Who is the manufacturer of WOUND PRO APEX?

Accuro Medical Products, LLC filed the 510(k) submission for WOUND PRO APEX (K100823).

What is the FDA product code for WOUND PRO APEX?

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 WOUND PRO APEX?

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

Who can help prepare an FDA 510(k) submission like WOUND PRO APEX?

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.

WOUND PRO APEX

Q: What are the predicate devices for WOUND PRO APEX?

Medela Invia (K080357); Blue Sky Vista (K061367).

K100823 · Accuro Medical Products, LLC · OMP · Jan 24, 2011 · General, Plastic Surgery

Device Facts

Record ID	K100823
Device Name	WOUND PRO APEX
Applicant	Accuro Medical Products, LLC
Product Code	OMP · General, Plastic Surgery
Decision Date	Jan 24, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The WoundPro Apex Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. The WoundPro Apex is intended for use in a healthcare facility only.

Device Story

WoundPro Apex is a powered suction pump for negative pressure wound therapy (NPWT). It utilizes a brushless DC motor to generate controlled negative pressure (20-150mmHg) to drain and remove fluids/infectious material from wounds. Input is managed via push-button interface; system includes electronic monitoring, display, and audible/visual alarms. Powered by rechargeable battery or mains power via medical-grade converter. Used in healthcare facilities by clinicians; mountable to IV poles, bed rails, or footboards. Output is continuous or intermittent vacuum, facilitating wound healing. System includes pump, disposable canisters (300cc/800cc), and sterile dressing kits (contact layer, gauze, tubing, cover dressing).

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1-2), electromagnetic compatibility, software validation, canister volume accuracy, filter performance, tubing integrity, battery life, vacuum setting accuracy, and fluid extraction efficiency compared to predicate devices.

Technological Characteristics

Powered suction pump; brushless DC motor; 20-150mmHg vacuum range; 5 L/min suction capacity. Materials: injection-molded plastic housing, biocompatible sterile dressing components. Power: 18VDC lithium-ion battery or 90-264VAC mains adapter. Connectivity: standalone. Sterilization: sterile dressing kits. Software: electronic monitoring and control of vacuum settings.

Indications for Use

Indicated for patients with chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, diabetic/neuropathic ulcers, pressure ulcers, flaps, and grafts requiring negative pressure wound therapy. Intended for use in healthcare facilities only.

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

Medela Invia (K080357)
Blue Sky Vista (K061367)

