The BILI-THERAPY Spot Type is an overhead unit available in two versions: Arm and Stand. The BILI-THERAPY Spot Type phototherapy unit shines a blue light onto the patient for the treatment of hyperbilirubinemia. The unit has no direct contact with the patient.

AI/ML Overview

This document describes the regulatory submission for the BILI-THERAPY Spot Type, a neonatal phototherapy unit. The submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness through a standalone study of the device's diagnostic or therapeutic performance using statistical metrics like sensitivity and specificity. Therefore, many of the requested criteria related to such studies (e.g., sample size for test sets, expert qualifications, HRMR, standalone performance) are not applicable or derivable from this type of regulatory summary.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to the predicate device (Respironics Bili-Tx K070180) across various parameters and compliance with recognized standards. The "performance" reported is primarily in relation to these equivalency criteria and bench testing.

Acceptance Criterion (Compared to Predicate Device & Standards)	Reported Device Performance (BILI-THERAPY Spot Type)
Indications for Use	The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia. (Identical to predicate's intended use according to the summary).
Patient Population	Neonatal. (Identical to predicate).
Environment of Use	Hospital or institutional. (Identical to predicate's hospital/institutional use, though predicate also permits home use).
Prescriptive	Yes. (Identical to predicate).
Patient Connection	No. (Equivalent to predicate's overhead unit, but predicate also has a fiber optic panel with patient connection).
Technology	Blue light-emitting diodes (LEDs). (Identical to predicate).
Dimensions	Arm Type: 1000W x 130D x 450H (mm); Stand Type: 450W x 710D x 1900H (mm). (Varies from predicate's illuminator dimensions, but form factor differs).
Weight	Arm Type: approx 2.2 kg; Stand Type: approx 12 kg. (Varies from predicate's 1.3 Kg).
Irradiation Intensity	30-40 µW/cm²/nm (measured at 30 cm). (Comparable to predicate's 32 µW/cm²/nm at 30 cm).
Irradiation Area	Effective irradiated area 20 x 30 cm. (Predicate does not specify this directly).
Change in Irradiance	After 6 hours +/- 10%. (Predicate does not specify this directly).
Wavelength	Peak 450 to 475 nm. (Comparable to predicate's peak between 450 nm and 485 nm).
Sound Level	60 dB or less. (Predicate is 52 dB, but both are within acceptable noise limits for medical devices).
Power Supply	Rated, Voltage 120VAC, Power consumption 30VA, frequency 50/60 Hz; Working voltage range 120VAC +/-10%. (Comparable to predicate's 100-240 VAC, 50/60 Hz, 1.0 A input).
Operating Temperature	Ambient: 10-30°C; Relative Humidity 30-85% (non-condensing). (Comparable to predicate's 15°C to 35°C).
Storage Temperature	Ambient 0-45°C; Relative Humidity 0-90% (non-condensing). (Comparable to predicate's -20°C to 55°C).
Mounting Options	Arm or Stand. (Predicate has overhead option with standard IV pole and bracket).
Compliance with Standards	Met all pass/fail criteria and cited standards requirements (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50). (Predicate also declared compliance with these standards).

Details of the Study Proving Acceptance Criteria

The study described is a bench testing program and an equivalency comparison to a predicate device, as typically performed for a 510(k) premarket notification. It is not a clinical study involving patients or diagnostic performance metrics.

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

Test Set Sample Size: Not applicable. This was a physical device comparison and bench testing, not a study involving patient data.
Data Provenance: Not applicable, as no patient data was used. The performance data comes from the specific BILI-THERAPY Spot Type device under test.

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

Not applicable. There was no "ground truth" to establish in the context of clinical outcomes, as this was a bench test and comparison study. The "ground truth" for the technical specifications would be metrology standards and predefined engineering specifications.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical data or expert review requiring adjudication in this context. The "adjudication" was based on adherence to engineering specifications and international standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is relevant for comparing human diagnostic performance with and without AI assistance, or comparing different diagnostic methods. This document describes a medical device's technical and safety equivalence to a predicate, not a diagnostic AI or imaging device requiring such a study.

