Houva-NET Control System

{0}------------------------------------------------ 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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 10, 2015 National Biological Corporation Ms. Jennifer Cartledge REU Associates Incorporated 409 Woodridge Drive Seneca, South Carolina 29672 Re: K150912 Trade/Device Name: HOUVA-Net Control System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: June 15, 2015 Received: June 16, 2015 Dear Ms. Cartledge: 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. 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 {1}------------------------------------------------ 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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. # Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K150912 Device Name HOUVA-Net Control System Indications for Use (Describe) The Houva-NET Control System is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for the treatment of psoriasis and vitiligo. Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for National Biological Corporation. The logo features the company name in a bold, sans-serif font, with the words "NATIONAL" stacked above "BIOLOGICAL". To the left of the text is a blue square with a white sine wave running through it. Below the company name is the tagline "The Phototherapy Experts!" in a smaller, italicized font. # 5. 510(k) Summary Type of submission: Traditional 510(k); this is the first submission for this device. Date of Submission: March 28, 2015 Preparation of Submission: This submission has been prepared by J. Cartledge on behalf of National Biological Corporation. ## Name and Address of Manufacturer and 510(k) Owner: National Biological Corporation 23700 Mercantile Road Beachwood, Ohio 44122 (216) 831-0600 X227 (216) 765-0271 FAX Establishment registration number: 1521608 Contact: Lynn Keller, Director of Regulatory Affairs, Quality and Engineering #### US contact person: Jennifer Cartledge REU Associates Inc. 409 Woodridge Drive Seneca, SC 29672 Tel.: (864) 500-0097 Email: jcartledge@reuassociates.com ## Device Identification | Trade Name: | <i>Houva V</i> with <i>Houva-NET</i> Control System | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Model number: | <i>Houva V</i> | | Common names: | Ultraviolet lamp for dermatologic disorders | | Classification(s) of the device: | Light, Ultraviolet, Dermatological, 21CFR 878.4630<br>Product Code: FTC<br>Classification Panel: General and Plastic Surgery<br>Class II | ## Equivalent legally marketed devices: - Houva III Phototherapy System with PhotoSense II™ (K041212) Houva V with Houva-NET Control System – Traditional 510(k) 510(k) Summary Section 5: Page 1 of 5 {4}------------------------------------------------ The Daavlin Smart Touch Multi-Machine Software (K110912) provides an example of a cleared device considering a single control board managing multiple phototherapy devices via a single control board. Smart Touch UV Therapy Multiple Machine. Under this pre-market clearance, the Smart Touch UV Therapy Multiple Machine utilizes a single control board to manage operation of multiple phototherapy devices. # Device Description: The Houva V with Houva-NET Control System is simply the integration of the new Houva-NET Control System software, into the predicate device, the Houva III Phototherapy System with PhotoSense II™. The Houva -NET Control System software is utilized to monitor multiple phototherapy devices from a single computer, the Houva-NET Central Computer. The central computer may be used to monitor mulitiple phototherapy devices from one central location. A custom built interface board. 5PCB-040, supplied by National Biological Corporation is installed in each phototherapy device. An "off-the shelf" replacement is not possible and a replacement may only be obtained from National Biological Corporation. Schematics are located in the Device Description of this 510(k) submission, Section 11. The integration of the new Houva-NET Control System software into the predicate device, the Houva III Phototherapy System with PhotoSense II™, results in the modified system or the Houva V with Houva-NET Control System. The modification, as compared to the predicate, is limited to the replacement of the PhotoSense II Controller with the new Houva-NET Control. The Houva V with Houva-NET Control System software is designed to provide Ultraviolet A (UVA) and/or Ultraviolet B (UVB) radiation treatments in the same manner as the predicate device. The Houva-NET Control System may be retrofitted into any Houva Phototherapy Systems, constructed in the same design configuration as the predicate device. Houva III Phototherapy System with PhotoSense II™ (K041212) and utilizing identical energy source (UV Lamps) and materials of identical composition. The Houva V with Houva-NET Control System's only variation from the predicate device is that the control system hardware and software have been updated to control multiple phototherapy units. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principals of the Houva V with Houva-NET Control System are the same as those of the predicate. Additionally, the use of control system software and interface board to manage multiple phototherapy devices have already received FDA market clearance under K110912 integrated into the Daavlin Smart Touch Multi-Machine Software. # Intended Use: ● The Houva-NET Control System may also be integrated into the following HOUVA models: - Houva II UVA (K885025) - Houva II UVB (K885026) - Houva II UVA/UVB (K885029) Houva V with Houva-NET Control System – Traditional 510(k) 510(k) Summary Section 5: Page 2 of 5 {5}------------------------------------------------ - Houva III Phototherapy System with PhotoSense II™ (K041212) - Houva III/IV Phototherapy System with PhotoSense II™ ● NOTE- the Houva III and Houva III/IV Phototherapy System are identical in every way apart from a Marketing Name change; therefore, the clearance for Houva III also applies to the Houva III/V system. Additionally, the Houva -NET Control System is intended as a retro-fit kit for the following Daavlin Distributing Company models: - . 