Related Devices

K150960 — WoundPro Negative Pressure Wound Therapy System · Pensar Medical, LLC · Dec 1, 2016
K111949 — AC WOUND TREATMENT SYSTEM · Nanovibronix, Inc. · Jun 29, 2012
K151326 — RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device · Smith & Nephew, Inc. · Jul 16, 2015
K132446 — RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE · Smith & Nephew, Inc. · Oct 23, 2013
K231646 — Carilex VT¿200-i NX · Carilex Medical, Inc. · Apr 17, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The string starts with the letter 'K', followed by the numbers '100825'. After that, there is a fraction-like structure with 'A2' in the numerator and '53' in the denominator. The handwriting is somewhat cursive and the overall impression is that of a code or identifier written down quickly. Image /page/0/Picture/1 description: The image shows a logo with a stylized black circle on the left and the text "ccurro Medical" on the right. A curved line extends from the circle and underlines the word "ccurro". The word "Medical" is positioned below "ccurro". JA'N: 2 4' 2011 Page 1/7 **510(k) Summary** Applicant: Accuro Medical, 2655 Wisconsin Avenue, Downers Grove, II. 60515 FDA CDRH DMC Traditional 510(k) Submission for Accuro Medical WoundPro Apex DEC 27 2010 Date: 12/3/2010 Received Section E - 510(k) Summary This 510(k) Summary for Accuro Medical WoundPro Apex meets the requirements of 21 CFR 807.92. #### 1 Sponsor's Name, Address and Contact Person Contact for Submission: Todd Hubbard CEO Accuro Medical Products LLC 2655 Wisconsin Avenue Downers Grove, IL 60515 Tel: (630) 829-1675 Fax: (630) 829-1677 Email: todd.hubbard@accuromedical.com Sponsor: Accuro Medical Products LLC 2655 Wisconsin Avenue Downers Grove, IL 60515 Contact: Tim Costa Telephone: 630-829-1631 FDA Registration# 3007793449 #### Name of Device 2 Trade Name: Wound Pro Apex Common Name: Powered Suction Pump Classification Name: Negative Pressure Wound Therapy Suction Pump Product Code: OMP (class 2, 21 CFR 878.4780) #### Name of the Predicate Device(s) 3 Medela Invia - K080357 Blue Sky Vista- K061367 {1}------------------------------------------------ K100823 Page 2/7 Image /page/1/Picture/2 description: The image shows the logo for curo Medical. The logo consists of a black circle with three small protrusions, one at the top and two at the bottom. To the right of the circle is the text "ccuro" in a stylized font, with a line underneath it. Below the line is the word "Medical" in a smaller, simpler font. #### 4 Device Description The Apex is part of the Wound Pro family of products offered by Accuro Medical Products LLC. The Apex is a powered suction pump that uses controlled negative pressure. The control unit incorporates a maintenance free brushless DC motor and is powered by a rechargeable battery power source. Optionally the unit can be connected to mains power using the included Medical Grade Switching power converter. Apex has a negative pressure setting range of 20mm to 150mmHg which is electronically monitored and controlled. The pump includes push button user interface controls and an electronic display with audible and visual alarm indicators. The device can accommodate 300cc and 800cc canister sizes. The unit can be operated on a countertop and has provisions for connection to IV poles, bed side rails, or footboard mounting. The unit may be sold individually or as part of a system includes the following items: - . 1 Apex NPWT Pump - . 1 Mounting Clamp for IV Pole, Bedrail, or Footboard mounting - . 1 Hospital grade Charging Connection to 110V power source - 1 Medium (flat drain) dressing kit. Kit includes: . - Non-adherent contact layer o - o Anti-bacterial Gauze - Drain Tube 0 - Drain Ciamp 0 - o Cover Dressing - Instructions for use 0 - 1 Disposable 300cc Canister . - 1 Canister Tubing Set. Set includes: . - Dual lumen Tubing (runs between the canister and the connector) 0 - Clamp 0 - Connector for attachment to dual lumen tube to the drain 0 - Carrying Case {2}------------------------------------------------ K100823 Page 3/7 Image /page/2/Picture/1 description: The image shows the text "510(k) Summary" in a bold, sans-serif font. The text is black and appears to be the title or heading of a document. The phrase suggests that the document is related to a 510(k) premarket submission to the FDA, which is a type of regulatory submission for medical devices. ## ccuro Medical ### System Specifications: | Feature | Specification | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Weight - Control Unit | 3.8 lbs (1.7 Kg) | | Dimensions | 6 3/4"(w) x 8 1/2" (h) x 3 1/2" (d) (17 x 21 x 9 cm) | | Electrical - Battery Powered | 18VDC 25 Watts | | Optional connection to mains power | Medical Grade Switching Power Adapter Model: TR30RAM180 Input: 90-264VAC, 0.8-0.4A, 47-63Hz Output: 18VDC 1.67A | | Collection Canister | 300cc and 800cc | | Modes - Continuous and Intermittent Therapy | 20 - 150mmHg Vacuum | #### 5 Indications for Use The WoundPro Apex Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. The WoundPro Apex is intended for use in a healthcare facility only. Types of Wounds Indicated are: - Diabetic/Neuropathic ulcers - Pressure ulcers - Chronic wounds . - . Acute wounds - Dehisced wounds {3}------------------------------------------------ K100823/ Page4/7 Image /page/3/Picture/1 description: The image shows the text "510(k) Summary". The text is in a bold, sans-serif font. The text is centered on the image and takes up a majority of the space. # ccuro Medical #### 6 Technological Characteristics ## Comparison Chart | | Accuro Medical | Medela | BlueSky Vista | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The WoundPro Apex Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. Types of Wounds Indicated are: Diabetic/Neuropa thic ulcers Pressure ulcers Chronic wounds Acute wounds Dehisced wounds | The Medela INVIA Wound Therapy is indicated to help promote wound healing, through means including drainage and removal of infectious material and other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patientstraumatic, subacute, and dehisced wounds, partial thickness bums, ulcers (such as diabetic or pressure), flaps or grafts. Types of Wounds Indicated are: Diabetic/Neuropa thic ulcers Pressure ulcers Chronic wounds Acute wounds Dehisced wounds | The Blue Sky Vista Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. | | Weight | 3.8 lbs (1.7 Kg) | <2.2 lbs | 4.3 lbs | | Dimensions | 6 3/4"(w) x 8 1/2" (h) x 3 1/2" (d) (17 x 21 x 9 cm) | 3.74" x 6.69" x 6.91" 150mm x 170mm x 95mm | 10.2" x 9.8" x 4.2" 260mm x 250mm x 106mm | | Power Source | Lithium Ion Battery