(269 days)
The Intrauterine Access Balloon Catheter is used for delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6 French in diameter to access the uterine cavity for assessment of tubal patency.
The Selective Salpingography Catheter is intended to be used through a uterine access device and positioned at the tubal ostium for injection of contrast medium for fluoroscopic evaluation of tubal patency.
The IAB and SSG Catheters facilitate access to the uterus and tubal ostium to deliver contrast media during diagnostic procedures.
The IAB Catheter is 9 French (Fr) in diameter and has a 23 cm working length. It is designed with a polyurethane shaft and a silicone distal balloon with a 2-cc inflation volume. The catheter includes two lumens, one for balloon inflation and the other can be used to inject contrast medium into the uterus for hysterosalpingography (HSG) and as an access channel that accepts devices up to 6 Fr in diameter for use in assessing tubal patency. The Intrauterine Access Balloon Catheter is packaged with a shipping stylet and a 3 mL syringe that is used to inflate the balloon with sterile media.
The SSG Catheter is manufactured from braided polyethylene and is designed with an angled distal tip with a radiopaque tungsten band. The catheter is 5.5 Fr in diameter and has a 40 cm working length. The SSG Catheter is intended to be used through a dimensionally compatible access catheter (IAB Catheter) to gain access to the uterine cavity for a more selective visualization of the fallopian tubes when positioned at the tubal ostium.
Both devices are supplied sterile (ethylene oxide) and are intended for single-use only.
The provided document focuses on the K181770 510(k) submission for the Intrauterine Access Balloon Catheter and the Selective Salpingography Catheter, demonstrating substantial equivalence to predicate devices. It does not contain information about a study proving device meets acceptance criteria in the manner described in the request, such as a clinical study with a test set, expert ground truth, multi-reader, multi-case study, or standalone algorithm performance.
However, the document does list performance data from bench studies that were conducted to ensure reliable design and performance, with predetermined acceptance criteria being met. This implies that the device does meet specific acceptance criteria based on these bench tests.
Here is the information extracted from the document regarding the acceptance criteria and the "studies" (bench performance tests) that prove the device meets them:
Acceptance Criteria and Reported Device Performance
Note: The document describes "predetermined acceptance criteria" rather than specifying precise quantitative values for each. The reported performance indicates that these criteria were met.
| Acceptance Criteria Category | Specific Test/Performance Characteristic | Reported Device Performance |
|---|---|---|
| General | Sterilization validation | Met per ISO 11135-1:2014 |
| Ethylene oxide residual | Met per ISO 10993-7:2008(R)2012 | |
| Transportation simulation | Met per ASTM D4169-16 | |
| Package integrity (dye penetration) | Met per ASTM F1929-15 after 3 years real-time aging | |
| Package integrity (seal strength) | Met per ASTM F88/F88M-15 after 3 years real-time aging | |
| Biocompatibility (cytotoxicity) | Met per ISO 10993-5:2009 | |
| Biocompatibility (sensitization) | Met per ISO 10993-10:2010 | |
| Biocompatibility (irritation) | Met per ISO 10993-10:2010 | |
| IAB Catheter Specific | Shelf-life | Supported for two years |
| Compatibility (with other components) | Met (dimensional compatibility) | |
| Compatibility (with SSG Catheter) | Met (dimensional compatibility) | |
| Tensile strength (junctions) | Peak load value greater than predetermined criterion | |
| Lumen patency | Lumen was patent; predetermined acceptance criteria met | |
| Balloon leakage and integrity | Met predetermined acceptance criteria; no leakage | |
| Balloon burst volume | Met predetermined acceptance criteria; burst above labeled volume | |
| Dimensional accuracy (critical dimensions) | Met acceptance criteria | |
| Check-Flo valve leak reduction | Met predetermined acceptance criteria for leakage reduction | |
| SSG Catheter Specific | Shelf-life | Supported for three years |
| Compatibility (with IAB Catheter) | Dimensional compatibility assessed and met | |
| Compatibility (with 0.039-inch wire guides) | Dimensional compatibility assessed and met | |
| Tensile strength (junctions) | Peak load value greater than predetermined criteria | |
| Lumen patency | Lumen was patent; predetermined acceptance criteria met | |
| Torque response | Met acceptance criterion (per Cook's internal procedures) | |
| Radiopacity of marker band | Determined to be radiopaque in a simulated clinical setting | |
| Kink radius | Adequately characterized | |
| Dimensional accuracy (critical dimensions) | Met acceptance criteria |
The remaining requested information pertains to clinical performance studies, which are not detailed in this 510(k) submission as no such studies were needed for substantial equivalence based on the provided document. The document lists bench performance studies as the primary evidence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided for the device. The document describes bench performance studies (e.g., tensile testing, lumen patency, balloon integrity). These are laboratory tests on device units, not tests on clinical patient data. Therefore, concepts like "test set" in the clinical sense, "data provenance," "country of origin," or "retrospective/prospective" do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. The device performance was assessed against engineering specifications and industry standards in bench testing, not against expert clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments, which were not part of the described bench performance 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
- No, an MRMC study was not done. This type of study is for AI/human-in-the-loop performance, which is not relevant to this medical device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This submission is for a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering specifications, industry standards, and internal procedures served as the "ground truth" or reference for the bench performance tests. For instance, material properties (tensile strength), dimensional tolerances, and functional requirements (balloon integrity, lumen patency) were assessed against predefined, objective criteria.
8. The sample size for the training set
- Not applicable / Not provided. No "training set" in the context of machine learning or clinical data was mentioned or used for this device. The bench tests involved samples of manufactured devices.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there was no training set in the clinical or AI context, no ground truth needed to be established for it. The "ground truth" for the device's acceptable performance was established by engineering design specifications, relevant ISO standards, ASTM standards, and Cook's internal procedures.
§ 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.