3 Series SP Models (K063621): - 3 Series PC Models (K063621): ● - 3 Series X Models (K042502): ● - Spectra (K828654): ● The integration of the Houva -NET Control System as a retro-fit kit for the above noted models has been assessed through extensive verification and validation testing as documented in Section 18 of this submission, Section 18C, HN-502 Daavlin System Test. This testing confirms that retrofitting the above noted models with the Houva -NET Control System results in an equivalent system as compared to the Houva III (III/V) Phototherapy System with PhotoSense II™ predicate. The Indication for Use for the Houva V with Houva -NET Control System is identical to that of the predicate. the Houva III Phototherapy System with PhotoSense II™ and is as follows: The Houva V with Houva -NET Control System is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders. The Houva-NET Control System will be applicable to additional phototherapy systems once the complete verification and validation are completed for each individual system. ## Comparison to Predicate Device The modified Houva V with Houva-NET Control System is substantially equivalent to the cleared Houva 3 Phototherapy System with PhotoSense II™ in terms of intended use, technology, and performance. Table 5-1 compares the proposed Houva -NET Control System with the predicate. {6}------------------------------------------------ | Table 5-1: Substantial Equivalence Table | | |------------------------------------------|--| |------------------------------------------|--| | Characteristic | Houva V with Houva-NET<br>Control System | Houva 3 Phototherapy<br>System with PhotoSense<br>IITM | Comparison | |---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Intended Use<br>Target population<br>Indication for Use | "The Houva-NET Control<br>System is a therapeutic<br>product designed for<br>individuals who require<br>specific Ultraviolet<br>radiation therapy for the<br>treatment of psoriasis and<br>vitiligo." | "The Houva 3<br>Phototherapy System with<br>PhotoSense II is a<br>therapeutic product<br>designed for individuals<br>who require specific<br>Ultraviolet radiation<br>therapy for the treatment of<br>psoriasis and vitiligo." | Identical | | Software | The controller board<br>manages the function for<br>the applied system, but is<br>designed to interface with<br>multiple systems; however,<br>the control boards use on a<br>single unit continues to<br>manage the functions for<br>that applied system in an<br>equivalent fashion | The controller board<br>manages the function for<br>the applied system | Equivalent | | Lamp Type(s) and<br>Wavelengths | UVA-F72T12/BL/HO<br>(PUVA) @ 320-400 nm<br>UVB-NB-TL100W/01<br>FS72 @ 311-313 nm | UVA-F72T12/BL/HO<br>(PUVA) @ 320-400 nm<br>UVB-BB-<br>FSX72T12/UVB-HO @<br>265-320 nm<br>UVB-NB-TL100W/01<br>FS72 @ 311-313 nm | Identical | | Control (Timer)<br>Type | Digital Timer Crystal<br>controlled | Digital Timer Crystal<br>controlled | Identical | | Electrical Safety | Devices is certified to meet<br>current electrical safety<br>standards | Designed and is certified to<br>current UL and CSA<br>standards | Identical | | Compatibility with<br>environment and | Device meets current<br>electromagnetic | Device meets current<br>electromagnetic | Identical | | other devices | compatibility standards | compatibility standards | | | Where Used | Primarily used in a clinical<br>settings | Primarily used in clinical<br>settings | Identical | | Mechanical Safety | Physical characteristics are<br>identical | Physical characteristics are<br>identical | Identical | | Human Factors | LCD Touch screen, user<br>programmable options,<br>alarms and lockouts | LCD Touch screen, user<br>programmable options,<br>alarms and lockouts | Identical | Houva V with Houva-NET Control System – Traditional 510(k) {7}------------------------------------------------ # Summary of technological characteristics / performance data: This modified device has the same indications for use and technological characteristics as the predicate devices. Comparisons of the following technological characteristics, and non-clinical performance data (indicated by *), were assessed, and the results demonstrate the substantial equivalence to the predicates: # Description of Testing The safe and effective performance of the Houva V with Houva-NET Control System has been clearly demonstrated by bench tests: - System Verification Section 18 A-M - Software Validation Section 16 A-L ● Performance data demonstrates continued conformance with IEC 60601-1 Ed.2 Clinical testing was not required to establish equivalency of the device. The comparison of technological characteristics, non-clinical performance data, safety testing, and software validation, demonstrates that the device is as safe, as effective, and performs as well or better than the predicate devices. ## Conclusion: National Biological Corporation concludes that the device is substantially equivalent to the currently legally marketed predicate devices. The Houva V with Houva -NET Control System does not introduce new indications for use or intended use, has identical or equivalent technological characteristics, provides images of equivalent diagnostic capability, and does not introduce new potential hazards or safety risks. The device is as safe, as effective, and performs as well or better than the predicate devices. > Houva V with Houva-NET Control System – Traditional 510(k) 510(k) Summary Section 5: Page 5 of 5