The extriCARE® 1000 NPWT System is intended to generate negative pressure to remove wound exudates, infectious material, and tissue debris from the wound bed.

The extriCARE® 1000 NPWT System is intended for use in wounds with low to moderate levels of exudate. Appropriate wound types include:

Chronic wounds
Acute wounds
· Traumatic wounds
· Subacute and dehisced wounds
· Partial-thickness burns
· Ulcer wounds (such as diabetic or pressure)
· Flaps and grafts
· Closed surgical incisions

The extriCARE 1000 NPWT System is intended for use in healthcare facilities.

Device Description

The extriCARE 1000 Negative Pressure Wound Therapy (NPWT) system consists of a portable, battery-powered pump unit intended to generate vacuum pressure to remove low to moderate level of wound exudates, infectious material, and tissue debris from the wound bed. Three preset vacuum pressures can be selected by the user - 80, 100, and 125mmHg. The extriCARE 1000 is packaged and provided with the following components:

1. extriCARE 1000 Negative Pressure Wound Therapy Pump
1. extriCARE 1000 50cc Collection Canister

The extriCARE 1000 Negative Pressure Wound Therapy (NPWT) Pump accessory that is included in this 510(k) applications and will be commercialized separately is the extriCARE 1000 50cc Collection Canister (additional cannister replacements).

AI/ML Overview

The provided document describes the extriCARE® 1000 Negative Pressure Wound Therapy System and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria, performance metrics, and a dedicated test set as typically found in AI/ML performance evaluations.

Therefore, many of the requested fields cannot be directly extracted from the provided text because the document does not detail a clinical or performance study in the way a medical device utilizing AI/ML would. The document focuses on regulatory clearance for a physical medical device (a negative pressure wound therapy system) based on its technological characteristics, intended use, and non-clinical testing demonstrating safety and performance.

However, I can extract information related to the non-clinical testing performed and the general claims of performance the device makes.

Here's the closest possible interpretation of your request based on the provided text:

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

The document categorizes "non-clinical testing" as proof of meeting internal standards and regulations and having performance characteristics substantially equivalent to predicate devices. Specific quantitative acceptance criteria are not explicitly stated as numerical targets, but the "Results" कॉलम indicates success.

Acceptance Criteria (Test Items)	Reported Device Performance (Results)
Attribute Test	All requirements met
Measurement Test	All requirements met
System and Pneumatic Test	All requirements met
Exudate Removal Test	All requirements met
General Destructive Test	All requirements met
Performance Degradation Test	All requirements met
Hot and Cold Operation Test	All requirements met
Hot and Cold Temperature Test	All requirements met
Transportation Simulation Test	All requirements met
Electromagnetic Compatibility and Electrical Safety Testing
IEC 60601-1:2005 (Third Edition) + A1:2012(or IEC 60601-1: 2012 reprint)	Passed
IEC 60601-1-2:2014	Passed
IEC 60601-1-6:2010 Edition 3.1, AMD1:2013	Passed
IEC 60601-1-11:2015 Edition 2.0	Passed
Software Verification and Validation
Software functionality and safety	Completed, no unresolved anomalies; determined to be of "moderate" level of concern.

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 non-clinical tests described are likely laboratory-based and do not involve "test sets" in the context of patient data for AI/ML evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/provided. The evaluation is for a physical medical device, not an AI/ML algorithm requiring expert ground truth in the traditional sense.

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

This information is not applicable/provided. Adjudication methods are typically relevant for human review of AI/ML outputs, which is not the subject of this 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 information is not applicable/provided. This document concerns a standalone medical device (Negative Pressure Wound Therapy System), not an AI-assisted diagnostic tool that would involve human readers.

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

The document mentions "Software Verification and Validation" for the device's proprietary algorithm, stating it was completed and had no unresolved anomalies. The software was determined to be of a "moderate" level of concern. While this confirms standalone software performance was evaluated, it's not in the context of an AI/ML diagnostic algorithm making predictions requiring human review. It pertains to the control software of the NPWT pump.

