(28 days)
HSG Catheter Set (5F & 7F) is indicated for use to fill the uterus with sterile saline to facilitate the ultrasound examination of the uterus.
The device is to be used by physicians in hospitals. The HSG catheter set consists of two parts: a double lumen catheter and a semi-rigid introducing sheath. The catheter is available in two different sizes 5 and 7 French diameter with a length of 30 cm. The distal end has a side port and a non-latex Kraton balloon whose capacity is 1.5 cc for 5F and 3cc for 7F. The proximal end that ends in side port is fitted with a halkey clamp and female luer lock hub. The other channel is fitted with one way stop cock and a 3cc syringe.
The provided text is a 510(k) summary for the HSG Catheter Set (5F and 7F). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than detailed clinical study data showing primary safety and effectiveness.
Therefore, the document does not contain a traditional study with acceptance criteria and reported device performance in the way a clinical trial for a new drug or a novel, high-risk device would. Instead, it relies on demonstrating that its technological characteristics are equivalent to a predicate device that has already been deemed safe and effective.
Here's an analysis based on the provided text, addressing your points where possible:
Acceptance Criteria and Device Performance
The acceptance criteria here are implicitly met by demonstrating "substantial equivalence" to the predicate device. The performance is deemed "Identical" to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Indications for Use | Identical |
| Target Population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Similar (Ethylene Oxide instead of Gamma) |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |
Study Proving Acceptance Criteria:
The "study" in this context is the 510(k) submission itself, where the manufacturer provides a detailed comparison of their device to a legally marketed predicate device (K943494 from Lyco Enterprises. Inc.). The FDA reviewed this descriptive information and concluded that the device is substantially equivalent, thereby accepting the manufacturer's claim of identical performance and safety, with a minor difference in sterilization method.
2. Sample Size Used for the Test Set and the Data Provenance
This document does not mention a test set with a specific sample size for evaluating the new device's performance in a clinical or user-based study. The determination of substantial equivalence is primarily based on a comparison of technological characteristics with the predicate device, not on new clinical performance data from a test set.
The data provenance for the comparison itself is the manufacturer's internally generated comparison table and potentially existing data/information from the predicate device within FDA files or literature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable or not provided in the context of this 510(k) summary. "Ground truth" for a test set, typically established by experts, is relevant for performance studies (e.g., diagnostic accuracy for AI devices). This submission focuses on demonstrating equivalence through comparison of design, materials, and intended use, not through a new performance study requiring expert ground truth.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Without a specific test set or performance study, there's no need for an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess the impact of AI assistance on human reader performance. This device is a catheter for hysterisalpingography, and the submission's focus is substantial equivalence based on design and materials, not diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study was not done. This concept is primarily relevant for AI algorithms. The HSG Catheter Set is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used here is a comparison to the established characteristics of the predicate device (Lyco Enterprises. Inc.'s HSG Catheter Set, K943494). The predicate device serves as the benchmark against which the new device's technological characteristics, safety, and performance are evaluated for equivalence. This is not "expert consensus," "pathology," or "outcomes data" for the new device, but rather a reference to an already cleared device's known attributes.
8. The Sample Size for the Training Set
This information is not applicable or not provided. There is no "training set" in the context of this 510(k) submission. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided. As there is no training set mentioned, there is no method for establishing its ground truth.
§ 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.