(33 days)
THE SONOHYSTEROGRAPHY CATHETER (5 Fr) IS INDICATED FOR USE TO FILL THE UTERUS WITH STERILE SALINE TO FACILITATE THE ULTRASOUND EXAMINATION OF THE UTERUS
The 5F SH catheter consists of two parts: a single lumen catheter and a semi-rigid introducing sheath. The catheter is available in a 5 French diameter with a length of 32 cm. The distal end has a side port. The proximal end is fitted with a female luer-lock hub. The catheter is banded with a non-toxic ink 7 cm from the distal tip. The semi-rigid sheath has an internal diameter to allow movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. The sheath is 17.5 cm long and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.
The provided text describes a 510(k) submission for a medical device (5F SH Catheter) claiming substantial equivalence to a predicate device. This type of submission does not typically include detailed studies with acceptance criteria for device performance as a standalone product in the way AI/ML algorithms or novel devices would. Instead, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, largely based on a comparison of technological characteristics.
Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or not explicitly detailed in this type of regulatory document.
However, I can extract the relevant information where available and explain why other points are not present based on the nature of a 510(k) submission for this specific device.
Description of Acceptance Criteria and Study for the 5F SH Catheter
The acceptance criteria and "study" for this device are fundamentally wrapped in the concept of Substantial Equivalence (SE) to a predicate device. The performance of the new device is accepted if it is demonstrated to be identical or similar enough to a legally marketed predicate device such that it raises no new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion (Technological Characteristic) | Acceptance Criteria (Compared to Predicate) | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Indications for use | Identical | Identical |
| Target population | Identical | Identical |
| Design | Identical | Identical |
| Materials | Identical | Identical |
| Performance | Identical | Identical |
| Sterility | Similar (no new safety/effectiveness questions) | Similar (Ethylene Oxide instead of Gamma) |
| Biocompatibility | Identical | Identical |
| Mechanical safety | Identical | Identical |
| Chemical safety | Identical | Identical |
| Anatomical sites | Identical | Identical |
| Human factors | Identical | Identical |
| Energy used and/or delivered | Identical | Identical |
| Compatibility with environment and other devices | Identical | Identical |
| Where used | Identical | Identical |
| Standards met | Identical | Identical |
| Electrical safety | Identical (not applicable) | Identical (not applicable) |
| Thermal safety | Identical (not applicable) | Identical (not applicable) |
| Radiation safety | Identical (not applicable) | Identical (not applicable) |
Explanation: The "study" in this context is the comparison itself, as presented in the "Summary comparing technological characteristics with other predicate device" (Section 14). The acceptance criterion for each characteristic is that the new device must be "Identical" to the predicate, or "Similar" in a way that doesn't raise new safety or effectiveness concerns (e.g., sterilization method). The reported "performance" for the new device is its characteristic relative to the predicate, as shown in the "Comparison result" column.
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 a device like a catheter seeking substantial equivalence through a direct comparison of characteristics, a "test set" in the sense of clinical data or image data is typically not required or detailed in this summary. The comparison is based on the design, materials, and intended use of the device itself against the predicate. If any limited testing was performed (e.g., for biocompatibility or mechanical safety), the sample size and provenance are not disclosed in this 510(k) summary. The document states "limited testing information is sometimes required," but does not provide details for this specific submission.
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 / Not Provided: Since there isn't an explicit "test set" or diagnostic performance claim being evaluated via expert review, there is no mention of experts establishing ground truth for a test set. The evaluation is primarily by the FDA reviewers against the characteristics of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: As no specific test set or clinical data requiring adjudication is presented in this summary.
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: This device is a catheter, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance are not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Explicitly Stated: The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate device (Ultra Catheter Set for Sonohysterography from Lyco Enterprises, Inc.). The new device is considered acceptable if its characteristics align with this predicate, implying it will have similar safety and effectiveness.
8. The sample size for the training set
- Not Applicable / Not Provided: There is no "training set" in the context of this catheter device. The device's design, materials, and manufacturing are based on established engineering principles and comparison to the predicate, not machine learning training.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As there is no training set for this device.
§ 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.