(267 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for diagnostic purposes (evaluation of tubal patency, access for saline infusion sonohysterography), not for treating a condition.
No
Explanation:
This device is a catheter used for delivery of contrast medium into the uterine cavity and fallopian tubes for evaluation using other methods (hysterosalpingography or saline infusion sonohysterography). It is an accessory to diagnostic procedures, not a diagnostic device itself as it does not perform the diagnostic imaging or analysis.
No
The device description clearly outlines a physical catheter with a balloon, syringes, and packaging. The performance studies focus on physical properties like sterilization, biocompatibility, package integrity, and bench performance of the catheter itself. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the Cook® Silicone Balloon HSG Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the delivery of contrast medium or saline into the uterine cavity and fallopian tubes for imaging procedures (hysterosalpingography and saline infusion sonohysterography). It is a tool used during the diagnostic procedure, not a device that performs the diagnostic test itself on a sample taken from the body.
- Device Description: The description details a catheter with a balloon for physical manipulation and delivery of substances. It does not describe a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, or controls, which are typical components or uses of IVD devices.
- Performance Studies: The performance studies focus on the physical and functional integrity of the catheter (sterilization, biocompatibility, balloon integrity, lumen patency, tensile strength), not on the accuracy or reliability of a diagnostic test result.
The device is a medical device used to facilitate an imaging-based diagnostic procedure, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.
Product codes (comma separated list FDA assigned to the subject device)
LKF
Device Description
The Cook® Silicone Balloon HSG Catheter is a dual lumen polyurethane catheter that is manufactured in 5.0 or 7.0 French (Fr) sizes and is 30 cm in length. The Cook® Silicone Balloon HSG Catheter is available with an open-end tip, or a closed-end tip with a single side port. The silicone balloon is designed with a balloon volume of 1.0 mL (5.0 Fr) or 1.5 mL (7.0 Fr). Depending upon the device a 1 or 3 mL syringe is provided with the balloon catheter.
The Cook® Silicone Balloon HSG Catheter will be supplied sterile (ethylene oxide) and is intended for one-time use. The set is packaged in a peel-open pouch. The 5.0 Fr size catheter has a three-year shelf-life, and the 7.0 Fr size catheter has 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 and fallopian tubes
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)
The following testing was performed to demonstrate that the Cook® Silicone Balloon HSG Catheter met applicable design and performance requirements. All predetermined acceptance criteria were met in the following tests.
- . Sterilization Validation testing per ISO 11135-1:2007
- . Biocompatibility studies, as follows:
- Cytotoxicity testing per 10993-5:2009 o
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010 o
- Intracutaneous Irritation testing per ISO 10993-10:2010 o
- Transportation Simulation study per ASTM D4169-16
- Package Integrity testing after aging to two (7.0 Fr) or three (5.0 Fr) years:
- Bubble Leak test per ASTM F2096-11 O
- Seal Strength testing per ASTM F88-09
- Visual Inspection per ASTM F1866-09 O
- Bench Performance studies before and after aging to two (7.0 Fr) or three (5.0 Fr) years demonstrated that all predetermined acceptance specifications were met in the following tests:
- Simulated Use: Testing demonstrated that the catheter was able to be inserted through the cervical canal of a model of a nulliparous cervix, the syringe was able to mate with catheter check valve, inflate balloon to labeled volume, and deflate balloon fully.
- Balloon Integrity Test: Testing demonstrated that the catheter and balloon did not show any abnormalities such as breakage, leakage, or cracking at the balloon joint or balloon material when filled to the labeled volume. It also demonstrated that the catheter and balloon did not leak after being filled to the labeled volume and submerging in a 37°C water bath for a minimum of 10 minutes.
- Balloon Diameter and Maximum Balloon Volume Testing: Testing assessed the balloon diameter when filled with the maximum fill volume (i.e., 1.0 or 1.5 mL), and the maximum balloon pressure and volume at catastrophic failure of the test articles. Test results met the pre-defined acceptance specifications for these devices.
