The Whisper Pump System™ is a suction device intended for aspiration of secretions and body fluids from wounds and is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. Whisper Pump System™ is appropriate for use on the following wounds:

Pressure ulcers
Diabetic/neuropathic ulcers
Venous insufficiency ulcers
Traumatic wounds
Post-operative and dehisced surgical wounds
Explored fistulas
Skin flaps and grafts

Device Description

The Whisper Pump System™ is a device to remove bodily fluids for wound drainage and can be used by patients over an extended period of time as recommended by a physician. The device has a rechargeable battery and therefore is portable. A microprocessor controlled electronic battery charging unit in the suction device guarantees the safe charging of the battery, and overcharging of the battery. The Whisper Pump System™ itself is not a sterile device but can use disposable (sterile) items from other manufacturers but these items are not a part of the Whisper Pump System™, (e.g. various hose sets, containers, trocars and catheters) which have been designed for the wound drainage. The purpose of this traditional 510(k) was to modify the outer case dimensions, carrying handle ergonomics, canister bracket, and internal component reconfiguration.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Whisper Pump System™. It is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically involve traditional clinical studies with patient data and ground truth for AI algorithms, as it is for a physical device (a powered suction pump) and not an AI/ML software as a medical device (SaMD).

Therefore, many of the requested categories for AI/ML performance studies are not applicable or cannot be extracted from this document, as the "device" in question is hardware.

Here's an analysis based on the provided text, focusing on the engineering and safety performance rather than AI/ML diagnostic performance:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed against established medical device safety and electromagnetic compatibility standards, and functionality relating to its purpose as a suction pump.

Acceptance Criteria (Standard / Test)	Reported Device Performance
Safety and EMC Standards
IEC 60601-1-2 (2014) - Radiated Emission	Met acceptance criterion (device compared to predicate for this)
IEC 60601-1-2 (2014) - Electrostatic Discharge Immunity	Met acceptance criterion (device compared to predicate for this)
IEC 60601-1-2 (2014) - Thermal Protection	Met acceptance criterion (device compared to predicate for this)
Software Verification Test	Met acceptance criterion
Product Validation Test	Met acceptance criterion
ISO 10993-1:1998 - Biological Compatability	Not needed as device parts do not normally touch patient
EN 60601-1-2 (2001)	Designed and tested to applicable safety standards
EN ISO 61000-3-2 (2000)	Designed and tested to applicable safety standards
EN ISO 61000-3-3 (1995) + A1 (2001)	Designed and tested to applicable safety standards
CEN EN 980:1996+A1:1999+A2:2001 (Labeling)	Designed and tested to applicable safety standards
EN ISO 14971 (Risk Management)	Application of risk management to medical devices (risk analysis demonstrates substantial equivalence)
IEC 60601-1 (1988, 1991, 1995)	Designed and tested to applicable safety standards
Functional Performance (Implied)
Suction pressure maintenance	Pump switches off after creation of vacuum and on again when vacuum drops below a certain value
Secretion containment	Collected in collection jar
Prevention of fluid ingress into pump	Hydrophobic bacterial filter prevents secretion from being drawn into pump head
Battery charging and overheating prevention	Microprocessor controlled charging unit ensures safe charging and prevents overcharging; electronic unit prevents overheating by a high-temperature switch

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the context of an AI/ML algorithm. The "testing" referred to in the document is for the physical device's engineering and safety characteristics against standards. No patient data or clinical images are involved in this type of submission for this device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. Ground truth, in the context of AI studies, refers to expert interpretations or pathological diagnoses on patient data. This document describes testing of a physical pump device against engineering standards.

4. Adjudication Method for the Test Set

This is not applicable. No expert adjudication for clinical data is mentioned as this is not an AI/ML device.

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

No such study was conducted or is relevant for this type of device. The Whisper Pump System™ is a stand-alone physical suction pump, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is not applicable. The device is a physical pump, not an algorithm. Its "standalone performance" refers to its ability to meet the specified engineering and safety standards.

7. The Type of Ground Truth Used

This is not applicable in the context of AI/ML. The "ground truth" for this device's performance relies on objective measurements and tests against established engineering and safety standards, and functional specifications defined by the manufacturer. For example, pressure measurements to verify suction, electrical tests for EMC, and thermal tests for overheating.

