(70 days)
extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.
extriCARE® Negative Pressure Wound Therapy 100cc canister extriCARE® Negative Pressure Wound Therapy 250cc canister extriCARE® Negative Pressure Wound Therapy 400cc canister
I apologize, but the provided text from the FDA 510(k) summary (K132252) for the ExtriCARE® Negative Pressure Wound Therapy system does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or details of a device performance study.
The document is a letter of substantial equivalence from the FDA, confirming that the ExtriCARE® device is substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory classification, general controls, and labeling requirements.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance: This information is not present.
- Sample size and data provenance for the test set: Not mentioned.
- Number and qualifications of experts for ground truth: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- MRMC comparative effectiveness study details: Not mentioned.
- Standalone algorithm performance: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not applicable, as this is a physical medical device.
- How ground truth for the training set was established: Not applicable.
The document states the device's Indications for Use, which is: "extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing." This describes the intended function but does not provide performance metrics or studies to support specific claims.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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
September 27, 2013
Devon Medical Incorporated Ms. Ruth Wu Chief Operating Officer 1100 156 Avenue, Suite 202 King of Prussia. Pennsylvania 19406
Re: K132252
Trade/Device Name: ExtriCARE® Negative Pressure Wound Therapy 100cc, 250cc, and 400cc Canisters Regulation Number: 21 CFR 878.4780 · Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: August 26, 2013 Received: August 28, 2013
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 enacunent date of the Medical Device Amendments, or to connered processified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (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 roundly, mercers, manys 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 cither 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 Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean r reast be devices of the Fermination that your device complies with other requirements of the Act mar i Dr. has Intact and regulations administered by other Federal agencies. You must or any I edetal station and registements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Ruth Wu
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 forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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,
Long H. ------Chen -A - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Mark N. Melkerson, M.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K132252
- Device Name: extriCARE® Negative Pressure Wound Therapy 100cc canister extriCARE® Negative Pressure Wound Therapy 250cc canister extriCARE® Negative Pressure Wound Therapy 400cc canister
Indications for Use:
extriCARE® 2400 Negative Pressure Wound Therapy System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR -(Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
§ 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.