(266 days)
The Margolin HSG Cannula is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Margolin HSG Cannula can be used for evaluation of tubal patency.
The Goldstein Sonohysterography Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).
The Margolin HSG Cannula and Goldstein Sonohysterography Catheter are single lumen uterine catheters that facilitate access to the uterus to deliver fluid (contrast media or saline) during diagnostic procedures. Both feature a silicone "acom" wedge that seals the cervical canal and maintains the position of the catheter during the procedure.
This is a 510(k) summary for medical devices (Margolin HSG Cannula and Goldstein Sonohysterography Catheter) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for novel performance metrics with acceptance criteria, expert ground truth, or statistical power.
Therefore, many of the requested data points (e.g., effect size of human readers with/without AI, sample size for training set, specific study design for clinical performance against pre-defined acceptance criteria, detailed ground truth establishment for a test set) are not presented in this document because they are not typically required for a 510(k) submission for these types of devices. The "performance data" section rather lists engineering and biocompatibility tests.
However, based on the provided text, I can extract the following information:
1. A table of acceptance criteria and the reported device performance
The document states: "All predetermined acceptance specifications were met in the following tests." However, the specific numerical acceptance criteria for each test are not explicitly detailed in this summary. The performance is reported as meeting these unspecified specifications.
| Test Category | Acceptance Criteria (Not Explicitly Stated Numerically) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Per ISO 11135-1:2007 requirements | Met applicable design and performance requirements |
| Transportation Simulation | Per ASTM D4169-16 requirements | Met applicable design and performance requirements |
| Package Integrity | Per ASTM F2096-11 (Bubble Leak), ASTM F88-09 (Seal Strength), ASTM F1866-09 (Visual Inspection) requirements after aging to three years | Met applicable design and performance requirements |
| Biocompatibility | Per ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization), ISO 10993-10:2010 (Irritation) | Met applicable design and performance requirements |
| Dimensional Verification | Conformance with Cook's predetermined acceptance specifications for catheter, stylet, ink marker bands, silicone positioner dimensions | Verified conformance to predetermined acceptance specifications |
| Lumen Patency and Liquid Leakage Test | Fluid path of catheter patent and no leakage from joints/parts at predetermined injection pressure | Fluid path was patent and did not leak |
| Tensile Testing | Peak load value greater than predetermined acceptance specification (for hub to shaft (both devices), hub to stylet wire (Margolin HSG Cannula), and tip to shaft (Margolin HSG Cannula)) | Peak load value was greater than the predetermined acceptance specification |
| Positioner Force to Displace | Conformance to Cook requirements for force needed to displace movable silicone positioner (Goldstein Sonohysterography Catheter) | Predetermined acceptance specification was met |
| Stylet Compatibility Testing | Stylet fits within catheter lumen and does not extend beyond tip (Margolin HSG Cannula) | Predetermined acceptance specification was met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the "performance data" tests. The data provenance is not mentioned, as these are primarily engineering and bench tests, not clinical studies in a specific geographical location. The studies are prospective in the sense that they are conducted on manufactured devices to test design specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. These are engineering performance tests, not clinical performance studies requiring expert ground truth for interpretation (e.g., image analysis, diagnosis).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to clinical studies where multiple reviewers' opinions need to be reconciled to establish a ground truth, which is not the case for these bench tests.
5. 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. These are medical devices (cannulas and catheters) used for fluid delivery, not AI-powered diagnostic or assistive tools. Therefore, an MRMC study related to human readers improving with AI assistance is entirely irrelevant to this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As stated above, these are physical medical devices, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests listed, the "ground truth" is defined by the technical specifications and standards (e.g., ISO 11135-1:2007 for sterilization, ASTM D4169-16 for transportation, ASTM F2096-11 for bubble leak, ISO 10993 series for biocompatibility, and "Cook's predetermined acceptance specifications" for dimensional, patency, tensile, and force tests). There's no clinical ground truth established by experts or pathology for these types of tests.
8. The sample size for the training set
Not applicable. There is no AI or machine learning model being "trained" for these medical devices.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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.