(833 days)
The Ackrad IUI Set is intended for use in cases where the recipient has had difficulty in achieving pregnancy in the customary way.
The Ackrad IUI Set consists of two parts: a calibrating probe and an introducing catheter, each of which is accompanied by a placement sheath to aid in insertion.
The calibrating probe is a clear flexible tube, closed and rounded at the distal tip. A movable stop is attached to assist in calibrating the depth of insertion. Five narrow bands, one cm apart, designate distances of 25, 26, 27, 28 and 29cm from the distal tip, with a wide band at 30cm from the tip. The proximal end is fitted with a two-cm length of large outside diameter tubing to serve as a handle. The diameter of the probe is 1.8 mm and the working length is 44.0 cm.
The introducing catheter is identical to the calibrating probe except that the distal end has an end port or side port within 3 mm of the tip, and the proximal end is fitted with a standard female luer-lock hub.
Both the probe and the catheter are composed of clear, naturally flexible polyurethane material. The movable stop is composed of clear polyvinyl chloride of a 55-60A durometer.
Both the calibration probe and the catheter have a placement sheath through which they pass as an aid in insertion. The sheath is composed of rigid polypropylene material, 20 cm long with an inside diameter of 3.4 mm and an outside diameter of 4.6 mm. The distal end is rounded to minimize trauma.
The ink used for the banding of the catheter and probe is No-tox no. M-1000, manufactured by the Colorcon Corp. of West Point, PA.
The device functions as a means of accurately injecting the sperm into the uterus of the receptor patient. The calibrating probe is first used to measure the proper depth for insertion. Then sperm is introduced into the uterus via the catheter and expelled at the proper depth. The placement sheath allows both the probe and the catheter to be advanced through the cervix of the patient easily and non-traumatically without buckling or inadvertently touching the vagina.
The provided text is a 510(k) summary for the Ackrad IUI Set for Intrauterine Insemination. It outlines the device description, intended use, technological characteristics, and performance data, primarily comparing it to predicate devices. However, it does not explicitly define "acceptance criteria" in a quantitative manner as would typically be seen in a modern medical device submission with clear performance metrics.
Based on the information provided, here's an interpretation of the "acceptance criteria" through the lens of predicate device equivalence and the "study" that supports it:
Interpretation of Acceptance Criteria and Device Performance:
The primary acceptance criteria for the Ackrad IUI Set appear to be demonstrating equivalence in design, materials, and function to previously cleared predicate devices, coupled with satisfactory performance in limited non-clinical and clinical tests to confirm safety and effectiveness for its intended use.
Here's a table based on the provided text, outlining implicit acceptance criteria derived from the comparisons to predicate devices and the reported test results. Since explicit numerical acceptance criteria are not stated, the "Reported Device Performance" column reflects the findings that implicitly demonstrate the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Implicit Acceptance Criteria (Derived from text) | Reported Device Performance (from text) |
|---|---|---|
| Material Biocompatibility/Safety | Materials should be safe for intrauterine use and not leach harmful substances or affect sperm viability. | - Polyurethane material is "naturally flexible." |
- Movable stop is "clear polyvinyl chloride of a 55-60A durometer."
- Placement sheath is "rigid polypropylene material."
- Marking ink (No-tox no. M-1000) and movable stop are FDA-approved materials and "do not contact body tissue during the procedure."
- Laboratory tests showed "Sperm motility as determined the next morning was not different from that of control sperm not incubated in the catheter" after overnight incubation at 37℃. |
| Mechanical Integrity | Device components (e.g., proximal fittings) should withstand expected forces during handling and use. | - Pull tests on proximal fittings (5 samples) "all samples resisted a force of 1 kg." |
| Marking Integrity | Graduations/bands should remain legible and intact during use. | - Wiping tests on banded area (10 samples) with warm water showed "No smearing or removal of the black markings was observed." |
| Insertion Characteristics | Device should allow for easy, non-traumatic, and accurate insertion into the uterus. | - "The placement sheath allows both the probe and the catheter to be advanced through the cervix of the patient easily and non-traumatically without buckling or inadvertently touching the vagina." - The device affords "flexibility and ease of insertion into the uterus." |
| Functional Equivalence | Device should function similarly to predicate devices for intrauterine insemination, allowing for accurate depth calibration and sperm delivery. | - "The calibrating probe is first used to measure the proper depth for insertion." - "Then sperm is introduced into the uterus via the catheter and expelled at the proper depth."
- "The intended use is the same as the Royal Women's Coaxial Catheter Set (i.e. intrauterine insemination)."
- The IUI probe and catheter are passed into the uterus "in exactly the same way" as the Ackrad H/S Catheter (for diagnostic use) which uses the same placement sheath. |
| Clinical Safety & Effectiveness | Use in patients should be safe, without adverse effects or complications, and effective in achieving its intended purpose (intrauterine insemination). | - Clinical testing on 24-42 year old female patients (number not specified) at The Malden Hospital: "None of the patients experienced adverse affects and no complication occurred." - Conclusion: "The Ackrad IUI set is a safe and effective device for achieving pregnancy following intrauterine insemination." |
2. Sample Size Used for the Test Set and Data Provenance
- Non-clinical/Laboratory Tests:
- Pull Tests: 5 samples.
- Marking Integrity Tests: 10 samples.
- Sperm Motility Tests: Undisclosed number of samples, referred to as "sperm were loaded into the catheter."
- Clinical Testing:
- Sample Size: Undisclosed number of female patients, ranging in age from 24 to 42.
- Data Provenance: Prospective, from "The Reproductive Endocrinology and Fertility Services department of The Malden Hospital (100 Hospital Road, Malden, MA 02148)," USA. Patients participated under informed consent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not detail the establishment of "ground truth" by experts in the context of a diagnostic or classification device. For this device (an IUI catheter set), clinical safety and effectiveness are assessed by medical professionals in a clinical setting; however, specific "expert" roles for establishing a ground truth as one might find for imaging or AI algorithm evaluation are not described. The clinical testing was performed at "The Reproductive Endocrinology and Fertility Services department" by medical personnel there.
4. Adjudication Method for the Test Set
Not applicable. The study is not an evaluation of diagnostic accuracy requiring adjudication of interpretations. The clinical testing assessed safety and general effectiveness in a real-world clinical application scenario.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study, which typically evaluates the performance of human readers (with and without AI assistance) on a set of cases, was not mentioned or performed. This type of study is more relevant for diagnostic AI tools.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (catheter set), not an AI algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the clinical testing, the "ground truth" was essentially the clinical outcome data (no adverse effects or complications, and suitability for achieving pregnancy via IUI). For the non-clinical and laboratory tests, the ground truth was based on objective measurements (e.g., 1 kg force withstood, no smearing, sperm motility comparison to control). There was no "expert consensus," "pathology," or other typical diagnostic ground truth mentioned as this is not a diagnostic device.
8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).