(105 days)
The intended use of "The Advance Catheter for HSG and SIS" is for the delivery of contrast media or saline during hysterosalpingogram (HSG) and saline infusion sonohysterography (SIS) into the female reproductive tract for examination of the uterus and/or fallopian tubes.
The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or selective evaluation of fallopian tube patency.
The Advance Catheter for HSG and SIS will be available in 5F size for patients with a nulliparous cervix and 7F size for patients with a multiparous cervix.
The "The Advance Catheter for HSG and SIS (Advance Catheter) consist of a plastic tube, the distal end of which has an inflatable balloon. When the balloon is inflated inside the uterus, the device seals the cervix. A stopcock is provided at the proximal end of the device to allow inflation of the balloon with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids.
An introducing sheath is placed over the tube to provide a stiffener and quide. The sheath can be placed into the endocervix to the level of the internal os with no dilatation required; therefore, allowing the catheter to pass easily through the cervix and into the uterine cavity. The Advance catheter like its predicate will be available in 5F and 7F sizes.
This summary describes the acceptance criteria and study information for "The Advance Catheter for HSG and SIS" based on the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Meets requirements per ISO10993 |
| Flow Rate | Meets set requirements |
| Joints Tensile Strength | Meets set requirements |
| Operational Equivalence | "The Advance Catheter for HSG and SIS" is substantially equivalent to predicate devices with minor differences. |
2. Sample Size and Data Provenance
The submission does not explicitly state sample sizes for tests such as biocompatibility, flow rate, or tensile strength. It refers to "test reports in sections 15 and 18," which are not provided in this excerpt. The tests appear to be non-clinical, laboratory-based performance tests, not human trials. Therefore, data provenance related to human subjects (e.g., country of origin, retrospective/prospective) is not applicable.
3. Number of Experts and Qualifications for Ground Truth
The provided document does not indicate the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy. The study focused on engineering performance characteristics and substantial equivalence to legally marketed devices.
4. Adjudication Method
Not applicable. The study primarily describes non-clinical performance testing and a comparison to predicate devices, not an assessment requiring expert adjudication of a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted or reported in this submission. This device is an instrument for delivering contrast media, not a diagnostic imaging AI with human-in-the-loop performance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical catheter, not an algorithm.
7. Type of Ground Truth Used
For the non-clinical tests (biocompatibility, flow rate, tensile strength), the "ground truth" was defined by pre-specified engineering requirements and ISO standards (e.g., ISO10993). For the overall device, the "ground truth" for regulatory clearance was substantial equivalence to existing legally marketed devices, demonstrating comparable safety and effectiveness based on similar design, materials, and intended use.
8. Sample Size for Training Set
Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.
9. How Ground Truth for Training Set was Established
Not applicable. As described above, there was no training set in the context of an algorithm.
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K123258
PAGE 1 OF 2
SECTION 5 510(k) Summary
JAN 3 1 2013
Applicant/Sponsor:
Catheter Research, Inc. 5610 W. 82nd St. Indianapolis, IN 46278
Contact Person:
Babacar Diouf 317-872-0074 x3512
10/03/2012
Date:
Proprietary Name:
Classification Name:
Product Code:
LKF
Classification Regulation:
Unclassified, Pre-Amendment 510(k) Submission
The Advance Catheter for HSG and SIS
Cannula, Manipulator/Injector, Uterine;
Legally Marketed Devices to Which Substantial Equivalence Is Claimed:
| HS and SHG Catheters | K032835 |
|---|---|
| FemVue™ Catheter System | K083690 |
Device Description: The "The Advance Catheter for HSG and SIS (Advance Catheter) consist of a plastic tube, the distal end of which has an inflatable balloon. When the balloon is inflated inside the uterus, the device seals the cervix. A stopcock is provided at the proximal end of the device to allow inflation of the balloon with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids.
An introducing sheath is placed over the tube to provide a stiffener and quide. The sheath can be placed into the endocervix to the level of the internal os with no dilatation required; therefore, allowing the catheter to pass easily through the cervix and into the uterine cavity. The Advance catheter like its predicate will be available in 5F and 7F sizes.
Intended Use: Delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes
The predicate device is intended for the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes.
{1}------------------------------------------------
Summary of Technologies: The subject Advance Catheter has the identical technologies as the predicate device. Both devices are assembled in the same work environment using the same manufacturing lines.
The Advance Catheter is identical in materials and function to CRI's presently marketed product with the exception of the sheath.
The Advance catheter also shares substantially equivalent key features with the FemVue™ Catheter System (K083690), including similar principles of operation for device placement and an equivalent transcervical sheath.
Non-clinical/Clinical Testing: Biocompatibility testing per ISO10993 and performance testing (balloon integrity, tensile testing, flow testing, etc.).
| Equivalence Summary | |||
|---|---|---|---|
| Item | Predicate | Proposed | Comments/Discussions |
| CatheterComponents | HSG Catheter | The AdvanceCatheter for HSGand SIS | Substantially Equivalent: Nosignificant differences indesign, manufacturing,material, sterilization, orpackaging. |
| Sheath | Tube flaired at thedistal end | Tube with two stepsand smaller OD | Allows for placement insidecervical canal and increasepatient comfort. |
| Indication forUse | Delivery of diagnosticcontrast media agentsor saline into thefemale reproductivetract for examinationof the uterus andfallopian tubes | Delivery ofdiagnostic contrastmedia agents orsaline into the femalereproductive tract forexamination of theuterus and fallopiantubes | Identical |
| Procedure | Sheath is placed atthe face of the cervix. | Sheath is placedinside the cervicalcanal. | Enhances ease of insertion(see attached letter from Dr.Charles E. Miller) |
| Biocompatibilitytesting andperformancetesting | Flow rate and jointstensile strength meetset requirements.The product isbiocompatible perISO10993 | Flow rate and jointstensile strengthmeet setrequirements. Theproduct isbiocompatible perISO10993 | See test reports in sections15 and 18. |
In conclusion, since both catheters are similar, we feel that testing performed on the Advance catheter and the information from the predicates devices are sufficient to support the safety and effectiveness of the Advance catheter.
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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, black and white design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2013
Catheter Research, Inc. % Mr. Babacar Diouf Vice President of Regulatory Affairs and Quality Systems 5610 West 82nd Street INDIANAPOLIS IN 46278
Re: K123258
Trade/Device Name: The Advance Catheter for HSG and SIS Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: January 9, 2013 Received: January 23, 2013
Dear Mr. Diouf:
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.
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Page 2 - Mr. Babacar Diouf
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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
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SECTION 4 - Indications for Use Statement
510(k) Number (if known): K123258
Device Name: The Advance Catheter for HSG and SIS
Indications for Use:
The intended use of "The Advance Catheter for HSG and SIS" is for the delivery of contrast media or saline during hysterosalpingogram (HSG) and saline infusion sonohysterography (SIS) into the female reproductive tract for examination of the uterus and/or fallopian tubes.
The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or selective evaluation of fallopian tube patency.
The Advance Catheter for HSG and SIS will be available in 5F size for patients with a nulliparous cervix and 7F size for patients with a multiparous cervix.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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
Herbert P. Lerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123258 510(k) Number
Exhibit 4R - Page 4 -1 of 1
§ 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.