(169 days)
To facilitate delivery of a fetus during vaginal deliver
Prism's Mityvac and Gesco's Vac-U-Nate consist primarily of the following components: (1) a suction cup and shaft; and (2) handle and valve assemblies. Each device's cup and shaft have a positioning reference printed on them and the shaft has three molded ridges on it. Both devices have the same components. These components are composed of the same materials and processed in the same manner.
This is a 510(k) premarket notification for a medical device called Mityvac, an obstetrical vacuum cup. The submission aims to demonstrate substantial equivalence to a predicate device, Gesco International, Inc.'s Vac-U-Nate. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving device performance is not typically found in this type of submission.
Here's why and what information is available:
This document describes a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study in the way you've outlined.
In a 510(k), the manufacturer argues that their new device is as safe and effective as a legally marketed predicate device. This is achieved by comparing the intended use, technological characteristics, and principles of operation. Clinical studies to establish new safety and effectiveness (and thus, acceptance criteria and performance data) are usually required for Premarket Approval (PMA) applications, which are for higher-risk devices or those without a substantially equivalent predicate.
Therefore, for this specific document:
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A table of acceptance criteria and the reported device performance: Not applicable. The document does not define specific performance acceptance criteria for the Mityvac, nor does it report performance data from a study designed to meet such criteria. It states that the Mityvac has the "same intended use and very similar indications, principles of operation, and technological characteristics" as the predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no test set or associated data mentioned for a novel performance study.
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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, as there is no specific test set requiring expert ground truth establishment mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 a physical obstetrical vacuum cup, not an AI or imaging device with "readers."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the context of device performance studies is not relevant to this 510(k) submission.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
What the document does provide in lieu of a performance study is a "Summary Basis for the Finding of Substantial Equivalence":
- Comparison to Predicate Device:
- Intended Use: Identical to the predicate device (Gesco's Vac-U-Nate) for facilitating fetal delivery during vaginal childbirth.
- Indications for Use: Mityvac's only indication (vaginal delivery) is the same as one of the predicate device's indications.
- Principles of Operation: Identical (connection to vacuum, cup insertion, attachment to fetal scalp, negative pressure application, traction, release/removal).
- Technical Characteristics: Consist of the same primary components (suction cup, shaft, handle, valve assemblies), which are composed of the same materials and processed in the same manner.
This approach demonstrates that because the Mityvac is so similar to a device already deemed safe and effective, it can also be considered safe and effective without requiring a new, extensive clinical trial.
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JUL - 9 1998
PION
510(k) SUMMARY FOR PRISM TECHNOLOGIES, INC.'S MITYVAC
Submitter's Name, Address, Telephone Number, And Contact Person
Prism Technologies, Inc. 6952 Fairgrounds Parkway San Antonio, Texas 78238
| Contact: | Howard M. Holstein | or | Merle M. Smith |
|---|---|---|---|
| Hogan & Hartson, L.L.P. | Prism Technologies, Inc. | ||
| Phone: | (202) 637-5813 | (210) 520-8051 | |
| Facsimile: | (202) 637-5910 | (210) 520-8039 |
Date Prepared
July 7, 1998
Name of the Device
Mityvac
Common or Usual Name
Obstetrical Vacuum Cup
Classification Name
Fetal Vacuum Extractor (21 C.F.R. § 884.4340)
Product Code
HDB
Predicate Device
Gesco International, Inc.'s Vac-U-Nate
\\DC - 62868/] - 0680117.01
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Intended Use
Prism Technologies, Inc. ("Prism") Mityvac and Gesco International, Inc.'s ("Gesco") Vac-U-Nate are intended to be used to facilitate the delivery of the fetus during childbirth. Both devices are indicated for use during vaginal delivery. The Vac-U-Nate is also indicated for use during caesarean delivery with a transverse incision only. Thus, Prism's Mityvac has the same intended use and as Vac-U-Nate and the Mityvac's only indication is the same as one of this predicate device's indications.
Principles of Operation
Prism's Mityvac and Gesco's Vac-U-Nate are connected to the hospital vacuum or a hand-held vacuum pump using the appropriate regulator. Next, the suction cup is inserted through the vaginal canal during vaginal delivery and attached to the fetus's scalp. After the user confirms that neither maternal tissue nor the placenta are under the cup, the negative pressure is supplied and the user applies traction. The vacuum pressure is released when either the fetus's head is delivered or the fetus's head has not been delivered but certain events have occurred. The user then removes the cup, discards the tubing, and cleans the device. Thus, the principles of operation of Prism's Mityvac and Gesco's Vac-U-Nate are identical.
Technical Characteristics
Prism's Mityvac and Gesco's Vac-U-Nate consist primarily of the following components: (1) a suction cup and shaft; and (2) handle and valve assemblies. Each device's cup and shaft have a positioning reference printed on them and the shaft has three molded ridges on it. Both devices have the same components. These components are composed of the same materials and processed in the same manner. Thus, Prism's Mityvac and Gesco's Vac-U-Nate have the same technological characteristics.
Summary Basis for the Finding of Substantial Equivalence
FDA has granted 510(k) clearance to Gesco's Vac-U-Nate. Prism's Mityvac has the same intended use and very similar indications, principles of operation, and technological characteristics as Gesco's Vac-U-Nate. Therefore, Prism's Mityvac is substantially equivalent to this legally marketed predicate device.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 1998
Prism Technologies, Inc. c/o Howard M. Holstein Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Re: K980212
Mityvac (Obstetrical Vacuum Cup) Dated: April 30, 1998 Received: April 30, 1998 Regulatory Class: II 21 CFR 884.4340/Procode: 85 HDB
Dear Mr. Holstein:
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, 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 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 reguirements, 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/odrh/dsmadsmam.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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к980212 510(k) Number (if known): __
Prism Enterprises' Mityvac Device Name:
Indications For Use: To facilitate delivery of a fetus during vaginal deliver
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concerrence of CDRH, Office of Devise Evaluation (ODE)
Robert R. Satlming/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1980212 510(k) Number _
Prescription Use
X
(Per 21 CFR 801.109)
..
OR
Over-The-Counter Use
. .
(Optional Formal 1-2-90)
§ 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).