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

For the functional performance testing and electrical safety/EMC testing, the "ground truth" would be established by engineering standards, regulatory requirements (e.g., IEC standards), and internal specifications for the device's operation. For the software verification and validation, the ground truth would be the software requirements specifications and expected behavior to ensure the device operates safely and effectively. This is not "ground truth" in the clinical sense of pathology or expert consensus on a medical finding.

8. The sample size for the training set

This information is not applicable/provided. This device is not described as involving an AI/ML model that is trained on a dataset. The software mentioned is control software, not a learning algorithm.

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

This information is not applicable/provided. As above, there is no mention of a training set or AI/ML model development.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 8, 2023

Alleva Medical Ltd Max Choi CEO Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan Street Shek Mun, New Territories Hong Kong

Re: K213906

Trade/Device Name: extriCARE® 1000 Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: November 30, 2021 Received: December 14, 2021

Dear Max Choi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K213906

Device Name

extriCARE® 1000 Negative Pressure Wound Therapy System

Indications for Use (Describe)

The extriCARE® 1000 NPWT System is intended to generate negative pressure to remove wound exudates, infectious material, and tissue debris from the wound bed.

The extriCARE® 1000 NPWT System is intended for use in wounds with low to moderate levels of exudate. Appropriate wound types include:

Chronic wounds
Acute wounds
· Traumatic wounds
· Subacute and dehisced wounds
· Partial-thickness burns
· Ulcer wounds (such as diabetic or pressure)
· Flaps and grafts
· Closed surgical incisions

The extriCARE 1000 NPWT System is intended for use in healthcare facilities.

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)

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Image /page/3/Picture/0 description: The image shows the logo for Alleva Medical. The logo consists of the word "ALLEVA" in a bold, dark blue font, with a stylized "A" symbol to the left. Below the word "ALLEVA" is the word "MEDICAL" in a smaller, dark blue font.

510(k) Summary

[as required by 21 CFR 807.92(c)]

extriCARE 1000 Negative Pressure Wound Therapy System

510(k) K213906

DATE PREPARED:	March 8, 2023
APPLICANT	Alleva Medical LtdSuite M-Q, 12th Floor, Kings Wing Plaza 21 On Kwan Street, Shek Mun, ShatinNew Territories, Hong Kong
CONTACT	Mr. Max ChoiChief Executive OfficerPhone: +852-3166-7239Fax: +852-2355-7663Email: max@allevamedical.com
TRADE NAME:	extriCARE 1000 NPWT System
DEVICE CLASSIFICATION:	Class II per 21 CFR 878.4780
CLASSIFICATION NAME:	Negative Pressure Wound Therapy Pump
PRODUCT CODE	OMP
PREDICATE DEVICE:	PICO 14 Single Use Negative Pressure Wound Therapy System(K191760)
REFERENCE DEVICES:	SVED Wound Treatment System (K142916)extriCARE 2400 Negative Pressure Wound Therapy System (K140634)

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MEDICAL

Indications for Use:

The extriCARE® 1000 NPWT System is intended to generate negative pressure to remove wound exudates, infectious material, and tissue debris from the wound bed.

The extriCARE 1000 NPWT System is intended for use in wounds with low to moderate levels of exudate. Appropriate wound types include:

Chronic wounds
Acute wounds
Traumatic wounds
Subacute and dehisced wounds
Partial-thickness burns
· Ulcer wounds (such as diabetic or pressure)
Flaps and grafts
Closed surgical incisions

The extriCARE 1000 NPWT System is intended for use in healthcare facilities.

Device Description:

1. extriCARE 1000 Negative Pressure Wound Therapy Pump
1. extriCARE 1000 50cc Collection Canister

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Summary of Technological Characteristics

The extriCARE 1000 pump, similar to its predicate and reference device, operates by having an air pump, a solenoid valve, and a pressure sensor working in conjunction to deliver a specific target vacuum pressure on the wound bed. When the therapy begins, air and wound exudate are removed from the dressing's underside (wound bed) via the connection tubing into the collection canister until the target vacuum is reached. A pressure sensor inside the pump, along with a proprietary algorithm, approximates and monitors the pressure on the wound site. If a leakage on the wound dressing occurs, the device activates its air pump to remove air until the target vacuum is reestablished. In the event that actual vacuum pressure exceeds target vacuum pressure, a solenoid valve and a check valve will act to allow ambient air into the system and lower the vacuum pressure to the desired level.

