(91 days)
The intended use of the HS Catheter is for the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes. The intended use of the SHG Catheter is for the delivery of saline into the female reproductive tract for examination of the uterus and fallopian tubes.
The HS Catheter devices consist of a plastic tube, the distal end of which has an inflatable cuff. A sheath is over the tube to provide a stiffener and guide. When the cuff is inflated inside the uterus, the device seals the cervix. A stopcock is provided at the proximal end of the device to allow inflation of the cuff with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. The HS catheters will be available in 5F and 7F sizes.
The SHG Catheter devices consist of a plastic tube with a blunt tip and one or more side holes at the distal tip. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. A sponge stop is provided to press on the external os of the cervix to reduce the back leakage of injected fluids. This devices is intended for use with saline solution, only. I n addition to the individual catheters, convenience kits will be offered that provide the physician with items helpful to the completion of the procedure.
The provided text is a 510(k) summary for a medical device (HS and SHG Catheters) and does not describe a study involving acceptance criteria in the typical sense of a performance study for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, and expert involvement are not applicable in this context, as they pertain to clinical or performance studies that were not provided or performed for this specific 510(k) submission.
Here's the breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The 510(k) summary does not report on specific performance metrics or acceptance criteria for a new clinical study. The basis for clearance is substantial equivalence to legally marketed predicate devices, not meeting specific performance thresholds in a new study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or associated data provenance is mentioned as no new clinical study was provided.
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. No ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is mentioned.
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 is a medical catheter, not an AI/ML device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical catheter, not an AI/ML device. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. No new clinical data requiring ground truth was presented. The substantial equivalence argument relies on comparing the device's technological characteristics, intended use, and operating principles to those of predicate devices.
8. The sample size for the training set
- Not Applicable. This is a medical catheter, not an AI/ML device. No training set was used.
9. How the ground truth for the training set was established
- Not Applicable. This is a medical catheter, not an AI/ML device. No training set or ground truth for it was established.
Summary of Device and Regulatory Pathway based on the Input:
- Device Name: H/S Catheter Set (Proprietary Name: HS and SHG Catheters)
- Applicant: Catheter Research, Inc. (CRI)
- Intended Use: For the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes.
- Regulatory Pathway: 510(k) Pre-market Notification, claiming substantial equivalence to predicate devices (K020292, K020951 & K020951, K022503).
- Key Basis for Clearance: The device has "the same technological characteristics as the predicate devices. The intended use and operating principles are identical. The H/S Catheter Set incorporates similar product design, materials packaging and sterilization as the predicate products."
- Clinical/Non-Clinical Testing: "None provided." This indicates that the substantial equivalence argument was made without new performance data, relying instead on comparison to existing legally marketed devices.
§ 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.