(122 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a swaddling blanket made of spun bond polypropylene, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The Little Angels Swaddling Blanket is an adjunct to phototherapy systems, which means it assists a therapeutic device but is not therapeutic itself. Its purpose is to facilitate the delivery of phototherapy by ensuring proper swaddling and light transmission, not to directly treat hyperbilirubinemia.
No
The device is a swaddling blanket intended to be an adjunct to neonatal phototherapy systems for treating hyperbilirubinemia. It is used to position the infant and ensure proper exposure to the phototherapy source, which is a treatment, not a diagnostic process.
No
The device is a physical swaddling blanket made of spun bond polypropylene material, not software.
Based on the provided information, the Little Angels Swaddling Blanket is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Little Angels Swaddling Blanket Function: The Little Angels Swaddling Blanket is a physical accessory used in conjunction with phototherapy systems. Its function is to facilitate the delivery of light to the infant's skin for the treatment of hyperbilirubinemia. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's an "adjunct to neonatal phototherapy systems" for treatment, not for diagnosis or analysis of biological samples.
- Device Description: The description focuses on the material composition and how it's used to swaddle the infant and allow light transmission. There is no mention of analyzing biological samples.
Therefore, the Little Angels Swaddling Blanket falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes
PDH
Device Description
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.
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
neonatal
Intended User / Care Setting
Used by or under the direction of a licensed physician in the clinical 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)
Bench Testing: Samples of the spun bond polypropylene material used in the construction of the Little Angels Swaddling Blanket from Bionix, along with the spun bond polypropylene material used in the manufacture of the BiliSoft disposable pad covers, were tested for light transmittance properties using a light meter. Fabric weights of the materials used in each device were also determined.
Key Results:
- Little Angels Blanket (Bionix) with GE Giraffe SPOT PT LITE: 91.7 % Transmittance
- Little Angels Blanket (Bionix) with Drager PT 4000: 90.0 % Transmittance
- Billisoft Cover (Lumitex) with GE Giraffe SPOT PT LITE: 59.2 % Transmittance
- Billisoft Cover (Lumitex) with Drager PT 4000: 58.8 % Transmittance
- Maximum Light Transmittance for BiliSoft Phototherapy System Disposable Pad Covers: 59.21 %
- Maximum Light Transmittance for Little Angels Swaddling Blanket: ≥90%
- Fabric Weight for BiliSoft Phototherapy System Disposable Pad Covers: 118 g/m2
- Fabric Weight for Little Angels Swaddling Blanket: 15.29 g/m2
No clinical testing was performed on the Little Angels Swaddling Blanket from Bionix Development Corporation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Light Transmittance (%, µw/cm2/nm).
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
510(K) Summary:
MAR 0 7 2013
Image /page/0/Picture/3 description: The image shows the logo for Bionix. The logo consists of a stylized letter "B" inside a circle on the left, followed by the word "BIONIX" in bold, sans-serif font. A registered trademark symbol is located to the upper right of the "X".
Corporate Office 5154 Enterprise Blvd., Toledo, Ohio 43612 Phone 419.727.8421 · Fax 419.727.8426
October 25, 2012
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92
1. Submitter Information:
a. Applicant: Bionix Development Corporation 5154 Enterprise Blvd. Toledo, Ohio 43612
James Huttner M.D., Ph.D. b. Contact: Vice President, New Product Development Phone: (419) 727-8421 Fax: (419) 727-4430 Email: jhuttner@bionix.com
2. Device Name:
- a. Trade Name: Little Angels Swaddling Blanket
- Swaddling blanket for use with neonatal phototherapy systems b. Common Name:
- c. Classification Name: Blanket, Neonatal Phototherapy (Per CFR section 880.5700)
3. Intended Use:
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.
Page 11
1
4. Substantial Equivalence Device(s):
The Little Angels Swaddling Blanket is similar in composition and function to the following device used as an adjunct to current neonatal phototherapy systems used to treat neonatal hyperbilirubinemia.
- a. Disposable fiber optic pad covers use with the BiliSoft Phototherapy System manufactured and legally marketed by Lumitex, Inc., Strongsville, OH. This device is listed under regulation number 880.5700, Unit, Neonatal Phototherapy, and is classified as a Class II device. This device has been cleared by the FDA under K053568.
5. Device Description:
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.
