(78 days)
Not Found
No
The summary describes a mechanical device with improvements to the vacuum tubing attachment and release valve, with no mention of AI, ML, or data processing.
Yes
The device is used to assist in childbirth, which is a therapeutic intervention aimed at improving patient outcomes.
No
The device is described as a "Vacuum Extractor Cup used in child birth," which is used for delivery, not for diagnosing a condition.
No
The device description clearly states it is a "vacuum extractor" with physical components like a "vacuum tubing attachment point and vacuum release valve," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "Vacuum Extractor Cup used in child birth." This is a surgical/obstetrical tool used directly on the patient during a medical procedure. It does not analyze biological specimens.
Therefore, based on the provided information, this device falls under the category of a surgical or obstetrical instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Vacuum Extractor Cup used in child birth
Product codes
85HDB
Device Description
The new product is an improved vacuum extractor The improvement is found in the location of the vacuum tubing attachcup. ment point and vacuum release valve.
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
Not Found
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
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 delivery product.
Key Metrics
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
1970170
Premarket Notification (510k) Summary
MAR 2 8 1997
| Submitters Name: | Swift Delivery Products |
|---|---|
| Address: | 6824 Elk Canyon Road, Okla. City, Okla. 73162 |
| Phone: | 405-721-8227 |
| Fax: | 405-721-8781 |
| Contact Person: | Richard G. Lindsay (Ric Lindsay) |
| Date: | This summary was prepared 1-1-97 |
| Name of Device: | Swift Delivery Product #002 |
| Common Name: | Vacuum Extractor Cup |
| Classification Panel: | OB/GYN |
| Product Code: | 85HDB |
| C.F.R. Section: | CFR - 21 (884.4340) |
| Device Class: | Class II |
| Indication Use: | Vacuum Extractor Cup used in child birth |
| Equivalence to: | K890307 Mityvac Vacuum Extractor with release valve |
Description of the Device: The new product is an improved vacuum extractor The improvement is found in the location of the vacuum tubing attachcup. ment point and vacuum release valve.
Description of use: This vacuum device is used in child birth to allow a physician to assist the mother in a safe vaginal delivery.
oarison of Mityvac and our new 002 Cup: The cup and stem on both Jucts are substantial equivalent. The tubing attachment locations are different. This new location will reduce cup pop-offs and increase physician comfort and control of the cup. The new vacuum release valve location and design allow easy single handed delivery and vacuum control.
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 delivery product.
Conclusions drawn from non-clinical data: The vacuum delivery products now in use can be improved. The new 002 product WILL INCREASE the SAFETY of delivery for the baby, REDUCE the AMOUNT OF TIME of delivery for the mom and provide an IMPROVED CUP for the physician.
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