(82 days)
These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.
H.O.C. Set™ Hazout oocyte collector with or without valve Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip Optional: 3-way valve
The device features a simple flux metallic needle, 30 cm in useful length, 17 gauge in outside diameter and 18 gauge in inside diameter, with double chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance.
The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a 30 ml round-bottomed vial fitted with a screw-cap, or to a 30 ml round-bottomed vial fitted with a flexible cap (model HOC Set 2).
The model with a three-way valve set between the puncture needle and the collecting vial allows suction and rinsing of the follicles in turn.
Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs. H.O.C. vials are also sold alone by 50 units.
O.P.S. Oocyte Puncture Set™ Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip
The device features a simple flux metallic needle, 30 cm in useful length and 17 gauge in outer diameter and 18 gauge in inside diameter, with doublechambered point and echogenic distal tip on two centimeters for easier ultrasound guidance. The device must be connected to an irradiation sterilized Falcon tube.
The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a Falcon tube.
Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs.
Luer-lock Needle for Ovum recovery Needle: 25 cm or 30 cm; O.D. 17 gauge, echogenic tip; I.D. 18 gauge
Simple flux steel needle, 17 gauge in outside diameter and 18 gauge in inside diameter, with double-chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance.
Two sizes: 25 cm or 30 cm long.
The needle has a Luer-lock to attach a syringe, and a green plastic inner madrel. The needle is placed in a Teflon packing tubing for protection. Packaging: Disposable device in single unit sealed bag. Irradiation sterilized. Available in 10 unit packs.
This submission describes the "PRODIMED Assisted Reproduction Needles" which include "HOC SET," "OPS," and "Luer-lock Needle for Ovum recovery."
Here's an analysis of the provided text in relation to acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state any quantitative acceptance criteria or present a table of reported device performance metrics. This is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against pre-defined criteria.
The "Function of Devices/Significant Physical Characteristics of Device" section describes the intended functionality qualitatively:
| Device Function/Characteristic | Desired Outcome (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Ova Recovery | Safe and effective recovery of maximum ova. | Achieves safe and effective recovery of maximum ova. |
| Traumatic Handling | Elimination of risks of traumatic handling detrimental to zona pellucida integrity. | Eliminates risks of traumatic handling of the ovum that would be detrimental to zona pellucida integrity. |
| Operating Conditions | Ensuring optimal operating conditions for ovum conservation and better fertilization rate. | Insures optimal operating conditions for ovum conservation and better fertilization rate. |
| Luer-lock Needle Use | Acts as a laparoscopic or ultrasonographic ovum recovery device. | Acts as a laparoscopic or ultrasonographic ovum recovery device (transvesical, transvaginal, periurethral or endovaginal). |
2. Sample Size for the Test Set and Data Provenance:
The document does not provide any information regarding a test set sample size or data provenance. The 510(k) summary focuses on device description and intended use, not clinical study data for acceptance.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not describe any expert-established ground truth or the qualifications of such experts. This type of information would typically be found in a clinical study report, which is not provided here.
4. Adjudication Method:
Since no expert ground truth establishment or clinical study is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention any MRMC comparative effectiveness study, nor does it provide information on the effect size of human readers with vs. without AI assistance. The device described is a physical medical instrument (needles), not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance:
As the device is a physical medical instrument and not an algorithm or AI system, the concept of standalone algorithm performance does not apply and is not mentioned.
7. Type of Ground Truth Used:
The document does not specify any type of ground truth used, as it does not present data from studies requiring a ground truth.
8. Sample Size for the Training Set:
The submission does not mention any training set or its sample size. The device is a physical product, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
Since there is no training set and no machine learning model, the method for establishing ground truth for a training set is not applicable and therefore not described.
In summary, this 510(k) submission is for a physical medical device (assisted reproduction needles) and seeks clearance based on substantial equivalence to a predicate device. It does not contain the kind of detailed performance study data, acceptance criteria, or ground truth establishment information that would be present for a diagnostic or AI-driven medical device requiring extensive clinical validation against specific performance metrics. The "acceptance criteria" can only be implicitly inferred from the description of the device's function.
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).