VT - 100, VT - 200

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 9, 2018 Carilex Medical, Inc. Henry Kao RA Specialist No. 77 Keji 1st Rd., Guishan Dist. Taoyuan City, Taiwan 333 ### Re: K173407 Trade/Device Name: VT - 100, VT - 200 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: July 6, 2018 Received: July 9, 2018 Dear Henry Kao: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ### David Krause -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: 06/30/2020 | | See PRA Statement below. | | 10(k) Number (if known) | K172407 | |-------------------------|---------| |-------------------------|---------| ### になるということです。 2008年には、2008年には、2008年には、2008年には、2008年には、2008年には、2008年には、2008年には、2008年には、2008年には、2008年には、2000年には、2000年には、2000年には、2000年には、2000年には、2000年には、2000年には、2000年には、2000年には、2 51 Carilex VT · 100/VT · 200 Device Name ## Indications for Use (Describe) and and for and of finds and of finites and in the care pur ship is in the sunselves with and Co wound healing. spunow guiwollot all think stually asu uo baksibui si ijun yakeet noisos 002 • TV odl - · Traumatic 91111 17 - Dehisced wounds - Partial-thickness burns - Chronic wounds including pressure ulcers, disbetic foot ulcers and venous leg ulcers - Acute wounds - Flaps and grafts Type of Use (Select one or both, as applicable) A Presscription Use (Part 21 CFR 801 Suppart DJ _ Over-The-Counter Use (2) CFR 801 Support C # CONTINUE ON A SEPARATE PAGE IF NEEDED This section a lighten only of evenune of the Pressure Act of The section Act of 1995 # A model and and the cours and the other of the more and and and of the subdiser red sund of effectives of beterminent in noticellos sing to result reprint of emit reprint of the əsindən birin əsasən əlib qulpubların ən ən bir nümani in qibəli ərazi və bir və və və və və və və və və və və və v Department of Health and Human Services Office of Chief Information Officer Food and Drug Administration aperwork Reduction Act (PRA) Staff Asstaff@fda.hhss.gov Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov Department of Health and Human Service Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov Department of Health and Human Servic Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov Department of Health and Human Servic Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov Department of Health and Human Servi Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov Department of Health and Human sel Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov o un a not puodsar of paintes serving is not e program is not person to to collection a information unless it displays a currently valid OMB number. Page 1 of 1 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "carilex" in a light blue color. The letters are lowercase, and the "e" has a swoosh extending from the top right. There is a registered trademark symbol to the right of the "x". K173407 Carilex VT.100/VT.200 Page 1/4 ### 510(k) SUMMARY The assigned 510(k) number is: K173407 ### Submitter's Information 1. Carilex Medical, Inc. No. 77, Keji 186 Rd., Guishan Dist., Taoyuan City, Taiwan 333 Registration Number: 9710603 Contact: Henry Kao Tel: +886-3-3287882 Fax: +886-3-3288622 Email: henry.kao@carilexmedical.com Date Summary Prepared: October 27, 2017 - Trade Name of the Device: Carilex VT · 100 & VT · 200 2. - 3. Common or Usual Name: Powered Suction Pump - 4. Classification Name: Negative Pressure Wound Therapy Powered Suction Pump Regulation Number: 878.4780 Product Code: ОМР Panel: General & Plastic Surgery ### 5. Predicate Device Information: VOLTERA Powered Suction Pump, S1001-3 Series, K112853 ### 6. Device Description Carilex VT • 100 and VT • 200 are suction pumps with collection canisters for negative pressure wound therapy. The VT · 100 and VT · 200 are modified from their precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853). The pump is connected to the wound dressing via a tube connected to a disposable canister. The devices provide 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 devices can operate either by a mains power supply or internal battery. The VT • 200 is developed with technology and components that are almost identical to VT • 100, but for marketing differentiation it is designed with a new outer case which contains extra room to allow incorporation with different types of air compressors in the future. {4}------------------------------------------------ ### 7. Intended Use Carilex VT • 100/VT • 200 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 VT · 100/VT · 200 suction therapy unit is indicated on use with patients with the following wounds: Traumatic, Dehisced wounds, Partial-thickness burns, Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers, Acute wounds, Flaps and grafts. | Item | Proposed Devices | | Predicate Device | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | VT · 200 | VT · 100 | VOLTERA Powered Suction<br>Pump | | Model | S1002-0012 | S1001-0032 | S1001-3 Series | | Classification | Class II | Class II | Class