(246 days)
Not Found
No
The device description details a system that responds to sucking based on preset values and user-controlled sensitivity, without mentioning any learning or adaptive algorithms.
Yes
The device is described as encouraging and reinforcing effective non-nutritive sucking in premature infants by providing positive feedback in the form of music or a mother's voice, which directly addresses a physiological need or behavior for therapeutic benefit.
No
The device is designed to encourage and reinforce non-nutritive sucking in premature infants by providing auditory feedback. It does not collect medical data, analyze or interpret physiological signals for diagnostic purposes, nor does it identify or monitor any disease, condition, or injury.
No
The device description explicitly mentions hardware components such as a player module, pacifier sensor module (with a wired transmitter, pressure transducer, and receiver), power supply, and speaker. The performance studies also include electrical/EMC testing and PAL unit stability and sensor wire positioning, which are related to hardware.
Based on the provided information, the Pacifier Activated Lullaby (PAL®) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The PAL® device interacts directly with the infant through a pacifier and auditory input. It does not analyze any biological samples (like blood, urine, tissue, etc.).
- The intended use and device description clearly outline a behavioral intervention. The device encourages and reinforces sucking behavior through contingent auditory feedback. This is a therapeutic or developmental intervention, not a diagnostic test performed on a specimen.
The description focuses on the device's mechanical and electronic functions in response to the infant's sucking, not on analyzing biological markers or substances.
N/A
Intended Use / 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 a mother's voice as auditory input in direct response to sucking.
Product codes
HCC
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.
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
premature 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)
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
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, composed of multiple curved lines.
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
1
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
2
Indications for Use
510(k) Number (if known) K151050
Device Name Pacifier Activated Lullaby ("PAL®")
Indications for Use (Describe)
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.
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, LLC
1615 S. Congress Ave, Ste 13
Delray Beach, FL 33445 |
|-------------------|-----------------------|---------------------------------------------------------------------------------------|
| Official Contact: | | Patricia Palmer, CEO
Powers 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:
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.
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.
4
- 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.