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

No. This device is a phototherapy unit, not an algorithm or AI system. Its performance is directly related to its physical properties and light output, not an algorithm's output.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is established through international safety and performance standards (e.g., IEC 60601 series) and the technical specifications of the predicate device. The BILI-THERAPY Spot Type demonstrates its performance by meeting or being equivalent to these established benchmarks.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of device.

Summary

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510(k) Summary Page 1 of 3 11-Mar-11

MAR 2 9 2011

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

Device Description:

The BILI-THERAPY Spot Type is an overhead unit available in two versions:

. Arm
. Stand

The BILI-THERAPY Spot Type phototherapy unit shines a blue light onto the patient for the treatment of hyperbilirubinemia. The unit has no direct contact with the patient.

Indications for Use:

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

Environment of Use: Hospital or institutional

Summary of substantial equivalence

The Atom Phototherapy Units

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

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

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

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510(k) Summary Page 2 of 3 l 1-Mar-1 l

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

Environment for use – The BILI-THERAPY Spot Type has the identical environments for use as the predicate (hospital/institutional)

Prescriptive - The BILI-THERAPY Spot Type is prescriptive as is the predicate.

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

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

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

Conclusion

The BILI-THERAPY Spot 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 Spot Type met all pass /fail criteria, cited standards requirements and were 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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510(k) Summary Page 3 of 3

11-Mar-1 l

Device Comparison

	BILI-THERAPY Spot Type	RespironicsBili-Tx (K070180)
General Attributes
Indications for Use	The BILI-THERAPY Spot Type is aphototherapy unit intended for thetreatment of neonatal hyperbilirubinemia.	The Bili-Tx is intended to treathyperbilirubinemia through phototherapy ina home or hospital/institutional environment
Patient Population	Neonatal	Neonatal
Environment of Use	Hospital or institutional	Home or hospital/institutional
Prescriptive	Yes	Yes
Patient Connection	No	No with Bili-Tx overheadYes with Bili-Tx Fiber optic light panel
Technology	Blue light-emitting diodes (LEDs)	Blue light-emitting diodes (LEDs)
Technical specifications
Dimensions	Arm Type: 1000W x 130D x 450H(mm)Stand Type: 450W x 710D x 1900H(mm)	Illuminator16.10 cm x 7.40 cm (6.34 in x 2.92 in)
Weight	Arm Type: approximately 2.2 kgStand Type: approximately 12 kg	1.3 Kg (2.86 lb)
Irradiation Intensity	30-40 $μW/cm^2/nm$(measurement obtained by BiliBlanket®meter at irradiation distance of 30 cm)	Spectral Irradiance Level
		Distance Irradiance ( $µW/cm^2/nm$ )
		15 cm (6 in) 75 $µW/cm^2/nm$
		30 cm (12 in) 32 $µWcm^2/nm$
		45 cm (18 in) 10 $µWcm^2/nm$
		60 cm (24 in) 9 $µWcm^2/nm$
	Change in irradiance after 6 hours +/-10% (in effective area)Effective irradiated area 20 x 30 cm
Wavelength	Peak 450 to 475 nm	Peak between 450 nm and 485 nm
Sound level	60 dB or less	52 dB
Power Supply	Rated, Voltage 120VACPower consumption 30VA, frequency50/60 HzWorking voltage range 120VAC +/-10%	(Input) 100 - 240 VAC, 50/60 Hz, 1.0 A
OperatingTemperature	Ambient: 10-30°CRelative Humidity 30-85% (non-condensing)	15°C to 35°C
Storage Temperature	Ambient 0-45°CRelative Humidity 0-90% (non-condensing)	-20 °C to 55 °C
Mounting Options	Arm or Stand	Overhead mounting option (standard IVpole and bracket)

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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 ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K103828

MAR 2 9 2011

Trade/Device Name: BILI-THERAPY Spot Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: March 11, 2011 Received: March 14, 2011

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 Federal 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. 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

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number:

K/Q3828 (To be assigned)

Device Name:

BILI-THERAPY Spot

Indications for Use:

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

Prescription Use X (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)

Richard C. Chapman 3/29/11

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

510(k) Number: K103828

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).