cavity, which is a therapeutic or procedural function, not a diagnostic one. It does not gather information about a patient's health condition.
No
The device description explicitly lists physical materials (NRT (TFE), polyethylene, Echosight polyethylene, and stainless steel) and describes a physical function (placing embryos into the uterine cavity), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "place embryos into the uterine cavity." This is a direct intervention on the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description focuses on the physical components and materials used for the transfer process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Embryo Transfer Catheters/Sets are used to place embryos into the uterine cavity.
Product codes
85MOF
Device Description
The Embryo Transfer Catheters/Sets are used for transferring IVF embryos into the uterine cavity. The materials used in these devices are NRT (TFE), polyethylene, Echosight polyethylene, and stainless steel. Biocompatibility is assured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 2 1 1998
510(k) Premarket Notification Embryo Transfer Catheter/Set Cook OB/GYN
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted By:
Debbie Schmitt Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 (812) 829-4069 (Fax) October 13, 1998
Device
Trade Name: Proposed Classification Name: Embryo Transfer Catheters/Sets Assisted Reproduction Catheters Class II 85MOF
Predicate Devices:
Cook OB/GYN understands due to the recent reclassification there are no predicate devices. However, we have used Cook Australia products as our predicate to illustrate safety and effectiveness.
The Embryo Transfer Catheters/Sets are substantially equivalent to other Embryo Transfer Catheters/Sets in terms of indications for use, design, construction and materials equivalence. Specifically, these devices are similar to the Embryo Transfer Catheters/Sets manufactured by Cook Australia.
Device Description:
The Embryo Transfer Catheters/Sets are used for transferring IVF embryos into the uterine cavity. The materials used in these devices are NRT (TFE), polyethylene, Echosight polyethylene, and stainless steel. Biocompatibility is assured.
Substantial Equivalence:
These devices will be manufactured according to specified controls and a Quality Assurance Program. These devices 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, these devices meet the requirements for section 510(k) substantial equivalence.
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1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1998
Ms. Debbie Schmitt Regulatory Affairs Manager Cook Ob/Gyn® 1100 West Morgan Street Spencer, IN 47460
Re: K983594 Transvaginal Embryo Transfer Catheters/Sets Dated: October 13, 1998 Received: October 13, 1998 Regulatory Class: II 21 CFR 884.6110/Procode: 85 MQF
Dear Ms. Schmitt:
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 (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 requiration 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 oblication 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 regulations.
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
K 983594
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not yet assigned
Device Name: Embryo Transfer Catheters/Sets
Indications for Use: The Embryo Transfer Catheters/Sets are used to place embryos into the uterine cavity.
(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
Emil A. Segner
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number