- Lumen Patency and Liquid Leakage Test: Testing demonstrated that the fluid path of the catheter was patent and did not leak under a predetermined injection pressure.
- Tensile Testing (hub to shaft, shaft, shaft to manifold, extension tubing to manifold): Testing demonstrated that that the peak load value was greater than the predetermined acceptance specification.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 26, 2018
Cook Incorporated Yan Li Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K180291
Trade/Device Name: Cook® Silicone Balloon HSG Catheter Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: September 24, 2018 Received: September 25, 2018
Dear Yan Li:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -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
Indications for Use
510(k) Number (if known) K180291
Device Name Cook® Silicone Balloon HSG Catheter
Indications for Use (Describe)
The Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font on a red background. The red background is shaped like a trapezoid.
COOK INCORPORA 750 DANIELS WAY, P.O. BC BLOOMINGTON, IN 47402-048 12.339.2235 TOLL FREE: 800.457 WWW.COOKMEDICAL.CO
K180291 Page 1 of 4
510(k) Summary Cook® Silicone Balloon HSG Catheter Date Prepared: October 26, 2018
| Submitted By: | |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Yan Li |
| Rohini Patel | |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone: | (812) 339-2235 x104987 |
| Contact Fax: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | Cook® Silicone Balloon HSG Catheter |
| Device Common Name: | HSG Catheter |
| Regulation Number: | 21 CFR §884.4530 |
| Regulation Name: | Obstetric-Gynecologic Specialized Manual Instrument |
| Product Code: | LKF (Cannula, Manipulator/Injector, Uterine) |
| Device Classification: | Class II |
Predicate Device:
u Vue® HSG/SHG Catheter, Cook Incorporated, K160217
The predicate device has not been subject to any design-related recalls.
Device Description:
The Cook® Silicone Balloon HSG Catheter is a dual lumen polyurethane catheter that is manufactured in 5.0 or 7.0 French (Fr) sizes and is 30 cm in length. The Cook® Silicone Balloon HSG Catheter is available with an open-end tip, or a closed-end tip with a single side port. The silicone balloon is designed with a balloon volume of 1.0 mL (5.0 Fr) or 1.5 mL (7.0 Fr). Depending upon the device a 1 or 3 mL syringe is provided with the balloon catheter.
The Cook® Silicone Balloon HSG Catheter will be supplied sterile (ethylene oxide) and is intended for one-time use. The set is packaged in a peel-open pouch. The 5.0 Fr size catheter has a three-year shelf-life, and the 7.0 Fr size catheter has a two-year shelf-life.
4
Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, uppercase letters on a red background. To the right of the word "COOK" is a registered trademark symbol. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 48 BLOOMINGTON, IN 47402-0489 U.S 812.339.2235 TOLL FREE: 800.457 WWW.COOKMEDICAL.COM
Indications for Use:
The Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.
Comparison to Predicate Device:
The following table compares the Cook® Silicone Balloon HSG Catheter to the predicate device:
| Device
Characteristics | K180291
Cook® Silicone
Balloon HSG Catheter | K160217
uVue® HSG/SHG
Catheter | Comparison |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Cook® Silicone
Balloon HSG Catheter
is used for delivery of
contrast medium or
saline into the uterine
cavity and fallopian
tubes for the evaluation
of tubal patency using
hysterosalpingography,
or to access the uterine
cavity for saline
infusion
sonohysterography. | The uVue™ HSG/SHG
Catheter is intended to
access the uterine
cavity for
sonohysterography
(SHG) and
hysterosalpingography
(HSG). | Same intended use: Both
devices are intended for use
in delivery of contrast
medium or saline to the
uterine cavity for HSG and
sonohysterography
procedures |
| Balloon
Material | Silicone | Silicone | Same |
| Balloon Volume
(mL) | 5.0 Fr: 1 mL
7.0 Fr: 1.5 mL | 1.5 mL | Different: The subject device
includes a smaller diameter
device version. This
difference does not raise
different questions of safety
and effectiveness (S&E). |
| Catheter
Tubing Material | Polyurethane | Polyurethane | Same |
| Catheter
Tubing Outer
Diameter (Fr) | 5.0 and 7.0 | 6.2 | Different: The subject device
catheter diameters are smaller
and larger than the predicate
device. This difference does
not raise different questions
of S&E. |
| Length (cm) | 30 | 26 | Different: The subject device
is longer than the predicate
device. This difference does
not raise different questions
of S&E. |
| Lumen Number | 2 | 3 | Different: Both devices have
two functional lumens for
balloon inflation and contrast
medium/saline infusion. The
third lumen of the predicate
device contains the internal |
| Device
Characteristics | K180291
Cook® Silicone
Balloon HSG Catheter | K160217
uVue® HSG/SHG
Catheter | Comparison |
| Radiopaque
Positioner | None | Yes | stylet. This difference does
not raise different questions
of S&E. |
| Internal Stylet | None | Yes | Different: The subject device
does not include a positioner
along the catheter shaft. This
difference does not raise
different questions of S&E. |
| | | | Different: The subject device
does not include an internal
stylet in the catheter shaft.
