(100 days)
No
The summary describes a negative pressure wound therapy (NPWT) foam dressing kit, which is a passive device used in conjunction with an NPWT system. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is described as a component of a Negative Pressure Wound Therapy (NPWT) system, which "may promote wound healing." Promoting wound healing indicates a therapeutic effect.
No
The device is a wound dressing kit used in conjunction with Negative Pressure Wound Therapy (NPWT) systems for wound healing, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like foam wound dressings, drains, tubes, and film drapes, indicating it is a hardware-based medical device kit.
Based on the provided information, the Renasys™ -F NPWT Foam Dressing Kits are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to be used in conjunction with NPWT systems to deliver negative pressure to wounds and promote wound healing. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a dressing kit containing foam, a drain, tube, and film drapes. These are physical components used for wound management, not for analyzing biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to testing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Renasys™ -F NPWT Foam Dressing Kits are a wound care product used for treatment.
N/A
Intended Use / Indications for Use
Renasys™ -F NPWT Foam Dressing Kits are intended to be used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to the wound. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.
NPWT is appropriate for use on the following wounds:
- Pressure ulcers
- · Diabetic/neuropathic ulcers
- · Venous insufficiency ulcers
- · Traumatic wounds
- · Post-operative and dehisced surgical wounds
- · Explored fistulas
- · Skin flaps and grafts
Product codes
BTA, OMP
Device Description
The NPWT Foam Dressing Kits are a line extension to Smith & Nephew's current Chariker-Jeter™ wound dressing kits. The foam kits are offered in four sizes: small, medium, large and extra-large. In addition to the foam wound dressing, the kits contain a drain and tube to connect to a waste canister and one or more transparent film drapes, depending on kit size. The kits are supplied sterile and are single-use.
The foam is a polyurethane material that is substantially equivalent to other foam dressings currently on the market. The drain and tube materials are silicone or PVC and the drapes are clear polyurethane film; all common materials currently found in similar wound care products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (Pressure ulcers, Diabetic/neuropathic ulcers, Venous insufficiency ulcers, Traumatic wounds, Post-operative and dehisced surgical wounds, Explored fistulas, Skin flaps and grafts)
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)
Not Found
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
K082211
pg 1 of 2
510(k) Summary NPWT Foam Dressing Kits
NOV 1 4 2008
| 1. | Submitter: | Smith & Nephew, Inc.970 Lake Carillon Drive, Suite 110St. Petersburg, FL 33716 |
|---|---|---|
| ---- | ------------------- | -------------------------------------------------------------------------------- |
| 2. | Contact: | Laura Krejci |
|---|---|---|
| Regulatory Affairs Manager | ||
| 727-329-7702 |
- Device Name: NPWT Foam Dressing Kits 3. Common Name: Powered Suction Pump and Accessories . Classification Name: Powered Suction Pump (21 CFR 878.4780) Product Classification/Code: Class II, BTA
Predicate Device Information: 4.
Versatile 1 EZCare Wound Vacuum System 510(k) #K061919 BlueSky Medical
Antlia II™ Suction Pump System Innovative Therapies, Inc.
510(k) #K070904
5. Device Description:
The NPWT Foam Dressing Kits are a line extension to Smith & Nephew's current Chariker-Jeter™ wound dressing kits. The foam kits are offered in four sizes: small, medium, large and extra-large. In addition to the foam wound dressing, the kits contain a drain and tube to connect to a waste canister and one or more transparent film drapes, depending on kit size. The kits are supplied sterile and are single-use.
The foam is a polyurethane material that is substantially equivalent to other foam dressings currently on the market. The drain and tube materials are silicone or PVC and the drapes are clear polyurethane film; all common materials currently found in similar wound care products.
6. Intended Use:
NPWT Foam Dressing Kits are intended to be used in conjunction with Smith & Nephew Neqative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to the wound. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.
NPWT is appropriate for use on the following wounds:
- · Pressure ulcers
- · Diabetic/neuropathic ulcers
- · Venous insufficiency ulcers
- · Traumatic wounds
- · Post-operative and dehisced surgical wounds
- · Explored fistulas
- · Skin flaps and grafts
1
K082211
pg 2
Substantial Equivalence 7.
The NPWT Foam Dressing Kits are substantially equivalent in design, materials, technology, function and intended use to the predicate devices named above. toonhology, fansition and interness deemonstrate the devices are safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH * HUMAN SERVICES * USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 2009
Smith & Nephew, Inc. % Ms. Laura Kreici 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716
Re: K082211
Trade/Device Name: Renasys™-F NPWT Foam Dressing Kits Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: October 31, 2008 Received: November 3, 2008
Dear Ms. Krejci:
This letter corrects our substantially equivalent letter of November 14, 2008.
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 (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
3
Page 2 - Ms. Laura Krejci
limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/dsma/dsmamain.html.
Sincerely yours.
s,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K08 2211
Indications for Use
510(k) Number (if known): K082211
Device Name: Renasys ™-F NPWT Foam Dressing Kits
Indications for Use:
Renasys™ -F NPWT Foam Dressing Kits are intended to be used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to the wound. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.
NPWT is appropriate for use on the following wounds:
- Pressure ulcers
- · Diabetic/neuropathic ulcers
- · Venous insufficiency ulcers
- · Traumatic wounds
- · Post-operative and dehisced surgical wounds
- · Explored fistulas
- · Skin flaps and grafts
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K082211 |
|---|---|
| --------------- | --------- |