VOLTERA POWERED SUCTION PUMP

{0}------------------------------------------------ VOLTERA Powered Suction Pump S1001-3 Series ### NOV 9 2012 ### 510(k) Summary - న. 1 Type of Submission: 、Traditional - 5.2 Preparation Date: Jul 7, 2011 - 5.3 Revised Date: August 1, 2012 | <b>5.4 Submitter:</b> | Carilex Medical, Inc. | |-----------------------|-------------------------------------------------------------------------------| | <b>Address:</b> | No.77, keji 1st Road, Guishan Township, Taoyuan County<br>333, Taiwan, R.O.C. | | <b>Phone:</b> | +886-03-3287882 | | <b>Fax:</b> | +886-03-3288622 | | <b>Contact:</b> | Clytie Chiou | - Establishment Registration Number: 9710603 #### 5.3 Identification of the Device: | Proprietary/Trade name: | VOLTERA Powered Suction Pump, S1001-3 Series | |-------------------------|-------------------------------------------------| | Common Name: | Powered Suction Pump | | Classification Name: | Negative Pressure Wound Therapy Powered Suction | | | Pump | | Device Classification: | II | | Regulation Number: | 878.4780 | | Panel: | General & Plastic Surgery | | Product Code: | OMP | ### 5.4 Identification of the Predicate Device: | Predicate Device Name: | NovaSpine Powered Suction Pump PRO-I | |-----------------------------------------|---------------------------------------------| | Manufacturer: | NovaSpine LLC | | 510(k) Number or Clearance Information: | K062456 | | Predicate Device Name: | Prospera PRO-I, PRO-II and PRO-III Negative | Pressure Wound Therapy System ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {1}------------------------------------------------ VOLTERA Powered Suction Pump S1001-3 Series Manufacturer: Medica-Rents Co LTD 510(k) Number or Clearance Information: K112458 ### 5.5 Intended Use and Indications for Use of the subject device. The VOLTERA Powered Suction Pump, S1001-3 Series is indicated for patients who would · benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VOLTERA Powered Suction Pump is indicated for removal of exudate from traumatic, dehisced wounds, partial thickness burns, chronic wounds such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, acute wounds, and flaps and grafts. ### 5.6 Device Description The VOLTERA Powered Suction Pump, S1001-3 Series is a lightweight, suction device intended for wound management via application of continual or intermittent negative pressure wound therapy to the wound for removal of fluids, including wound exudates, irrigation fluids, and infectious materials. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery. ### 5.7 Non-clinical Testing A series of in vitro and in vivo preclinical physical and mechanical tests were performed to assess the safety and effectiveness of the VOLTERA Powered Suction Pump. The tests were conducted in accordance with IEC 60601-1-1 Safety Requirements for Medical Electrical Systems (06/92), Am.1 (11/95), Ed.2 (12/00), IEC 60601-1-2 Electromagnetic Compatibility - Requirements and Tests (04/93), Ed.2 (09/01), Am.1 (09/04), Ed. 2.1 (11/04), ISO 14971:2007 Medical devices- Application of risk management to medical devices. All the test results demonstrate the performance of VOLTERA Powered Suction Pump meets the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the VOLTERA Powered Suction Pump is substantially equivalent to the predicate devices. {2}------------------------------------------------ ### 5.8 Substantial Equivalence Determination The VOLTERA Powered Suction Pump submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared NovaSpine Powered Suction Pump PRO-I which is the subject of K062456 and Prospera PRO-I, PRO-II and PRO-III Negative Pressure Wound Therapy System which is the subject of K 112458. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness. | Item | Proposed Device<br>(VOLTERA Powered<br>Suction Pump,<br>S1001-3 Series) | Predicate Device<br>(NovaSpine Powered<br>Suction Pump PRO-I,<br>K062456) | Predicate Device<br>(Prospera PRO-I,<br>PRO-II and PRO-III<br>Negative Pressure<br>Wound Therapy<br>System, K112458) | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | Class II | Class II | Class II | | Code or Federal<br>Regulations | 878.4780 | 878.4780 | 878.4780 | | Prescription<br>Medical Devices | YES | YES | YES | | Intended Use | The VOLTERA<br>Powered Suction<br>Pump, S1001-3 Series<br>is indicated for patients<br>who would benefit<br>from wound<br>management via the<br>application of negative<br>pressure for removal of<br>fluids and excess | The NovaSpine<br>Powered Suction Pump<br>PROMI is indicated<br>for patients who would<br>benefit from a suction<br>device particularly as<br>the device may<br>promote wound<br>healing or for the<br>aspiration and removal | The Prospera Negative<br>Pressure Wound<br>Therapy System is<br>indicated for patients<br>that would benefit<br>from a suction device<br>particularly as the<br>device may promote<br>wound healing by<br>removal of wound | | | exudate, infectious<br>material, and tissue<br>debris which may<br>promote wound<br>healing. The<br>VOLTERA Powered<br>Suction Pump is<br>indicated for removal<br>of exudate from<br>traumatic, dehisced<br>wounds, partial<br>thickness burns,<br>chronic wounds such<br>as pressure ulcers,<br>diabetic foot ulcers,<br>venous leg ulcers,<br>acute wounds, and<br>flaps and grafts. | of surgical fluids,<br>tissue (including<br>bone), gases, bodily<br>fluids or infectious<br>materials from a<br>patient's airway