(52 days)
No
The document describes a standard negative pressure wound therapy device and does not mention any AI or ML capabilities.
Yes
The device is indicated for patients who would benefit from a suction device that may promote wound healing, which is a therapeutic purpose.
No
The device description and intended use clearly state that it is a suction device for wound healing and fluid removal, which are therapeutic functions, not diagnostic ones. It does not analyze conditions or collect diagnostic information.
No
The device description explicitly states it is a "lightweight, portable suction device" with a "suction pump" and operates via "mains power supply or internal battery," indicating it is a hardware device.
Based on the provided information, the Renasys EZ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies negative pressure to a wound to remove fluids and promote healing. This is a therapeutic intervention applied directly to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a suction pump, tubing, and a canister for collecting exudates. This aligns with a wound therapy device, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on in vitro analysis.
Therefore, the Renasys EZ falls under the category of a therapeutic medical device, specifically a Negative Pressure Wound Therapy (NPWT) system, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Renasys EZ is indicated for patients who would benefit from a suction device (negative pressure) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.
Examples of appropriate wound types include: Chronic, Acute, Traumatic, Sub-Acute and dehisced wounds, Ulcers (such as pressure or diabetic), Partial-thickness burns, Flaps and Grafts.
Product codes
OMP
Device Description
The RENASYS™ EZ NPWT device is a lightweight, portable suction device intended to deliver negative pressure to a wound at a range of pressure settings via a tube set connected to a wound dressing. The suction pump creates negative pressure and removes exudates from the wound site to a disposable canister. The device can operate either by a mains power supply or internal battery. Renasys EZ is suitable for use in both a hospital and homecare setting.
RENASYS™ EZ is compatible with existing Smith & Nephew wound dressing kits currently on the market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound site
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)
Performance testing and electrical safety testing has been successfully completed to demonstrate that Renasys EZ is substantially equivalent to the marketed devices and is safe and effective for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K091470
pg. 1 of 2
JUL - 9 2009.
510(k) Summary Renasys™ EZ Negative Pressure Wound Therapy
- Smith & Nephew, Inc. 1. Submitter: 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
- Laura Kreici Reynolds 2. Contact: Regulatory Affairs Manager 727-329-7702
- RENASYS™ EZ Negative Pressure Wound Therapy 3. Device Name: Powered Suction Pump Common Name: Classification Name: Powered Suction Pump (21 CFR 878.4780) Product Classification/Code: Class II, OMP
Predicate Device Information: 4.
RENASYS™ EZ Negative Pressure Wound Therapy System 510(k) # K082426 Smith & Nephew, Inc. Largo, FL
RENASYS™ GO Negative Pressure Wound Therapy System 510(k) # K083375 Smith & Nephew, Inc. Largo, FL
5. Device Description:
The RENASYS™ EZ NPWT device is a lightweight, portable suction device intended to deliver negative pressure to a wound at a range of pressure settings via a tube set connected to a wound dressing. The suction pump creates negative pressure and removes exudates from the wound site to a disposable canister. The device can operate either by a mains power supply or internal battery. Renasys EZ is suitable for use in both a hospital and homecare setting.
RENASYS™ EZ is compatible with existing Smith & Nephew wound dressing kits currently on the market.
1
6091470 2 of 2
6. Intended Use:
The Renasys EZ is indicated for patients who would benefit from a suction device (negative pressure) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.
Examples of appropriate wound types include: Chronic, Acute, Traumatic, Sub-Acute and dehisced wounds, Ulcers (such as pressure or diabetic), Partial-thickness burns, Flaps and Grafts.
7. Substantial Equivalence
In establishing substantial equivalence to the current marketed devices, Smith & Nephew, Inc. evaluated the indications for use, materials, technology, product specifications and energy requirements of the currently marketed devices. Performance testing and electrical safety testing has been successfully completed to demonstrate that Renasys EZ is substantially equivalent to the marketed devices and is safe and effective for the intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circle around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc % Ms. Laura Krejci Reynolds Regulatory Affairs Manager 970 Lake Carillon Drive, Suite 110 Saint Petersburg, Florida 33719
Re: K091470
Trade/Device Name: RENASYS™ EZ Negative Pressure Wound Therapy Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: May 14, 2009 Received: May 18, 2009
JUL - 9 2009
Dear Ms. Reynolds:
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.
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
3
Page 2 - Ms. Laura Krejci Reynolds
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N.Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K091470
pg. 1 of 1
Indications for Use
510(k) Number: K091470
Device Name: RENASYS™ EZ Negative Pressure Wound Therapy
Indications for Use:
The Renasys EZ is indicated for patients who would benefit from a suction device (negative pressure) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.
Examples of appropriate wound types include: Chronic, Acute, Traumatic, Sub-Acute and dehisced wounds, Ulcers (such as pressure or diabetic), Partialthickness burns, Flaps and Grafts.
Over-The-Counter Use Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Kramer for MKM
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091470