(449 days)
No
The summary describes a standard negative pressure wound therapy system with user-selectable pressure settings and no mention of AI/ML capabilities or related performance studies.
Yes.
The device's intended use is to generate negative pressure to remove wound exudates, infectious material, and tissue debris from the wound bed for various types of wounds, indicating a direct therapeutic action on the patient.
No
The device is a Negative Pressure Wound Therapy (NPWT) system, which is intended to remove wound exudates and debris, not to provide a diagnosis.
No
The device description explicitly states it consists of a "portable, battery-powered pump unit" and a "50cc Collection Canister," which are physical hardware components. While software verification and validation were performed, the device is not solely software.
Based on the provided information, the extriCARE® 1000 NPWT System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to generate negative pressure to remove wound exudates, infectious material, and tissue debris from the wound bed. This is a therapeutic function applied directly to the patient's wound.
- Device Description: The device is a pump that creates vacuum pressure for wound therapy. It collects exudate in a canister.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (blood, tissue, etc.) outside of the body to diagnose a condition or provide information about a patient's health status.
- Anatomical Site: The device is applied to the "Wound bed," which is a part of the patient's body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The extriCARE® 1000 NPWT System is a therapeutic device used for wound management directly on the patient.
N/A
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 incisions
The extriCARE 1000 NPWT System is intended for use in healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
OMP
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:
-
- extriCARE 1000 Negative Pressure Wound Therapy Pump
-
- 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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
Functional Performance Testing:
- 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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:
-
- extriCARE 1000 Negative Pressure Wound Therapy Pump
-
- 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.