(251 days)
Not Found
No
The device description and performance studies focus solely on the mechanical and material properties of a catheter for diagnostic media delivery, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is intended for diagnostic imaging procedures (sonohysterography and hysterosalpingography) to access the uterine cavity, not for treating a disease or condition.
Yes
Justerification: The intended use of the device is for sonohysterography (SHG) and hysterosalpingography (HSG), which are diagnostic procedures to visualize the uterine cavity and fallopian tubes. The device itself is used to inject diagnostic media into the uterus to facilitate these imaging studies.
No
The device description clearly details a physical catheter with multiple lumens, a balloon, a stylet, and associated hardware components. It is a tangible medical device, not software.
Based on the provided information, the uVue™ HSG/SHG Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to access the uterine cavity for sonohysterography (SHG) and hysterosalpingography (HSG). These are imaging procedures performed in vivo (within the living body) to visualize the uterus and fallopian tubes.
- Device Description: The device is a catheter designed for insertion into the body to facilitate these imaging procedures. It is a physical tool used to deliver diagnostic media and inflate a balloon within the uterus.
- Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such testing on specimens.
- Focus on In Vivo Procedures: The entire description and intended use revolve around facilitating imaging procedures performed directly on the patient.
Therefore, the uVue™ HSG/SHG Catheter is a medical device used in in vivo diagnostic imaging procedures, but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The uVueTM HSG/SHG Catheter is intended to access the uterine cavity for sonohysterography (SHG) and hysterosalpingography (HSG).
Product codes (comma separated list FDA assigned to the subject device)
LKF
Device Description
The uVue™ HSG/SHG Catheter is a 6.2 French polyurethane catheter molded inside a 9.0 French polyurethane integrated catheter as a single piece. The device has a 26 centimeter working length. Along the distal end of the catheter, there is a silicone radiopaque positioner. In addition, distal from the positioner is a 1.5 milliliter silicone balloon. The catheter consists of three lumens: a closed lumen that contains a stainless steel stylet, an open lumen used to inflate the balloon, and an open lumen used to inject diagnostic media into the uterus. The catheter features a proximal fitting of a double lumen polyurethane hub with a polyethylene and polyetherimide stopcock attached. Both the hub and stopcock accept standard Luer lock or Luer slip syringes.
The purpose of the first luer is to allow for inflation of the balloon with saline via a proximally extending inflation line. The purpose of the second luer to allow for installation of diagnostic media into the uterine cavity. A 3 mL syringe will be provided with the catheter as a set.
The set will be supplied sterile and is intended for one-time use. The set is packaged in a Tyvekpolyethylene peel-open pouch with a two year shelf life.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The following testing was performed in order to demonstrate that the uVue™ HSG/SHG Catheter met applicable design and performance requirements.
- Tensile Strength - Testing shows the tensile force during proper clinical use should not fracture the uVue™ HSG/SHG Catheter materials and bonds. The results showed that the predetermined acceptance criteria were met.
- Dimensional Analysis – Testing was performed with the requirement that specific product dimensions should be within set tolerances. The results showed that the predetermined acceptance criteria were met.
- Balloon Integrity - Testing was performed with the requirement that the balloons should not burst or leak during nominal inflation and after a predetermined time period at nominal inflation in a water bath. The results showed that the predetermined acceptance criteria were met.
- Balloon Diameter and Maximum Balloon Volume - Testing was performed with the requirement that the balloons, subjected to a desired volume, should achieve a desired diameter while not having any rupture, leakage, or herniation of the entire balloon and/or catheter, or leakage at the hub during placement in a constant temperature bath. Upon achieving the desired diameter, testing continued until maximum burst volume. The results showed that the predetermined acceptance criteria were met.
- Balloon Deflation Reliability - Testing was performed with the requirement that the balloons subject to a desired volume and subsequently deflated, should achieve a desired diameter. The results showed that the predetermined acceptance criteria were met.