8. The Sample Size for the Training Set

This is not applicable. There is no AI/ML algorithm involved, therefore no training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable. There is no AI/ML algorithm involved, therefore no training set or ground truth establishment for it.

Summary for this specific device (Whisper Pump System™):

The Whisper Pump System™ is a physical medical device (a powered suction pump). The "performance" and "acceptance criteria" discussed in this 510(k) document relate to its engineering specifications, safety, electromagnetic compatibility, and manufacturing quality, primarily demonstrating substantial equivalence to a predicate device. The information requested regarding AI/ML algorithm performance (test sets, training sets, ground truth, expert adjudication, MRMC studies) is not relevant to this type of device submission. The study proving the device meets acceptance criteria involved engineering and safety testing against recognized international and national standards (e.g., IEC 60601 series, ISO 10993) and internal software/product validation tests.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2015

Wound RX Medical, LLC Richard Deslauriers, M.D. Chief Executive Officer 25 Depot Road, Building One, Suite 104 Southbury, Connecticut 06488

Re: K142385

Trade/Device Name: Whisper Pump System™ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: April 20, 2015 Received: April 22, 2015

Dear Dr. Deslauriers:

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

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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.

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/Resourcesfor You/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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Indications for Use

510(k) Number (if known) K142385

Device Name Whisper Pump System™

Indications for Use (Describe)

· Pressure ulcers
· Diabetic/neuropathic ulcers
· Venous insufficiency ulcers
· Traumatic wounds
· Post-operative and dehisced surgical wounds
· Explored fistulas
· Skin flaps and grafts

Contraindications

The use of the Whisper Pump System™ is contraindicated in the presence of:

· Eschar
· Untreated osteomyelitis
· Malignancy in wound (with the exception of palliative care to enhance quality of life)
· Untreated malnutrition
· Exposed , arteries, veins or organs
· Necrotic tissue
· Non-enteric unexposed fistulas
· Exposed nerves
· Exposed anastomotic sites
· Exposed bone or tendons
· Exposed vasculature

The Whisper Pump System™ is not designed for use with emergency medical services.

Not to be used:

· In non-medical applications
· In presence of combustible or explosive fluids or gases

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Contact:	Richard Deslauriers, M.D.CEO, Wound RX Medical, LLC(203) 982 – 4239
Device Trade Name:	Whisper Pump System™
Common Name:	Powered suction pump
Manufacturer:	Wound RX Medical, LLC25 Depot RoadBuilding One, Suite 104Southbury, CT 06488
Date Prepared:	May 12, 2015
Classification:	21 CFR §878.4780; Pump, portable, aspiration (manual orpowered)
Class:	II
Product Code:	OMP
Indications For Use:	The Whisper Pump System™ is a suction device intendedfor aspiration and collection of secretions and body fluidsfrom wounds and is indicated for patients who would benefitfrom a suction device particularly as the device may promotewound healing. Whisper Pump System™ is appropriate foruse on the following wounds:
	Pressure ulcersDiabetic/neuropathic ulcersVenous insufficiency ulcersTraumatic woundsPost-operative and dehisced surgical woundsExplored fistulasSkin flaps and grafts
Contraindications	The use of the Whisper Pump System™ is contraindicated inthe presence of:
	EscharUntreated osteomyelitis

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Malignancy in wound (with the exception of palliative care to enhance quality of life)
Untreated malnutrition
Exposed , arteries, veins or organs
Necrotic tissue
Non-enteric unexposed fistulas
Exposed nerves
Exposed anastomotic sites
Exposed bone or tendons
. Exposed vasculature

The Whisper Pump System™ is not designed for use with emergency medical services.

Not to be used:

In non-medical applications .
In presence of combustible or explosive fluids or ● qases

Prescription-Use Only: Federal law restricts the sale by or on the order of a physician.

