(288 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and function of a swaddling blanket, with no mention of AI or ML.
No.
The device is a swaddling blanket that provides comfort and boundaries for infants during phototherapy, which is a therapeutic treatment. However, the blanket itself does not provide the therapy; it facilitates the delivery of phototherapy by keeping the infant still and comfortable.
No
Explanation: The device is a swaddling blanket used during phototherapy and does not perform any diagnostic functions. Its purpose is to provide boundaries and facilitate light exposure, not to detect or identify medical conditions.
No
The device description clearly states it is a "translucent, highly breathable, phototherapy-compatible, disposable infant swaddling blanket" made of "spun bond polypropylene non-woven fabric." This describes a physical, hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Luma Wrap™ Function: The Luma Wrap™ is a physical swaddling blanket used on the infant's body during phototherapy. Its purpose is to provide comfort and boundaries, not to analyze biological samples or diagnose a condition.
The description clearly indicates it's a physical device for external use on an infant. It does not involve any testing of biological samples.
N/A
Intended Use / Indications for Use
To swaddle infants during neonatal phototherapy in the hospital or home setting. Single patient use only.
Product codes
PDH
Device Description
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.
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
infants / neonatal
Intended User / Care Setting
hospital or home setting
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)
No performance tests were performed on the Luma Wrap™ in animals or in the clinical setting.
Bench performance tests were conducted for:
- Light transmittance:
- Test Location: Laboratory, Light Source: Overhead LED light, Distance: 6" - 18", Result: 92.0%
- Test Location: Laboratory, Light Source: Overhead LED light sources, Distance: 12", Result: 93.7%
- Test Location: Empty hospital room, Light Source: Overhead phototherapy halogen light source, Distance: 7.5"- 19.5", Result: 94.0%
- Test Location: Empty hospital room, Light Source: Beneath-the-infant phototherapy fluorescent light source, Distance: Not applicable, Result: 97.7%
- 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).
- Adhesive pull strength: Average 200g, met performance specification.
- Closure reliability / adhesive cycle test: Adhesive could be opened and closed at least 20 times.
- Air flow resistance: For two layers of fabric with an air flow of 8 lpm was measured to be 0.066 mmH2O/sq cm. Met performance specification and confirmed no impairment of infant's breathing if the device slips over the infant's nose and/or mouth.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
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.
1
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
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.
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 Swaddling
Blanket
(510(k) #K123411) | Luma Wrap™
(this submission) |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Manufacturer | Bionix Development
Corporation Toledo, Ohio | Beevers Manufacturig &
Supply Inc., / Salter Labs,
Carlsbad CA. |
| Intended Use | Phototherapy-compatible
infant swaddling blanket | Phototherapy-compatible
infant swaddling blanket |
| Indications for Use | Infant swaddling during
phototherapy | Infant swaddling during
phototherapy |
| Principal of Operation /
Mechanism of Action | Fabric allows phototherapy
light to pass through to the
infant during swaddling | Fabric allows phototherapy
light to pass through to the
infant during swaddling |
| Clinical Setting /
Sites of Use | Clinical / Hospital Use
and Home Use | Clinical / Hospital Use
and Home Use |
| Disposable / Reusable | Disposable device
(Single-patient use) | Disposable device
(Single-patient use) |
| Material /
Device Composition | Lightweight spun bond
nonwoven
polypropylene fabric | Lightweight spun bond
nonwoven
polypropylene fabric |
| Fabric Weight | 15.3 g/m2 (0.45 oz/yd2) | 15.0 g/m2 (0.44 oz/yd2) |
| Manufacturing Process of
Device from Material | Die-cut | Die-cut |
| Skin Contact Duration | Less than 24 hours | Less than 24 hours |
| Material Between Infant and
Phototherapy Source | Single layer | Single layer (for majority of
blanket) with some areas of
double 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 Securing
Two Parts of Swaddling
Blanket 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 Location
Light Source | Test Location Light
Source | Test Location
Light Source | Test Location
Light Source |
|--------|-------------------------------|-------------------------------------------------------------------|-------------------------------|-------------------------------|
| 1 | Laboratory | Overhead LED light | 6" - 18" | 92.0% |
| 2 | Laboratory | Overhead LED light
sources | 12" | 93.7% |
| 3 | Empty hospital
room | Overhead
phototherapy
halogen light source | 7.5" - 19.5" | 94.0% |
| 4 | Empty hospital
room | Beneath-the-infant
phototherapy
fluorescent light
source | 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.