(158 days)
K895700, Mitvyac Obstetrical Vacuum Extraction System by Neward Enterprises, Tender Touch Obstetrical Vacuum Delivery Kit by Columbia Medical Inc.
Not Found
No
The device description and performance studies focus on mechanical components and fluid handling, with no mention of AI or ML.
Yes.
The device is used to aid in vaginal or Cesarean delivery of infants, which is a therapeutic intervention.
No
The device is a vacuum-assist cup and fluid retention trap used to aid in delivery, not to diagnose a condition. Its function is to facilitate a procedure (delivery) and collect fluids, not to identify or monitor a disease or condition.
No
The device description clearly outlines physical components (housing segment, polyurethane foam filter) and its function involves collecting fluids, indicating it is a hardware device with a physical mechanism.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap is a device used during a medical procedure (delivery) to physically assist in the process. It is not used to analyze samples from the body for diagnostic purposes.
- Fluid Retention Trap: While the fluid retention trap collects fluids, its purpose is to manage fluids aspirated during the delivery procedure, not to analyze those fluids for diagnostic information.
The device is a surgical/obstetrical instrument used for mechanical assistance during childbirth, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap is a sterile, single use, device intended to be connected to an externally powered fetal vacuum extractor to aid in vaginal or Cesarean delivery of term or near term infants. The Fluid Retention Trap is intended to collect fluids aspirated during the delivery procedure.
Indications For Use:
- Delay in second stage with the fetal head stationed at the outlet; on the pelvic floor; or in the . mid-pelvis.
- Delay in the second stage associated with borderline cephalopelvic disproportion .
- Fetal distress .
- Shortening of second stage labor for fetal or maternal benefit .
- Prolapse of the umbilical cord when the cervix is fully dilated ●
Product codes (comma separated list FDA assigned to the subject device)
85 HDB
Device Description
The purpose of this premarket notification is to add a fluid retention trap option to the current Ameda Disposable Vacuum Assist Cup in order to collect fluids that may be aspirated during the delivery procedure. The fluid retention trap consists of a housing segment that is constructed of high impact polystyrene and a polyurethane foam filter. The fluid retention trap, when used, is connected to the tubing of the device between the vacuum cup and the vacuum pump.
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
term or near term infants
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory Testing: The objective of the laboratory testing was to determine substantial equivalence of the Hollister Disposable Vacuum Assist Cup's Fluid Retention Trap to the predicate devices. Laboratory testing was performed to evaluate fluid handling capacity and resistance to air flow. The results of the laboratory testing support Hollister's claim of substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K895700, Mitvyac Obstetrical Vacuum Extraction System by Neward Enterprises, Tender Touch Obstetrical Vacuum Delivery Kit by Columbia Medical Inc.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows a date, AUG 21 1998. The month is August, the day is the 21st, and the year is 1998. The text is in a simple, sans-serif font and is left-aligned. The image is a close-up of the date.
llister
Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781
Hollister Incorporated Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048
Contact Person Joseph S. Tokarz Manager, Regulatory Affairs Phone (847)680-2849 (847)918-3860 Fax
Date Summary Prepared - March 11, 1998
2. Name of Device:
Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap
3. Name of Predicate Device(s)
Ameda Disposable Vacuum Assist Cup, K895700 Mitvyac Obstetrical Vacuum Extraction System by Neward Enterprises Tender Touch Obstetrical Vacuum Delivery Kit by Columbia Medical Inc.
4. Description of Device
The purpose of this premarket notification is to add a fluid retention trap option to the current Ameda Disposable Vacuum Assist Cup in order to collect fluids that may be aspirated during the delivery procedure. The fluid retention trap consists of a housing segment that is constructed of high impact polystyrene and a polyurethane foam filter. The fluid retention trap, when used, is connected to the tubing of the device between the vacuum cup and the vacuum pump.
5. Statement of Intended Use
The Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap is a sterile, single use, device intended to be connected to an externally powered fetal vacuum extractor to aid in vaginal or Cesarean delivery of term or near term infants. The Fluid Retention Trap is intended to collect fluids aspirated during the delivery procedure.
