(191 days)
The CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device is indicated for use to access the uterine cavity for sonohysterography and sonohysterosalpingography procedures. The SonoFlow Device can instill salineonly or a mixture of saline and air for performance of saline infusion sonohysterography and sono-hysterosalpingography (Sono-HSG), respectively, for the evaluation of the fallopian tubes and/or the uterus. The following are generally recognized clinical indications for saline infusion sonohysterography and sonohysterosalpingography procedures: suspected polyps, fibroids, adhesions, endometrial thickening, and/or the selective evaluation of fallopian tube patency.
The CrossBay Medical SonoFlow™ Device is a catheter that enables saline and air infusion of contrast media to perform sonohysterosalpingography and sonohysterography procedures. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains an aeration component that provides an alternating pattern of saline and air as a stream of contrast media into the uterus and fallopian tubes. The proximal end of the device contains a handle with an air supply opening that allows the physician to reduce or eliminate the amount of air infusion selectively by occluding the opening of the air supply. The proximal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.
This document is a 510(k) Summary for the CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device. It outlines the device's characteristics and demonstrates its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, nor does it detail AI performance or ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on demonstrating substantial equivalence through bench testing, biocompatibility, sterilization validation, and packaging/shipping validation, rather than clinical performance testing with specific acceptance criteria that would typically involve AI evaluation.
Here's what the document does provide regarding testing:
1. A table of acceptance criteria and the reported device performance
- Not present in the document. The document states "Bench testing confirmed that the CrossBay Medical SonoFlow Device performs according to the product specifications" and "Passing results were obtained" for various tests, but it does not specify what those product specifications or acceptance criteria were for device performance. It also doesn't provide specific performance metrics beyond "passing."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present in the document. The document mentions that tests were conducted on "ethylene oxide sterilized units at baseline and on devices subjected to accelerated aging conditions equivalent to six (6) months." However, it does not specify the sample size for these units or the provenance of any data beyond mechanical testing. There's no mention of a "test set" in the context of diagnostic performance or clinical data.
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 present in the document. This type of information would be relevant for a study evaluating diagnostic performance, particularly with AI. This document does not describe such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present in the document. This would pertain to a diagnostic performance study, which is not described.
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 present in the document. There is no mention of AI in this submission, nor of a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present in the document. There is no mention of an algorithm or AI in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present in the document. This would be relevant for a diagnostic performance study, which is not described.
8. The sample size for the training set
- Not present in the document. No training set is mentioned as there's no AI component.
9. How the ground truth for the training set was established
- Not present in the document. No training set is mentioned as there's no AI component.
Summary of available information related to performance testing:
The document primarily focuses on demonstrating the device's substantial equivalence to existing predicate devices (Femasys, Inc. - FemVue Saline-Air Device K110288 and FemVue Catheter System K083690, and CrossBay Medical Inc. - SonoSure Sonohysterography and Endometrial Sampling Device K133144).
The "Performance Data" section details the following:
- Bench Testing: Confirmed performance according to product specifications (details not provided), including functionality, bond/joint tests, and fluid/air delivery. Tests were done on new and aged units.
- Biocompatibility testing: Asserted applicability of data from the reference device (CrossBay SonoSure device K133144) due to similar materials and manufacturing. This included Cytotoxicity, Vaginal Irritation, and Sensitization.
- Sterilization Validation: Asserted applicability of data from the reference device (CrossBay SonoSure device K133144) due to equivalent components, materials, dimensions, weight, and sterilization methodology. Complied with ISO 11135-1:2007 and ISO 10993-7:2008.
- Packaging and Shipping Validation: Successfully conducted per ASTM guidelines (ASTM F1929, D642, 5276).
In conclusion, this document primarily addresses the mechanical, material, and sterility aspects of the medical device for a 510(k) submission, not the diagnostic or AI performance with associated acceptance criteria and ground truth studies that your questions suggest.
§ 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.