WoundPro Negative Pressure Wound Therapy System

K150960 · Pensar Medical, LLC · OMP · Dec 1, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K150960
• Device Name: WoundPro Negative Pressure Wound Therapy System
• Applicant: Pensar Medical, LLC
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Dec 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

WoundPro is a powered suction pump providing continuous or intermittent negative pressure (20-200mmHg) to wound sites to promote healing via drainage of infectious material and fluids. System includes control unit with brushless DC motor, rechargeable battery or AC power, and electronic display. Operates with 300cc or 800cc single-use collection canisters containing integrated hydrophobic/bacterial filters. Dressing assembly consists of gauze/foam, polyurethane drape, and flange/tubing. Used in healthcare facilities; operated by clinicians. Device monitored by software with audio/visual alarms for pressure regulation. Mounts to IV poles, bedside rails, or countertops. Benefits patients by facilitating wound closure and fluid removal.

Clinical Evidence

Bench testing only. Evidence includes electrical safety and electromagnetic compatibility (EMC) testing, software verification and validation, performance verification testing, and biocompatibility assessment per ISO 10993-1.

Technological Characteristics

Powered suction pump; brushless DC motor; 20-200mmHg vacuum range; 300cc/800cc collection canisters with integrated hydrophobic/bacterial filters; injection-molded plastic housing; rechargeable Li-ion battery or AC power (90-264VAC); software-controlled; dimensions 6.75 x 8.5 x 3.5 in; weight 3.8 lbs. Biocompatibility per ISO 10993-1. Gamma sterilization for foam kits.

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. 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

• WoundPro Apex Negative Pressure Wound Therapy Suction Pump (K100823)
• Medela INVIA Liberty (K080357)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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)

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# 510(K) SUMMARY

#### SUBMITTER:

Submitted on behalf of:

| Company Name:<br>Address:<br>Telephone:<br>Fax: | Pensar Medical LLC<br>42225 Remington Rd, Unit A3<br>Temecula, CA 92590<br>[phone]<br>NA |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| by:<br>Telephone:<br>Fax: | Elaine Duncan, M.S.M.E., RAC<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082<br>715-549-6035<br>715-549-5380 |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | December 1, 2016 |
| TRADE NAME:<br>COMMON NAME:<br>CLASSIFICATION NAME: | Pensar WoundPro Negative Pressure Wound Therapy<br>System<br>Negative Pressure Wound Therapy System<br>Negative Pressure Wound Therapy Suction Pump (and<br>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.

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#### 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<br>K100823 | Pensar Medical<br>WoundPro | |
| Manufacturer | Accuro<br>(acquired by Pensar) | Pensar Medical | Pensar acquired stock and<br>refurbished units |
| Product Type | Negative Pressure Wound<br>Therapy System | Negative Pressure Wound Therapy<br>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<br>Pressure Wound Therapy<br>System may promote wound<br>healing, through the drainage<br>and removal of infectious<br>material and other fluids from<br>the wound site. The WoundPro<br>can provide continuous,<br>intermittent and variable<br>intermittent negative pressure<br>therapies to achieve this goal.<br>Patients with chronic, acute,<br>traumatic, subacute and<br>dehisced wounds, partial-<br>thickness burns, ulcers (such as<br>diabetic or pressure), flaps and<br>grafts may benefit from the use<br>of this device. At no time should<br>the WoundPro, or any NPWT<br>device, be used without an<br>order from a physician.<br>Types of Wounds Indicated are:<br>· Diabetic/Neuropathic ulcers<br>· Pressure ulcers<br>· Chronic wounds<br>· Acute wounds<br>· Dehisced wounds | The WoundPro Negative Pressure<br>Wound Therapy System may<br>promote wound healing, through<br>the drainage and removal of<br>infectious material and other fluids<br>from the wound site, with<br>continuous and/or, intermittent<br>negative pressure. Patients with<br>chronic, acute, traumatic, subacute<br>and dehisced wounds, partial-<br>thickness burns, ulcers (such as<br>diabetic or pressure), flaps, grafts<br>may benefit from the use of this<br>device. The WoundPro is intended<br>for use in a healthcare facility only.<br>Additional Wounds Indicated are:<br>● Diabetic/Neuropathic<br>ulcers<br>● Pressure ulcers<br>● Chronic wounds<br>● Acute wounds<br>● Dehisced wounds | SAME except for minor<br>editorial difference |
| Therapy Unit | Software controlled pump for<br>delivery of negative pressure<br>wound therapy | Software controlled pump for delivery of<br>negative pressure wound therapy | SAME |

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## 510(k) Summary-Continued

| | PREDICATE | SUBJECT | SIMILARITY or DIFFERENCE |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| | Accuro APEX WoundPro<br>K100823 | Pensar Medical<br>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<br>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<br>(17 x 21 x 9 cm) | 6.75 x 8.5 x 3.5 in<br>(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<br>protection/bacterial filter<br>integrated into the single-use<br>collection canister | Hydrophobic overflow<br>protection/bacterial filter integrated<br>into the single-use collection canister | SAME |
| Dressing System | Gauze dressing with<br>polyurethane drape. | Gauze and foam dressing with<br>polyurethane drape. | SAME |
| Gauze Dressing Kit Assembly | Off the shelf components<br>purchased sterilized. | Off the shelf components purchased<br>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<br>sterile) | gamma sterilization black foam kit | Qualified by vendor;<br>documented in submission |
| Single-Use | Single-use in Tyvek pouch | Single-use in Tyvek pouch | SAME |
| Disposable<br>Packaging for<br>Dressings | | | |
| Biocompatibility | ISO10993-1 | ISO10993-1 | SAME |
| Accessories | EX clamp system for<br>head/footboard or I.V. pole<br>-WoundPro Carrying Case | EX clamp system for head/footboard or<br>I.V. pole<br>-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 | <2.2 lbs | 3.8lbs (1.7kg) | Pensar a bit heavier |
| dimensions | 3.74" x 6.69 "x5.91 " | 6 ¾" (w) x 8 ½" (h) x 3 ½" (d) (17 x<br>21 x 9 cm) | Pensar is similar in size |
| Power source | Lithium Ion Battery<br>AC Power | Lithium Ion Battery<br>AC Power | No difference |
| Electrical voltage | 110-240V AC<br>47-63 Hz | 90-260V AC<br>47-63Hz | No difference |
| Electrical amperage | 0.8-4A | .8-.4A | No difference |
| Housing | Injection Molded Plastic | Injection Molded Plastic | No difference |
| Vacuum range | 60-200mmHg | 20-200 mm Hg | Similar upper limit |
| Suction capacity | 5 L/min | 5L/min | No difference |
| Canister volumes | 0.3L/ 0.8L | 0.3L/0.8L | No difference |
| Modes | Continuous or<br>Variable/Intermittent Modes | Continuous or<br>Variable/Intermittent Modes | No difference |
| Filters | Hydrophobic overflow<br>protection/bacteria filter<br>integrated into the single use<br>collection canister | Hydrophobic overflow<br>protection/bacteria filter<br>integrated into the single use<br>collection canister | No difference |

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### 510(k) Summary-Continued

This comparison shows no differences in technological characteristics and functions between the Pensar WoundPro Negative Pressure Wound Therapy System and the predicate devices.

#### SUMMARY OF PERFORMANCE TESTING:

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

#### SUMMARY OF CONCLUSIONS

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.