(334 days)
No
The device description and performance studies focus on the physical characteristics and biological compatibility of a catheter, with no mention of AI or ML.
No
The device is described as a catheter used for the introduction of washed spermatozoa into the uterine cavity, not for treating a disease or condition. It facilitates a procedure but does not directly provide therapy.
No
The device is described as an IUI catheter used for the introduction of sperm into the uterine cavity, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components made of polyethylene, polypropylene, and ABS, 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 the "introduction of washed spermatozoa into the uterine cavity through the cervix." This is a procedure performed directly on the patient's body, not on a sample taken from the body for diagnostic purposes.
- Device Description: The device is a catheter designed for physical delivery of material into the uterus. It does not involve analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information. The performance studies focus on the device's physical properties, biocompatibility, and impact on sperm viability, not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is therapeutic/procedural, not diagnostic.
N/A
Intended Use / Indications for Use
MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
Product codes (comma separated list FDA assigned to the subject device)
MQF
Device Description
MedGyn straight IUI, mini IUI, and curved, mini IUI catheters are used for intrauterine insemination for delivery of washed spermatozoa through the cervical os.
The straight IUI is composed of a 21.4 cm length tube with subparts consisting of a polyethylene tube connecting with a polypropylene tube. The outer diameter of the polyethylene tube is 2.1 mm. That of the polypropylene tube is 2.75 cm. The tube is connected proximally to an ABS connector for attachment to a syringe.
The mini IUI is exactly the same as the straight IUI except that the outer diameter of the inner polyethylene tube is 1.6 mm. The curved, mini IUI is exactly the same as the mini IUI except that it is slightly curved at its distal tip.
The materials used in this device are the same materials used in predicate devices. The combination of an inner polyethylene tube with an outer polypropylene tube is the exact same material and the same concept as that used in the "Select IUI" and "The Curve", (K954099 and K012935, respectively). Additionally, the dimensions of the MedGyn IUI catheters are almost identical with those of the Select IUI and the Select "The Curve" catheters.
(Note syringe is not included with catheters)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterine Cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician's Office
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)
Stability testing was conducted in accordance with ASTM F1980-07 (accelerated aging) to substantiate a shelf life of 1 year.
Mouse Embryo Assay (MEA) testing was conducted on each version of the MedGyn IUI catheters.
Endotoxin Testing (LAL) was conducted per USP for each version of the MedGyn IUI catheters.
Human Sperm Survival Assay (HSSA) testing has been performed on the device the test results shows that the motility remained consistent, both the test and control samples showed no sign of affecting motility during the course of the assay.
The biocompatibility of the device includes cytotoxicity, Intracutaneous Reactivity and sensitization of the final device tests were performed on the IUI device;
a. Cytotoxicity: Microscopic evaluation of the cells showed that the extract from the test article received a cytotoxicity grade of '0' at 24 ± 3, 48 ± 3 and 72 ± 3 hours and was considered Non-Cytotoxic.
b. Intracutaneous Reactivity: The USP 0.9% Sodium chloride for injection ( NaCl) and Cottonseed Oil (CSO) extracts of the test article, IUI catheters, were evaluated for their potential to produce irritation after intracutaneous injection in white rabbits. The test article sites did not show a significantly greater biological reaction than the sites injected with the control article.
c. Skin Sensitization: A comparison of the biological responses seen following guinea pig sensitization of the test item extracts and solvents were reported and interpreted, results of the IUI Catheter did not show any sensitization reactions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cytotoxicity: '0'
Intracutaneous Reactivity: "The test article sites did not show a significantly greater biological reaction than the sites injected with the control article."
Skin Sensitization: "did not show any sensitization reactions."
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.
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.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, often associated with healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medgyn Products, Inc. Amar Agadi Chief Medical Officer 100 W. Industrial Rd. Addison, Illinois 60101
Re: K143669
Trade/Device Name: MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn Curved, Mini IUI Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted Reproduction Catheters Regulatory Class: Class II Product Code: MQF Dated: October 20, 2015 Received: October 26, 2015
Dear Amar Agadi:
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 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) 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143669
Device Name
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn Curved,Mini IUI Catheter.
24.589
Indications for Use (Describe)
MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
MedGyn IUI Catheters
(MedGyn straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved,mini IUI catheter)
This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92
Prepared on: December 26, 2014
Submitter:
MedGyn Products, Inc. 100 W Industrial Road, Addison, Il 60101, USA
Contact Person :
Dr. Amar Agadi M.D. MedGyn Products, Inc. 100 W Industrial Rd Addison, IL 60101 Tel: 630 6274105 Ex: 7446 Fax: 630 6270127 Email: amar@medgyn.com
| Device Trade Name: | MedGyn Straight IUI Catheter
MedGyn Mini IUI Catheter
MedGyn Curved,Mini IUI Catheter |
|------------------------|---------------------------------------------------------------------------------------------|
| Common Name: | Intrauterine Insemination (IUI) Cannula |
| Device Classification: | II |
| Classification Name | Assisted reproduction catheters |
| Product Code: | MFQ |
| Regulation Number: | 21 CFR 884.6110 |
4
Predicate Devices:
510(K) Number: K954099 Product Name: Select IUI Manufacturer: Select Medical Systems, Inc.
Device description:
MedGyn straight IUI, mini IUI, and curved, mini IUI catheters are used for intrauterine insemination for delivery of washed spermatozoa through the cervical os.
The straight IUI is composed of a 21.4 cm length tube with subparts consisting of a polyethylene tube connecting with a polypropylene tube. The outer diameter of the polyethylene tube is 2.1 mm. That of the polypropylene tube is 2.75 cm. The tube is connected proximally to an ABS connector for attachment to a syringe.
