(60 days)
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on a mechanical modification (CO2 canister vs. hand pump).
Yes
The device is intended to assist in the delivery of an infant during childbirth, which directly addresses a physiological condition (childbirth) and aids in the therapeutic outcome of a successful delivery.
No.
The device is intended to assist a clinician in the delivery of an infant during childbirth, which is a therapeutic or assistive function, not a diagnostic one.
No
The device description explicitly states it is a "System" and describes hardware components like a CO2 canister and vacuum cups, indicating it is not software-only.
Based on the provided information, the Mityvac® Merlin™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "assist a clinician in the delivery of an infant during childbirth." This is a direct medical intervention on a patient, not a test performed on a sample taken from the body.
- Device Description: The device is described as a vacuum assist delivery system, which is a mechanical tool used during labor and delivery.
- Lack of IVD Characteristics: The description 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 Mityvac® Merlin™ is a medical device used for a therapeutic/assistive purpose during childbirth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Merlin™ System and the MityOne™ System are intended to be used to facilitate the delivery of the fetus during childbirth. These devices are indicated for use during vaginal delivery and caesarean sections. Thus, Merlin™ and MityOne™ have the same intended use and the same indications.
Prism Enterprises, Inc.'s Mityvac® Merlin™ is intended to be utilized to assist a clinician in the delivery of an infant during childbirth. This device is indicated for use during vaginal delivery and Cesarean sections.
Product codes
HDB
Device Description
The Mityvac® Merlin™ System is a modification of the cleared Mityvac® MityOne™ System with M-Style® or MitySoft® Bell Cups (K011532). The primary difference between the Mityvac® Merlin™ System and the MityOne™ System is that the Merlin™ System utilizes a CO2 canister to create the energy for vacuum, while the MityOne™ uses a builtin hand driven pump as the energy source. This difference does not raise new questions of safety or effectiveness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fetus' scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician during 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
APR 1 2 2002
Attachment 9
510(k) SUMMARY FOR PRISM ENTERPRISES LP MITYVAC® MERLIN™ Vacuum Assist Delivery System
Submitter's Name, Address, Telephone Number, and Contact Person
Prism Enterprises LP 6952 Fairgrounds Parkway San Antonio, TX 78238-4528
| Contact: | Frances D. Menard |
|---|---|
| Prism Enterprises LP | |
| Phone: | (210) 256-3113 |
| Facsimile: | (210) 509-7463 |
Merle M. Smith or Prism Enterprises LP (210) 520-8051 (210) 520-8039
Date Prepared
February 8, 2002
Name of the Device
Mityvac® Merlin™
Common or Usual Name
Obstetrical Vacuum Assist Delivery System
Classification Name
Fetal Vacuum Extractor (21 C.F.R. § 884.4340)
Product Code
HDB
Predicate Devices
The Mityvac® Merlin™ System is a modification of the Mityvac® MityOne™ Obstetrical Vacuum Assist Delivery System with M-Style® or MitySoft® ("MityOne™").
1
Intended Use
The Merlin™ System and the MityOne™ System are intended to be used to facilitate the delivery of the fetus during childbirth. These devices are indicated for use during vaginal delivery and caesarean sections. Thus, Merlin™ and MityOne™ have the same intended use and the same indications.
2
Principles of Operation
The Mityvac® Merlin™ and MityOne™ combine the cup and pump into one unit that allows one clinician to operate the system without an assistant. First, the user opens the sterile package and removes the Merlin™. Next, the user checks the integrity of the system by pressing the cup to the palm of a gloved hand and applying vacuum. Then, the user examines the fetus' presentation and position and inserts the extractor cup through the vaginal canal during vaginal delivery and through the transverse incision during caesarean delivery and attaches it to the flexion point on the fetus' scalp. After confirming that neither maternal tissue nor the placenta is under the cup, the user supplies the negative pressure and applies traction. The user releases vacuum pressure when either the fetus' head is delivered or the fetus' head has not been delivered but certain events have occurred. The user then removes the cup and discards the system per hospital protocol. Thus, the principles of operation of Mityvac® Merlin™ System and Mityvac MityOne™ System are very similar. The only difference in the principle of operation is that the user of the Merlin™ must puncture the device's Carbon Dioxide ("CO2") canister to activate its pressure source.
Technical Characteristics
The Mityvac® Merlin™ System is a modification of the cleared Mityvac® MityOne™ System with M-Style® or MitySoft® Bell Cups (K011532). The primary difference between the Mityvac® Merlin™ System and the MityOne™ System is that the Merlin™ System utilizes a CO2 canister to create the energy for vacuum, while the MityOne™ uses a builtin hand driven pump as the energy source. This difference does not raise new questions of safety or effectiveness.
Summary Basis for the Finding of Substantial Equivalence
The FDA has granted 510(k) clearance to the MityOne™. Merlin™ has the same intended use and indications and very similar principles of operation and technological characteristics as the predicate device. Therefore, Merlin™ is substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2002
Prism Enterprises, Inc. % Mr. Howard M. Holstein Partner Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004-1109 Re: K020447 Trade/Device Name: MityVac Merlin, Model 10027 Obstetrical Vacuum Cup Regulation Number: 21 CFR 884.4340 Regulation Name: Fetal Vacuum Extractor Regulatory Class: II Product Code: 85 HDB Dated: March 15, 2002 Received: March 15, 2002
Dear Mr. Holstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_KΩΩΟ 447
Device Name: Prism Enterprises, Inc.'s Mityvac® Merlin™
Indications for Use: Prism Enterprises, Inc.'s Mityvac® Merlin™ is intended to be utilized to assist a clinician in the delivery of an infant during childbirth. This device is indicated for use during vaginal delivery and Cesarean sections.
(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 C.F.R. 801.109)
OR
Over-The-Counter Use_
Nancy C. Gordon
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K020447
510(k) Number
\\DC - 62868/1 - #1489299 v1