(601 days)
Not Found
No
The description focuses on the mechanical and electronic aspects of a negative pressure wound therapy pump, with no mention of AI or ML capabilities. The software mentioned is for monitoring and alarm functions, not for intelligent analysis or decision-making.
Yes
The device promotes wound healing and drainage/removal of infectious material, which are therapeutic actions.
No
The device description clearly states its function is to promote wound healing through drainage and removal of infectious material and fluids using negative pressure. It is a therapy system, not a device used to diagnose a medical condition.
No
The device description clearly states it is a "powered suction pump" with a "maintenance free brushless DC motor," a "rechargeable battery power source," and "push button user interface controls and an electronic display." These are all hardware components, indicating it is not a software-only device. While it mentions software for monitoring and alarms, the core functionality relies on physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that applies negative pressure to a wound to promote healing by removing fluids and infectious material. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a powered suction pump and its components. This aligns with a therapeutic device used for wound management, not a device that analyzes samples to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic results.
- Performance Studies: The performance studies listed focus on electrical safety, EMC, software verification, and biocompatibility – all relevant to a therapeutic medical device, but not typical for demonstrating the performance of an IVD.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The WoundPro Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site, with 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 is intended for use in a healthcare facility only.
Additional Wounds Indicated are:
- Diabetic/Neuropathic ulcers
- Pressure ulcers
- Chronic wounds
- Acute wounds
- Dehisced wounds
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The WoundPro is part of a family of products offered by Pensar Medical LLC. The WoundPro is a powered suction pump that uses controlled negative pressure to a dressing and flange assembly through tubing.
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. The device is monitored by software and contains an alarm function with audio and visual prompts.
The WoundPro has a negative pressure setting range of 20mm to 200mmHg 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, bedside rails, or footboard mounting.
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 following performance data was provided in support of the substantial equivalence determination.
- Electrical Safety and Electromagnetic Compatibility (EMC)
- Software Verification and Validation Testing
- Verification and Validation Testing
- Biocompatibility Assessment
Substantial Equivalence for the Pensar WoundPro Negative Pressure Wound Therapy System is based on the same indications, intended use, technological features and functions as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or movement. The profiles are stacked slightly overlapping each other. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2016
Pensar Medical, LLC % Elaine Duncan, Ms.ME, RAC President Paladin Medical, Inc. PO Box 560 Stillwater, Minnesota 55082
Re: K150960
Trade/Device Name: WoundPro Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 28, 2016 Received: October 31, 2016
Dear Ms. Duncan:
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 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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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
510(k) Number (if known) K150960
Device Name
PENSAR WoundPro Negative Pressure Wound Therapy System
Indications for Use (Describe)
The WoundPro Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site, with 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 is intended for use in a healthcare facility only.
Additional Wounds Indicated are:
- · Diabetic/Neuropathic ulcers
- · Pressure ulcers
- · Chronic wounds
- · Acute wounds
- · Dehisced wounds
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510(K) SUMMARY
SUBMITTER:
Submitted on behalf of:
| Company Name:
Address:
Telephone:
Fax: | Pensar Medical LLC
42225 Remington Rd, Unit A3
Temecula, CA 92590
(800) 669-4757
NA |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| by:
Telephone:
Fax: | Elaine Duncan, M.S.M.E., RAC
President, Paladin Medical, Inc.
PO Box 560
Stillwater, MN 55082
715-549-6035
715-549-5380 |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | December 1, 2016 |
| TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME: | Pensar WoundPro Negative Pressure Wound Therapy
System
Negative Pressure Wound Therapy System
Negative Pressure Wound Therapy Suction Pump (and
components) |
| PRO CODE: | OMP (Class II, 21 CFR 878.4780) |
SUBSTANTIALLY EQUIVALENT TO:
PREDICATE: WoundPro Apex Negative Pressure Wound Therapy Suction Pump, Accuro Medical Products, LLC -K100823 and also features of Medela INVIA Liberty K080357
DESCRIPTION of the DEVICE:
The WoundPro is part of a family of products offered by Pensar Medical LLC. The WoundPro is a powered suction pump that uses controlled negative pressure to a dressing and flange assembly through tubing.
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. The device is monitored by software and contains an alarm function with audio and visual prompts.
The WoundPro has a negative pressure setting range of 20mm to 200mmHg 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, bedside rails, or footboard mounting.
4
INDICATIONS FOR USE:
The WoundPro Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site, with 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, grafts may benefit from the use of this device. The WoundPro is intended for use in a healthcare facility only.