or<br>respiratory support<br>system either during<br>surgery or at the<br>patient's bedside. | exudate, debris, and<br>infectious material or<br>for the aspiration and<br>removal of surgical<br>fluids, tissue<br>(including bone),<br>gases, bodily fluids or<br>infectious material<br>from the patient's<br>airway or respiratory<br>support system. The<br>Prospera Negative<br>Pressure Wound<br>Therapy may be used<br>during surgery or at the<br>patient's bedside and is<br>indicated for home use. | | Model | S1001-3 Series | PRO-I | PRO-I, PRO-II,<br>PRO-III | | Indications<br>for<br>Use | The Voltera suction<br>pump is indicated on<br>use with patients with<br>the following wounds:<br>> Traumatic<br>> Dehisced wounds<br>> Partial thickness<br>burns (the<br>epidermis and<br>some portion of<br>the dermis have<br>been burned or | For management of<br>chronic, acute,<br>traumatic, sub acute<br>and dehisced wounds,<br>partial thickness burns,<br>ulcers (such as diabetic<br>or pressure), flaps and<br>grafts. | For management of<br>chronic, acute,<br>traumatic, sub acute<br>and dehisced wounds,<br>partial thickness burns,<br>ulcers (such as diabetic<br>or pressure), flaps and<br>grafts. | | | injured) | | | | | Chronic wounds | | | | | (pressure | | | | | ulcers,diabetic | | | | | foot ulcers, venous | | | | | leg ulcers) | | | | | Acute wounds | | | | | Traumatic | | | | | Flaps and grafts | | | | Contraindications | Contraindicated for<br>patients with the<br>following conditions:<br>1. Presence of<br>necrotic tissue<br>2. Malignancy<br>3. Untreated<br>Osteomyelitis<br>4. Untreated<br>malnutrition<br>5. Exposed arteries,<br>veins, nerves, or<br>organs<br>6. Use over<br>anastomotic sites | The PRO-I is<br>contraindicated in the<br>presence of:<br>1. Necrotic tissue<br>2. Unexplored or<br>non-enteric<br>fistulas<br>3. Untreated<br>osteomyelitis<br>4. Malignancy in the<br>wound<br>5. Exposed arteries,<br>veins, or organs | The PRO-I, PRO-II,<br>PRO-III is<br>contraindicated in the<br>presence of:<br>1. Necrotic tissue<br>2. Unexplored or<br>non-enteric<br>fistulas<br>3. Untreated<br>osteomyelitis<br>4. Malignancy in the<br>wound<br>5. Exposed arteries,<br>veins, or organs | | Specification | Suction: 2.5 liters/min | Suction: 9 liters/min | Suction: 9 liters/min | | | Maximum Vacuum:<br>-200 mmHg | Maximum Vacuum:<br>-200 mmHg | Maximum Vacuum:<br>-200 mmHg | | | Noise: 30dba at 190<br>cm | Noise: 35 dba | Noise: 35 dba | | | Weight: 1.35 kg | Weight: 2.8 kg | Weight: 1.8~2.8 kg | | | Voltage: 100-240V / | Voltage: 100-240V / | Voltage: 100-240V / | | | 50-60Hz | 50-60Hz | 50-60Hz | | | Operation: Continuous | Operation: Continuous | Operation: Continuous | | | and Intermittent | and Intermittent | and Intermittent | | | Battery Operation: | Battery Operation: | Battery Operation: | | | 24~48hrs depending | 24~48hrs depending | 24~48hrs depending | | | on use | on use | on use | | | Dimensions: | Dimensions: | Dimensions: | | | 170*160*90 mm | 290*359*130 mm | 290*359*130 mm | | Consumable/<br>Disposable<br>components | Collection canister<br>(secretion container) | Collection canister<br>(secretion container) | Collection canister<br>(secretion container) | | | Related hoses (tubing) | Related hoses (tubing) | Related hoses (tubing) | | | Hose connectors | Hose connectors | Hose connectors | | | Filters | Filters | Filters | | | Other accessories | Other accessories | Other accessories | {3}------------------------------------------------ # VOLTERA Powered Suction Pump S1001-3 S1001-3 Series {4}------------------------------------------------ # VOLTERA Powered Suction Pump S1001-3 Series S1001-3 Series . {5}------------------------------------------------ ### VOLTERA Powered Suction Pump S1001-3 Series #### રું. કે તે જે Conclusion · After analyzing bench tests, electrical safety testing data, it can be concluded that VOLTERA Powered Suction Pump, S1001-3 Series is substantially equivalent to the predicate device. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 Letter Dated: November 9, 2012 Suzric Enterprise Co., Ltd. % AcmeBiotechs Co., Ltd. Mr. Michael Lee No. 77, Keji 1st Road Guishan Township Taoyuan County, 333 Taiwan Re: K112853 Trade/Device Name: Voltera Powered Suction Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 02, 2012 Received: October 04, 2012 Dear Mr. Lee: 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 for assessed in the encreations of 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 {7}------------------------------------------------ Page 2 – Mr. Michael Lee 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 de rice related adverse overse) (2) egulation (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/ResourcesforYou/Industry/default.htm. Sincerely yours, ### Mark N. Melkerson Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ### Indication for Use Statement 510(k) Number (if known): K112853 Device Name: VOLTERA Powered Suction Pump, S1001-3 Series ### Indications for Use: The VOLTERA Powered Suction Pump, S1001-3 Series is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VOLTERA Powered Suction Pump is indicated for removal of exudate from traumatic, dehisced wounds, partial thickness burns, chronic wounds such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, acute wounds, and flaps and grafts. Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R. Ogden for mxn (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K112853