II | | Code for Federal<br>Regulations | 878.4780 | 878.4780 | 878.4780 | | Product Code | OMP | OMP | OMP | | Prescription Medical<br>Device | YES | YES | YES | | Compatible NPWT<br>Dressing | DeRoyal Foam Kits<br>(K112458) | DeRoyal Foam Kits<br>(K112458) | DeRoyal Foam Kits<br>(K112458) | | Intended Use | Carilex VT · 200 is indicated<br>for patients who would benefit<br>from wound management via<br>the application of negative<br>pressure for removal of fluids<br>and excess exudate, infectious<br>material, and tissue debris<br>which may promote wound<br>healing. | Carilex VT · 100 is indicated<br>for patients who would benefit<br>from wound management via<br>the application of negative<br>pressure for removal of fluids<br>and excess exudate, infectious<br>material, and tissue debris<br>which may promote wound<br>healing. | The VOLTERA Powered<br>Suction Pump, S1001-3 Series<br>is indicated for patients who<br>would benefit from wound<br>management via the<br>application of negative<br>pressure for removal of fluids<br>and excess exudate, infectious<br>material, and tissue debris<br>which may promote wound<br>healing. | | | The VT • 200 suction therapy | The VT • 100 suction therapy | The VOLTERA suction pump | | | unit is indicated on use with | unit is indicated on use with | is indicated on use with | | | patients with the following | patients with the following | patients with the following | | | wounds: | wounds: | wounds: | | | > Traumatic | > Traumatic | > Traumatic | | | > Dehisced wounds | > Dehisced wounds | > Dehisced wounds | | | > Partial thickness burns | > Partial thickness burns | > Partial thickness burns | | Indications for Use | > Chronic wounds<br>including pressure<br>ulcers, diabetic foot<br>ulcers, and venous leg<br>ulcers | > Chronic wounds<br>including pressure<br>ulcers, diabetic foot<br>ulcers, and venous leg<br>ulcers | > Chronic wounds<br>including pressure<br>ulcers, diabetic foot<br>ulcers, and venous leg<br>ulcers | | | > Acute wounds | > Acute wounds | > Acute wounds | | | > Flaps and grafts | > Flaps and grafts | > Flaps and grafts | | | > Presence of necrotic<br>tissue | > Presence of necrotic<br>tissue | > Presence of necrotic<br>tissue | | | > Malignancy | > Malignancy | > Malignancy | | | > Untreated Osteomyelitis | > Untreated Osteomyelitis | > Untreated Osteomyelitis | | | > Untreated malnutrition | > Untreated malnutrition | > Untreated malnutrition | | Contraindications | > Exposed arteries, veins,<br>nerves, or organs. | > Exposed arteries, veins,<br>nerves, or organs. | > Exposed arteries, veins,<br>nerves, or organs. | | | > Use over anastomotic<br>sites | > Use over anastomotic<br>sites | > Use over anastomotic<br>sites | | | > Unexplored or<br>non-enteric fistulas | > Unexplored or<br>non-enteric fistulas | | | | > Exposed bone or tendons | > Exposed bone or tendons | | | Suction Capacity | 9.5 Liter / min | 2.5 Liter / min | 2.5 Liter / min | | Max. Vacuum | -200 mmHg | -200 mmHg | -200 mmHg | | Power Input | AC 100-240V / 50-60 Hz | AC 100-240V / 50-60 Hz | AC 100-240V / 47-63 Hz | | Power Output | DC 9.1V / 3.3A | DC 9.1V / 3.3A | DC 9V / 3A | | Battery Type | Lithium-ion | Lithium-ion | Lithium-ion | | Operating Time<br>(Battery) | At least 24 hours,<br>depend on use | At least 24 hours,<br>depend on use | At least 24 hours,<br>depend on use | | Dimensions | 18 x 17.5 x 9 cm | 18 x 17 x 9 cm | 17 x 16 x 9 cm | | Weight | 1.35 kg | 1.35 kg | 1.35 kg | | Operating Mode | Continuous & Intermittent | Continuous & Intermittent | Continuous & Intermittent | | Canister | 300/500 ml | 300/500 ml | 300/800 ml | | Life-time | 3 years | 3 years | 3 years | ### Technological Comparison to Predicate Devices: 8. {5}------------------------------------------------ ### carilex* {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "carilex" in a light blue color. The letters are lowercase and have a rounded, modern font. There is a small registered trademark symbol to the upper right of the word. ### 9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: The following tests were performed to determine substantial equivalence: AAMI/ANSI ES60601-1:2005/(R)2012+A1:2012, C1:2009/(R)2012+A2:2010/(R)2012 Medical Electrical Equipment – Part 1:General Requirements for basic safety and essential performance IEC 60601-1-2:2007 Medical Electrical Equipment – Part 1-2: General Requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests Performance/Comparison Testing of VT · 100/VT · 200 with the predicate. The pumps met all pre-determined acceptance criteria and passed the tests (suction pressure, fluid removal rate, alarm functionality). ### 10. Discussion of Clinical Tests Performed Clinical tests were not performed. ### 11. Conclusion After analyzing intended use, indications for use, technology, bench test report, shelf-life test reports, software documents, and EMC and electrical safety test reports, it can be concluded that Carilex VT • 100 and VT • 200 are substantially equivalent to the predicate device (K112853).