The Pacifier Activated Lullaby (PAL®) encourages and reinforces effective non-nutritive sucking of premature infants. This is accomplished by giving positive feedback to the infant in the form of music or a mother's voice as auditory input in direct response to sucking.

Device Description

The Pacifier Activated Lullaby ("PAL®") has a player module, pacifier sensor module and power supply. The pacifier sensor module senses the strength and duration of an infant's sucking on an attached pacifier and responds with music or a recorded sound (i.e. mother's voice) contingent to the infant's sucking. The pacifier module consists of a wired transmitter with a built in pressure transducer that connects to the pacifier and a receiver. The receiver decodes the signal and plays music or a recorded sound for a predetermined length of time via a speaker to the infant contingent on his/her sucking on the pacifier transmitter. This action occurs when the sucking strength and duration exceeds preset values. The user can control the sensitivity of the transducer.

This application describes modifications to the FDA cleared K010388 P.A.L. System.

AI/ML Overview

The provided document does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the way typically expected for clinical performance evaluation (e.g., sensitivity, specificity, accuracy against a ground truth).

This document is a 510(k) Premarket Notification for the Pacifier Activated Lullaby (PAL®). Its primary purpose is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), not to prove clinical efficacy or accuracy against specific performance metrics with a clinical study.

The "Performance Testing" section (I) lists several types of engineering and compliance tests, but these are related to software, electrical safety, electromagnetic compatibility, and physical stability, rather than clinical performance for its stated indication. The document explicitly states: "Differences do not raise different issues of safety or performance, and issues of safety are assessed in the risk analysis. The Pacifier Activated Lullaby (PAL®) is expected to perform per its Indications for Use and is substantially equivalent to the predicate device."

Therefore, I cannot populate the table or answer the other questions as the information is not present in the provided text. The document focuses on regulatory compliance and substantial equivalence, not a clinical study proving specific performance criteria.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2015

Powers Medical Devices, LLC % Sharyn Orton, Ph.D. Senior Consultant MEDIcept, Inc, 200 Homer Avenue Ashland, Massachusetts 01721

Re: K151050

Trade/Device Name: Pacifier Activated Lullaby (PAL®) Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback device Regulatory Class: Class II Product Code: HCC Dated: November 24, 2015 Received: November 25, 2015

Dear Sharyn Orton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Part 807); labeling (Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

William J. Heetderks -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151050

Device Name Pacifier Activated Lullaby ("PAL®")

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Summary as required by 21 CFR 807.92(a) K151050

A ) Submitted by:		Powers Medical Devices, LLC1615 S. Congress Ave, Ste 13Delray Beach, FL 33445
Official Contact:		Patricia Palmer, CEOPowers Medical Devices
Date prepared:		November 21, 2015
B)	Device Name:	Device, Biofeedback
	Proprietary Name:	Pacifier Activated Lullaby (“PAL®”)
	Device Class:	Class II
	Regulation number:	21 CFR 882.5050
	Regulation name:	Biofeedback device
	Product code:	HCC
	Classification panel:	General & Plastic Surgery

C) Predicate: K010388 P.A.L. System Ohmeda Medical

D) Device Description:

This application describes modifications to the FDA cleared K010388 P.A.L. System.

E) Indications For Use:

The Pacifier Activated Lullaby (PAL®) encourages and reinforces effective non-nutritive sucking of premature infants. This is accomplished by giving positive feedback to the infant in the form of music or mother's voice as auditory input in direct response to sucking.

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F) Substantial Equivalence Comparison and Discussion
The Pacifier Activated Lullaby (PAL®) has the same Indications for Use and basic functionality as the predicate device. Modifications to the device include changes to the speaker configuration and pacifier to control unit transmitter and associated software changes, as well as technology updates. Differences do not raise different issues of safety or performance, and issues of safety are assessed in the risk analysis. The Pacifier Activated Lullaby (PAL®) is expected to perform per its Indications for Use and is substantially equivalent to the predicate device.

G) Biocompatibility

All patient contacting materials used in the PAL are biocompatible

H) Sterilization and reprocessing

NA - No component is provided sterile and the pacifier sensor module is single use, disposable.

I) Performance Testing

Performance testing included the following:

Software verification and validation ●
Electrical/EMC ●
PAL unit stability and sensor wire positioning ●

Compliance with the following standards, regulations or guidelines:

AAMI ES 60601-1, 2005/(R) 2012 and A2: 2010/(R)2012: Medical Electrical Equipment ●
IEC 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety ● and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
FCC Part 15 Subpart B ●
ICES-003 Issue 4 for a Class B Device Digital apparatus ●
ISTA-6 Testing Packaging Product Weighing up to 150 lbs

Conclusion

The Pacifier Activated Lullaby (PAL®) performs per its Indications for Use and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.5050 Biofeedback device.

(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.