(22 days)
The H/S Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.
The H/S Catheter Set can be used for conducting either Hysterosalpingography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and fallopian tubes using ultrasound sonography). All components are provided sterile for single use only.
Here's an analysis of the provided text regarding the acceptance criteria and study for the H/S Catheter Set:
The provided document (K020951) is a 510(k) Pre-market Notification for a medical device. These types of submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy studies with specific performance metrics and acceptance criteria as might be seen for novel devices or PMAs.
Based on the information provided, there are no explicit, quantifiable acceptance criteria or detailed study results for device performance as requested in the prompt. The submission primarily relies on demonstrating that the H/S Catheter Set is "substantially equivalent" to a predicate device.
Here's an attempt to answer the questions based on the available information:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance (Not explicitly stated in the document as quantifiable performance metrics for efficacy or safety) "Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described. It was determined that the H/S Data Catheter Set performs safely and effectively." Substantial Equivalence to predicate device (Modified Hysterosalpingography Set K953034) "The H/S Catheter Set has the same technological characteristics as the predicate device. The intended use, operating principle are identical. The H/S Catheter Set incorporates the same product design and is packaged and sterilized using the same materials and processes."
"The H/S Catheter Set is substantially equivalent to the predicate Modified Hysterosalpingography Set." |
**Note:** The document states "Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described." However, **these specific performance requirements are not described or quantified in the provided text.** The "performance requirements" likely refer to bench testing for material compatibility, strength, sterility, etc., to ensure it functions similarly to the predicate, rather than clinical efficacy metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
* **Sample Size:** Not specified. The document mentions "Pre-clinical testing," which typically refers to lab-based or bench testing, not patient data in the context of device performance.
* **Data Provenance:** Not specified. Given it's pre-clinical testing, it would likely be internal lab data, not patient data from a specific country.
* **Retrospective or Prospective:** Not applicable as it refers to pre-clinical testing, not patient studies.
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. The document does not describe a clinical study requiring expert-established ground truth. The "ground truth" for pre-clinical testing would be engineering specifications and test standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical adjudication 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
No. This device is a catheter set, not an AI or imaging interpretation device. Therefore, an MRMC study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a catheter set, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "pre-clinical testing" mentioned, the ground truth would likely be based on engineering specifications, material standards, and functional requirements applicable to the device's design and intended use, demonstrating equivalence to the predicate. No clinical outcomes data or expert consensus on clinical findings is discussed.
8. The sample size for the training set
Not applicable. This device is a catheter set, and the submission does not mention machine learning or AI requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a catheter set, not an AI/ML 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.