(306 days)
Not Found
No
The description focuses on standard negative pressure wound therapy technology with electronic controls and alarms, without mentioning any AI or ML capabilities for analysis, prediction, or automated decision-making.
Yes
The device is described as promoting "wound healing" and aiding in the "drainage and removal of infectious material and other fluids from the wound site," which are therapeutic actions.
No
This device is a negative pressure wound therapy system, which is a therapeutic device designed to promote wound healing by removing fluids. It does not diagnose medical conditions.
No
The device description clearly outlines hardware components such as a powered suction pump, brushless DC motor, rechargeable battery, user interface controls, electronic display, audible and visual alarms, and canisters. It is a physical device with integrated software for control and monitoring.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "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." This describes a therapeutic action on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "powered suction pump" that applies negative pressure to a wound. This is a physical intervention, not a method for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is to remove fluids and promote healing, not to provide diagnostic information about a patient's condition based on laboratory analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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
Product codes
OMP
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
- Mounting Clamp for IV Pole, Bedrail, or Footboard mounting
- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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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 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
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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 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
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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) |