(77 days)
Not Found
No
The device description focuses on mechanical improvements to a vacuum extractor cup and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a vacuum extractor cup used in childbirth to address uterine inertia, maternal exhaustion, and fetal/maternal distress, which are conditions that require medical intervention. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is a vacuum extractor cup used during childbirth. It is an operative device, not a diagnostic one, as its purpose is to assist in delivery rather than to identify or classify a medical condition.
No
The device description explicitly states it is an "improved vacuum extractor cup," which is a physical hardware device used in childbirth. It describes physical components like the tubing attachment point, vacuum release valve, and an adaptor. There is no mention of software as the primary or sole component.
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 for diagnosis, monitoring, or screening.
- Device Function: This device is a vacuum extractor cup used during childbirth to assist in delivery. It is applied externally to the fetal head and uses vacuum pressure to aid in extraction.
- Intended Use: The intended use clearly describes its application in assisting with labor and delivery, not in analyzing biological specimens.
- Device Description: The description focuses on the physical components and improvements of the vacuum cup itself, not on any analytical or testing capabilities.
The device is a surgical/obstetrical instrument used directly on the patient, not for testing samples in vitro (outside the body).
N/A
Intended Use / Indications for Use
The Indications For Use for this vacuum device in childbirth are the following: Uterine inertia Maternal Exhaustion - ineffective voluntary effort Vertex Presentation Engagement of the Head Optional: A. Maternal distress B. Fetal distress
Product codes
85HDB
Device Description
The new product is an improved vacuum extractor cup. The improvement is found in the location of the vacuum tubing attachment point, vacuum release valve and an adaptor for electric vacuum pumps.
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 / childbirth
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 (an adaptor and 2 extra feet of tubing) was needed in our 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
Swift Delivery Products Submitters Name: 6824 Elk Canyon Road, Okla. City, Okla. 73162 Address: 405-721-8227 Phone : 405-721-8781 Fax : Richard G. Lindsay (Ric Lindsay) Contact Person: This summary was prepared 9-21-97 Date: Swift Delivery Product #003 Name of Device: Common Name: Vacuum Extractor Cup OB/GYN Classification Panel: Product Code: 85HDB (884.4340) C.F.R. Section: CFR - 21 -Device Class: Class Il Indication Use: Vacuum Extractor Cup used in child birth Equivalence to: K970170 Swift Vacuum Extractor with release valve
Description of the Device: The new product is an improved vacuum extractor cup. The improvement is found in the location of the vacuum tubing attachment point, vacuum release valve and an adaptor for electric vacuum pumps.
Description of use: This vacuum device is used in child birth to allow a physician to assist the mother in a safe vaginal delivery.
sarison of our 002 Cup and our new 003 Cup: The cup and stem on both ,ducts are substantial equivalent. The tubing attachment locations and vacuum release valves are the same. The new #003 product has 6 feet of tubing (instead of 4 feet) and an adaptor to connect to electric pumps.
Non-Clinical Performance Data: A survey was distributed to a select group of physicians in nine states. They indicated this improvement (an adaptor and 2 extra feet of tubing) was needed in our vacuum delivery product.
Conclusions drawn from non-clinical data: The vacuum delivery products now in use can be improved. The new 003 product WILL INCREASE the SAFETY of delivery for the baby, REDUCE the AMOUNT OF TIME of delivery for the mom, provide an IMPROVED CUP for the physician and be allow the hospital to use existing approved electric vacuum pumps.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 1997
Mr. Richard Lindsay President Swift Delivery Products, Inc. 6824 Elk Canyon Road Oklahoma City, Oklahoma 73162 Re: K973942
Swift Delivery Tulip Vacuum Cup (Product #003) Dated: September 21, 1997 Received: September 26, 1997 Regulatory class: II 21 CFR §884.4340/Product code: 85 HDB
Dear Mr. Lindsay:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements conceming your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K973942
(vice Name: Swift Delivery Product #003 - Vacuum Extractor Cup with Vacuum Release Valve
Indications For Use: 6 feet of tubing and an Adaptor for electric
vacuum pumps.
The Indications For Use for this vacuum device in childbirth are the following:
Uterine inertia
Maternal Exhaustion - ineffective voluntary effort
Vertex Presentation
Engagement of the Head
Optional:
A. Maternal distress
B. Fetal distress
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K97.3942
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | X |
| OR | |
| Over-The-Counter Use |
(Optional Format 1-2-96)