BT-400 Neonatal phototherapy is designed to emit the blue light wave length range 450-470nm spectrum to treat Neonatal Jaundice to use in Bassinets, Incubators, Open beds or Radiant warmer and consists of Head ( Light Source ) Control box with LCD window Roll Stand ( optional)

AI/ML Overview

This document describes the premarket notification (510(k)) for the BT-400 Neonatal Phototherapy device. It compares the device to a predicate device, the BILI-THERAPY Spot type (K103828), to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for a study outcome. Instead, it compares the proposed device's performance to that of a legally marketed predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are implied to be that the proposed device performs comparably to or better than the predicate device across key technical and functional characteristics.

Characteristic	Acceptance Criteria (Implied: Comparable to Predicate)	Reported Device Performance (BT-400)	Predicate Device Performance (BILI-THERAPY Spot type K103828)
Light Source	Blue LEDs	Blue LEDs	Blue LEDs
Wavelength	Peak 450-475nm	Peak 450-475nm	Peak 450-475nm
Intensity	30-40 uW/cm² at 30cm distance	30-45 uW/cm² at 30cm distance	30-40 uW/cm² at 30cm distance
Variation in intensity in 6 hrs	±10% in Illumination area	±10% in Illumination area	Identical
Effective Surface	30x20cm	40x20cm	30x20cm
Head output over 6 hrs	<10°C warmer than ambient	<10°C warmer than ambient	Identical
Electrical Main power	100-120v ac 50/60 hz 70va	100-120v ac 50/60 hz 70va	Identical
Leakage current	<100uA	<100uA	Identical
Audible Noise	<60dB	<60dB	Identical
Maximum height	190cm	200cm	190cm
Header	320x200x700mm	340x210x750mm	320x200x700mm
Light assembly / Roll Stand Weight	3.6kg / 8.4kg	3.6kg / 8.4kg	Identical
Operating Temp/Humidity	10-30°C / 30-85%	10-40°C / 30-75%	10-30°C / 30-85%
Storage Temp / Humidity	0-45°C / 10-90%	0-50°C / 10-100%	0-45°C / 10-90%
Atmospheric Pressure	70 kPa-106 kPa	70 kPa-106 kPa	Identical
Regulatory Standard Compliance	EN6001-1, EN60601-1-2, EN60601-2-50	EN6001-1, EN60601-1-2, EN60601-2-50	Identical
Intended use	Treatment of Neonatal Hyperbilirubinemia	Treatment of Neonatal Hyperbilirubinemia	Treatment of Neonatal Hyperbilirubinema

Note: The document explicitly states: "Note performance is similar since subject device intensity is few microwatts higher and effective area is slightly large compared to the predicate device." This indicates the device meets or exceeds the predicate's performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "Bench Tests" for performance data. These are typically laboratory tests conducted on the device itself, rather than tests on human subjects using a "test set" of patient data. Therefore, concepts like sample size for a test set, country of origin, or retrospective/prospective data are not applicable in this context. The provenance would be the test conditions within a manufacturing or testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a phototherapy unit, not an AI or diagnostic imaging device that requires expert review for ground truth establishment. The performance is assessed through physical and electrical bench testing against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data (e.g., medical images) where discrepancies need to be resolved. This device underwent bench testing.

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

This information is not applicable. The device is a phototherapy unit, not an AI-assisted diagnostic tool. Therefore, MRMC studies or effect sizes related to human reader improvement with AI are irrelevant to this submission.

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

This information is not applicable. The device is a physical medical device (phototherapy unit), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" for evaluating its performance comes from established engineering and medical device standards. Specifically, the device was tested against:

IEC60601-1 Medical Electrical Equipment: General requirements for basic safety and essential performance.
IEC 60601-1-2: Electromagnetic compatibility test.
IEC60601-2-50 Medical Electrical Equipment part 2-50: Particular requirements for the basic safety and essential performance of Infant Phototherapy Equipment.

The "ground truth" or reference for evaluating its properties (like wavelength, intensity, safety parameters) is defined by the requirements outlined in these standards.

8. The sample size for the training set

This information is not applicable. The BT-400 Neonatal Phototherapy device is a hardware medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as there is no training set for a hardware device.

Summary

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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 caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and clean, and it is easily recognizable.

