BILI-MIRROR MODEL BLM-1

{0}------------------------------------------------ 093618 510(k) Summary (21 CFR 807.92) - restated and updated: Submitter's Demographics: Physician Engineered Products, Inc. Owner: - 103 Smith Street Fryeburg, ME 04037 207-935-1256 Phone: 207-935-1257 Fax: Rob Rose, MD, CEO Contact person: Date of Summary preparation: APR 9 8 2010 Name of the Device: | Trade Name: | Bili-Mirror | |------------------------|--------------------------------------| | Common Name: | phototherapy device mirror | | Classification Number: | 878.4370 | | Classification Name: | Surgical Drape and Drape Accessories | | Regulatory Class: | II | | Product Code: | MMP | November 2, 2009 ## Substantial Equivalence to Predicate Device: | 510(k) #: | K043234 | |------------------------|--------------------------------------| | Trade/Device Name: | Light Drape (by Natus) | | Classification Number: | 878.4370 | | Classification Name: | Surgical Drape and Drape Accessories | | Regulatory Class: | II | | Product Code: | MMP | | Dated: | April 5, 2005 | #### Description of Device The Bili-Mirror was developed under a patent licensing agreement with Stanford University – see attachments. - The Bili-Mirror serves as an enhancement to several existing phototherapy devices in the US market such as the Natus neoBlue or the Olympic BILI-LITE that treat neonatal hyperbilirubinemia (jaundice) with bright blue-range light. The Bili-Mirror is simply a 10"-high by 54"-wide metalized, 3 mil polyester film that removably attaches (like a skirt) to the lower edge of overhead phototherapy devices. It serves three useful purposes. - First, the 3 ohm metalized film serves as a mirror to reflect phototherapy light from the 1. overhead device back onto baby - thereby increasing the phototherapy dose by up to 70% depending upon the distance of light-to-baby. (See attached data sheet.) Overhead lights provide light doses ranging from 15 to 30 uWatts/cm²/nm. By increasing the light dose by up to 70%, the result is light doses are often over 30 uWatts/cm²/nm. Other phototherapy devices in the US market, such as PEP's Ultra Bili Light, provide light doses over 60 uWatts/cm²/nm, so the increased dose for overhead devices with a Bili-Mirror attached is well within the accepted and safe range of light dosing. - Second, the Bili-Mirror decreases by over 95% the bright "scatter" from the 2. phototherapy device from reaching the eyes of caregivers. {1}------------------------------------------------ - 3. Third, unlike the predicate device, the 3 ohm metalizing of the Bill-Mirror provides for a seethrough mirror that allows good visibility of baby as viewed through the Bili-Mirror. Thus, during the delivery of phototherapy, the baby is not hidden from view. - To secure the Bili-Mirror to a phototherapy device, all along the inside top edge of the film sheet, 1/8″ from the top, is attached a ½" wide 3M double-sided adhesive strip with a peel-off cover paper. This adhesive strip: a) adheres well to the metal or plastic housings of various phototherapy devices, b) releases well from the phototherapy device without leaving adhesive residue, and c) does not mar the surface of the phototherapy device. - To install the Bill-Mirror onto an overhead neonatal phototherapy device, the peel-off cover is removed from the adhesive strip which is then pressed onto the lower, outer edge of the device housing. Depending upon the phototherapy device being used, the 54"-long Bili-Mirror will wrap around most of the perimeter of the device housing – leaving a gap of at least 5″ at the back. This gap prevents thermal trapping inside the "skirt" created by the wrap-around Bili-Mirror situated below the light source. - The overhead phototherapy device is then positioned over the baby bassinette so as to leave at least 1" between the bottom of the Bili-Mirror and the top of the bassinette. This positioning: a) prevents the Bili-Mirror from coming into direct contact with baby, and b) provides for air circulation into and out of the bassinette. #### Intended Use - Bili-Mirrors are intended to attach to overhead phototherapy light fixtures to limit the scattering of light. #### Technological Characteristics There are only 2 components that comprise the Bili-Mirror: metalized polyester film and an adhesive strip. Their technological characteristics are as follows: #### Film: | Material: | clear polyester plastic<br>metalized to 3 ohms - provides:<br>reflectance of 95% of blue light<br>transmission of 5% of blue light | |-------------|------------------------------------------------------------------------------------------------------------------------------------| | Dimensions: | 10" high x 54" long x 3mil thick | | Serated: | at 18" intervals to allow convenient folding and packaging | #### Adhesive strip: 3M Model 476XL - ½" wide double-sided adhesive strip Material: adhesed 1/8" from the top edge along the entire 54" length of film with peel-off paper to expose the adhesive surface for reversibly bonding to an overhead phototherapy device ## Summary of Non-Clinical and Clinical testing: - i) 3 mil thick polyester film metalized to 3 ohms tested for: - reflection of blue phototherapy light; - see-through capability: - resistance to scratching {2}------------------------------------------------ - no residue from use - ii) 3M 476XL adhesive strip tested for: - Adhesion - - Release after use l - Effect on phototherapy device surface ﺖ - iii) Bili-Mirror tested on two commonly-used overhead infant phototherapy devices: Olympic Bili-Lite and Natus neoBlue for: - Light dose at baby area; । - Temperature change at baby area; t - Light transmission through Bili-Mirror; i - Subjective visibility of baby through Bili-Mirror - - Distance to baby - ### Discussion of Clinical Testing: Enclosed please find test results that determined: - 1) the light dose effect onto baby with or without the Bili-Mirror; - 2) the temperature effect on baby's immediate environment with or without the Bili-Mirror: - 3) the distance of the Bili-Mirror to baby under operating conditions; - 4) blue light transmission through and inside reflectance from the Bill-Mirror; - 5) subjective visibility of baby through the Bili-Mirror with the phototherapy lights on. To summarize. - 1) the light dose from two commonly-used phototherapy devices alone ranged from 21.9 to 27.4 µWatts/cm²/nm -- less than the recommended 30+ µWatts/cm²/nm. With the addition of the Bili-Mirror, the light doses rose to the 30.7 to 32.5 uWatts/cm²/nm range -- within the recommended dose range. Light doses were not increased to dangerous levels which may exist over 100 µWatts/cm³/nm. - 2) the temperature around baby rose from the two commonly-used phototherapy devices alone by 1.5 to 2.9°C – within the desirable temperature range for unclad babies. With the addition of the Bili-Mirror, the temperature rose another 0.1 to 0.7°C - still well within the desirable range and well below the upper limit normally provided in a hospital setting. - 3) depending upon the phototherapy device being used, the Bili-Mirror edge remains at least 2 inches from the maximum reach of a baby in a bassinette – therefore not in contact with the baby; - 4) the normal scatter of light from an overhead phototherapy device is reduced by 95% in the area covered by the Bili-Mirror; - 5) visibility of the baby through the Bili-Mirror is deemed to be good. ## Conclusions from Testing: - 1) Use of the Bili-Mirror predictably raises the light dose onto baby -- often to a more desirable dose - but not to a dangerous level; - 2) Use of the Bili-Mirror predictably raises the temperature of the immediate environment of the baby by a relatively small amount - within the desirable range but not to a dangerous level; {3}------------------------------------------------ - 3) The Bili-Mirror does not come in contact with baby during use; therefore does not require additional biocompatibility testing; - 4) Use of the Bill-Mirror effectively limits the scatter of light from the phototherapy device: - 5) The visibility of baby by the caregiver through the Bili-Mirror may provide improved safety over an opaque device ## Additional Conclusions: - 1) The following data demonstrate Substantial Equivalence to the predicate device: - a) Both the Bili-Mirror and the Light Drape are constructed of flexible materials that removably attach to the lower edge of an overhead infant phototherapy device; b) Both the Bili-Mirror and the Light Drape span 9 to 10 inches below the lower edge of the overhead infant phototherapy device and surround or nearly surround the lower perimeter of the device; c) Both the Bili-Mirror and the Light Drape, when properly positioned, do not come in contact with the baby undergoing phototherapy; ## d) Both the Bili-Mirror and the Light Drape limit the scattering of light from the phototherapy device by 95% or more over the surface area covered by both devices. - 2) The following data areas do not contribute to a determination of Substantial Equivalence to the predicate device because there is no published data for the oredicate device with which to compare: - a) the effect of the device upon the light dose on baby, - b) the effect of the device upon the temperature around baby, or - c) the effect of the device upon the visibility of baby. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ## APR 2 3 2010 Robert Rose, MD Chief Executive Officer Physician Engineered Products, Incorporated 103 Smith Street Fryeburg, Maine 04037 Re: K093618 Trade/Device Name: Bili-Mirror (Accessory to Neonatal Phototherapy Light) Regulation Number: 21CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: MMP Dated: April 2, 2010 Received: April 6, 2010 Dear Dr. Rose: 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. {5}------------------------------------------------ #### Page 2- Dr. Rose 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, Susan Runng Anthony 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 {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): K093618 Device Name: Bili-Mirror (Accessory to Neonatal Phototherapy Light) Indications For Use: Bili-Mirrors are intended to attach to overhead phototherapy light fixtures to limit the scattering of light. Prescription Use (Part 21 CFR 801 Subpart D) . AND/OR · Over-The-Counter Use (21 CFR 801 Subpart C) 一 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) *(Division Sign-Off)* Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K062618 Page 1 of _