The Nurture Rest (including models 100-1-C) is indicated for premature infants undergoing oxygen therapy to maintain an airway and for whom treatment may be facilitated by this repositioning and stabilization device. The premature infants are being continuously monitored for oxygen saturation levels and heart rate in the Neonatal Intensive Care Unit (NICU) by medical professionals.

Device Description

Nurture Rest is an infant sleep positioning device used by medical staff to position and secure premature infants in a prone, supine, or side position to limit mobility within an incubator in the neonatal intensive care unit (NICU). The Nurture Rest is shaped like the female anatomy in order to encourage a "Kangaroo Care" style positioning technique that mimics being held against a female body/chest while also keeping the infant's head, neck, and spine aligned. This device gives nurses a useful tool in their daily role of repositioning and caring for these special premature infants. The infants for whom the device is used are undergoing oxygen therapy to maintain an airway (intubation, nasal CPAP, bubble CPAP, high flow nasal cannula, or nasal cannula) and are continuously monitored for oxygen saturation levels and heart rate. The Nurture Rest consists of a washable, flame-retardant cloth material.

There are two models of the device (Models 100-1-O and 100-2-C). Both devices are appropriate for prone, supine and side positioning of premature infants. One model of the device (Model 100-1-O) has customizable opening at the head to allow for prone face-down positioning of micro-preemies for whom positioning with the head turned to the side would increase the chance of hemorrhaging due to increased intracranial pressure. The other model (Model 100-2-C) does not have an opening and is for prone with head turned positioning. The device comes with pillows to help stabilize the infant and swaddling straps to minimize motion of the arms and body of the infant. As with standard NICU practices, the Nurture Rest enables the infant to be re-positioned and treated as needed (typically every 4 to 6 hours), which allows NICU staff to cluster care in order to let the infants rest and grow in between physical and emotional stimulation.

AI/ML Overview

The Nurture Rest device is a pediatric position holder for premature infants in the Neonatal Intensive Care Unit (NICU). Below is a summary of its acceptance criteria and the study that proves the device meets them.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Functionality	Device is able to position an infant within the NICU.	Bench top testing: "In all instances, the Nurture Rest functioned as intended and all test results observed were as expected." & Usability Testing: "This study demonstrated that the device was successfully able to be used to position, align and retain a doll which was representative of actual premature patients, and therefore, meet the intended use."
Usability	NICU nurses can safely and effectively use the Nurture Rest as intended, including positioning of infant patients and care/maintenance of the device.	Summative Usability Testing: "The goal of the study was to ensure that NICU nurses can safely and effectively use the Nurture Rest as intended. The simulated use study focused on all anticipated interactions of the intended users with the device including positioning of infant patients (micro-preemie) using the Nurture Rest as well as care and maintenance of the device. This study demonstrated that the device was successfully able to be used to position, align and retain a doll..."
Biocompatibility	Materials are non-cytotoxic, non-irritating, and non-sensitizing.	Biocompatibility testing (per ISO 10993-1 surface contact testing): "The Nurture Rest was found to be non-cytotoxic, a non-irritant and did not elicit a sensitization response."
Durability	The product's shape shall still enable a user to position a Preemie doll per the instructions for use after 4 weeks of use.	Durability Testing: Demonstrated that the product's shape enabled a user to position a Preemie doll per IFU after 4 weeks of use.
Material Properties	Coefficient of Friction is comparable to other products in contact with patient skin in the NICU. Bioburden is comparable to other items in contact with patient skin in the NICU.	Coefficient Friction Testing: Performed to demonstrate comparability. Bioburden Testing: Performed to ensure comparability.
Storage & Packaging	The packaged device can withstand worst-case storage and shipping scenarios.	Storage testing: Performed to ensure the packaged device could withstand worst-case storage scenarios. Packaging and ship testing: Performed to ensure the packaged device could withstand worst-case shipping scenarios.