The mini IUI is exactly the same as the straight IUI except that the outer diameter of the inner polyethylene tube is 1.6 mm. The curved, mini IUI is exactly the same as the mini IUI except that it is slightly curved at its distal tip.
The materials used in this device are the same materials used in predicate devices. The combination of an inner polyethylene tube with an outer polypropylene tube is the exact same material and the same concept as that used in the "Select IUI" and "The Curve", (K954099 and K012935, respectively). Additionally, the dimensions of the MedGyn IUI catheters are almost identical with those of the Select IUI and the Select "The Curve" catheters.
(Note syringe is not included with catheters)
Indications for Use:
MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix
Technological Comparison to Predicate Devices:
The indication for use and technology of the MedGyn IUI catheters are substantially equivalent to the identified predicate devices.
5
Table :1 Comparison of Predicates with MedGyn Candidate Device
| Manufacturer | Select Medical
Systems, Inc | MedGyn IUI Catheters
comparison to predicate | Comparison of
Predicate with
MedGyn
Candidate Device |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K954099 | N/A | N/A |
| Product Code | MFD | MFD | Same |
| Regulation Number | 884.5250 | 884.5250 | Same |
| Regulation Name | Cannula, intrauterine
insemination | Cannula, intrauterine
insemination | Same |
| Anatomical Site | Uterine Cervix | Uterine Cervix | Same |
| Intended Use | Artificial insemination | Artificial insemination | Same |
| Where Used: | Physician's Office | Physician's Office | Same |
| Indications for use: | The Select IUI is
used for intrauterine
artificial insemination. | The MedGyn straight,
mini, and curved,mini IUI
catheters are to be used
for the introduction of
washed spermatozoa into
the uterine cavity through
the cervix. | Same |
| Overall Design | The Select IUI
consists of an 20 cm
in length catheter
composed of an inner
polyethylene tube
and an outer
polypropylene tube.
the exposed
polyethylene tube
measures 4.5cm in
length, and is located
at the distal end of
the catheter/cannula.
The outer diameter of
the polypropylene
tube and
polyethylene tube are
2.6 mm and 2.1 mm,
respectively. The
distal tip has two side
holes. There are six
(6) colored
graduation marks
each cm from the
distal tip of the
catheter starting at 5
cm and ending at 10
cm. A syringe is not
included with the
products. | The MedGyn straight,
mini, and curved,mini IUI
catheters are each 21.4
cm in length. The straight
catheter has a proximal
tube with outer diameter
of 2.75 mm and length of
16.4 cm. The distal tube
has an outer diameter of
2.1 mm and is 5 cm in
length. The mini IUI
catheter has a proximal
tube outer diameter of
2.75 mm with a length of
16.4 cm and a distal tube
outer diameter of 1.6 mm
of length 5 cm. the
curved, mini IUI catheter
has a proximal tube
length of 16.4 cm with an
outer diameter of 2.75
mm with a distal tube
outer diameter of 1.6 mm
of length 5 cm. The distal
3mm aspect of this tube is
slightly curved for
insertion into a variably-
positioned uterus
(retroverted, etc.). All
catheters are smooth in
texture down to the tip.
The straight catheter has
two side holes at the tip.
The mini and curved, mini
catheters have a single
hole at the tip. | The MedGyn
cannula/catheter is
approximately 1.4
cm longer, and the
outer diameter is
approximately .15
mm larger. The
distal inner tubes
are the same |
6
The comparison of the above mentioned in Table 1 the predicates devices the outer diameter IUI straight is 2.6mm and 2.1mm respectively, the curved 2.6mm and 1.6mm in diameter. The MedGyn cannula/catheter is approximately 1.4 cm longer, and the outer diameter is approximately .15 mm larger. The distal inner tubes are the same. The differences in dimensions between the subject and predicate device do not raise different questions of safety and effectiveness.
Summary of Performance Testing:
Stability testing was conducted in accordance with ASTM F1980-07 (accelerated aging) to substantiate a shelf life of 1 year.
Mouse Embryo Assay (MEA) testing was conducted on each version of the MedGyn IUI catheters.
Endotoxin Testing (LAL) was conducted per USP for each version of the MedGyn IUI catheters.
Human Sperm Survival Assay (HSSA) testing has been performed on the device the test results shows that the motility remained consistent, both the test and control samples showed no sign of affecting motility during the course of the assay.
The biocompatibility of the device includes cytotoxicity, Intracutaneous Reactivity and sensitization of the final device tests were performed on the IUI device;
a. Cytotoxicity: Microscopic evaluation of the cells showed that the extract from the test article received a cytotoxicity grade of '0' at 24 ± 3, 48 ± 3 and 72 ± 3 hours and was considered Non-Cytotoxic.
b. Intracutaneous Reactivity: The USP 0.9% Sodium chloride for injection ( NaCl) and Cottonseed Oil (CSO) extracts of the test article, IUI catheters, were evaluated for their potential to produce irritation after intracutaneous injection in white rabbits. The test article sites did not show a significantly greater biological reaction than the sites injected with the control article.
c. Skin Sensitization: A comparison of the biological responses seen following guinea pig sensitization of the test item extracts and solvents were reported and interpreted, results of
7
the IUI Catheter did not show any sensitization reactions..
The above test reports data proven that device is safe for the use.
Substantially Equivalent Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared with the predicate device.
The MedGyn IUI Catheters are substantially equivalent to the proposed predicate device.