(302 days)
No
The summary describes a standard negative pressure wound therapy system with programmable pressure and mode settings, but there is no mention of AI or ML capabilities.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device 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," which describes a therapeutic function.
No
The device is used for wound management by applying negative pressure to remove wound exudate, infectious materials, and tissue debris, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the system consists of a vacuum pump, canister, tubing, and NPWT bandages or foam kits, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for wound management by applying negative pressure to remove exudate, infectious materials, and tissue debris. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a vacuum pump system designed to physically interact with a wound. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly treat a wound through physical means.
N/A
Intended Use / Indications for Use
The extriCARE® 3600 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® 3600 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 grafis.
Product codes
OMP
Device Description
The system consists of a vacuum pump, canister, tubing, NPWT bandage or NPWT Foam Kits. In operation, the device is attached via the tubing to a Negative Pressure Wound bandage or foam kits. Maximum pressure and continuous mode or intermittent mode selection are digitally programmable. The extriCARE 3600 pump can be sold alone or as a part of the extriCARE 3600 system with extriCARE bandages or foam kits. The extriCARE bandages are an all-in-one wound dressing; with no wound packing required which is cleared in the predicate K110078. The foam kit consists of Polyurethane foam, transparent film drape, paper ruler, Suction Bell with connecting (drainage) tube and clamp, which is included in this submission for review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound bed
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
To ensure the performance of extriCARE® 3600 device meet the design input when conjunction with NPWT bandage and foam kits, a series of bench tests were conducted to ensure device's functions, which include the sensors, hook, canister, clamp, air filter and a simulated wound performance test.
To verify that the device design met it's functional and performance requirements, representative samples of the device underwent function and mechanical testing, EMC testing in accordance with IEC 60601-1:2005, IEC 60601-1-2:2007 and electrical safety testing in accordance with AAMI ES 60601-1:2005 standards.
Per ISO-10993 requirements, the bandage samples and foam kits samples were tested for the following items and all tests were successfully passed.
- In-vitro Cytotoxicity
- Skin irritation
- Skin Sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110078, K032310, K100823, K082211
Reference Device(s)
Not Found
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
510K Summary
page 1 of 3
c
Cara Cara Cara Ca
510(K) SUMMARY
Submitter:
Devon Medical Inc.
Contact Person:
Ruth Wu, COO 1100 First Avenue, Suite 202 King of Prussia, PA 19406 866.446.0092 Phone: 484.636.0211 Fax:
Common Classification & Proprietary Names:
Negative Pressure Wound Therapy System Common Names: Proprietary Names: extriCARE 3600 extriCARE Foam Kit
Date Prepared:
January 16th, 2013
Classification
The classification name, 21 CFR Part and Paragraph number, product code and classification of the extriCARE 3600:
| FDA | Classification | Product
Code | Class |
|--------------------|-------------------------|-----------------|-------|
| 21 CFR
878.4780 | Powered Suction
Pump | OMP | II |
Predicate Devices:
The extriCARE 3600 Negative Pressure Wound Therapy System and extriCARE Foam Kit is substantially equivalent to the following:
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| extriCARE 2400 | Devon Medical | K110078 |
| V.A.C.® Freedom™ | Kinetic Concepts, Inc. | K032310 |
| Wound Pro Apex | Accuro Medical Products | |
| LLC | K100823 | |
| NPWT Foam | ||
| Dressing Kits | Smith & Nephew | K082211 |
Device Description
The system consists of a vacuum pump, canister, tubing, NPWT bandage or NPWT Foam Kits. In operation, the device is attached via the tubing to a
1
510K Summary
Negative Pressure Wound bandage or foam kits. Maximum pressure and continuous mode or intermittent mode selection are digitally programmable. The extriCARE 3600 pump can be sold alone or as a part of the extriCARE 3600 system with extriCARE bandages or foam kits. The extriCARE bandages are an all-in-one wound dressing; with no wound packing required which is cleared in the predicate K110078. The foam kit consists of Polyurethane foam, transparent film drape, paper ruler, Suction Bell with connecting (drainage) tube and clamp, which is included in this submission for review.
Intended Use:
The extriCARE 3600 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 3600 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.
Technological Characteristics:
The manufacturer believes that the technological characteristic of the extriCARE 3600 are substantially similar to those of the predicate devices. The extriCARE 3600 has very similar components to its predicate devices and very similar principles of operation. The device consists of an electrically generated source of vacuum and a canister. Like the predicates, vacuum, is applied for a specified period of time and intensity, according to the physician's prescription.
Both extriCARE bandages and foam dressing kits are alternatively used together with the extriCARE 3600 pumps. The extriCARE bandages are the same as stated in the previously cleared submission K110078.
The extriCARE foam kits use similar components and similar principles of operation to the predicate device. Like the predicate, the foam is placed into the wound and attached to a vacuum device, which may provide negative pressure to the wound site which may promote healing by removing wound exudates.
Performance Testing
To ensure the performance of extriCARE® 3600 device meet the design input when conjunction with NPWT bandage and foam kits, a series of bench tests were conducted to ensure device's functions, which include the sensors, hook, canister, clamp, air filter and a simulated wound performance test.
2
510K Summary
EMC Testing
To verify that the device design met it's functional and performance requirements, representative samples of the device underwent function and mechanical testing, EMC testing in accordance with IEC 60601-1:2005, IEC 60601-1-2:2007 and electrical safety testing in accordance with AAMI ES 60601-1:2005 standards.
K13225 page 3 of 3
Biocompatibility
The extriCARE 3600 system consists of the pump, bandages or alternative foam kits. While the pump has no direct body contact when used as indicated, the bandage and foam kits do have direct body contact. Per ISO-10993 requirements, the bandage samples and foam kits samples were tested for the following items and all tests were successfully passed.
- In-vitro Cytotoxicity .
- Skin irritation .
- Skin Sensitization .
Statement of Substantial Equivalence
The extriCARE 3600 system is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.
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, Devon Medical Products, believes that the extriCARE 3600 system (pump, bandage, foam, and accessories) is safe and effective and substantially equivalent to the predicate devices as described herein.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
May 15, 2014
Devin Medical, Inc. Ruth Wu, Chief Operating Officer 1100 First Avenue, Suite 202 King of Prussia, Pennsylvania 19406
Re: K132225
Trade/Device Name: extriCARE® 3600 Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: February 11, 2014 Received: February 14, 2014
Dear Ms. Wu:
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 that I Dr has master and regulations administered by other Federal agencies. You must or any it all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ruth Wu, Chief Operating Officer
.
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
for
Binita Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
cc: DMC 510(k) Staff Division D.O.
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K132225
Device Name
extriCARE 3600 Negative Pressure Wound Therapy System
Indications for Use (Describe)
The extriCARE® 3600 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® 3600 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 grafis.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
ound Da
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