Additional Wounds Indicated are:
- Diabetic/Neuropathic ulcers ●
- Pressure ulcers ●
- . Chronic wounds
- Acute wounds
- Dehisced wounds
SUMMARY OF THE TECHNICAL CHARACTERISTICS OF THE DEVICE COMPARED TO PREDICATE
The primary predicate is the Accuro APEX WoundPro K100823 with the same indication for use and intended use.
| PREDICATE | SUBJECT | SIMILARITY or DIFFERENCE | |
|---|---|---|---|
| Accuro APEX WoundPro | |||
| K100823 | Pensar Medical | ||
| WoundPro | |||
| Manufacturer | Accuro | ||
| (acquired by Pensar) | Pensar Medical | Pensar acquired stock and | |
| refurbished units | |||
| Product Type | Negative Pressure Wound | ||
| Therapy System | Negative Pressure Wound Therapy | ||
| System | SAME | ||
| Product Code | OMP (Class 2, 21 CFR 878.4780) | OMP (Class 2, 21 CFR 878.4780) | SAME |
| Indication For Use | The WoundPro Negative | ||
| Pressure Wound Therapy | |||
| System may promote wound | |||
| healing, through the drainage | |||
| and removal of infectious | |||
| material and other fluids from | |||
| the wound site. The WoundPro | |||
| can provide continuous, | |||
| intermittent and variable | |||
| intermittent negative pressure | |||
| therapies to achieve this goal. | |||
| 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. At no time should | |||
| the WoundPro, or any NPWT | |||
| device, be used without an | |||
| order from a physician. | |||
| Types of Wounds Indicated are: | |||
| · Diabetic/Neuropathic ulcers | |||
| · Pressure ulcers | |||
| · Chronic wounds | |||
| · Acute wounds | |||
| · Dehisced wounds | The WoundPro Negative Pressure | ||
| Wound Therapy System may | |||
| promote wound healing, through | |||
| the drainage and removal of | |||
| infectious material and other fluids | |||
| from the wound site, with | |||
| 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, grafts | |||
| may benefit from the use of this | |||
| device. The WoundPro is intended | |||
| for use in a healthcare facility only. | |||
| Additional Wounds Indicated are: | |||
| ● Diabetic/Neuropathic | |||
| ulcers | |||
| ● Pressure ulcers | |||
| ● Chronic wounds | |||
| ● Acute wounds | |||
| ● Dehisced wounds | SAME except for minor | ||
| editorial difference | |||
| Therapy Unit | Software controlled pump for | ||
| delivery of negative pressure | |||
| wound therapy | Software controlled pump for delivery of | ||
| negative pressure wound therapy | SAME |
5
510(k) Summary-Continued
| PREDICATE | SUBJECT | SIMILARITY or DIFFERENCE | |
|---|---|---|---|
| Accuro APEX WoundPro | |||
| K100823 | Pensar Medical | ||
| WoundPro | |||
| Housing | Injection molded plastic | Injection molded plastic | SAME |
| Modes | Continuous or Intermittent Modes | Continuous or Intermittent Modes | SAME |
| Vacuum Range | 20-150 mgHg | 20-200mg Hg | Same as Medela, see chart |
| below | |||
| Weight (control unit) | 3.8 lbs (1.7kg) | 3.8 lbs (1.7kg) | SAME |
| Dimensions | 6.75 x 8.5 x 3.5 in | ||
| (17 x 21 x 9 cm) | 6.75 x 8.5 x 3.5 in | ||
| (17 x 21 x 9 cm) | SAME | ||
| External Power Supply | Input: 90-264VAC, 0.8-0.4A, 47-63Hz;Output:18VDC 1.67A | Input: 90-264VAC, 0.8-0.4A, 47-63Hz;Output:18VDC 1.67A | SAME |
| Electrical Battery Powered | 18VDC 25 Watts | 18VDC 25 Watts | SAME |
| Power Source | Lithium Ion Battery or AC | Lithium Ion Battery or AC | SAME |
| Expected Useful Life | 3 years | 3 years | SAME |
| Collection Canisters | 300 c and 800c | 300 c and 800c | SAME |
| Filter | Hydrophobic overflow | ||
| protection/bacterial filter | |||
| integrated into the single-use | |||
| collection canister | Hydrophobic overflow | ||
| protection/bacterial filter integrated | |||
| into the single-use collection canister | SAME | ||
| Dressing System | Gauze dressing with | ||
| polyurethane drape. | Gauze and foam dressing with | ||
| polyurethane drape. | SAME | ||
| Gauze Dressing Kit Assembly | Off the shelf components | ||
| purchased sterilized. | Off the shelf components purchased | ||
| sterilized. | SAME | ||
| Drape | Polyurethane with adhesive | Polyurethane with adhesive | SAME |
| Dome/exudates line assembly | Flange and Tubing | Flange and Tubing | SAME |
| Method of Sterilization | (gauze dressing purchased | ||
| sterile) | gamma sterilization black foam kit | Qualified by vendor; | |
| documented in submission | |||
| Single-Use | Single-use in Tyvek pouch | Single-use in Tyvek pouch | SAME |
| Disposable | |||
| Packaging for | |||
| Dressings | |||
| Biocompatibility | ISO10993-1 | ISO10993-1 | SAME |
| Accessories | EX clamp system for | ||
| head/footboard or I.V. pole | |||
| -WoundPro Carrying Case | EX clamp system for head/footboard or | ||
| I.V. pole | |||
| -WoundPro Carrying Case | SAME |
The Pensar WOUNDPRO is also compared to the Medela predicate for pressure range only.
| PERFORMANCE | MEDELA INVIA Liberty | WOUNDPRO PENSAR- | DIFFERENCE/ impact of |
|---|---|---|---|
| PARAMETER | K080357 | subject of this 510(k) | difference |
| weight |