6. Statement of Technological Characteristics of the Device
a. Laboratory Testing: The objective of the laboratory testing was to determine substantial equivalence of the Hollister Disposable Vacuum Assist Cup's Fluid Retention Trap to the predicate devices. Laboratory testing was performed to evaluate fluid handling capacity and resistance to air flow. The results of the laboratory testing support Hollister's claim of substantial equivalence to the predicate devices.
1
Image /page/1/Picture/0 description: The image shows the word "Hollister" in a serif font, with a symbol to the left of the word. The symbol is a geometric design that looks like a stylized flower or star. The text and symbol are in black and the background is white.
K98076
82092
Hollister Incorporated Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap
b. Biocompatibility: The biocompatibility for the Ameda Disposable Vacuum Assist Cup has been documented and cleared in previously submitted 510(k) K895700 "Ameda /Egnell Dolphin Dispo-Soft Vacuum Extractor." The biocompatibility of the Fluid Retention Trap was assessed based on principles and guidelines established by various governmental and standard setting organizations, such as: ISO 10993, International Standard Organization (ISO) Standard; General Program Memorandum #G95-1, U.S. FDA Office of Device Evaluation; United States Pharmacopeia (USP).
Material biocompatibility issues have been addressed based upon biomaterial history or in separate in vitro or in vivo laboratory evaluations using licensed commercial reference laboratories. These evaluations have been contracted either by Hollister or the suppliers of the materials.
Based upon the results of this assessment, the materials used to fabricate the Fluid Retention Trap are considered biocompatible and appropriate for their intended use.
c. Comparison to Predicate Devices: The Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap is substantially equivalent to other devices that are in commercial distribution. This is based on the following:
· The Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap is substantially equivalent in its intended use as a fetal vacuum extractor as described in 21 CFR 884.4340.
· The predicate device, the Ameda Dolphin Dispo-Soft Vacuum Extractor, K895700 and the proposed device are identical in intended use, materials, and manufacturing processes with the exception of the addition of the fluid retention trap option on the proposed device.
· The predicate devices, the Mityvac Extractor Cup System by Neward Enterprises, Inc., and the Tender Touch by Columbia Medical Inc.; and the proposed device are identical in intended use. The predicate and proposed devices include fluid collection capabilities.
7. Conclusion
Based upon the information presented above it is concluded that the proposed Ameda Vacuum Assist Cup with Fluid Retention Trap is safe and effective for its intended use and is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized representation of three human figures, with their heads connected and bodies flowing into each other. The figures are depicted in black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K980976
Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap Dated: July 29, 1998 Received: July 30, 1998 Regulatory Class: II 21 CFR 884.4340/Procode: 85 HDB
Dear Mr. Tokarz:
AUG 21 1998
Mr. Joseph S. Takarz
Hollister Incorporated
Libertyville, IL 60048
2000 Hollister Drive
Manager, Regulatory Affairs
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 Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning 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 542 of the Act for devices under the Electronic Product 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/dsmadsmamain.html".
Sincerely yours.
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
3
Hollister Incorporated Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap
Statement of Indications for Use b.
510(k) Number (if Known): _ K980976 Ameda Disposable Vacuum Assist Cup w/ Fluid Retention Trap Device Name:
The Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap is a sterile, single use, device intended to be connected to an externally powered fetal vacuum extractor to aid in vaginal or Cesarean delivery of term or near term infants. The Fluid Retention Trap is intended to collect fluids aspirated during the delivery procedure.
Indications For Use:
- Delay in second stage with the fetal head stationed at the outlet; on the pelvic floor; or in the . mid-pelvis.
- Delay in the second stage associated with borderline cephalopelvic disproportion .
- Fetal distress .
- Shortening of second stage labor for fetal or maternal benefit .
- Prolapse of the umbilical cord when the cervix is fully dilated ●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter-Use (Optional Format 1-2-96)
Robert D. Salling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K980976