AC Power | Lithium Ion Battery AC power | Nickel Metal Hydride Battery AC Power | | Electrical Voltage | 90-260VAC 47-63Hz | 100-240V AC 47-63Hz | 100-240V AC 50-60 Hz | | | Accuro Medical | Medela | Blue Sky Vista | | Electrical Amperage | .8-.4A | .8-.4A | 1.0A | | Housing | Injection molded plastic | Injection molded plastic | Vacuum molded plastic | | Vacuum Range | 20-150mm Hg | 60-200mm Hg | Up to 200mm Hg | | Suction Capacity | 5 L/min | 5 L/min | 8 L/min | | Canister Volumes | 0.3 L / 0.8 L | 0.3 L / 0.8 L | 0.25 L / 0.8 L | | Modes | Continuous or Variable / Intermittent Modes | Continuous or Intermittent Mode | Continuous | | Filter | Hydrophobic overflow protection / bacteria filter integrated into the single use collection canister | Hydrophobic overflow protection / bacteria / odor filter integrated into the single use collection canister | Single Patient Antibacterial Filter | {4}------------------------------------------------ K100823 page 5/7 Image /page/4/Picture/1 description: The image shows a logo with a black sphere on the left and the text "ccuro Medical" on the right. The word "ccuro" is above the word "Medical". There is a line that extends from the sphere to the right, underlining the word "ccuro". ## Summary of Technological Characteristics as Compared to Predicate Devices The Apex is compliant with all electrical safety requirements including IEC 60601-1-2. The Apex pump's mechanical performance characteristics are substantially equivalent to the predicate devices and other legally marketed devices. The technology used in the Apex pump is substantially equivalent to the predicate devices and other legally marketed devices. The materials used in construction of the Apex are substantially equivalent to the predicate devices and other legally marketed devices. While there are slight differences, the Apex's weight, dimensions, and power source are substantially equivalent to the predicate devices and other legally marketed devices. The Apex is substantially equivalent to the predicate devices and other legally marketed devices with regards to vacuum range, suction capacity, canister volume, and modes of operation. The Apex and the predicate devices are substantially equivalent with regards to indications for use and patient contact materials. All three devices utilize off-the-shelf sterile wound dressing materials composed of biocompatible materials. The technological features in the WoundPro Apex do not affect the safety and effectiveness of this device. {5}------------------------------------------------ K100823 Page 6/7 Image /page/5/Picture/1 description: The image shows a logo with a stylized atom on the left and the text "ccuro Medical" on the right. The atom is depicted as a black circle with three smaller protrusions. The word "ccuro" is written in a cursive font, and the word "Medical" is written in a smaller, italicized font below it. A horizontal line separates the two words. #### 7 Performance Data The subject device was subjected to and passed all non-clinical testing including: - Electrical safety . - Electromagnetic compatibility (EMC) . - Software validation . - Accuracy of Canister Volume Marks . - Testing of filters ability to shut fluid flow off when it gets wet (compare to predicate devices) . - Test ability of tubing clamp and cap to keep fluid from leaking out of tubing (compare to . predicate devices). - Test batteries to determine how long they will last on a completely sealed wound (compared to . predicate devices). - Test ability of the system to maintain a consistent vacuum running on batteries until all battery . power is depleted and the unit shuts down (compared to predicate devices). - Vacuum Setting Accuracy testing at different vacuum setting (comparing to predicate devices). . - Fluid Extraction Test comparing fluid volumes removed from simulated wound at different flow . rates and different vacuum settings (compared to predicate devices). {6}------------------------------------------------ K100823 Page 7/7 Image /page/6/Picture/1 description: The image shows the logo for "ccuro Medical". The logo consists of a black circle with three small protrusions around its perimeter. To the right of the circle is the text "ccuro" in a stylized font, with the word "Medical" underneath it in a smaller font. A line is drawn underneath the word "ccuro". #### 8 Conclusion All conclusions are made in accordance with the decision making process recommendations as outlined in the 510(k) SE Decision Making Process document. The Accuro Medical Products WoundPro Apex's intended uses are substantially equivalent to the predicate devices. The technological characteristics and components used to build the Accuro Medical Products WoundPro Apex are all substantially equivalent to the two predicate devices. The performance and technology of the WoundPro Apex are substantially equivalent to the predicate devices. At no time does the subject device perform inferiorly to the predicate devices. It is our belief that the information submitted supports our claim that the Accuro Medical Products WoundPro Apex is substantially equivalent to the two predicate devices and other legally marketed devices. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 Accuro Medical Products. LLC % Mr. Todd Hubbard CEO/President 3879 East 12010 Avenue, Suite 328 Denver, Colorado 80233 Re: K100823 Trade/Device Name: Wound Pro Apex Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: December 17, 2010 Received: December 27, 2010 Dear Mr. Hubbard: 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 JAN' 2 4 2011 {8}------------------------------------------------ Page 2 - Mr. Todd Hubbard 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. 1f 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.hypn 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 fire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, F. D.A. Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number: K100823 Device Name: Wound Pro Apex Indications for use: The WoundPro Apex Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partialthickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. The WoundPro Apex is intended for use in a healthcare facility only. Types of Wounds Indicated are: - Diabetic/Neuropathic ulcers - Pressure ulcers · - Chronic wounds . - Acute wounds . - Dehisced wounds Prescription Use (Part 21 CFR 801 Subpart D) X AND/OR Over-the-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Da Concurrence of CDRH, Office of Device Evaluation (ODE) one m (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices. 510(k) Number K100823 · Page 1 of 1