2. Sample Size and Data Provenance for Test Set

Sample Size for Test Set: The document does not specify a numerical sample size for "test sets" in the traditional sense, as the studies primarily involve bench, simulated, and material testing.
- For the bench top and usability testing, the 'sample' involved the "Nurture Rest" device itself and a "doll which was representative of actual premature patients." The number of devices or dolls tested is not explicitly stated.
- For biocompatibility, durability, coefficient friction, bioburden, storage, and packaging/ship testing, the 'sample' refers to units of the Nurture Rest device. The specific number of units tested is not provided.
Data Provenance: Not explicitly stated as retrospective or prospective data from human subjects. The studies are primarily lab-based (bench, simulated, material testing) and do not involve data from patients. The testing was conducted by Neonatal Loving Kare, Inc. or their contracted labs. The country of origin of the data is not specified but implicitly within the US given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This information is not applicable or not provided in the document. The ground truth for the performance tests was established by objective measurements and functional assessments against predetermined criteria, rather than expert consensus on diagnostic interpretations or outcomes. For usability, the study involved "NICU nurses," but the number and their specific qualifications (e.g., years of experience) beyond being NICU nurses are not detailed.

4. Adjudication Method for Test Set

Not applicable. The reported studies are primarily objective performance, usability, and material tests, not clinical evaluations requiring adjudication of subjective assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. The device is a physical pediatric position holder, not an AI or diagnostic imaging device that would typically undergo such a study. The document describes a comparison to a predicate device primarily based on technological characteristics and intended use, not a comparative clinical effectiveness study against human performance.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device, not an algorithm or software. Therefore, a standalone (algorithm only) performance study is not applicable.

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria was based on:

Objective functional performance: Whether the device could physically position and retain a representative doll (simulated use).
Material properties standards: Adherence to biocompatibility standards (ISO 10993-1) and comparison of properties like coefficient of friction and bioburden to existing NICU standards/products.
Usability observation: Direct observation and assessment of NICU nurses using the device during simulated scenarios to confirm safe and effective use.
Durability and integrity standards: Confirmation that the device maintains its form and function over time and through transport.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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January 18, 2018

Neonatal Loving Kare, Inc. % Nicole Spaniel Principal Specialist Regulatory and Quality Solutions, Inc. 2790 Mosside Blvd #800 Monroeville, Pennsylvania 15146

Re: K172962

Trade/Device Name: Nurture Rest Regulation Number: 21 CFR 880.5680 Regulation Name: Pediatric Position Holder Regulatory Class: Class I Product Code: OUW Dated: December 20, 2017 Received: December 22, 2017

Dear Nicole Spaniel:

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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tina
Kiang-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172962

Device Name

Nurture Rest

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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510(k) SUMMARY K172962

Neonatal Loving Kare's Nurture Rest

Sponsor: Neonatal Loving Kare, Inc. 1702 Treasure Lake DuBois, PA 15801
Applicant: Nicole Sawyers, President Neonatal Loving Kare, Inc. 1702 Treasure Lake DuBois, PA 15801 Phone: 814-590-4519
Contact Person: Niki Spaniel, RAC, Regulatory Correspondent R&Q Solutions, Inc. Phone: 724-681-6050

Date Prepared: January 4, 2018

Regulation and Classification Information:

	Subject Device	Predicate Device
Proprietary Name:	Nurture Rest	RES-Q Infant Wedge & Sling
Manufacturer	Neonatal Loving Kare, Inc.	CR Enterprises, LLC
Common Name:	Pediatric Position Holder	Pediatric Position Holder
Classification Name:	Infant Positioner, Rx, UseMonitoredHighlylnSetting
Classification:	Class 1	Class 1
Classification Panel:	General Hospital:	General Hospital:
Regulation Number:	21 CFR §880.5680	21 CFR §880.5680
Product Code:	OUW	FRP
510(k) Number:	K161983	K090284

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Device Description

Intended Use

The Nurture Rest is intended for the positioning of premature infants who are in the Neonatal Intensive Care Unit (NICU).

