(142 days)
Not Found
No
The device description and performance studies focus on the physical components and their function in delivering negative pressure wound therapy, with no mention of AI or ML.
Yes
The device is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention, directly impacting the healing process of various wound types.
No
The device is intended to promote wound healing by creating an environment for the wound bed, reducing edema, promoting tissue formation, and removing exudate. This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly lists physical components (gauze, pad, drapes, ruler) and the performance studies evaluate the physical delivery of negative pressure and exudate removal, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that is applied externally to a wound to promote healing through negative pressure therapy. It focuses on physical processes (reducing edema, promoting granulation, removing exudate) and preparing the wound bed for closure.
- Device Description: The components are all physical items used for wound dressing and connection to a therapy unit. There are no reagents, test strips, or components designed to analyze biological samples in vitro.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body in vitro to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., outside of the body to provide diagnostic or other health-related information. This device is a therapeutic device used directly on the wound.
N/A
Intended Use / Indications for Use
The KCI NPWT Gauze Dressing is intended to be used with the following KCI Therapy Units (ActiV.A.C.®, InfoV.A.C.®, V.A.C. Simplicity™, V.A.C. ® Freedom, V.A.C. ATS® and V.A.C.Ulta™ Therapy Systems). The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and by removing exudate and infectious material. Wound types include chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. The KCI NPWT Gauze Dressing is not intended for use with instillation therapy, intermittent therapy or over closed incisions.
Product codes
OMP, FRO
Device Description
The KCI NPWT Gauze Dressing is a convenience kit that consists of the following currently marketed products:
• One Kerlix AMD Roll, identical to predicate (antimicrobial gauze wound dressing)
• One V.A.C. SensaT.R.A.C.™ Pad (connection to KCI NPWT source)
• Two V.A.C. Drapes
• One wound measuring ruler
The currently marketed sterile products are kitted in a non-sterile package. The kit is provided in one size and is intended to be single use.
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)
The KCI NPWT Gauze Dressing was evaluated under a number of design verification and validation tests to assure performance requirements for delivery of negative pressure wound therapy were met.
● The KCI NPWT Gauze Dressing when used with the V.A.C. Negative Pressure Wound Therapy Units delivers negative pressure within specification to the top of the wound site for a period of 72 hours.
● The KCI NPWT Gauze Dressing when used with the V.A.C. Negative Pressure Wound Therapy Units removes exudate from the wound for a period of 72 hours.
● The KCI NPWT Gauze Dressing when used with the V.A.C. Negative Pressure Wound Therapy Units do not contribute to false blockage alarms.
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
510(k) SUMMARY
APR 4 2013
KCI NPWT Gauze Dressing
| Date prepared | March 4, 2013 | ||
|---|---|---|---|
| 510(k) owner | |||
| • Name | KCI USA, Inc. (Kinetic Concepts, Inc.) | ||
| • Address | 6203 Farinon Drive; San Antonio, Texas 78249 | ||
| • Phone number | 210 255-6345 | ||
| • Fax number | 210 255-6727 | ||
| • Name of | |||
| contact person | Anona Goebel | ||
| Name of the device | |||
| Trade or | |||
| proprietary | |||
| name | KCI NPWT Gauze Dressing | ||
| Common or | |||
| usual name | Negative pressure wound therapy system (gauze dressing component) | ||
| Classification | |||
| name | Negative pressure wound therapy powered suction pump | ||
| (and components) | |||
| Legally | |||
| marketed | |||
| device(s) to | |||
| which | |||
| equivalence is | |||
| claimed | Smith and Nephew's RENASYS™ Gauze NPWT Wound Dressing Kit with | ||
| Softport | |||
| 510(k) Number: K110647 | |||
| Device description | |||
| • Device design | The KCI NPWT Gauze Dressing is a convenience kit that consists of the | ||
| following currently marketed products: | |||
| • One Kerlix AMD Roll, identical to predicate (antimicrobial gauze wound | |||
| dressing) | |||
| • One V.A.C. SensaT.R.A.C.™ Pad (connection to KCI NPWT source) | |||
| • Two V.A.C. Drapes | |||
| • One wound measuring ruler | |||
| The currently marketed sterile products are kitted in a non-sterile package. | |||
| The kit is provided in one size and is intended to be single use. | |||
| • Indications for | |||
