The BILI-THERAPY Pad Type is a Bili-therapy unit available with large and small pads. The light source can be mounted to the incubator / warmer or an optional stand. The unit provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital / institutional settings. The BILI-THERAPY Pad Type emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia. Light is generated in the light source and conducted to the patient via light guides to the pads are reusable and are intended to be covered with disposable pad covers. Eye masks are recommended for use with this product but are not included in this submission. Reference to commercially available eye masks is provided in the instructions for use.

AI/ML Overview

The provided text describes the BILI-THERAPY Pad Type, a neonatal phototherapy unit, and its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be structured (e.g., using a test set, ground truth established by experts, sample sizes for training/test sets, MRMC studies, or standalone algorithm performance).

Instead, this document (a 510(k) summary) focuses on demonstrating substantial equivalence to an already legally marketed predicate device (Respironics Bili-Tx K070180) based on similarities in intended use, patient population, environment of use, technology, and performance specifications. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence and conforming to relevant safety and performance standards.

Here's a breakdown of the information that is available, formatted to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in this context are primarily the performance and safety standards, and the "reported device performance" are the specifications stated for the BILI-THERAPY Pad Type and compared against the predicate.

Criterion	Acceptance Criteria (Predicate: Respironics Bili-Tx K070180)	Reported Device Performance (BILI-THERAPY Pad Type)	Notes
Indications for Use	Treatment of hyperbilirubinemia through phototherapy	A phototherapy unit intended for the treatment of neonatal hyperbiliremia.	Stated as having the "same intended use."
Patient Population	Neonatal	Neonatal	Stated as having the "same patient population."
Environment of Use	Home or hospital/institutional	Hospital or institutional	Similar, with the BILI-THERAPY Pad Type specifically listing "Hospital or institutional" while the predicate also includes "Home." This is considered acceptable for substantial equivalence.
Technology	Blue light-emitting diodes (LEDs)	Blue light-emitting diodes (LEDs)	Identical technology.
Irradiation Intensity	Neonatal fiber-optic panel: 90 µW/cm²/nm (measured with Joey™ Dosimeter (JD-100))	High: 53 µW/cm²/nm +/-25%Medium: 40 µW/cm²/nm +/-25%Low: 26.5 µW/cm²/nm +/-25%(measurement obtained by BiliBlanket® meter placed on the pad surface without a pad cover)Change in irradiance over 6 hours +/- 10% (in effective area)	While numerically different, the comparison implies that the BILI-THERAPY Pad Type's intensities are within acceptable ranges for effective treatment, noting the different measurement methods and variability. A specific range for efficacy is not provided for the predicate.
Wavelength	Peak between 450 nm and 485 nm	Peak 450 to 480 nm	The BILI-THERAPY Pad Type's wavelength range falls within the predicate's range.
Sound Level	52 dB	60 dB or less	The BILI-THERAPY Pad Type's sound level is slightly higher but still within generally accepted limits for medical devices and considered substantially equivalent.
Compliance with Standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50	IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995IEC 60601-1-2: Collateral standard: Electromagnetic Compatibility (Edition 2:2001 with Amendment 1:2004; Edition 2.1)IEC 60601-2-50: 2009 Medical Electrical Equipment - Part 2-50	Both devices declare compliance with the relevant IEC 60601 series standards for medical electrical equipment, including general safety, EMC, and particular requirements for infant phototherapy equipment, indicating compliance with recognized safety and performance benchmarks. The BILI-THERAPY Pad Type specifically lists the versions it complies with.
Bench Tests	Not explicitly detailed beyond standard compliance, but inferred to be met by predicate approval.	Performed and found to meet all pass/fail criteria, cited standards requirements, and found to be equivalent in comparison to the predicate.	This indicates direct testing of the new device to ensure it performs as expected and meets safety requirements.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a test set or data provenance in the context of an algorithm or clinical performance study. The "testing" mentioned refers to bench tests to verify compliance with engineering specifications and safety standards, as well as a comparison to the predicate device's specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a phototherapy unit, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is hardware, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of an AI/algorithm study. For device performance validation, the "ground truth" would be the engineering specifications and the requirements of the international standards (e.g., IEC 60601 series).

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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KIJ1547

APR 1 2 2012

510(k) Summary Page 1 of 4 29-Nov-11

Atom Medical Corporation3-18-15, Hongo, Bunkyo-kuTokyo, Japan 113-0033	Tel - 011-81-3-3815-3632Fax - 011-81-3-3812-3199
Official Contact:	Tsuyoshi Sugino - Regulatory Affairs Manager
Proprietary or Trade Name:	BILI-THERAPY Pad Type
Common/Usual Name:	Neonatal phototherapy unit.
Classification Name/Code:	LBI - Neonatal phototherapy unit.21CFR 880.5700Class II
Device:	BILI-THERAPY Pad
Predicate Device:	Respironics - Bili-Tx K070180

Device Description:

The BILI-THERAPY Pad Type is a Bili-therapy unit available with large and small pads.

The light source can be mounted to the incubator / warmer or an optional stand.

The unit provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital / institutional settings. The BILI-THERAPY Pad Type emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia. Light is generated in the light source and conducted to the patient via light guides to the pads are reusable and are intended to be covered with disposable pad covers. Eye masks are recommended for use with this product but are not included in this submission. Reference to commercially available eye masks is provided in the instructions for use.

