Who is the manufacturer of extriCARE 1000 Negative Pressure Wound Therapy System?

Alleva Medical, Ltd. filed the 510(k) submission for extriCARE 1000 Negative Pressure Wound Therapy System (K213906).

What is the FDA product code for extriCARE 1000 Negative Pressure Wound Therapy System?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for extriCARE 1000 Negative Pressure Wound Therapy System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like extriCARE 1000 Negative Pressure Wound Therapy System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

extriCARE 1000 Negative Pressure Wound Therapy System

K213906 · Alleva Medical, Ltd. · OMP · Mar 8, 2023 · General, Plastic Surgery

Device Facts

Record ID	K213906
Device Name	extriCARE 1000 Negative Pressure Wound Therapy System
Applicant	Alleva Medical, Ltd.
Product Code	OMP · General, Plastic Surgery
Decision Date	Mar 8, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended 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 Story

Portable, battery-powered NPWT pump; generates negative pressure to remove wound exudates, infectious material, and tissue debris. Operates via air pump, solenoid valve, and pressure sensor; user selects 80, 100, or 125mmHg. Used in healthcare facilities by clinicians. System monitors wound site pressure via proprietary algorithm; maintains target vacuum by activating pump for leaks or using valves to vent excess pressure. Output is vacuum therapy; healthcare providers use to promote wound healing. Benefits include exudate management and wound bed preparation.

Clinical Evidence

Bench testing only. Testing included electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11) and functional performance testing (attribute, measurement, pneumatic, exudate removal, destructive, degradation, temperature, and transportation simulation). All requirements met.

Technological Characteristics

Portable battery-powered pump (2x AA 1.5V alkaline). Components: pump unit and 50cc collection canister. Sensing: pressure sensor. Actuation: air pump, solenoid valve, check valve. Vacuum settings: 80, 100, 125mmHg. Flow rate: ~0.5LPM. Connectivity: standalone. Software: moderate level of concern.

Indications for Use

Indicated for patients with chronic, acute, traumatic, subacute, dehisced wounds, partial-thickness burns, diabetic/pressure ulcers, flaps, grafts, and closed surgical incisions with low to moderate exudate. Contraindicated for exposed vessels, organs, or nerves; anastomotic sites; fistulas (unexplored/non-enteric); untreated osteomyelitis; malignancy in the wound; necrotic tissue with eschar; wounds too large/deep for dressing; inability to follow medical professional instructions; and allergy to silicone dressings/adhesives.

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

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)

Related Devices

K221223 — extriCARE® 3000 Negative Wound Pressure Therapy System · Alleva Medical Devices · Feb 9, 2023
K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System · Alleva Medical Devices · Oct 3, 2025
K180614 — PICO Single Use Negative Pressure Wound Therapy System · Smith & Nephew Medical Limited · Apr 6, 2018
K110078 — EXTRICARE · Devon Medical Products, Inc. · Feb 10, 2012
K181929 — MiMo(TM) Negative Pressure Wound Therapy System · Baymax Research, Inc. · Mar 27, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12" x="0" y="0"></rect> <path d="M2,2 L10,10 M2,10 L10,2" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 Ltd Suite M-Q, 12th Floor, Kings Wing Plaza 2 1 On Kwan Street, Shek Mun, Shatin New Territories, Hong Kong | | CONTACT | Mr. Max Choi Chief Executive Officer Phone: +852-3166-7239 Fax: +852-2355-7663 Email: 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) | {4}------------------------------------------------ # 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: 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 - 2. 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). {5}------------------------------------------------ #### 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 | {6}------------------------------------------------ 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). {7}------------------------------------------------ | Selected Features | extriCARE 1000 NPWT System (Subject Device) | Smith & Nephew PICO 14 NPWT System (Predicate) K191760 | SVED Wound Treatment System (Reference) K142916 | extriCARE 2400 NPWT System (Reference) K140634 | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ 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 | PICO is indicated patients who would benefit from a suction device (NPWT) as it may promote would healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include • chronic, • acute, • traumatic, • subacute and dehisced wounds, • partial- thickness burns • flaps and grafts • closed surgical incisions • ulcers (such as diabetic or pressure) | The Cardinal Health NPWT SVED system is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings. | The extriCARE® NPWT foam kit is intended to be used in conjunction with the extriCARE® 2400 NPWT pump. The extriCARE® 2400 Negative Pressure Wound Therapy System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The extriCARE Negative Pressure Wound Therapy System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. | | Selected Features | extriCARE 1000 NPWT System (Subject Device) | Smith & Nephew PICO 14 NPWT System (Predicate) | SVED Wound Treatment System (Reference) | extriCARE 2400 NPWT System (Reference) | | | | K191760 | K142916 | K140634 | | | incisions The extriCARE 1000 NPWT System is intended for use in healthcare facilities. | PICO 14 Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting. | | | | Contra- indications for 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 | | Selected Features | extriCARE 1000 NPWT System (Subject Device) | Smith & Nephew PICO 14 NPWT System (Predicate) K191760 | SVED Wound Treatment System (Reference) K142916 | extriCARE 2400 NPWT System (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 | | Prescription Use | Yes | Yes | Yes | Yes | | Vacuum mode | Continuous and Intermittent | Continuous only | Continuous and Intermittent | Continuous and Intermittent | | Pressure settings | 3, selectable; 80/100/125mmHg | Vary from 60 to 100 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 Rechargeable Battery | Internal Rechargeable Lithium battery, 3.7V, 1500mAh | | Use barometric environment | 800hPa – 1060hPa | 800hPa – 1060hPa | 50kPa-110kPa | 800hPa – 1060hPa | ## Summary of Substantial Equivalence {8}------------------------------------------------ # �ALLEVA MEDICAL {9}------------------------------------------------ # �ALLEVA MEDICAL {10}------------------------------------------------ # 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.