| Use | The KCI NPWT Gauze Dressing is intended to be used with the following | ||
| KCI Therapy Units (ActiV.A.C.®, InfoV.A.C.®, V.A.C. Simplicity™, V.A.C.® | |||
| Freedom, V.A.C. ATS® and V.A.C.Ulta™ Therapy Systems). The system is | |||
| intended to create an environment that promotes wound healing by | |||
| secondary or tertiary (delayed primary) intention by preparing the wound | |||
| bed for closure, reducing edema, promoting granulation tissue formation | |||
| and perfusion, and by removing exudate and infectious material. Wound | |||
| types include chronic, acute, traumatic, subacute and dehisced wounds, | |||
| partial-thickness burns, ulcers (such as diabetic, pressure or venous | |||
| insufficiency), flaps and grafts. | |||
| The KCI NPWT Gauze Dressing is not intended for use with instillation | |||
| Summary of the | |||
| technological | |||
| characteristics | |||
| of the device | |||
| compared to | |||
| the predicate | |||
| device | Feature | KCI NPWT Gauze | |
| Dressing | Predicate Renasys | ||
| Gauze NPWT | |||
| Dressing Kit | |||
| Dressing | |||
| Material | Same as predicate | ||
| Configuration | Identical to the large size of | ||
| the predicate | |||
| Drape | Currently marketed V.A.C. | ||
| Drape (polyurethane film | |||
| with acrylic adhesive) | |||
| Interface pad and | |||
| tubing | Currently marketed | ||
| V.A.C. SensaT.R.A.C.TM | |||
| Pad | |||
| Wound measuring | |||
| ruler | Same as predicate | ||
| Accessories: Saline, | |||
| skin prep, non- | |||
| adherent layer | Not provided | ||
| NPWT Therapy Units | |||
| Compatibility | Compatible with the | ||
| following KCI V.A.C. | |||
| Negative Pressure Wound | |||
| Therapy Units: | |||
| ActiV.A.C. | |||
| InfoV.A.C. | |||
| V.A.C. ATS | |||
| V.A.C. Freedom | |||
| V.A.C. Simplicity | |||
| V.A.C.Ulta | Compatible with S&N | ||
| therapy units: | |||
| RENASYS EZ | |||
| RENASYS GO | |||
| Summary of non- | |||
| clinical tests | |||
| conducted for | |||
| determination of | |||
| substantial | |||
| equivalence | The KCI NPWT Gauze Dressing was evaluated under a number of design | ||
| verification and validation tests to assure performance requirements for | |||
| delivery of negative pressure wound therapy were met. | |||
| ● The KCI NPWT Gauze Dressing when used with the V.A.C. Negative | |||
| Pressure Wound Therapy Units delivers negative pressure within | |||
| specification to the top of the wound site for a period of 72 hours. | |||
| ● The KCI NPWT Gauze Dressing when used with the V.A.C. Negative | |||
| Pressure Wound Therapy Units removes exudate from the wound for | |||
| a period of 72 hours. | |||
| ● The KCI NPWT Gauze Dressing when used with the V.A.C. Negative | |||
| Pressure Wound Therapy Units do not contribute to false blockage | |||
| alarms. | |||
| Summary of | |||
| clinical tests | |||
| conducted for | None required for determining substantial equivalence |
1
[ [ [ [ ] [ ] ] ] therapy, intermittent therapy or over closed incisions.
2
| determination of
substantial
| equivalence | |
|---|---|
| Conclusions | |
| drawn | Testing demonstrates that the KCI NPWT Gauze Dressing and the |
| RENASYS™ Gauze NPWT Wound Dressing Kits with Softport are | |
| substantially equivalent in terms of both indications for use and delivery of | |
| negative pressure wound therapy. |
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3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 4, 2013
KCI USA, Inc. % Ms. Anona Goebel Senior Manager, Regulatory Affairs 6203 Farinon Drive San Antonio, Texas 78249
Re: K123507
Trade/Device Name: KCI NPWT Gauze Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP, FRO Dated: March 04, 2013 Received: March 07, 2013
Dear Ms. Goebel:
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 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
4
Page 2 - Ms. Anona Goebel
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/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, FOR
Peter Di Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K123507 Device Name: KCI NPWT Gauze Dressing
Indications for Use:
The KCI NPWT Gauze Dressing is intended to be used with the following KCI Therapy Units (ActiV.A.C.®, InfoV.A.C.®, V.A.C. Simplicity™, V.A.C. ® Freedom, V.A.C. ATS® and V.A.C.Ulta™ Therapy Systems). The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and by removing exudate and infectious material. Wound types include chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The KCI NPWT Gauze Dressing is not intended for use with instillation therapy, intermittent therapy or over closed incisions.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Page of of a
(Posted November 13, 2003)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123507