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

March 20, 2015

Bio-Med USA Inc. Mr. Young Chi President 27 New England Drive Ramsey, NJ 07446

Re: K142332

Trade/Device Name: BT-400 Neonatal Phototherapy Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: February 9, 2015 Received: February 18, 2015

Dear Mr. Chi:

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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Page 2 - Mr. Young Chi

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Division 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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Indication for use statement

510 (K) Number	: K142332
Device Name	: BT-400 Neonatal Phototherapy
Indication for use	: BT-400 is the Phototherapy unit intended for the treatment of Neonatal Hyperbilirubinemia caused by Indirect Hyperbilirubinemia.
Prescription use	XX or/and Over the Counter use
	(Part CFR 801 sub part D) (Part 21CFR 801 Sub part C)

Please do not write below line- continued an another pages if needed

Concurrence of CDRH office of ODE

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510 (K) Summary

As required by CFR 807.92(c)

1. Manufacturer

Revised Mar 18,2015

Bistos Co Ltd. Reg Nr: 3005179052 7th fl, A bldg WooLim Lions Valley, 302 Galmachi ro, JungWon gu, Seoung Nam, GeongGi, Rep of Korea t: 82 31 750 0340 f: 82 31 750 0344

2. Applicant and Contact person

Bio-Med USA Inc. Young Chi, President. 27 New England Drive, Ramsey, NJ 07446. U.S.A. t: 1-973 278 5222 f: 1 201 934 6030 e mail: biomedusa@msn.com

3. Name of Device

Trade name	:	BT-400 Neonatal Phototherapy
Classification name	:	Unit, Neonatal Phototherapy
Common name	:	Neonatal Phototherapy
Regulation	:	880.5700 Class II
Classification Panel	:	General Hospital.
Product Code	:	LBI

4. Legally marketed Predicate Device

K103828 Atom Medical Corp, Japan BILI-THERAPY Spot type.

5. Device Description

Head ( Light Source ) Control box with LCD window Roll Stand ( optional)

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6. Intended use

BT-400 Phototherapy unit is intended for the treatment of Neonatal Hyperbilinemia caused by indirect Hyperbilinemia.

7. Performance Data

Performed below listed Bench Tests, and all data met cited standard required criteria.

IEC60601-1 Medical Electrical Equipment :2006 part 1 : General requirements for basic safety and essential performance.

IEC 60601-1-2:2007 Electromagnetic compatibility test

IEC60601-2-50 Medical Electrical Equipment part 2-50: Particular requirements for the basic safety and essential performance of Infant Phototherapy Equipment

The Device is non contacted mode.

8.Technological Characteristics .

BT-400 Phototherapy is light emitting Blue LED ( Light Emitting Diode) to treat Neonatal Hyperbilirubinemia in the range of 450-475 nm wave length, which are considering most effective for the degradation of Bilirubin.

The The BT-400 Phototherapy and the predicate device are phototherapy units intended to treat neonatal hyperbilirubinemia. The wavelength and intensity of blue light utilized is comparable between the two devices. Operational and functional parameters between the two devices are also highly similar. Both devices are in compliance with the applicable IEC 60601 standards.

Note performance is similar since subject device intensity is few microwatts higher and effective area is slightly large compared to the predicate device.

Comparison to Predicate Device

Feather	Proposed Device	Predicate Device
	Bistos Co., Ltd BT-400	Atom Medical Corp
	Model BT-400	Model : BILI-THERAPY spot typeK103828
Light Source	Blue LEDs	Blue LEDs
Wavelength	Peak 450-475nm	Peak 450-475nm
Intensity	30-45uW/cm2 at 30cm distance	30-40uW cm2 at 30cm distance
Variation in intensity in 6 hrs	$$\pm$$ 10% in Illumination area	Identical
Effective Surface	40x20cm	30x20cm
Head output over 6 hrs	<10'c warmer than ambient	Identical

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Electrical Main power	100-120v ac 50/60 hz 70va	Identical
Safety
Leakage current	<100uA	Identical
Audible Noise	<60dB	Identical
Dimension
Maximum height	200cm	190cm
Header	340x210x750mm	320x200x700mm
Weight
Light assembly / Roll Stand	3.6kg / 8.4kg	Identical
Environmental
Operating Temp/Humidity	10-40'C / 30-75%	10-30'C / 30-85%
Storage Temp / Humidity	0-50'C / 10-100%	0-45'C / 10-90%
Atmospheric Pressure	70 kPa-106 kPa	Identical
Regulatory Standard	EN6001-1, EN60601-1-2EN60601-2-50	Identical
Intended use	BT-400 is a phototherapy unitsintended for the treatment ofNeonatal Hyperbilirubinemiacaused by indirect Hyperbilirubinemia.	BILI-THERAPHY is a phototherapyunits intended for the treatment ofNeonatal Hyperbilirubinema.

9. Conclusion.

The BT-400 Neonatal Phototherapy is substantially equivalent to the predicate BILI-THERAPY Spot type (K103828) in indication for use, patient population, and environment for use, technical characteristics, specifications/ performance and compliance with international standards.

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).