(228 days)
Injection of fluid into the uterine cavity during Saline Infusion sonogram (SIS) & hysterosalpinogram (HSG). Following are some Clinical Indications:
- Infertility.
- Menorrahagia.
- Dysmenorrhea.
- Suspected Endometrial Polyp.
- Uterine Fibroid.
- Amenorrhea due to Uterine Synechea (Asherman Syndrome).
- Congenital Uterine Anomaly.
Foam Seal Catheter is a single channel catheter intended for use during Foam Seal Cadieter is a single endinsion sonogram. Foam Seal Catheter is a simplified version of double-channel balloon HSG catheter. This device has a single channel version of 1.6mm to 3mm in diameter and has a length of 370mm. Both ends of this catheter are open. The outer end has a luerlock device. A two way lock is attached to this end. The inner end is used to introduce fluid into the cavity of uterus. An introducer this cho. The finiter ens of agent is placed on its mid-segment. Both catherer and of an external caminate of plastic material. A cone-shaped foam component is attached close Calliula are made of placed in the cervical canal during the procedure. The foum to himel end so it can be placed find seal and to keep the catheter in place.
Fluid media is injected into the cavity of uterus using this catheter with a syringe. Thich media is injected into ax carry of on the injected fluid. Radiology procedures of ultrasound examination is performed at this time and images of the cavity of the uterus is taken. There are several advantages to this device. This is a single chamel device and is taken. There are several advantages to the cervical canal and keeps the catheter in place without the need of an assistant.
The provided text is a 510(k) summary for the Foam Seal Catheter, which is a medical device. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics. Therefore, it does not contain the information needed to fill out most of the requested table and sections.
However, I can extract the following relevant details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria or report specific performance metrics for the Foam Seal Catheter. Instead, it claims substantial equivalence to a predicate device (H/S Elliptosphere Catheter set with 510K number K013972) based on "same technological characteristics," "identical intended use and operating principles." Therefore, the implicit acceptance criterion is that the device is substantially equivalent to the predicate. No quantitative performance data is provided for the Foam Seal Catheter itself.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (H/S Elliptosphere Catheter set K013972) | "Same technological characteristics," "identical intended use and operating principles." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary does not describe a clinical study with a test set.
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)
This information is not provided in the document, as no test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as no test set or adjudication process is 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
This information is not provided in the document. The device is a catheter, not an AI-assisted diagnostic tool, so an MRMC study related to AI performance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document, as no ground truth is described.
8. The sample size for the training set
This information is not provided in the document, as no training set is described for this type of device.
9. How the ground truth for the training set was established
This information is not provided in the document, for the same reason as above.
§ 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.