Indications for Use

Contraindications: The Nurture Rest is contraindicated for the following:

Healthy, stable neonate
Home use;
Use in the prone position for any patient having an umbilical or venous line; ●
Use on infants who are not on oxygen therapy to maintain an airway;
Use on an infant who is not being continuously monitored for oxygen saturation levels and heart rate;
Use under radiant warmer systems may present overheating issues
Do not use with phototherapy systems

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Technological Characteristics of the Nurture Rest

The Nurture Rest allows professional caregivers to place and hold infants in the prone, side and supine positions (developmental care) to provide comfort to premature infants in the NICU. It contains bindings and enclosures to safely hold the infant in position. See Table 1 for a comparison between the predicate and subject device.

The Nurture Rest consists of

One Nurture Rest Positioning aid (open/face-down version or closed version)
Two small pillows for assisting in positioning infant
Swaddling straps (two in the closed model, three straps for the face-down version
. Bendy bar for face down version
Boundary pocket at bottom of Nurture Rest for infant's feet and legs ●

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	PREDICATE DEVICE	SUBJECT DEVICE:
	RES-Q Infant Wedge & Sling	Nurture Rest
DEVICE IMAGE		Model 100-1-OModel 100-1-C©Neonatal Loving Kare 2016
MANUFACTURER	CR Enterprises, LLC	Neonatal Loving Kare, Inc
REGULATIONNUMBER	880.5680	880.5680
REGULATIONMEDICAL SPECIALTY	General Hospital	General Hospital
REVIEW PANEL	General Hospital	General Hospital
FDA PRODUCT CODE	FRP	OUW
CLASSIFICATION	1	1
GMP Exempt	Yes	No
REGULATIONDESCRIPTION	Pediatric Position Holder	Pediatric Position Holder
	PREDICATE DEVICE	SUBJECT DEVICE:
	RES-Q Infant Wedge & Sling	Nurture Rest
INTENDED USE	The RES-Q Infant Wedge & Slingis designed to allow babies 0-12months with gastro-esophagealreflux to rest comfortably in asemi-upright position; it is used forsleeping and playtime in supine,prone, and side-lying positions.	The Nurture Rest is intended for thepositioning of premature infants whoare in the Neonatal Intensive CareUnit (NICU).
INDICATIONSFORUSE	The RES-Q Infant Wedge & Slingis designed to allow babies 0-12months with gastroesophagealreflux to rest comfortably in asemi-upright position; it is used forsleeping and playtime in supine,prone, and side-lying positions.	The Nurture Rest, Models (includingmodels 100-1-O and 100-21-C,) isindicated for premature infantsundergoing oxygen therapy to maintainan airway and for whom treatment maybe facilitated by this repositioning andstabilization device. The prematureinfants are being continuouslymonitored for oxygen saturation levelsand heart rate in the NeonatalIntensive Care Unit (NICU) by medicalprofessionals.
CONTRA-INDICATIONSFORUSE	Unknown	Contraindications: The Nurture Rest iscontraindicated for the following:Healthy, stable neonate Home use; Use in the prone position for any patient having an umbilical or venous line; Use on infants who are not on oxygen therapy to maintain an airway; Use on an infant who is not being continuously monitored for oxygen saturation levels and heart rate; Use under radiant warmer systems may present overheating issues; Do not use with phototherapy systems..
	PREDICATE DEVICE	SUBJECT DEVICE:
	RES-Q Infant Wedge & Sling	Nurture Rest
PHYSICALDESCRIPTION	Washable and reusable vinyl-covered foam wedge that has abibbed cotton sling that isattached with Velcro and holdsthe infant.	Nurture Rest consists of a washable,flame-retardant cotton flannel clothmaterial that is filled with a polyesterbatting. It provides cushionedsupport. It contains swaddling strapsand a pocket to hold the infant.
INTENDEDENVIRONMENT FORUSE	Hospital and Home Use, In crib	Prescription Use in a NeonatalIntensive Care Unit (NICU)environment, in crib or isolette.
PATIENTPOPULATION	Infants (premature and term) 0-12with gastro-esophageal reflux	Premature infants in NICU who areon oxygen therapy to maintain anairway, and are continuouslymonitored for oxygen saturationlevels and heart rate
TECHNOLOGY	Prone and Supine positioning tobenefit conditions associated withpremature and full term infants inthe NICU, hospital or home.	Prone, Side and Supine positioning(developmental care) to providecomfort to premature infants in theNICU.
BIOCOMPATIBILITY	Unknown	ISO 10993-1 surface contact testing
STERILITY	Non-sterile	Non-sterile
SINGLE USE	No	No
SINGLE PATIENT USE	Unknown	Yes