Indications for Use:

The BILI-THERAPY Pad Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.

Environment of Use: Hospital or institutional

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510(k) Summary Page 2 of 4 29-Nov-11

Summary of substantial equivalence

The Atom Phototherapy Unit

The BILI-THERAPY Pad Type was compared to the predicate Respironics BiliTx (K070180).

Indications for Use - The BILI-THERAPY Pad Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.

The BILI-THERAPY Pad Type has the same intended use (treatment of hyperbilirubinemia) as the Respironics BiliTx (K070180).

Patient Population - The BILI-THERAPY Pad Type is indicated for Neonates as is the predicate.

Environment for use - The BILI-THERAPY Pad Type functions in hospital / institutional settings as does the predicate (hospital/institutional or home setting)

Prescriptive - The BILJ-THERAPY Pad Type is prescriptive as is the predicate.

Design and Technology - The BILI-THERAPY Pad Type has equivalent design and features as the predicate and has the identical technology to the predicate.

Performance and Specifications - The BILI-THERAPY Pad Type has equivalent specifications of performance as the predicate.

Compliance with standards - The BILI-THERAPY Pad Type and predicate device declare compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-50.

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510(k) Summary Page 3 of 4 29-Nov-11

Device Comparison
	BILI-THERAPY Pad Type	RespironicsBili-Tx (K070180)
General Attributes
Indications for Use	The BILI-THERAPY Pad Type is aphototherapy unit intended for the treatmentof neonatal hyperbilirubinemia.	The Bili-Tx is intended to treathyperbilirubinemia through phototherapy
Patient Population	Neonatal	Neonatal
Environment of Use	Hospital or institutional	Home or hospital/institutional
Prescriptive	Yes	Yes
Patient Connection	Yes via pad	Yes with Bili-Tx Fiber optic light panel
Technology	Blue light-emitting diodes (LEDs)	Blue light-emitting diodes (LEDs)
Technical specifications
Dimensions	Light Source: 150w x 220d x 160h mmLarge Pad 170w x 480d mmSmall Pad 120w x 330 mmStand 550 x 500-1000mm H (adjustable)Rack 105w x 270d x 69 mm	Illuminator16.10 cm x 7.40 cm (6.34 in x 2.92 in)Neonatal fiber-optic panel: 127 mm x 177.8 mm
Weight	Light Source approx. 2.1 kgLarge Pad 0.8 kgSmall Pad: 0.6 kgStand: 10 kgRack 0.8 kg	1.3 Kg (2.86 lb)
Irradiation Intensity	High: 53 µW/cm²/nm +/-25%Medium: 40 µW/cm²/nm +/-25%Low: 26.5 µW/cm²/nm +/-25%(measurement obtained by BiliBlanket®meter placed on the pad surface without apad cover)Change in irradiance over 6 hours +/- 10%(in effective area)Effective irradiated area:Large Pad: 15 x 30 cmSmall Pad 10 x 15 cm	Neonatal fiber-optic panel: 90 µW/cm²/nmMeasured with the Joey™ Dosimeter (JD-100)Neonatal fiber-optic panel: 127 mm x 17.78 mm
Wavelength	Peak 450 to 480 nm	Peak between 450 nm and 485 nm
Sound level	60 dB or less	52 dB
Power Supply	Rated, Voltage 100-240 VACPower consumption 68 VA, frequency50/60 HzWorking voltage range 100-240 VAC +/-10%	(Input) 100 - 240 VAC, 50/60 Hz, 1.0 A
OperatingTemperature	Ambient Temperature: 10-30°CRelative Humidity 30-85% (non-condensing)	15°C to 35°C
Storage Temperature	Ambient Temperature :0-50°CRelative Humidity 30-75% (non-condensing)	-20 °C to 55 °C
Mounting Options	Light Source can be mounted to BILI-HOLDER on the warmer or to optionalstand	Not specified

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510(k) Summary Page 4 of 4 29-Nov-11

Conclusion

The BILI-THERAPY Pad Type is substantially equivalent to the predicate Respironics BiliTx (K070180) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards

Performance Testing

We have performed bench tests which included the list below and found that the BILI-THERAPY Pad Type met all pass /fail criteria, cited standards requirements and was found to be equivalent in comparison to the predicate.

IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
IEC 60601-1-2: Collateral standard: Electromagnetic Compatibility -● Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
. IEC 60601-2-50: 2009 Medical Electrical Equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

Atom Medical Corporation C/O Mr. Paul E. Dryden President Regulatory Consultant for Atom Medical ProMedic, Inc. 24301 Woodsage Drive Bonita Springs. Florida 34134

APR 1 2 2012

Re: K111547

Trade/Device Name: BILI-THERAPY Pad Type Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: April 9, 2012 Received: April 10, 2012

Dear Mr. Dryden:

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 Eederal Register.

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Page 2 - Mr. Dryden

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 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,

Anthony D. Swain

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

(To be assigned)

Page 1 of 1

510(k) Number:

Device Name:

BILI-THERAPY Pad Type

Indications for Use:

The BILI-THERAPY Pad Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.

Prescription Use X or (Part 21 CFR 801 Subpart D)

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Weekly Gen for RZC. 4/11/12

(Division Sign Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 4.2 Page 14 of 324

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).