(120 days)
The Wallace SIS/AI Catheter is intended to be used in artificial insemination procedures intended for insertion of the catheter and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/Al Catheter is also intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection abnormalities within uterine cavities.
The Wallace Artificial Insemination Catheter (K964848) is a single-use, sterile, disposable device that was originally submitted and cleared with the intended use for insertion of catheters and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/AI Catheter for the purpose of this submission is intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection of abnormalities within uterine cavities. The catheter is also intended to be used in artificial insemination (AI) procedures.
The Catheter has two opposing smooth side eyes and a rounded smooth closed distal tip. It has an overall length of 18cm and consists of a flexible-end inner catheter and a detachable outer sheath attached to the inner catheter by a luer lock. The inner catheter is 16 gauge with a uniform lumen throughout its length. When the outer sheath luer is attached to the hub of the catheter, the inner catheter protrudes from the outer sheath by 5cm. The outer sheath has a series of 1cm graduations at the distal end, the graduations are used to assess the depth of the insertion.
An inner tube with an outer sheath that covers 2/3 segments of the inner sheath with marks of the distance from the distal part of the catheter and a cover rigid protective tube.
The provided documentation is a 510(k) summary for the Wallace SIS/AI Catheter. It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than presenting a detailed study with specific acceptance criteria and detailed performance data on the device itself. Therefore, much of the requested information cannot be extracted directly from this document.
However, I can extract the available information and highlight what is not present.
Acceptance Criteria and Study Information for Wallace SIS/AI Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: The new device should be materially similar to the predicate devices for its intended use. | The device's material composition and design features (e.g., length, gauge, side eyes, rounded tip, graduations, flexible-end inner catheter, detachable outer sheath) are described and implicitly claimed to be equivalent to predicate devices. |
| Technological Characteristics Equivalence: The technology of the device should be equivalent to predicate devices. | The document states, "The proposed intended use of the Wallace Artificial Insemination and SIS Catheter is equivalent to the identified predicate devices." It highlights that similar catheters are "routinely used in Saline Infusion Sonography in diagnostic Obstetrics and Gynecological procedures." |
| Intended Use Equivalence: The intended use should be equivalent to existing legally marketed predicate devices. | The intended uses for both artificial insemination (introduction of washed spermatozoa) and Saline Infusion Sonography (detection of abnormalities within uterine cavities) are explicitly stated and compared to the intended uses of the listed predicate devices. |
| Safety and Effectiveness: Implied to be safe and effective for its intended use based on substantial equivalence. | The conclusion states: "The results from the field testing and evaluation of this product by the end-user demonstrate that the Wallace Artificial Insemination and SIS Catheter are suitable for their intended use." No specific safety or effectiveness metrics, such as complication rates or diagnostic accuracy rates, are provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document mentions "field testing and evaluation of this product by the end-user" but does not specify the sample size of patients or procedures, the design of the test, data provenance (e.g., country of origin), or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. It mentions "evaluation by the end-user" but does not specify the number or qualifications of these end-users, nor how they established any ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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 applicable/provided. The device is a physical catheter, not an AI algorithm. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/provided. The device is a physical catheter, not an AI algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
This information is not explicitly stated in the document. The "field testing and evaluation" implies clinical use and assessment by healthcare professionals (end-users), but the specific method of establishing ground truth (e.g., comparison to a gold standard like pathology or subsequent clinical outcomes) is not detailed.
8. The Sample Size for the Training Set
This information is not applicable/provided. As the device is a physical catheter and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. As the device is a physical catheter and not an AI algorithm, there is no "training set" or corresponding ground truth establishment in the context of machine learning.
§ 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.