Table 1: Predicate and Subject Device Comparison Table

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Comparison Discussion of Predicate and Subject Devices

Technological Characteristics

Both the Nurture Rest and the RES-Q-Wedge use an orthopedic positioning pillow/mattress technology. The device technology consists of a soft interior housed by an exterior fabric which supports the weight of an infant during rest. Both devices use a "nesting" technology to provide boundaries and containment in order to facilitate good musculoskeletal alignment during rest and during developmental care positioning. The fabric of the Nurture Rest and the fabric that is used in the RES-Q-Wedge sling are both cotton fabrics.

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The Nurture Rest technological characteristics differ from those of the RES-Q-Wedge in the shape of the device, the absence of the sling, as well as the exterior fabric as detailed below:

The RES-Q-Wedge technology is based on a firm wedge-shaped design that contains a sling into which the infant is secured. Due to the angle and density of the wedge, a sling is required to hold or "nest" the infant in place and maintain the angle of elevation. The RES-Q-Wedge is also intended to be reversible with the backside used during "tummy time," whereby an infant is placed in the prone position in order to build neck and arm muscles.

The Nurture Rest is indicated only for use on premature infants who are being cared for in the NICU environment and who are being monitored for heart rate and oxygen saturation 24/7. The Nurture Rest does not have an indication for "tummy time" or any home use, in fact home use is contraindicated for the Nurture Rest. Summative Usability Testing was performed via simulated use. This study demonstrated that the device was successfully able to be used to position, align and retain a doll which was representative of actual premature patients, and therefore, meet the intended use. Despite the differences in the indications for use, the subject device has demonstrated to be substantially equivalent to the predicate device.

Performance Data

Bench top testing was performed to confirm that the device is able to position an infant within the NICU. In all instances, the Nurture Rest functioned as intended and all test results observed were as expected.

Usability Testing was conducted to demonstrate that the intended user group could successfully use the device after watching the training DVD and reading the instructions for use. The summative usability study was completed to evaluate the usability of the Nurture Rest. The goal of the study was to ensure that NICU nurses can safely and effectively use the Nurture Rest as intended. The simulated use study focused on all anticipated interactions of the intended users with the device including positioning of infant patients (micro-preemie) using the Nurture Rest as well as care and maintenance of the device. This study demonstrated that the device was successfully able to be used to position, align and retain a doll which was representative of actual premature patients, and therefore, meet the intended use.

Biocompatibility testing was performed on the Nurture Rest to demonstrate that the materials are considered non-cytotoxic, non-irritating, and non-sensitizing. For characterization only, microbial testing was performed on the Nurture Rest to determine the bioburden of the device. The Nurture Rest was found to be non-cytotoxic, a non-irritant and did not elicit a sensitization response.

Durability Testing was performed to demonstrate that the product's shape shall still enable a user to position a Preemie doll per the instructions for use after 4 weeks of use.

Coefficient Friction Testing was performed to demonstrate that the Nurture Rest is comparable to other products that come into contact with patient skin in the NICU.

Bioburden Testing was performed to ensure that the Nurture Rest is comparable to other items that come into contact with patient skin in the NICU.

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Storage testing was performed to ensure that the packaged device could withstand worst case storage scenarios.

Packaging and ship testing was performed to ensure that the packaged device could withstand worst case shipping scenarios.

Conclusion

Based on the intended use, technological characteristics and performance testing, the subject device has demonstrated to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5680 Pediatric position holder.

Link to an amendment published at 90 FR 55987, Dec. 4, 2025. (a)
Identification. A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.(b)
Classification. Class I (general controls). Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is exempt from the good manufacturing practice regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.