(311 days)
The Medela® Single Use Silc Cup is intended to be used to facilitate the delivery of the fetus during childbirth. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp. It is larmedd by an external vacuum source and indicated for using during vaginal or cesarean delivery.
The Indications for use are
- Fetal distress in the second stage
- Maternal delay in the second stage
- Maternal conditions requiring a short second stage
The Medela® Single Use Silc Cup is a sterile, disposable device made of an elastomer and available in one size, 60mm inner diameter. The instrument is elastomer and consists of a handle and a suction cup to be used with an external vacuum pump and tubing.
The cup has a smooth external surface with a small longitudinal ridge, which makes it possible to observe any rotation. The inside of the cup is lined with mance it possible to objections enable the air between the cup and the child's Small projoctions: The projections that the cup sucks firmly against the child's head. The soft suction cup deforms, thereby ensuring optimal adhesion and minimizing trauma to the fetal scalp.
The provided text describes a 510(k) submission for the Medela Single Use Silc Cup, which is an Obstetrical Vacuum Delivery System. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing new acceptance criteria or proving performance through a new clinical study.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The core of this 510(k) submission is to assert that the Medela Single Use Silc Cup is substantially equivalent to legally marketed predicate devices, meaning its technological characteristics and intended use are similar enough that it does not raise new questions of safety and effectiveness.
Here's what can be extracted from the document based on your request, with the caveat that many points cannot be addressed due to the nature of a 510(k) submission for substantial equivalence:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than setting new acceptance criteria and reporting performance against them for this specific device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set data or sample sizes are mentioned. The submission relies on the established safety and effectiveness of predicate devices.
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. No new test set data requiring ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The submission relies on the established safety and effectiveness of predicate devices, not new ground truth data for this device.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device.
9. How the ground truth for the training set was established:
Not applicable.
Summary of the document's argument for meeting "acceptance criteria":
The "acceptance criteria" in this context are primarily the regulatory requirements for Substantial Equivalence under 21 CFR 884.4340, a Class II medical device. The study that "proves" the device meets these criteria is the comparison to predicate devices and the assertion that "The Technology of the Medela® Single Use Silc Cup is identical to the predicate... There are no technical differences which would raise new aspects regarding safety and effectiveness."
The key points of the submission are:
- Device Name: Medela® Single Use Silc Cup, Fetal Vacuum Extractor
- Common Name: Obstetrical Vacuum Delivery System
- Classification Name: Fetal Vacuum Extractor, Obstetrical and Gynecological Surgical (Class II, per 21 CFR Section § 884.4340)
- Predicate Devices:
- Technological Characteristics: The submission explicitly states, "The Technology of the Medela® Single Use Silc Cup is identical to the predicate... There are no technical differences which would raise new aspects regarding safety and effectiveness."
- Biocompatibility: The materials are considered appropriate for their intended use.
- Conclusion: Based on the information presented, it is concluded that the proposed device is safe and effective for its intended use and is substantially equivalent to the predicate devices.
§ 884.4340 Fetal vacuum extractor.
(a)
Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.(b)
Classification. Class II (performance standards).