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

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
- Anti-bacterial Gauze
- Drain Tube
- Drain Clamp
- Cover Dressing
- Instructions for use
1 Disposable 300cc Canister
1 Canister Tubing Set. Set includes:
- Dual lumen Tubing (runs between the canister and the connector)
- Clamp
- Connector for attachment to dual lumen tube to the drain
Carrying Case

AI/ML Overview

Accuro Medical WoundPro Apex Acceptance Criteria and Performance Study

The Accuro Medical WoundPro Apex is a powered suction pump designed for negative pressure wound therapy. The 510(k) submission (K100823) claims substantial equivalence to predicate devices (Medela Invia - K080357 and Blue Sky Vista - K061367) based on technological characteristics and performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a formal table with pass/fail metrics. Instead, the "Performance Data" section outlines various non-clinical tests conducted, and the "Summary of Technological Characteristics" asserts substantial equivalence to predicate devices across several features. For this analysis, the predicate device specifications are used as an implicit benchmark for acceptance.

Feature / Acceptance Criteria (Implicit from Predicate Devices)	Reported WoundPro Apex Performance
Electrical Safety	Compliant with all electrical safety requirements including IEC 60601-1-2. Passed non-clinical testing for electrical safety.
Electromagnetic Compatibility (EMC)	Passed non-clinical testing for electromagnetic compatibility (EMC).
Software Validation	Passed non-clinical testing for software validation.
Accuracy of Canister Volume Marks	Passed non-clinical testing for accuracy of canister volume marks.
Filter Ability to Shut off Fluid Flow (when wet)	Passed non-clinical testing; compared to predicate devices.
Tubing Clamp & Cap Ability to Prevent Leaking	Passed non-clinical testing; compared to predicate devices.
Battery Life (on sealed wound)	Passed non-clinical testing; compared to predicate devices.
System Ability to Maintain Consistent Vacuum (on batteries)	Passed non-clinical testing; compared to predicate devices.
Vacuum Setting Accuracy	Passed non-clinical testing at different vacuum settings; compared to predicate devices.
Fluid Extraction Test	Passed non-clinical testing, comparing fluid volumes removed from simulated wound at different flow rates and vacuum settings; compared to predicate devices.
Indications for Use	Substantially equivalent to predicate devices (Medela Invia and Blue Sky Vista).
Technological Characteristics (e.g., weight, dimensions,	Substantially equivalent to predicate devices. (While slight differences exist, these features, along with power source, vacuum range, suction capacity, canister volume, and modes of operation, were deemed substantially equivalent.) Construction materials are also substantially equivalent. Patient contact materials are biocompatible and off-the-shelf sterile wound dressing materials.

2. Sample Size for Test Set and Data Provenance

The document describes non-clinical bench testing for the performance evaluation of the WoundPro Apex. It does not specify a "test set" in terms of patient data or a clinical study. The data provenance is laboratory-based testing performed by the applicant, Accuro Medical Products LLC. There is no information provided about country of origin of data or whether it was retrospective or prospective, as it pertains to non-clinical tests.

3. Number of Experts for Ground Truth and Qualifications

Since the study described is a non-clinical bench testing and a substantial equivalence claim, there's no mention of experts establishing ground truth in the context of clinical outcomes or images. The "ground truth" for the performance tests would be defined by engineering specifications, regulatory standards (e.g., IEC 60601-1-2), and comparative measurements against predicate devices.

4. Adjudication Method for Test Set

Not applicable. As no human-interpretive test set (e.g., images for diagnosis) is described, there is no need for an adjudication method. The performance assessment is based on objective measurements and comparisons against established specifications and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader performance with or without AI assistance. This device is a negative pressure wound therapy pump, not an AI-powered diagnostic or assistive tool for human interpretation.

6. Standalone (Algorithm Only) Performance

Not applicable. The Accuro Medical WoundPro Apex is a medical device (powered suction pump) and not an algorithm or AI-driven system that would have "standalone performance" in the context of a diagnostic or interpretive task. Its performance is its functional operation.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance tests would be:

Engineering specifications and regulatory standards: For electrical safety, EMC, software validation, and accuracy of measurements (e.g., canister volume, vacuum settings).
Predicate device performance data: For comparative tests like filter ability, tubing clamp effectiveness, battery life, consistent vacuum maintenance, and fluid extraction. The assumption for substantial equivalence is that the predicate devices are safe and effective, and thus their performance serves as the benchmark.

8. Sample Size for Training Set

Not applicable. This device is a hardware medical device and does not involve AI or machine learning models that require a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI/ML model for this device.

Summary

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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

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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 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

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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 AdapterModel: TR30RAM180Input: 90-264VAC, 0.8-0.4A, 47-63HzOutput: 18VDC 1.67A
Collection Canister	300cc and 800cc
Modes - Continuous andIntermittent Therapy	20 - 150mmHg Vacuum

5 Indications for Use

Types of Wounds Indicated are:

Diabetic/Neuropathic ulcers
Pressure ulcers
Chronic wounds .
. Acute wounds
Dehisced wounds

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ccuro Medical

6 Technological Characteristics

Comparison Chart

	Accuro Medical	Medela	BlueSky Vista
Indications forUse	The WoundPro ApexNegative PressureWound Therapy Systemmay promote woundhealing, through thedrainage and removal ofinfectious material andother fluids from thewound site usingcontinuous and/orintermittent negativepressure. Patients withchronic, acute, traumatic,subacute and dehiscedwounds, partial-thicknessburns, ulcers (such asdiabetic or pressure),flaps and grafts maybenefit from the use ofthis device.Types of WoundsIndicated are:Diabetic/Neuropathic ulcers Pressure ulcers Chronic wounds Acute wounds Dehiscedwounds	The Medela INVIAWound Therapy isindicated to help promotewound healing, throughmeans includingdrainage and removal ofinfectious material andother fluids, under theinfluence of continuousand/or intermittentnegative pressures,particularly for patientstraumatic, subacute, anddehisced wounds, partialthickness bums, ulcers(such as diabetic orpressure), flaps or grafts.Types of WoundsIndicated are:Diabetic/Neuropathic ulcers Pressure ulcers Chronic wounds Acute wounds Dehiscedwounds	The Blue Sky Vista WoundVacuum System is indicatedfor patients who wouldbenefit from a suction deviceparticularly as the devicemay 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 31/2" (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 BatteryAC Power	Lithium Ion BatteryAC power	Nickel Metal Hydride BatteryAC Power
ElectricalVoltage	90-260VAC47-63Hz	100-240V AC47-63Hz	100-240V AC50-60 Hz
	Accuro Medical	Medela	Blue Sky Vista
ElectricalAmperage	.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
CanisterVolumes	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 IntermittentMode	Continuous
Filter	Hydrophobic overflowprotection / bacteria filterintegrated into the single usecollection canister	Hydrophobic overflowprotection / bacteria / odorfilter integrated into the singleuse collection canister	Single Patient AntibacterialFilter

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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.

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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).

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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.

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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

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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

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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)

AND/OR

Over-the-Counter Use (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)

one m

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices.

510(k) Number K100823

· Page 1 of 1

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
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.(b)
Classification. Class II.