This difference does not raise
different questions of S&E. |
| | | | Different: The 5 Fr device is
supplied with a 1.0 mL |
5
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S. 312.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
syringe. The inclusion of a
smaller syringe does not raise different questions of S&E.
Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, bold, sans-serif font in the upper portion of the image. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font.
IR P
In
Accessory
3 mL syringe
As shown above, the subject and predicate device have intended use. In regards to technological characteristics, the subject and predicate device are similar in that they utilize comparable materials and are both supplied with syringes for inflation of the silicone balloons. However, differences do exist as described in the table above (e.g., dimensions, balloon volume, lumen number, lack of a stylet and positioner in the subject device, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.
Performance Data:
The following testing was performed to demonstrate that the Cook® Silicone Balloon HSG Catheter met applicable design and performance requirements. All predetermined acceptance criteria were met in the following tests.
- . Sterilization Validation testing per ISO 11135-1:2007
- . Biocompatibility studies, as follows:
- Cytotoxicity testing per 10993-5:2009 o
1 or 3 mL syringe
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010 o
- Intracutaneous Irritation testing per ISO 10993-10:2010 o
- Transportation Simulation study per ASTM D4169-16
- 트 Package Integrity testing after aging to two (7.0 Fr) or three (5.0 Fr) years:
- Bubble Leak test per ASTM F2096-11 O
6
-
o Seal Strength testing per ASTM F88-09
MEDICA -
Visual Inspection per ASTM F1866-09 O
-
트 Bench Performance studies before and after aging to two (7.0 Fr) or three (5.0 Fr) years demonstrated that all predetermined acceptance specifications were met in the following tests:
- o Simulated Use: Testing demonstrated that the catheter was able to be inserted through the cervical canal of a model of a nulliparous cervix, the syringe was able to mate with catheter check valve, inflate balloon to labeled volume, and deflate balloon fully.
- Balloon Integrity Test: Testing demonstrated that the catheter and balloon did not o show any abnormalities such as breakage, leakage, or cracking at the balloon joint or balloon material when filled to the labeled volume. It also demonstrated that the catheter and balloon did not leak after being filled to the labeled volume and submerging in a 37°C water bath for a minimum of 10 minutes.
- Balloon Diameter and Maximum Balloon Volume Testing: Testing assessed the o balloon diameter when filled with the maximum fill volume (i.e., 1.0 or 1.5 mL), and the maximum balloon pressure and volume at catastrophic failure of the test articles. Test results met the pre-defined acceptance specifications for these devices.
- Lumen Patency and Liquid Leakage Test: Testing demonstrated that the fluid path of the catheter was patent and did not leak under a predetermined injection pressure.
- Tensile Testing (hub to shaft, shaft, shaft to manifold, extension tubing to o manifold): Testing demonstrated that that the peak load value was greater than the predetermined acceptance specification.
Conclusion:
The results of the performance testing described above demonstrates that the Cook® Silicone Balloon HSG Catheter is as safe and effective as the predicate device and supports a determination of substantial equivalence.