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.

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.

AI/ML Overview

Let's break down the information about the Mityvac® Merlin™ Vacuum Assist Delivery System based on the provided document.

Acceptance Criteria and Device Performance

The provided document (K020447) is a 510(k) summary for a medical device. In this context, "acceptance criteria" and "device performance" are typically evaluated by establishing substantial equivalence to a predicate device, rather than explicit numerical performance metrics like sensitivity/specificity for a diagnostic AI model.

The core acceptance criterion for a 510(k) device is demonstrating that the new device is substantially equivalent in intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance (Summary Basis for Finding)
Intended Use: Device has the same intended use as the predicate device.	The Merlin™ System and the MityOne™ System have the same intended use (to facilitate the delivery of the fetus during childbirth) and the same indications (for use during vaginal delivery and caesarean sections).
Indications for Use: Device has the same indications for use as the predicate device.	The Merlin™ System and the MityOne™ System have the same intended use and same indications.
Technological Characteristics: Device has similar technological characteristics to the predicate device, or if there are differences, those differences do not raise new questions of safety or effectiveness.	The primary difference is that the Merlin™ uses a CO2 canister for vacuum, while the MityOne™ uses a built-in hand pump. This difference "does not raise new questions of safety or effectiveness." The principles of operation are "very similar," with the only difference being the activation of the CO2 canister.
Safety and Effectiveness: Data demonstrates the device is as safe and effective as the predicate device, or that any differences in technological characteristics do not raise new questions of safety or effectiveness. (This is generally inferred from the above points for 510(k)s, rather than requiring extensive clinical trials for a modified device).	The document states, "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." This implicitly means it is considered as safe and effective as the predicate.

2. Sample size used for the test set and the data provenance:

Not applicable (N/A). This 510(k) submission for the Mityvac® Merlin™ is for a physical medical device (obstetrical vacuum assist delivery system), not an AI/ML-based device that would typically rely on a "test set" of data for performance evaluation in the way an AI model does.
The evaluation is based on a comparison of the device's design, intended use, and technological characteristics to an existing predicate device (Mityvac® MityOne™). No specific patient "data" or "test set" in the computational sense is mentioned or implied.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. As explained above, this is not an AI/ML device, so there is no "ground truth" established by experts for a test set in this context. The FDA's review process itself involves expert evaluation by their staff, but this is an regulatory assessment, not a ground-truth labeling process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

N/A. No test set or associated adjudication is relevant to this type of device submission.

5. 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:

N/A. This is a physical medical device, not an AI-assisted diagnostic or treatment device. Therefore, an MRMC study is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

N/A. This is a physical medical device; there is no "algorithm" or "standalone" performance in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

N/A. For this device, the "ground truth" for demonstrating safety and effectiveness relies on the legally marketed status and established safety/effectiveness profile of the predicate device (Mityvac® MityOne™). The manufacturer demonstrates that the new device is fundamentally similar and does not introduce new risks.

8. The sample size for the training set:

N/A. No training set is relevant for this type of device.

9. How the ground truth for the training set was established:

N/A. No training set is relevant for this type of device.

In summary, the provided document outlines a 510(k) submission for a physical medical device, not an AI/ML device. Therefore, many of the requested details concerning test sets, ground truth, experts, and AI-specific studies are not applicable to this type of regulatory submission. The device's "performance" and "acceptance" are determined through its substantial equivalence to a legally marketed predicate device based on its intended use and technological characteristics, as reviewed by the FDA.

Summary

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K020447

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™").

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K020447

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.

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

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.

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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.

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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

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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)

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

Regulation Number and Section

§ 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).