(38 days)
Not Found
Not Found
No
The provided text describes the intended use of medical devices for IVF/ART procedures but contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is used for procedures like embryo transfer and intra uterine insemination, which are used to assist in reproduction rather than treat a disease or condition.
No
Explanation: The intended use states that the devices are for embryo transfer and intra uterine insemination procedures, which are interventional procedures, not diagnostic ones.
No
The provided text only describes the intended use of physical devices (catheters and sets) for medical procedures. There is no mention of software as the device itself.
Based on the provided information, the devices described (Delphin, Emtrac Catheters, Semtrac Sets) are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these devices are for procedures performed within the body (embryo transfer and intra uterine insemination). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: While the description is "Not Found," the intended use is the primary indicator.
- Other Sections: The lack of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," and performance study details further supports that these are not IVDs, as these are often relevant for certain types of IVDs.
These devices appear to be medical devices used in assisted reproduction procedures, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Delphin is to be used for embryo transfer and intra uterine insemination procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.
Emtrac Catheters are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.
Semtrac Sets are to be used for embryo transfer procedures for in Semilac Sets are to be acount. In the substition technology (ART) procedures.
Product codes (comma separated list FDA assigned to the subject device)
85 MFD, 85 MQF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2001
Gynétics Medical Products N.V. % Ms. Grace Holland Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606
Re: K013536
Trade/Device Name: Emtrac, Delfin, and Semtrac Embryo Transfer and IUI Catheters Regulation Number: 21 CFR 884.5250 Regulation Name: Cervical cap Product Code: 85 MFD Regulation Number: 21 CFR 884 6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: 85 MQF Dated: October 22, 2001 Received: October 23, 2001
Dear Ms. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for and of the 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may , atest , visions 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 nouthoute 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), please 11 you used of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Other or Compilention" (21 CFR Part 807.97). Other general information on of received to promote 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Delphin Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Delphin is to be used for embryo transfer and intra uterine insemination procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.
(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 (Optional Format 1-2-96)
Nancy Brigion
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radioleglent Devices
K013536
3
Page 1 of 1 of 1 -------------------------------------------------------------------------------------------------------------------------------------------------------------
| 510(k) Number (if known): | K013536 |
|---|---|
| --------------------------- | --------- |
Device Name: Emtrac Catheters
Indications For Use:
Emtrac Catheters are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| ғанынан менен аласында қошылық қалым қарап қарап қарап қарап қарап қарақ қарап қаланы мен қаласын қаласының қаласының қаласының қаласының қаласының қаласының қаласының қа | ||
|---|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Dansy C Broodon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
| 510(k) Number | K013536 |
|---|---|
| --------------- | --------- |
4
Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________
・、
510(k) Number (if known): ماك35353 ما
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Semtrac Sets are to be used for embryo transfer procedures for in Semilac Sets are to be acount. In the substition technology (ART) procedures.
(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 (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K013536 |
|---|---|
| --------------- | --------- |