- Buckling Force - Characterization testing was performed to evaluate the buckling force of the distal length of the catheter. Results of the testing provided us with the peak load data.
- Stylet Puncture Force – Testing was performed to evaluate the force required to puncture the distal tip of the catheter and to confirm that it was greater than the buckling force. The results showed that the predetermined acceptance criteria were met.
- Biocompatibility – Testing demonstrated that the proposed device conforms with the biocompatibility requirements per ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process based on its intended use. The following biocompatibility tests were performed:
- Cytotoxicity, per ISO 10993-5:2009 (Extraction Method)
- Sensitiziation, per ISO 10993-10:2010 (Guinea Pig Maximization Sensitization)
- Irritation, per ISO 10993-10:2010 (Intracutaneous Reactivity)
All predetermined acceptance criteria were met.
- Shelf life - Testing demonstrated that the proposed device maintained conformed with the mechanical requirements described above and maintained sterility following aging for two years.
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
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
Cook Incorporated Kara Kanorr Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404
Re: K160217
Trade/Device Name: uVue™ HSG/SHG Catheter Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: September 7, 2016 Received: September 8, 2016
Dear Kara Kanorr:
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.
1
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-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 vours.
For Division
Douglas Silverstein -S 2016.10.06 16:06:16 -04'00'
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
Indications for Use
510(k) Number (if known) K160217
Device Name uVue™ HSG/SHG Catheter
Indications for Use (Describe) The uVue™ HSG/SHG Catheter is intended to access the uterine cavity for sonohysterography (SHG) and hysterosalpingography (HSG).
| Type of Use (Select one or both, as applicable) | |
|---|---|
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
COOK INCORPORATED 750 DANIELS WAY RLOOMINGTON, IN 47404 USA
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Submitted Bv: Kara Kanorr Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47404 Phone: (812) 339-2235 x104072 Fax: (812) 332-0281
Date Prepared: October 5, 2016
| Device: | |
|---|---|
| Submission: | Traditional 510(k) Premarket Notification, K160217 |
| Trade Name: | uVueTM HSG/SHG Catheter |
| Common Name: | Intrauterine Catheter |
| Classification Regulation: | None |
| Classification Name: | None |
| Regulatory Class: | Unclassified |
| Product Code: | LKF (Cannula, Manipulator/Injector, Uterine) |
Predicate Device:
The Advance Catheter for HSG and SIS, cleared under 510(k) K123258. This device has not been subject to a design-related recall.
Device Description:
The uVue™ HSG/SHG Catheter is a 6.2 French polyurethane catheter molded inside a 9.0 French polyurethane integrated catheter as a single piece. The device has a 26 centimeter working length. Along the distal end of the catheter, there is a silicone radiopaque positioner. In addition, distal from the positioner is a 1.5 milliliter silicone balloon. The catheter consists of three lumens: a closed lumen that contains a stainless steel stylet, an open lumen used to inflate the balloon, and an open lumen used to inject diagnostic media into the uterus. The catheter features a proximal fitting of a double lumen polyurethane hub with a polyethylene and polyetherimide stopcock attached. Both the hub and stopcock accept standard Luer lock or Luer slip syringes.
The purpose of the first luer is to allow for inflation of the balloon with saline via a proximally extending inflation line. The purpose of the second luer to allow for installation of diagnostic media into the uterine cavity. A 3 mL syringe will be provided with the catheter as a set.
The set will be supplied sterile and is intended for one-time use. The set is packaged in a Tyvekpolyethylene peel-open pouch with a two year shelf life.
Indications for Use:
The uVue™ HSG/SHG Catheter is intended to access the uterine cavity for sonohysterography (SHG) and hysterosalpingography (HSG).
