(68 days)
No
The summary describes a mechanical design change to a vacuum extractor cup and does not mention any AI or ML components or functionalities.
No
The device aids in childbirth by extracting the baby, but it does not treat a disease or medical condition.
No.
Explanation: The device is a vacuum extractor cup used in childbirth to assist in delivery, which is a therapeutic or assistive function, not a diagnostic one.
No
The device description clearly states it is a "Vacuum Extractor Cup," which is a physical hardware device used in childbirth. The change described is a design modification to the physical cup itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Vacuum Extractor Cup used in child birth." This is a device used on a patient during a medical procedure, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details a physical device used for extraction during childbirth.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
Therefore, the device described is a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Vacuum Extractor Cup used in child birth
Product codes
85HDB
Device Description
The new Tulip Cup is a design change to the current Mityvace (004M) vacuum extractor cup. The change is found in the location of the vacuum tubing attachment point.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data: A survey was distributed to a select group of physicians in nine states. They indicated this improvement was needed in the vacuum products.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image is a black and white drawing of a stork carrying a baby in a sling. The stork is standing on one leg and has a long beak. The baby is wrapped in a blanket and is being carried in a sling that is attached to the stork's beak. The drawing is simple and cartoonish.
OCT 28 1996
K963287
Premarket Notification (510k) Summary
| Submitters Name: | Swift Delivery Products |
|---|---|
| Address: | 6824 Elk Canyon Road, Oklahoma City, OK 73162 |
| Phone: | 405/721-8227 |
| Fax: | 405/721-8227 or 405/721-8032 |
| Contact Person: | Richard G. Lindsay (Ric Lindsay) |
| Date: | This summary was prepared 8/15/96 |
| Name of Device: | The Tulip Cup |
| Common Name: | Vacuum Extractor Cup |
| Classification Panel: | OB/GYN |
| Product Code: | 85HDB |
| C.F.R. Section: | CFR - 21 (884.4340) |
| Device Class: | Class 11 |
| Indication Use: | Vacuum Extractor Cup used in child birth |
| Equivalence to: | K890307 Mityvac®Vacuum Extractor 004M |
Description of the device: The new Tulip Cup is a design change to the current Mityvace (004M) vacuum extractor cup. The change is found in the location of the vacuum tubing attachment point.
Description of use: This vacuum device is used in child birth to allow a physician to assist the mother in a safe vaginal delivery.
Comparison of Mityvac Cand our new Tulip Cup: The cup and stem on both products are substantial equivalent The tubing attachment locations are different.
Non-clinical performance data: A survey was distributed to a select group of physicians in nine states. They indicated this improvement was needed in the vacuum products.
Conclusions drawn from non-clinical data: The vacuum delivery products now in use can be improved. The new Tulip Cup is a design modification.