(270 days)
Not Found
No
The device description and performance studies focus solely on the mechanical function and material properties of a double balloon catheter. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended to mechanically improve the favorability of the cervix of pregnant patients, which is a therapeutic purpose.
No
The device is described as a double balloon catheter intended to mechanically improve the favorability of the cervix by applying pressure for gradual cervical dilation. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines a physical, mechanical device (double balloon catheter, silicone materials, stainless steel stylet) used for cervical dilation. It is not software-only.
Based on the provided information, the UTAH CVX-RIPE™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "mechanically improve the favorability of the cervix of pregnant patients at term gestation." This is a direct mechanical intervention on the patient's body.
- Device Description: The device is a physical catheter with balloons that are inflated to apply pressure. This is a mechanical device.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of such specimens.
The UTAH CVX-RIPE™ is a medical device used for a therapeutic purpose (cervical ripening), not an IVD used for diagnostic purposes.
N/A
Intended Use / Indications for Use
The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.
Product codes (comma separated list FDA assigned to the subject device)
PFJ
Device Description
The UTAH CVX-RIPE™ is a double balloon catheter. The tip is placed through the vagina and into the cervical canal. The distal balloon is positioned against the internal cervical os and inflated with saline. The proximal balloon is positioned against the external cervical os and inflated with saline, providing gradual mechanical cervical dilation by simultaneously applying pressure on the internal and external cervical os. The materials used to manufacture the device, and which have patient contact, are all medical grade silicone.
The UTAH CVX-RIPE™ consists of an 18 Fr., 42 cm silicone catheter with a silicone tip and two silicone balloons. Each balloon is independently inflated via a separate inflation lumen through color coded check valves located at the proximal end of the device. The check valves are marked accordingly, "U" for the distal uterine balloon and "V" for the proximal vaginal balloon. A malleable stainless steel stylet is included for ease of placement. The stylet is placed through a third separate lumen that is closed at the distal tip. The stylet is preloaded in the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix
Indicated Patient Age Range
Pregnant patients at term gestation
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)
To demonstrate substantial equivalence, the following mechanical performance tests were conducted:
- Balloon Deflation Reliability Testing to demonstrate that the balloons deflate properly after use.
- Balloon Integrity Testing to demonstrate that the balloons do not burst at the maximum recommended inflation volume and duration under simulated use conditions.
- Balloon Overuse - Testing to demonstrate that balloons do not leak and properly deflate when using an inflation volume and duration greater than maximum recommendations.
- Balloon Volume Maintenance Testing to demonstrate that the balloons do not leak.
- Balloon Response to Traction - Testing to demonstrate that the distal balloon does not pull out from the patient under simulated use conditions.
- Bond Strength - Testing to demonstrate that bonded connections do not fail during simulated use conditions.
- Stylet Puncture - Testing to demonstrate that the stylet does not puncture through the catheter during simulated use.
The UTAH CVX-RIPE™ is biocompatible per the requirements of ISO 10993-1.
The shelf life of the UTAH CVX-RIPE™ was established based on the results of an accelerated aging study.
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.
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
§ 884.4260 Hygroscopic Laminaria cervical dilator.
(a)
Identification. A hygroscopicLaminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata orLaminaria japonica). The device is used to induce abortion.(b)
Classification. Class II (performance standards).
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 resembling an eagle or a stylized human profile, composed of three interconnected shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2015
Utah Medical Products, Inc. Ben Shirley VP of Quality Assurance & Product Development 7043 South 300 West Midvale, UT 84047
K143424 Re: Trade/Device Name: UTAH CVX-RIPE Regulation Number: 21 CFR 884.4260 Regulation Name: Hygroscopic Laminaria cervical dilator Regulatory Class: II Product Code: PFJ Dated: July 27, 2015 Received: July 29, 2015
Dear Ben Shirley,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 6.0
| 510(k) Number: | K143424 |
|---|---|
| Device Name: | UTAH CVX-RIPE™; UTMD Cervical Ripening Balloon Catheter |
| Indications for Use: The UTAH CVX-RIPE™ is intended to mechanically improve the | |
| favorability of the cervix of pregnant patients at term gestation, in which | |
| induction of labor is medically indicated. |
Prescription Use (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
Submitter Information
| 510(k) Owner: | Utah Medical Products, Inc |
|---|---|
| Address: | 7043 South 300 West |
| Midvale, UT 84047 | |
| USA | |
| Telephone No.: | (801) 566-1200 |
| Fax No.: | (801) 566-2062 |
| Contact: | Ben Shirley |
| Contact Phone No.: | (801) 569-4039 |
| Contact E-mail: | bshirley@utahmed.com |
| Date Prepared: | August 27, 2015 |
Device Information
| Trade Name: | UTAH CVX-RIPE™, UTMD Cervical Ripening Balloon
Catheter |
|-----------------|------------------------------------------------------------|
| Common Name: | Catheter, Balloon, Dilation of Cervix |
| Classification: | Class II |
| Regulation: | 21 CFR § 884.4260 |
| Description: | Hygroscopic Laminaria cervical dilator |
| Product Code: | PFJ (catheter, balloon, dilation of cervical canal) |
Predicate Device
The predicate device is the Cook® Cervical Ripening Balloon cleared September 27, 2013 under 510(k) number K131206.
Device Description
The UTAH CVX-RIPE™ is a double balloon catheter. The tip is placed through the vagina and into the cervical canal. The distal balloon is positioned against the internal cervical os and inflated with saline. The proximal balloon is positioned against the external cervical os and inflated with saline, providing gradual mechanical cervical dilation by simultaneously applying pressure on the internal and external cervical os. The materials used to manufacture the device, and which have patient contact, are all medical grade silicone.
4
The UTAH CVX-RIPE™ consists of an 18 Fr., 42 cm silicone catheter with a silicone tip and two silicone balloons. Each balloon is independently inflated via a separate inflation lumen through color coded check valves located at the proximal end of the device. The check valves are marked accordingly, "U" for the distal uterine balloon and "V" for the proximal vaginal balloon. A malleable stainless steel stylet is included for ease of placement. The stylet is placed through a third separate lumen that is closed at the distal tip. The stylet is preloaded in the catheter.
Intended Use
The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.
Predicate Device Comparison
The UTAH CVX-RIPE™ has the same intended use and technological characteristics as the Cook® Cervical Ripening Balloon cleared under K131206.
Performance Testing
To demonstrate substantial equivalence, the following mechanical performance tests were conducted:
- Balloon Deflation Reliability Testing to demonstrate that the balloons ● deflate properly after use.
- Balloon Integrity Testing to demonstrate that the balloons do not burst at ● the maximum recommended inflation volume and duration under simulated use conditions.
- Balloon Overuse - Testing to demonstrate that balloons do not leak and properly deflate when using an inflation volume and duration greater than maximum recommendations.
- Balloon Volume Maintenance Testing to demonstrate that the balloons ● do not leak.
- Balloon Response to Traction - Testing to demonstrate that the distal balloon does not pull out from the patient under simulated use conditions.
- Bond Strength - Testing to demonstrate that bonded connections do not fail during simulated use conditions.
- Stylet Puncture - Testing to demonstrate that the stylet does not puncture through the catheter during simulated use.
The UTAH CVX-RIPE™ is biocompatible per the requirements of ISO 10993-1.
The shelf life of the UTAH CVX-RIPE™ was established based on the results of an accelerated aging study.
5
Conclusion
The UTAH CVX-RIPE™ is substantially equivalent to the Cook® Cervical Ripening Balloon cleared under K131206.