Device Description: The Whisper Pump System™ is a device to remove bodily fluids for wound drainage and can be used by patients over an extended period of time as recommended by a physician. The device has a rechargeable battery and therefore is portable. A microprocessor controlled electronic battery charging unit in the suction device guarantees the safe charging of the battery, and overcharging of the battery. The Whisper Pump System™ itself is not a sterile device but can use disposable (sterile) items from other manufacturers but these items are not a part of the Whisper Pump System™, (e.g. various hose sets, containers, trocars and catheters) which have been designed for the wound drainage.
The purpose of this traditional 510(k) was to modify the outer case dimensions, carrying handle ergonomics, canister bracket, and internal component reconfiguration.

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Predicate Device:

The predicate information is summarized in the following table.

510(k) Number	K090130
Device Name	ATMOS S041 Wound™
Applicant	ATMOS Medical, Inc.
Regulation Number	21 CFR §878.4780
Classification Product Code	OMP
Decision Date	04/02/2009
Decision	Substantially equivalent (SE)
Classification Advisory	General & Plastic Surgery
Committee

Reference Device:

The following device was included as a reference device. It was not used to establish substantial equivalence.

510(k) Number	K061367
Device Name	BlueSky Vista Wound Vacuum
Applicant	Blue Sky MG, Inc
Regulation Number	21 CFR §878.4780
Classification Product Code	OMP
Decision Date	08/10/2006
Decision	Substantially equivalent (SE)
Classification AdvisoryCommittee	General & Plastic Surgery

Technoloqical Characteristics:

The Whisper Pump System™ is a small suction unit. The device is operated by an electromotive membrane pump which is maintenance-free. When it operates, the pump creates a vacuum in the hose system and in the collection jar, with the help of which secretions can be sucked off through the set of hoses. The pump switches off after creation of the vacuum and then switches on again when the vacuum lies below a certain value.

The secretion is collected in a collection jar. A hydrophobic bacterial filter prevents the secretion being inadvertently drawn into the pump head. The device is fitted with a rechargeable battery. A microprocessor controlled electronic charging unit in the suction device guarantees the safe

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charging of the battery, and thus overcharging of the battery is avoided. The electronic unit prevents overheating of the suction device by a high temperature switch. For the mobile use a carrying strap is available. Useful accessories are a shoulder bag and a device support.

The Whisper Pump System™ is substantially equivalent to other legally marketed devices in the United States and functions in a manner similar and is intended for the same use as the predicate device.

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Performance Testing: The risk analysis demonstrates the Whisper Pump System™ is substantially equivalent to the predicate device. The purpose of this 510(k) was to modify the external plastic shell dimensions to reduce the size of the pump. Performance testing involved comparing the device to the predicate device for radiated emission, electrostatic discharge immunity, and thermal protection following IEC60601-1-2 (2014). Previous testing performed on the device is listed below.

A software verification test and product validation test was performed and meet the acceptance criterion. The Whisper Pump System™ have been designed and tested to applicable safety standards (see next page) and does not raise any new issues of safety, efficacy, or performance of the product.

Number of standard	Std Date	Title of standard
ISO 10993-1:1998	1998	Biological Compatibility of medical devices - Part 1: Evaluationand Testing (No biocompatibility tests are needed becausedevice does not have parts that would normally touch patient.)
EN 60601-1-2 (2001)	2001	Medical electrical equipment -- Part 1-2: General requirementsfor safety -Collateral standard: Electromagnetic compatibility -Requirements and tests
EN ISO 61000-3-2(2000):	2000	Electromagnetic compatibility - Part 3-2: Limits - Limits forHarmonic current emissions (equipment input current < 16A perphase).
EN ISO 61000-3-3(1995) + A1 (2001)	1995 2001	Electromagnetic compatibility - Part 3: Limits - Section 3:Limitation of voltage fluctuations and flicker in low-voltagesupply systems for equipment with rated current < 16A.
CEN EN980:1996+A1:1999+A2:2001	1999 2001	Graphical symbols for use in the labeling of medical devices
EN ISO 14971	03/2001	Medical devices - application of risk management to medicaldevices
IEC 60601-1	1988,1991, 1995	Medical Electrical Equipment - Part 1: General Requirementsfor Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.(General)

Conclusion: The Traditional 510(k) for the Whisper Pump System™ contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device. The device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

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.