(122 days)
The Little Angels Swaddling Blanket developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.
It is intended to be used by or under the direction of a licensed physician.
The Little Angels Swaddling Blanket is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting. The Little Angels Swaddling Blanket is similar in composition and function to other devices used as adjuncts to current neonatal phototherapy systems used to treat neonatal hyperbilirubinemia.
The Little Angels Swaddling Blanket is comprised of a sheet of spun bond polypropylene material that is die-cut and heat welded in a pattern that allows an infant undergoing phototherapy for hyperbilirubinemia to be tightly swaddled in a fashion such that only a single layer of material is ever interposed between the infant and the phototherapy source.
Spun bond polypropylene is a commonly used fabric in medical products and garments. Spun bond polypropylene is non-irritating to the skin. soft, and has a good drape that allows it to easily conform to body contours. Spun bond polypropylene is available in different fabric weights, depending on the tightness of the weave and fabric density. Light-weight spun bond polypropylene fabric is used in the Little Angels Swaddling Blanket to ensure maximum light transmittance from the phototherapy source to the patient's skin. {See section on "Bench Testing".)
In use, an infant undergoing phototherapy for hyperbilirubinemia is first laid atop the Little Angels Swaddling Blanket, and the blanket is then folded around the infant in a prescribed fashion that ensures the infant is tightly swaddled and that only a single layer of fabric lies between the phototherapy source and the infant's skin. When an overhead phototherapy source is used, the swaddled infant is then placed under the light source in the usual fashion in order to receive the phototherapy treatment. The Little Angels Swaddling Blanket also has a pocket formed in its rear panel (under the infant). If a light emitting pad type phototherapy source is to be used, the light emitting pad is placed in this pocket and phototherapy is administered to the swaddled infant in the usual fashion. Also, double phototherapy can be administered to an infant swaddled using the Little Angels Swaddling Blanket by combining an overhead phototherapy source together with a light emitting pad type phototherapy source, each used as described above.
The provided text describes a 510(k) summary for the "Little Angels Swaddling Blanket". The primary acceptance criterion investigated here is light transmittance, specifically comparing it to a predicate device.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Little Angels Swaddling Blanket) |
|---|---|
| Light Transmittance: ~59% | Light Transmittance: ≥90% |
| Fabric Weight: 118 g/m² | Fabric Weight: 15.29 g/m² |
Note: The acceptance criteria for the new device are implicitly that it should perform at least as well as the predicate device, or ideally, better, in relevant metrics like light transmittance for effective phototherapy. The table shows the new device significantly surpasses the predicate device in light transmittance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For light transmittance testing, 2 samples of the "Little Angels Swaddling Blanket" material and 2 samples of the "BiliSoft Cover" material were tested for each phototherapy light source (GE Giraffe SPOT PT LITE and Drager PT 4000). This means a total of 4 material samples were tested.
- Data Provenance: This was "Bench Testing" conducted on material samples, not patient data. The origin of the material samples (e.g., country of manufacture) is not specified. It is a retrospective analysis of material properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. This device is not an AI/ML device, and no human experts were involved in establishing ground truth for the light transmittance bench testing. The ground truth (actual light transmittance values) was established by direct physical measurement using a light meter.
4. Adjudication Method for the Test Set
- Not applicable. There was no need for adjudication as the testing involved direct physical measurements of light transmittance and fabric weight.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI/ML device requiring human reader interaction or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This is not an AI/ML algorithm; it is a physical medical device (a swaddling blanket).
7. The Type of Ground Truth Used
- Direct Physical Measurement: The ground truth for light transmittance and fabric weight was established through direct physical measurements using a light meter and standard laboratory methods (not explicitly detailed but implied by "Fabric weights of the materials used in each device were also determined").
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is irrelevant.
§ 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).