BILI-THERAPY SPOT TYPE

K103828 · Atom Medical Corporation · LBI · Mar 29, 2011 · General Hospital

Device Facts

• Record ID: K103828
• Device Name: BILI-THERAPY SPOT TYPE
• Applicant: Atom Medical Corporation
• Product Code: LBI · General Hospital
• Decision Date: Mar 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

BILI-THERAPY Spot Type is an overhead neonatal phototherapy unit available in arm or stand configurations. Device emits blue light (peak 450-475 nm) onto patient to treat hyperbilirubinemia. No direct patient contact occurs. Operated by clinicians in hospital or institutional settings. Provides non-invasive therapeutic light exposure to reduce bilirubin levels. Benefits include effective management of neonatal jaundice. Device is a prescriptive, non-contact phototherapy system.

Clinical Evidence

Bench testing only. Testing confirmed compliance with IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), and IEC 60601-2-50 (Infant Phototherapy). Performance metrics including irradiance intensity (30-40 μW/cm²/nm at 30 cm) and wavelength (peak 450-475 nm) were verified against pass/fail criteria and compared to the predicate device.

Technological Characteristics

Overhead phototherapy unit using blue light-emitting diodes (LEDs). Peak wavelength 450-475 nm. Irradiance 30-40 μW/cm²/nm at 30 cm. Available in arm or stand form factors. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-50. Powered by 120VAC.

Indications for Use

Indicated for the treatment of neonatal hyperbilirubinemia in neonates. Intended for use in hospital or institutional environments by prescription.

Regulatory Classification

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.

Predicate Devices

• Respironics - Bili-Tx (K070180)

Submission Summary (Full Text)

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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.<br>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 | Respironics<br>Bili-Tx (K070180) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| General Attributes | | |
| Indications for Use | The BILI-THERAPY Spot Type is a<br>phototherapy unit intended for the<br>treatment of neonatal hyperbilirubinemia. | The Bili-Tx is intended to treat<br>hyperbilirubinemia through phototherapy in<br>a 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 overhead<br>Yes 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<br>(mm)<br>Stand Type: 450W x 710D x 1900H<br>(mm) | Illuminator<br>16.10 cm x 7.40 cm (6.34 in x 2.92 in) |
| Weight | Arm Type: approximately 2.2 kg<br>Stand Type: approximately 12 kg | 1.3 Kg (2.86 lb) |
| Irradiation Intensity | 30-40 $μW/cm^2/nm$<br>(measurement obtained by BiliBlanket®<br>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 +/-<br>10% (in effective area)<br>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 120VAC<br>Power consumption 30VA, frequency<br>50/60 Hz<br>Working voltage range 120VAC +/-10% | (Input) 100 - 240 VAC, 50/60 Hz, 1.0 A |
| Operating<br>Temperature | Ambient: 10-30°C<br>Relative Humidity 30-85% (non-<br>condensing) | 15°C to 35°C |
| Storage Temperature | Ambient 0-45°C<br>Relative Humidity 0-90% (non-<br>condensing) | -20 °C to 55 °C |
| Mounting Options | Arm or Stand | Overhead mounting option (standard IV<br>pole 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 [phone] or [phone] 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.

or

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