Summary of Non-Clinical Testing:

The following non-clinical testing has been completed to demonstrate that the extriCARE 1000 NPWT pump is performing as intended, has performance characteristic that are substantially equivalent to the listed predicate devices, and conforms to internal standards and regulations.

Electromagnetic Compatibility and Electrical Safety Testing

Standards and Regulations Applied	Results
IEC 60601-1:2005 (Third Edition) + A1:2012(or IEC 60601-1: 2012 reprint)	Passed
IEC 60601-1-2:2014	Passed
IEC 60601-1-6:2010 Edition 3.1, AMD1:2013	Passed
IEC 60601-1-11:2015 Edition 2.0	Passed

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Image /page/6/Picture/0 description: The image shows the logo for Alleva Medical. The logo consists of a stylized letter A with a blue triangle in the upper left corner, followed by the word "ALLEVA" in dark blue, sans-serif font. Below "ALLEVA" is the word "MEDICAL" in a smaller, dark blue, sans-serif font.

Functional Performance Testing

Test Items	Results
Attribute Test	All requirements met
Measurement Test	All requirements met
System and Pneumatic Test	All requirements met
Exudate Removal Test	All requirements met
General Destructive Test	All requirements met
Performance Degradation Test	All requirements met
Hot and Cold Operation Test	All requirements met
Hot and Cold Temperature Test	All requirements met
Transportation Simulation Test	All requirements met

Software Verification and Validation

Software verification and validation activities were completed and there were no unresolved anomalies. The software was determined to be of a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the user (and delayed therapy).

