Who is the manufacturer of VOLTERA POWERED SUCTION PUMP?

Suzric Enterprise Co., Ltd. filed the 510(k) submission for VOLTERA POWERED SUCTION PUMP (K112853).

What is the FDA product code for VOLTERA POWERED SUCTION PUMP?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for VOLTERA POWERED SUCTION PUMP?

510(k) clearance (submission type: Traditional).

What are the predicate devices for VOLTERA POWERED SUCTION PUMP?

NovaSpine Powered Suction Pump PRO-I (K062456); Prospera PRO-I, PRO-II and PRO-III Negative Pressure Wound Therapy System (K112458).

Who can help prepare an FDA 510(k) submission like VOLTERA POWERED SUCTION PUMP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VOLTERA POWERED SUCTION PUMP

K112853 · Suzric Enterprise Co., Ltd. · OMP · Nov 9, 2012 · General, Plastic Surgery

Device Facts

Record ID	K112853
Device Name	VOLTERA POWERED SUCTION PUMP
Applicant	Suzric Enterprise Co., Ltd.
Product Code	OMP · General, Plastic Surgery
Decision Date	Nov 9, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

VOLTERA Powered Suction Pump S1001-3 is a lightweight, portable negative pressure wound therapy (NPWT) device. It applies continuous or intermittent negative pressure to a wound site to remove exudate, irrigation fluids, and infectious materials into a disposable canister via tubing. Operated by mains power or internal battery, the device is used in clinical or home settings. Healthcare providers set the pressure parameters; the system facilitates wound management by maintaining a vacuum environment. Benefits include fluid removal and promotion of wound healing. The device is a compact alternative to larger suction pumps, featuring a maximum vacuum of -200 mmHg and a suction rate of 2.5 liters/min.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included in vitro and in vivo preclinical physical and mechanical assessments, and electrical safety/EMC testing per IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Powered suction pump; Class II; 21 CFR 878.4780. Max vacuum -200 mmHg; suction rate 2.5 L/min. Power: 100-240V AC or internal battery (24-48hr duration). Dimensions: 170x160x90 mm; Weight: 1.35 kg. Operation: Continuous and intermittent. Components: Disposable collection canister, tubing, connectors, filters. Standards: IEC 60601-1, IEC 60601-1-2, ISO 14971.

Indications for Use

Indicated for patients requiring negative pressure wound therapy for removal of fluids, exudate, infectious material, and tissue debris to promote healing. Applicable to traumatic wounds, dehisced wounds, partial thickness burns, chronic wounds (pressure, diabetic foot, venous leg ulcers), acute wounds, and flaps and grafts. Contraindicated for necrotic tissue, malignancy, untreated osteomyelitis, untreated malnutrition, exposed arteries/veins/nerves/organs, and use over anastomotic sites.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

NovaSpine Powered Suction Pump PRO-I (K062456)
Prospera PRO-I, PRO-II and PRO-III Negative Pressure Wound Therapy System (K112458)

Related Devices

K231646 — Carilex VT¿200-i NX · Carilex Medical, Inc. · Apr 17, 2024
K241023 — Negative Pressure Wound Therapy Device (V-Move, V-Grand) · Med Way, Inc. · Aug 19, 2024
K151326 — RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device · Smith & Nephew, Inc. · Jul 16, 2015
K090638 — GENADYNE A4-XLR8 WOUND VACUUM SYSTEM · Genadyne Biotechnologies, Inc. · Apr 29, 2009
K213906 — extriCARE 1000 Negative Pressure Wound Therapy System · Alleva Medical, Ltd. · Mar 8, 2023

Submission Summary (Full Text)

{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 | 5.4 Submitter: | Carilex Medical, Inc. | |-----------------------|-------------------------------------------------------------------------------| | Address: | No.77, keji 1st Road, Guishan Township, Taoyuan County 333, Taiwan, R.O.C. | | Phone: | +886-03-3287882 | | Fax: | +886-03-3288622 | | Contact: | 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 (VOLTERA Powered Suction Pump, S1001-3 Series) | Predicate Device (NovaSpine Powered Suction Pump PRO-I, K062456) | Predicate Device (Prospera PRO-I, PRO-II and PRO-III Negative Pressure Wound Therapy System, K112458) | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | Class II | Class II | Class II | | Code or Federal Regulations | 878.4780 | 878.4780 | 878.4780 | | Prescription Medical Devices | YES | YES | YES | | Intended 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 | The NovaSpine Powered Suction Pump PROMI is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for the aspiration and removal | The Prospera Negative Pressure Wound Therapy System is indicated for patients that would benefit from a suction device particularly as the device may promote wound healing by removal of wound | | | 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. | of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside. | exudate, debris, and infectious material or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from the patient's airway or respiratory support system. The Prospera Negative Pressure Wound Therapy may be used during surgery or at the patient's bedside and is indicated for home use. | | Model | S1001-3 Series | PRO-I | PRO-I, PRO-II, PRO-III | | Indications for Use | The Voltera suction pump is indicated on use with patients with the following wounds: > Traumatic > Dehisced wounds > Partial thickness burns (the epidermis and some portion of the dermis have been burned or | For management of chronic, acute, traumatic, sub acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. | For management of chronic, acute, traumatic, sub acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. | | | injured) | | | | | Chronic wounds | | | | | (pressure | | | | | ulcers,diabetic | | | | | foot ulcers, venous | | | | | leg ulcers) | | | | | Acute wounds | | | | | Traumatic | | | | | Flaps and grafts | | | | Contraindications | Contraindicated for patients with the following conditions: 1. Presence of necrotic tissue 2. Malignancy 3. Untreated Osteomyelitis 4. Untreated malnutrition 5. Exposed arteries, veins, nerves, or organs 6. Use over anastomotic sites | The PRO-I is contraindicated in the presence of: 1. Necrotic tissue 2. Unexplored or non-enteric fistulas 3. Untreated osteomyelitis 4. Malignancy in the wound 5. Exposed arteries, veins, or organs | The PRO-I, PRO-II, PRO-III is contraindicated in the presence of: 1. Necrotic tissue 2. Unexplored or non-enteric fistulas 3. Untreated osteomyelitis 4. Malignancy in the wound 5. Exposed arteries, veins, or organs | | Specification | Suction: 2.5 liters/min | Suction: 9 liters/min | Suction: 9 liters/min | | | Maximum Vacuum: -200 mmHg | Maximum Vacuum: -200 mmHg | Maximum Vacuum: -200 mmHg | | | Noise: 30dba at 190 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/ Disposable components | Collection canister (secretion container) | Collection canister (secretion container) | Collection canister (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