4
Comparison to Predicate Devices:
| Predicate Device | Subject Device | |
|---|---|---|
| The Advance Catheter for | ||
| HSG and SIS (K123258) | uVue HSG/SHG Catheter | |
| (K160217) | ||
| Intended Use | ||
| Indications for Use | Delivery of diagnostic contrast | |
| media or saline during | ||
| hysterosalpingoram (HSG) and | ||
| saline infusion | ||
| sonohysterography (SIS) into | ||
| the female reproductive tract for | ||
| examination of the uterus and/or | ||
| fallopian tubes. | The uVue™ HSG/SHG Catheter | |
| is intended to access the uterine | ||
| cavity for sonohysterography | ||
| (SHG) and | ||
| hysterosalpingography (HSG) | ||
| Technology | ||
| Size of catheter | 5 and 7 Fr | 6.2 Fr |
| Working length | 28 cm | 26 cm |
| Balloon size | 1.5 ml | 1.5 ml |
| Internal stylet | No | Yes |
| Tensile testing | Met performance testing | |
| requirements | Met performance testing | |
| requirements | ||
| Biocompatible | Yes | Yes |
| Sterile | Yes | Yes |
The table below provides a detailed comparison of the subject and predicate device:
The subject and predicate device have the same intended use - the delivery of contrast agents to the uterine cavity for HSG/SHG procedures.
The subject and predicate device have different technological characteristics, including different catheter sizes, working length, and the inclusion of an internal stylet. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions. All catheters must independently demonstrate they are biocompatible, sterile, and can maintiain their mechanical characteristics for their expected shelf life.
Performance Testing:
The following testing was performed in order to demonstrate that the uVue™ HSG/SHG Catheter met applicable design and performance requirements.
- . Tensile Strength - Testing shows the tensile force during proper clinical use should not fracture the uVue™ HSG/SHG Catheter materials and bonds. The results showed that the predetermined acceptance criteria were met.
- . Dimensional Analysis – Testing was performed with the requirement that specific product dimensions should be within set tolerances. The results showed that the predetermined acceptance criteria were met.
5
- 트 Balloon Integrity - Testing was performed with the requirement that the balloons should not burst or leak during nominal inflation and after a predetermined time period at nominal inflation in a water bath. The results showed that the predetermined acceptance criteria were met.
- . Balloon Diameter and Maximum Balloon Volume - Testing was performed with the requirement that the balloons, subjected to a desired volume, should achieve a desired diameter while not having any rupture, leakage, or herniation of the entire balloon and/or catheter, or leakage at the hub during placement in a constant temperature bath. Upon achieving the desired diameter, testing continued until maximum burst volume. The results showed that the predetermined acceptance criteria were met.
- Balloon Deflation Reliability - Testing was performed with the requirement that the balloons subject to a desired volume and subsequently deflated, should achieve a desired diameter. The results showed that the predetermined acceptance criteria were met.
- . Buckling Force - Characterization testing was performed to evaluate the buckling force of the distal length of the catheter. Results of the testing provided us with the peak load data.
- 트 Stylet Puncture Force – Testing was performed to evaluate the force required to puncture the distal tip of the catheter and to confirm that it was greater than the buckling force. The results showed that the predetermined acceptance criteria were met.
- . Biocompatibility – Testing demonstrated that the proposed device conforms with the biocompatibility requirements per ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process based on its intended use. The following biocompatibility tests were performed:
- Cytotoxicity, per ISO 10993-5:2009 (Extraction Method) o
- Sensitiziation, per ISO 10993-10:2010 (Guinea Pig Maximization Sensitization) o
- Irritation, per ISO 10993-10:2010 (Intracutaneous Reactivity) о
All predetermined acceptance criteria were met.
- . Shelf life - Testing demonstrated that the proposed device maintained conformed with the mechanical requirements described above and maintained sterility following aging for two years.
Conclusion:
The results of the testing described above demonstrates that the uVue™ HSG/SHG Catheter is as safe and effective as the predicate device and supports a determination of substantial equivalence.