The Luma Wrap™ by Beevers Manufacturing & Supply, Inc./Salter Labs is a translucent, highly breathable, phototherapy-compatible, disposable infant swaddling blanket. It is made of spun bond polypropylene non-woven fabric that is more than 90% light-permeable. The Luma Wrap™ provides centered and comfortable boundaries to benefit many babies who exhaust themselves with their hyper-reactive, frantic movements while receiving phototherapy. The Luma Wrap™ is a stand-alone device and has no accessories. It is available in two designs: a square and a shape similar to baseball's home plate. A 2" strip of self-adhesive is an added optional convenience feature to assist the user in positioning the device by adhering two parts of the device together.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Luma Wrap™ device.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical efficacy or diagnostic accuracy for an AI/algorithm-driven device. Therefore, many of the typical AI study components like training sets, ground truth establishment for AI, expert adjudication, or MRMC studies are not applicable here.

Acceptance Criteria and Device Performance for Luma Wrap™

The Luma Wrap™ is a neonatal phototherapy unit (specifically, an infant swaddling blanket). The primary acceptance criteria revolve around its physical properties and performance in allowing phototherapy light to pass through, as well as its safety features.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Light Transmittance	Single layer light transmittance ≥ 92% (to demonstrate substantial equivalence to predicate which had ≥ 90%)	Single Layer: 92.0% - 97.7% (bench test findings) - Test 1 (Lab, Overhead LED): 92.0% - Test 2 (Lab, Overhead LED): 93.7% - Test 3 (Hospital, Overhead Halogen): 94.0% - Test 4 (Hospital, Beneath-the-infant Fluorescent): 97.7% Double- and Triple-Layers: "light transmittances are still quite high" (No specific numeric value provided, but implied to meet an unstated internal acceptance criteria given the overall conclusion of substantial equivalence).
Adhesive Pull Strength	Adhesive pull strength to meet performance specification (specific value not explicitly stated as an "acceptance criteria" but implied by meeting the spec)	On average, 200g (measured with a force gauge pulled perpendicular to the adhesive). This "met the performance specification."
Adhesive Cycling / Reliability	Adhesive could be opened and closed at least 20 times (to verify functionality)	Adhesive cycle test verified that the adhesive could be opened and closed at least 20 times.
Air Flow Resistance (Safety)	Did not exhibit substantial resistance to air flow at rates of 1-12 lpm (to ensure infant's breathing is not impaired if device covers nose/mouth).	For two layers of fabric with an air flow of 8 lpm, resistance was 0.066 mmH2O/sq cm. This "met the device's performance specification and confirmed that an infant's breathing is not impaired if the device slips over the infant's nose and/or mouth."

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

Sample Size: Not explicitly stated for each test. The light transmittance tests refer to "Test #" (1-4), suggesting multiple measurements were taken for each. The adhesive pull strength mentions "on average, 200g," implying multiple measurements. The adhesive cycle test is for "the adhesive" (singular, but refers to the general feature). Air flow resistance is a single reported value for "two layers of fabric."
Data Provenance: The tests were bench tests and performed in a laboratory and an empty hospital room. This is entirely simulation/controlled environment data, not patient-derived data.

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

This is not applicable. The device is not an AI/diagnostic device that relies on expert interpretation or ground truth establishment in a human sense. The "ground truth" here is the physical measurement of material properties (light transmittance, strength, air flow) using calibrated equipment.

4. Adjudication method for the test set

Not applicable, as this refers to expert review processes for AI/diagnostic outputs. The tests here are physical measurements.

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

Not applicable. This device is a physical product (a blanket), not an AI system. No MRMC study was performed.

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

Not applicable. This is not an algorithm/AI device. The "standalone" aspect refers to the device itself as a physical product, acting without human input for its core function (e.g., transmitting light). The tests performed are analogous to standalone performance tests of the physical properties.

7. The type of ground truth used

The ground truth used for these performance tests is objective physical measurement against established standards and specifications. For example, for light transmittance, it's the measured light passing through the material compared to the light without the material. For adhesive strength, it's the force required to pull it apart. For air flow, it's the measured resistance using specialized equipment.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. There is no training set for this physical device.

Summary

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

June 12, 2015

Salter labs Ms. Aurelia Brownridge Regulatory Associate 2365 Camino Vida Roble Carlsbad, CALIFORNIA 92011

Re: K142416

Trade/Device Name: Luma Wrap™ Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal phototherapy unit Regulatory Class: II Dated: May 12, 2015 Received: May 13, 2015

Dear Ms. Brownridge:

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 (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 (21 CFR Part 801), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Tina
Kiang-S

for Erin I. Keith, M.S. 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) K142416

Device Name Luma Wrap™

Indications for Use (Describe)

To swaddle infants during neonatal phototherapy in the hospital or home setting. Single patient use only.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Revised

K142416, 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.

