(267 days)
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 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.
This document describes the safety and effectiveness testing for the Cook® Silicone Balloon HSG Catheter, but it is not an AI/ML medical device submission. Therefore, it does not contain the specific information requested about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details), which are typically required for AI/ML device submissions.
The provided document is a 510(k) Premarket Notification for a physical medical device. It demonstrates substantial equivalence to a predicate device through bench performance studies and other non-clinical tests.
However, I can extract and present the available information in a format that addresses some aspects of your request, even if it doesn't align with an AI/ML context:
Acceptance Criteria and Device Performance (Based on available information for a physical device)
| Test Category | Acceptance Criteria (Pre-defined Specifications) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Per ISO 11135-1:2007 requirements | All predetermined acceptance criteria were met. |
| Biocompatibility | Per ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization, Intracutaneous Irritation) requirements | All predetermined acceptance criteria were met for Cytotoxicity, Guinea Pig Maximization Sensitization, and Intracutaneous Irritation testing. |
| Transportation Simulation | Per ASTM D4169-16 requirements | All predetermined acceptance criteria were met. |
| Package Integrity | Per ASTM F2096-11 (Bubble Leak), ASTM F88-09 (Seal Strength), ASTM F1866-09 (Visual Inspection) after aging (2 or 3 years shelf-life) | All predetermined acceptance specifications were met for Bubble Leak test, Seal Strength testing, and Visual Inspection after aging. |
| Simulated Use | Catheter able to be inserted through cervical canal of nulliparous cervix model, syringe able to mate with check valve, inflate balloon to labeled volume, and deflate fully. | 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. (All predetermined acceptance specifications were met). |
| Balloon Integrity Test | Catheter and balloon show no abnormalities (breakage, leakage, cracking at joint/material) when filled to labeled volume. No leakage after 10 mins in 37°C water bath. | 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. (All predetermined acceptance specifications were met). |
| Balloon Diameter & Max. Balloon Volume | Test results meet pre-defined acceptance specifications for balloon diameter with max fill, and max balloon pressure/volume at catastrophic failure. | Test results met the pre-defined acceptance specifications for these devices (balloon diameter when filled with maximum fill volume, and maximum balloon pressure and volume at catastrophic failure). (All predetermined acceptance specifications were met). |
| Lumen Patency & Liquid Leakage | Fluid path is patent and does not leak under a predetermined injection pressure. | Testing demonstrated that the fluid path of the catheter was patent and did not leak under a predetermined injection pressure. (All predetermined acceptance specifications were met). |
| Tensile Testing | Peak load value greater than predetermined acceptance specification for hub to shaft, shaft, shaft to manifold, extension tubing to manifold. | Testing demonstrated that the peak load value was greater than the predetermined acceptance specification. (All predetermined acceptance specifications were met). |
Summary of Study Details (for a physical medical device, not AI/ML):
-
Sample Size used for the test set and data provenance:
- The document implies that an adequate number of units were tested to demonstrate statistical significance and meet pre-defined acceptance criteria for bench performance and other non-clinical tests.
- Specific numerical sample sizes for each test are not provided in this summary.
- Data Provenance: The tests are described as "Performance Data" and "Bench Performance studies," indicating the data was generated from laboratory testing of the physical catheter devices. Country of origin for data or retrospective/prospective nature is not applicable as this is not a clinical study on patient data.
-
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. This is not an AI/ML device that generates diagnostic outputs requiring expert interpretation for ground truth. The "ground truth" for this physical device is defined by the physical properties and performance specifications of the device itself (e.g., balloon inflates, no leaks, proper tensile strength).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/ML device or a clinical study requiring adjudication of diagnostic interpretations.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device, not an AI/ML software.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an AI/ML software.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on engineering specifications and testing standards (e.g., ISO, ASTM standards, pre-defined internal acceptance specifications).
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.
Conclusion from the document:
"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." (Page 6)
§ 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.