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

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.

AI/ML Overview

The provided text is a 510(k) summary for the Pensar WoundPro Negative Pressure Wound Therapy System. It describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, the document does not contain a study that proves the device meets specific device performance acceptance criteria in terms of clinical or analytical efficacy for wound healing.

Instead, the summary focuses on demonstrating equivalence through:

Identical Indications for Use: The WoundPro has the same indications as the predicate.
Similar technological characteristics: Comparisons of product type, product code, therapy unit, housing, modes, weight, dimensions, external power supply, electrical battery powered, power source, expected useful life, collection canisters, filter, dressing system, gauze dressing kit assembly, drape, dome/exudates line assembly, method of sterilization, single-use packaging for dressings, biocompatibility, and accessories.
Performance Testing: It mentions various performance tests but does not provide details on specific acceptance criteria or the numerical results of these tests relating to wound healing outcomes.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text as the information is not present. The document focuses on demonstrating substantial equivalence based on comparability to predicate devices rather than independent, quantitative performance criteria for clinical outcomes.

Here's what I can provide based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for clinical performance (e.g., wound healing rates, reduction in infection). Instead, it relies on the device having "SMILARITY or DIFFERENCE" to the predicate. The "performance" mentioned refers to engineering and safety characteristics.

Acceptance Criteria (Not explicitly stated for clinical efficacy)	Reported Device Performance (as compared to predicate)
Product Type	SAME as predicate
Product Code	SAME as predicate
Indication For Use	SAME except for minor editorial difference
Therapy Unit	SAME as predicate
Housing	SAME as predicate
Modes	SAME as predicate
Vacuum Range	20-200mmHg (Predicate: 20-150 mmHg for Accuro, 60-200mmHg for Medela). Stated as "Same as Medela, see chart below" for upper limit.
Weight (control unit)	SAME as predicate (3.8 lbs / 1.7kg)
Dimensions	SAME as predicate (6.75 x 8.5 x 3.5 in)
External Power Supply	SAME as predicate
Electrical Battery Powered	SAME as predicate
Power Source	SAME as predicate
Expected Useful Life	SAME as predicate (3 years)
Collection Canisters	SAME as predicate (300cc and 800cc)
Filter	SAME as predicate
Dressing System	SAME as predicate (Gauze and foam dressing with polyurethane drape)
Gauze Dressing Kit Assembly	SAME as predicate
Drape	SAME as predicate
Dome/exudates line assembly	SAME as predicate
Method of Sterilization	Qualified by vendor; documented in submission (Predicate: gauze dressing purchased sterile)
Single-Use Packaging for Dressings	SAME as predicate
Biocompatibility	SAME as predicate (ISO10993-1)
Accessories	SAME as predicate
Electrical Safety and EMC	Testing was performed (No specific criteria or results provided)
Software Verification and Validation	Testing was performed (No specific criteria or results provided)
Biocompatibility Assessment	Testing was performed (No specific criteria or results provided)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to engineering and software tests, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document discusses engineering and safety assessments, not clinical interpretation or ground truth establishment by medical experts for patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic or interpretive device that would involve "human readers" or "AI assistance" in the sense of image interpretation. No MRMC study was mentioned or performed for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the device is a physical medical device, not an algorithm, and its function involves direct interaction with a wound.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable in the context of clinical "ground truth" for wound therapy efficacy in this document. The "ground truth" for the engineering performance tests would be based on established engineering standards and specifications.

8. The sample size for the training set

This information is not provided. The document details hardware and software testing, not machine learning model training.

9. How the ground truth for the training set was established

This information is not provided.

Summary

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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 (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

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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)

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:Address:Telephone:Fax:	Pensar Medical LLC42225 Remington Rd, Unit A3Temecula, CA 92590(800) 669-4757NA
by:Telephone:Fax:	Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082715-549-6035715-549-5380
CONTACT PERSON:	Elaine Duncan
DATE PREPARED:	December 1, 2016
TRADE NAME:COMMON NAME:CLASSIFICATION NAME:	Pensar WoundPro Negative Pressure Wound TherapySystemNegative Pressure Wound Therapy SystemNegative Pressure Wound Therapy Suction Pump (andcomponents)
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 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 WoundProK100823	Pensar MedicalWoundPro
Manufacturer	Accuro(acquired by Pensar)	Pensar Medical	Pensar acquired stock andrefurbished units
Product Type	Negative Pressure WoundTherapy System	Negative Pressure Wound TherapySystem	SAME
Product Code	OMP (Class 2, 21 CFR 878.4780)	OMP (Class 2, 21 CFR 878.4780)	SAME
Indication For Use	The WoundPro NegativePressure Wound TherapySystem may promote woundhealing, through the drainageand removal of infectiousmaterial and other fluids fromthe wound site. The WoundProcan provide continuous,intermittent and variableintermittent negative pressuretherapies to achieve this goal.Patients with chronic, acute,traumatic, subacute anddehisced wounds, partial-thickness burns, ulcers (such asdiabetic or pressure), flaps andgrafts may benefit from the useof this device. At no time shouldthe WoundPro, or any NPWTdevice, be used without anorder from a physician.Types of Wounds Indicated are:· Diabetic/Neuropathic ulcers· Pressure ulcers· Chronic wounds· Acute wounds· Dehisced wounds	The WoundPro Negative PressureWound Therapy System maypromote wound healing, throughthe drainage and removal ofinfectious material and other fluidsfrom the wound site, withcontinuous and/or, intermittentnegative pressure. Patients withchronic, acute, traumatic, subacuteand dehisced wounds, partial-thickness burns, ulcers (such asdiabetic or pressure), flaps, graftsmay benefit from the use of thisdevice. The WoundPro is intendedfor use in a healthcare facility only.Additional Wounds Indicated are:● Diabetic/Neuropathiculcers● Pressure ulcers● Chronic wounds● Acute wounds● Dehisced wounds	SAME except for minoreditorial difference
Therapy Unit	Software controlled pump fordelivery of negative pressurewound therapy	Software controlled pump for delivery ofnegative pressure wound therapy	SAME

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510(k) Summary-Continued

	PREDICATE	SUBJECT	SIMILARITY or DIFFERENCE
	Accuro APEX WoundProK100823	Pensar MedicalWoundPro
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 chartbelow
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 overflowprotection/bacterial filterintegrated into the single-usecollection canister	Hydrophobic overflowprotection/bacterial filter integratedinto the single-use collection canister	SAME
Dressing System	Gauze dressing withpolyurethane drape.	Gauze and foam dressing withpolyurethane drape.	SAME
Gauze Dressing Kit Assembly	Off the shelf componentspurchased sterilized.	Off the shelf components purchasedsterilized.	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 purchasedsterile)	gamma sterilization black foam kit	Qualified by vendor;documented in submission
Single-Use	Single-use in Tyvek pouch	Single-use in Tyvek pouch	SAME
DisposablePackaging forDressings
Biocompatibility	ISO10993-1	ISO10993-1	SAME
Accessories	EX clamp system forhead/footboard or I.V. pole-WoundPro Carrying Case	EX clamp system for head/footboard orI.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	<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 x21 x 9 cm)	Pensar is similar in size
Power source	Lithium Ion BatteryAC Power	Lithium Ion BatteryAC Power	No difference
Electrical voltage	110-240V AC47-63 Hz	90-260V AC47-63Hz	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 orVariable/Intermittent Modes	Continuous orVariable/Intermittent Modes	No difference
Filters	Hydrophobic overflowprotection/bacteria filterintegrated into the single usecollection canister	Hydrophobic overflowprotection/bacteria filterintegrated into the single usecollection 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.

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.