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SelectedFeatures	extriCARE 1000NPWT System(Subject Device)	Smith & NephewPICO 14 NPWTSystem(Predicate)K191760	SVED WoundTreatment System(Reference)K142916	extriCARE 2400 NPWTSystem(Reference)K140634
IntendedUse/Indicationsfor Use	The extriCARE®1000 NPWTSystem is intendedto generatenegative pressureto remove woundexudates,infectious material,and tissue debrisfrom the woundbed.The extriCARE1000 NPWTSystem is intendedfor use in woundswith low tomoderate levels ofexudate.Appropriate woundtypes include:• Chronic wounds• Acute wounds• Traumaticwounds• Subacute anddehisced wounds• Partial-thicknessburns• Ulcer wounds(such as diabetic orpressure)• Flaps and grafts• Closed surgical	PICO is indicatedpatients whowould benefit froma suction device(NPWT) as it maypromote wouldhealing viaremoval of low tomoderate levels ofexudate andinfectiousmaterials.Appropriatewound typesinclude• chronic,• acute,• traumatic,• subacute anddehiscedwounds,• partial-thicknessburns• flaps andgrafts• closed surgicalincisions• ulcers (suchas diabetic orpressure)	The Cardinal HealthNPWT SVED systemis an integrated woundmanagement system,indicated for theapplication ofcontinual orintermittent negativepressure woundtherapy to the woundas the device maypromote woundhealing by the removalof fluids, includingwound exudates,irrigation fluids, bodyfluids and infectiousmaterials. The systemis intended for patientswith chronic, acute,traumatic, subacuteand dehisced wounds,partial-thicknessburns, ulcers (such asdiabetic or pressure),flaps and grafts. Thesystem is intended foruse in acute, extendedand home caresettings.	The extriCARE® NPWTfoam kit is intended to beused in conjunction withthe extriCARE® 2400NPWT pump.The extriCARE® 2400Negative Pressure WoundTherapy System isindicated for woundmanagement via theapplication of negativepressure to the wound bythe removal of woundexudate,infectiousmaterials, and tissue debrisfrom the wound bed.The extriCARE NegativePressure Wound TherapySystem is indicated for thefollowing wound types:chronic, acute, traumatic,subacute and dehiscedwounds, partial-thicknessburns, ulcers (such asdiabetic or pressure), flapsand grafts.
SelectedFeatures	extriCARE 1000NPWT System(Subject Device)	Smith & NephewPICO 14 NPWTSystem(Predicate)	SVED WoundTreatment System(Reference)	extriCARE 2400 NPWTSystem(Reference)
		K191760	K142916	K140634
	incisionsThe extriCARE1000 NPWTSystem is intendedfor use inhealthcarefacilities.	PICO 14 SingleUse NegativePressure WoundTherapy System issuitable for useboth in a hospitaland homecaresetting.
Contra-indicationsfor Use	Exposed vessels, organs, or nerves. Anastomotic sites. Exposed arteries or veins in a wound. Fistulas, unexplored or non-enteric. Untreated osteomyelitis. Malignancy in the wound. Excess amount of necrotic tissue with eschar. Wounds which are too large or too deep to be accommodated by the dressing. Inability to be followed by a medical professional or to keep scheduled appointments.	Patients with malignancy in the wound bed or margins of the wound (except in palliative care to enhance quality of life) Previously confirmed and untreated osteomyelitis Non-enteric and unexplored fistulas Necrotic tissue with eschar present Exposed arteries, veins, nerves or organs Exposed anastomotic sites The PICO 14	The SVED is contraindicated for patients with malignancy in the wound, untreated osteomyelitis, non-enteric and unexplored fistulas, or necrotic tissue with eschar present. Do not place the NPWT Dressing over exposed blood vessels or organs. The NPWT Dressings are also contraindicated for hydrogen peroxide and solutions which are alcohol based or contain alcohol. It is not recommended to deliver fluids to the thoracic cavity.	Exposed vessels, organs, or nerves. Anastomotic sites. Exposed arteries or veins in a wound. Fistulas, unexplored or non-enteric. Untreated osteomyelitis. Malignancy in the wound. Excess amount of necrotic tissue with eschar. Wounds which are too large or too deep to be accommodated by the dressing. Inability to be followed by a medical professional or to keep scheduled appointments. Allergy to urethane dressings and adhesives. Use of topical products which must
SelectedFeatures	extriCARE 1000NPWT System(Subject Device)	Smith & NephewPICO 14 NPWTSystem(Predicate)K191760	SVED WoundTreatment System(Reference)K142916	extriCARE 2400 NPWTSystem(Reference)K140634
	Allergy to silicone dressings and adhesives. Use of topical products which must be applied more frequently than the dressing change schedule allows	System should not be used for the purposes of: Emergency airway aspiration Pleural, mediastinal or chest tube drainage Surgical suction		be applied more frequently than the dressing change schedule allows
Use	Multi-patient	Single-patient	Multi-patient	Single-patient
PrescriptionUse	Yes	Yes	Yes	Yes
Vacuummode	Continuous andIntermittent	Continuous only	Continuous andIntermittent	Continuous andIntermittent
Pressuresettings	3, selectable;80/100/125mmHg	Vary from 60 to100 mm Hg	70, 120 and 150mmHg	40 - 140mmHg
Flow Rate	~0.5LPM	~0.5LPM	Unknown	About 1.0LPM @100mmHg
Canister	50cc	No	300cc and 500cc	100cc and 400cc
Battery	External alkaline,2 x AA 1.5V	External alkaline,2 x AA 1.5V	Internal RechargeableBattery	Internal RechargeableLithium battery, 3.7V,1500mAh
Usebarometricenvironment	800hPa – 1060hPa	800hPa – 1060hPa	50kPa-110kPa	800hPa – 1060hPa

Summary of Substantial Equivalence

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�ALLEVA MEDICAL

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�ALLEVA MEDICAL

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ALLEVA MEDICAL

Based on its operating principles, specifications, indications for use, the extriCARE 1000 is substantially equivalent to the predicate devices that were previously cleared. The system does not raise any new risks when compared to the predicate devices.

Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Alleva Medical Ltd, believes that the extriCARE 1000 NPWT system performs as well as the predicate device as described herein.

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.