2
6. Comparison to Predicate Devices:
The following table summarizes the comparison of Bionix Development Corporation Little Angel Swaddling Blanket to the predicate device:
Image /page/2/Figure/2 description: The image is a table comparing the attributes of two products: BiliSoft Phototherapy System Disposable Pad Covers (Lumitex, Inc.) and Little Angels Swaddling Blanket (Bionix). The table lists attributes such as intended use, composition, light transmittance, material weight, single patient use, pocket for fiberoptic phototherapy source, material between infant and phototherapy source, skin contact duration, and whether the product swaddles the infant. For example, the light transmittance for BiliSoft is 59% while it is >90% for Little Angels.
Table 1 Comparison of Substantial Equivalence
7. Bench Testing:
Samples of the spun bond polypropylene material used in the construction of the Little Angels Swaddling Blanket from Bionix, along with the spun bond polypropylene material used in the manufacture of the BiliSoft disposable pad covers, were tested for light transmittance properties using a light meter as described in the section titled "Bench Testing" of this document. Fabric weights of the materials used in each device were also determined. The results of these testing are summarized in the following tables:
3
| Phototherapy Light
Source | Material
Tested | Baseline
(no material) | Material
Test #1 | Material
Test #2 | Material
Test
(Average) | %
Transmittance |
|------------------------------|--------------------------------------|---------------------------|---------------------|---------------------|-------------------------------|--------------------|
| GE Giraffe SPOT PT
LITE | Little Angels
Blanket
(Bionix) | 36.9
µw/cm2/nm | 34.3
µw/cm2/nm | 33.4
µw/cm2/nm | 33.9
µw/cm2/nm | 91.7 % |
| Drager PT 4000 | Little Angels
Blanket
(Bionix) | 30.4
µw/cm2/nm | 27.4
µw/cm2/nm | 27.3
µw/cm2/nm | 27.4
µw/cm2/nm | 90.0 % |
| GE Giraffe SPOT PT
LITE | Billisoft Cover
(Lumitex) | 35.3
µw/cm2/nm | 19.4
µw/cm2/nm | 22.4
µw/cm2/nm | 20.9
µw/cm2/nm | 59.2 % |
| Drager PT 4000 | Billisoft Cover
(Lumitex) | 31.2
µw/cm2/nm | 18.0
µw/cm2/nm | 18.7
µw/cm2/nm | 18.4
µw/cm2/nm | 58.8 % |
Table 2 Bench Test Results Light Transmittance Testing
| Device | Manufacturer | Maximum Light
Transmittance
(%) | Fabric Weight |
|-------------------------------------------------------|---------------|---------------------------------------|---------------|
| BiliSoft Phototherapy System
Disposable Pad Covers | Lumitex, Inc. | 59.21 % | 118 g/m2 |
| Little Angels
Swaddling Blanket | Bionix | ≥90% | 15.29 g/m2 |
Table 3 Bench Test Results Light Transmittance and Material Weight
4
8. Clinical Testing:
No clinical testing was performed on the Little Angels Swaddling Blanket from Bionix Development Corporation.
9. Conclusion:
The similarity of composition, performance, and features indicate that the Little Angels Swaddling Blanket from Bionix Development Corporation will perform as well as the legally marketed disposable covers used with the BiliSoft Phototherapy System by Lumitex, Inc. for the intended use as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
--- -- March-7, 201-3 ---
James Huttner, M.S., Ph.D. Vice President Bionix Development Corporation 5154 Enterprise Boulevard TOLEDO OH 43612
Re: K123411
Trade/Device Name: Blanket, Neonatal Phototherapy Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: PDH Dated: January 9, 2913 Received: January 23, 2013
Dear Dr. Huttner:
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.
6
Page 2 - Dr. Huttner
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 devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
for
S
with
Urowitz
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement:
510(k) Number (if known): K123411
Device Name: Blanket, Neonatal Phototherapy
Indications for Use:
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.
X Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Consyrrence of CDRH, Office of In Vitro Diagnostic Devices (OVID)
Jacqueline
S. Ryan
| DN: | c=US, o=U.S. Government, |
|---|---|
| ou=HHS, ou=FDA, ou=People, | |
| 0.9.2342.19200300.100.1.1=20005702 | |
| 93, cn=Jacqueline S. Ryan | |
| Date: | 2013.03.05 10:33:03 -05'00' |
(Division Sign-Off)
Division of Anestheslology, General Hospital
Infection Control, Dental Devices
Page 1 of 1
| 510(k) Number: | 123411 |
|---|---|
| ---------------- | -------- |
Bionix Development Corporation
、一意看照