I. SUBMITTER

Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011

Phone: (760) 795-7102 Fax: (760) 683-6797

Contact Person: Aurelia Brownridge, Regulatory Associate Date Summary Prepared: April 13, 2015

II. DEVICE

Proprietary Name: Luma Wrap™ Common Name: Phototherapy infant swaddling blanket Classification Name: Neonatal Phototherapy Unit Regulation Number: 880.5700 Regulatory Class: II Product Code: PDH

III. PREDICATE DEVICE

Little Angels Swaddling Blanket (K123411) This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

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IV. DEVICE DESCRIPTION

V. INTENDED USE / INDICATIONS FOR USE

To swaddle infants during neonatal phototherapy in the hospital or home setting. Single patient use only.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

As shown in Table 5-1, the Luma Wrap™ is similar to the predicate device with regards to intended use, indications for use, target patient population, clinical setting, material, skin contact duration, and single-layer light transmittance. The Luma Wrap™ has areas of fabric overlap after wrapping it around the infant. However, the Luma Wrap™ also has a slightly higher single-layer light transmittance and the light transmittances are still quite high for double- and triple-layers of Luma Wrap™ fabric. Furthermore, the Luma Wrap™ Instructions for Use instructs the user to position the adhesive and multiple layers in a location where the infant is receiving the least amount (or no amount) of phototherapy light. The Little Angels Swaddling Blanket has a pocket feature for convenience when using the device in conjunction with light emitting pads. Although the Luma Wrap™ does not have this pocket feature, it offers a different optional convenience feature for all sizes: an adhesive strip for quickly and easily securing the device in place. The adhesive strip is used to secure two parts of the swaddling blanket together.

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Device	Little Angels SwaddlingBlanket(510(k) #K123411)	Luma Wrap™(this submission)
Manufacturer	Bionix DevelopmentCorporation Toledo, Ohio	Beevers Manufacturig &Supply Inc., / Salter Labs,Carlsbad CA.
Intended Use	Phototherapy-compatibleinfant swaddling blanket	Phototherapy-compatibleinfant swaddling blanket
Indications for Use	Infant swaddling duringphototherapy	Infant swaddling duringphototherapy
Principal of Operation /Mechanism of Action	Fabric allows phototherapylight to pass through to theinfant during swaddling	Fabric allows phototherapylight to pass through to theinfant during swaddling
Clinical Setting /Sites of Use	Clinical / Hospital Useand Home Use	Clinical / Hospital Useand Home Use
Disposable / Reusable	Disposable device(Single-patient use)	Disposable device(Single-patient use)
Material /Device Composition	Lightweight spun bondnonwovenpolypropylene fabric	Lightweight spun bondnonwovenpolypropylene fabric
Fabric Weight	15.3 g/m2 (0.45 oz/yd2)	15.0 g/m2 (0.44 oz/yd2)
Manufacturing Process ofDevice from Material	Die-cut	Die-cut
Skin Contact Duration	Less than 24 hours	Less than 24 hours
Material Between Infant andPhototherapy Source	Single layer	Single layer (for majority ofblanket) with some areas ofdouble or triple layers
Material Light Transmittance(Single Layer)	≥90%(90.0% - 91.7%;per 510(k) summary)	≥92%(92.0% - 97.7%;per bench test findings)
Adhesive Strip for SecuringTwo Parts of SwaddlingBlanket Together	No	Yes and No(optional feature)
Pocket for Light Emitting Pad	Yes	No

Table 5-1: Comparison Table, Luma Wrap™ vs. Little Angels Swaddling Blanket

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VII. PERFORMANCE DATA

No performance tests were performed on the Luma Wrap™ in animals or in the clinical setting. However, several performance tests were performed on the bench. Light transmittance tests were performed to demonstrate substantial equivalence to the predicate device. These tests were performed in a laboratory and in an empty hospital room. The light transmittance of the Luma Wrap™ fabric was calculated by measuring the throughput of blue phototherapy light with and without the presence of the fabric. These tests concluded that the light transmittance of a single layer of Luma Wrap™ fabric is slightly higher (92.0% - 97.7%) than the light transmittance of a single layer of the Little Angels Swaddling Blanket (90.0% - 91.7%; per K123411 510(k) summary). Specific findings are listed in Table 2.

Test #	Test LocationLight Source	Test Location LightSource	Test LocationLight Source	Test LocationLight Source
1	Laboratory	Overhead LED light	6" - 18"	92.0%
2	Laboratory	Overhead LED lightsources	12"	93.7%
3	Empty hospitalroom	Overheadphototherapyhalogen light source	7.5" - 19.5"	94.0%
4	Empty hospitalroom	Beneath-the-infantphototherapyfluorescent lightsource	Not applicable	97.7%

Table 5-2: Luma Wrap™ Light Transmittance Test Findings (Single-Laver)

Additional performance tests (pull strength and cycling / reliability) were performed on the adhesive to verify that this optional convenience feature of the Luma Wrap™ met performance specifications. The adhesive pull strength, as measured with a force gauge pulled perpendicular to the adhesive, was, on average, 200g. This adhesive pull strength measurement met the performance specification. The closure reliability / adhesive cycle test verified that the adhesive could be opened and closed at least 20 times. Finally, an air flow resistance bench performance test verified that the Luma Wrap™ fabric did not exhibit substantial resistance to air flow at rates of 1-12 lpm. Specifically, the air flow resistance for two layers of fabric with an air flow of 8 lpm was measured to be 0.066 mmH2O/sq cm. This met the device's performance specification and confirmed that an infant's breathing is not impaired if the device slips over the infant's nose and/or mouth.

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VIII. CONCLUSIONS

There are minor differences between the Luma Wrap™ and the predicate device in technological characteristics with regards to fabric weight, material between the infant and phototherapy light source, material light transmittance, and pocket and adhesive convenience features. However, these differences do not raise new questions of safety or effectiveness. Thus, the device characteristics compared in Table 5-1 and the results of the bench performance tests confirm that the Luma Wrap™ is substantially equivalent to the Little Angels Swaddling Blanket.

Regulation Number and Section

§ 880.5700 Neonatal phototherapy unit.

(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).