(73 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies, and the performance studies focus on basic device functionality and safety.
Yes
The device is described as an "integrated wound management system" that "promotes wound healing," which aligns with the definition of a therapeutic device.
No.
The device description and intended use clearly state that it is a therapy system designed to promote wound healing by creating a specific environment and removing exudates, rather than diagnosing a condition.
No
The device description and performance studies clearly indicate that this is a hardware-based negative pressure wound therapy system, not a software-only device. The studies include testing of the therapy unit's performance, electrical safety, and battery life, all of which are related to hardware components.
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 system for managing and promoting the healing of open wounds and closed surgical incisions by applying negative pressure. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: It is described as a "Negative pressure wound therapy system," which is a type of medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing tests in a laboratory setting
The V.A.C. ® Via™ Therapy System is a therapeutic medical device used for wound management.
N/A
Intended Use / Indications for Use
The V.A.C. ® Via™ Therapy System is an integrated wound management system for use in acute, extended and home care settings. When used on open wounds, it 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 exudates and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
Negative pressure wound therapy system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
acute, extended and home care settings.
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 V.A.C.® Via™ NPWT System was evaluated to ensure conformance to the design specifications. The following bench tests were conducted:
• Performance testing to confirm therapy unit delivers negative pressure therapy
• Software verification and validation testing to confirm that therapy unit performs as designed
• Testing to confirm device meets all applicable electrical safety and electromagnetic compatibility standards.
• Battery life testing to demonstrate that the battery will supply adequate power to provide the appropriate negative pressure to the wound.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/1 description: The image shows the logo for KCI. The logo consists of a series of curved lines on the left, followed by the letters "KCI" in bold, sans-serif font. There is a period after the "I".
NOW 15 2013
510(k) SUMMARY
V.A.C. ® V.A.C. ® Via™ | V.A.C. ® Via™
Negative Pressure Wound Therapy System
| Submitter Information [21 CFR 807.929(a)(1)] | |
|---|---|
| Name | KCI USA, Inc. (Kinetic Concepts, Inc.) |
| Address | 6203 Farinon Drive |
| San Antonio, TX 78249 | |
| Phone number | 210-515-4059 |
| Fax number | 210-255-6727 |
| Establishment | |
| Registration Number | 1625774 |
| Name of contact person | Melanie Avila |
| Date prepared | 08/23/2013 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary | |
| name | V.A.C. ® Via™ Negative Pressure Wound Therapy System |
| Common or usual name | Negative Pressure Wound Therapy System |
| Classification name | Negative Pressure Wound Therapy Powered Suction Pump |
| Regulation | 878.4780 |
| Product Code(s) | OMP |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | |
| [21 CFR 807.92(a)(3)] | V.A.C. ® Via™ Negative Pressure Wound Therapy System, originally cleared |
| under 510(k) K093526 and K120033 | |
| Device description | |
| [21 CFR 807.92(a)(4)] | Negative pressure wound therapy system |
| Indications for use | |
| [21 CFR 807.92(a)(5)] | The V.A.C. ® Via™ Therapy System is an integrated wound management |
| system for use in acute, extended and home care settings. When used on | |
| open wounds, it 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 exudates and infectious material. | |
| Open wound types include: chronic, acute, traumatic, subacute and dehisced | |
| wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous | |
| insufficiency), flaps and grafts. | |
| When used on closed surgical incisions, it is intended to manage the | |
| environment of surgical incisions that continue to drain following sutured or | |
| stapled closure by maintaining a closed environment and removing exudates | |
| via the application of negative pressure wound therapy |
1
Image /page/1/Picture/0 description: The image shows the logo for KCI. The logo consists of a graphic on the left and the letters "KCI" on the right. The graphic on the left is a series of curved lines that are stacked on top of each other. The letters "KCI" are in a bold, sans-serif font.
510(k) SUMMARY
V.A.C. ® Via™
Negative Pressure Wound Therapy System
| Summary of the technological characteristics of the device compared to the predicate device
| [21 CFR 807.92(a)(6)] | ||||||
|---|---|---|---|---|---|---|
| Feature | V.A.C.® Via™ NPWT System | |||||
| (Modified Device) | V.A.C.® Via™ NPWT System | |||||
| (Predicate ) | ||||||
| Therapy unit | Same as predicate | Software controlled pump for delivery of | ||||
| negative pressure wound therapy | ||||||
| • Operating Principle | Same as predicate | Software controlled pump for delivery of | ||||
| negative pressure wound therapy | ||||||
| • Pump Type | One brushed, DC powered, single | |||||
| diaphragm pump | Two piezoelectric disc pumps | |||||
| • Software | Software code drives the | |||||
| operation of one conventional | ||||||
| diaphragm pump | Software code drives the operation of two | |||||
| piezoelectric pumps | ||||||
| • Housing Dimensions | ||||||
| (inches) | Width | Length | Depth | Width | Length | Depth |
| 3.5 | 6.4 | 2.8 | 3.5 | 6.4 | 2.4 | |
| Therapy unit options | Same as predicate | Selectable negative pressure at either | ||||
| -125mmHg or -75mmHg | ||||||
| Dressing system | ||||||
| components | Same as predicate | System consists of Granufoam ™ | ||||
| Dressing, interface pad and tubing, and | ||||||
| adhesive drape | ||||||
| Performance Data [21 CFR 807.92(b)] | ||||||
| Summary of non-clinical tests conducted for determination of substantial equivalence | ||||||
| [21 CFR 807.92(b)(1)] | ||||||
| The V.A.C.® Via™ NPWT System was evaluated to ensure conformance to the design specifications. | ||||||
| The following bench tests were conducted: | ||||||
| • Performance testing to confirm therapy unit delivers negative pressure therapy | ||||||
| • Software verification and validation testing to confirm that therapy unit performs as designed | ||||||
| • Testing to confirm device meets all applicable electrical safety and electromagnetic compatibility standards. | ||||||
| • Battery life testing to demonstrate that the battery will supply adequate power to provide the appropriate negative pressure to the wound. |
Information [21 CFR 807.92(b)(2)] Not applicable
Conclusions drawn [21 CFR 807.92(b)(3)]
Testing indicates that the V.A.C. ® Via™ NPWT System is substantially equivalent in terms of both
indications for use and fundamental scientific technology to the predicate p
2
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
· November 15, 2013
KCI USA, Incorporated Ms. Melanie Avila Regulatory Affairs Project Manager 6203 Farinon Drive San Antonio, Texas 78249
Re: K132741
Trade/Device Name: V.A.C. Via" Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 14, 2013 Received: October 17, 2013
Dear Ms. Avila:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Melanie Avila
... ... ... ..
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.
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,
David Krause -S
for Mark N. Melkerson
Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K 132741
Device Name
V.A.C. Via Negative Pressure Wound Therapy System
Indications for Use (Describe)
The V.A.C. @ Via™ Therapy System is an integrated wound management system for use in acute, excended and home care settings. When used on open wounds, it 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 lissue formation and perfusion, and by removing exudates and infectious material. Open wound types include: chronic, acute, traumatic, subacute and debissed wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative wound therepy.
Type of Use (Select one or both, as applicable)
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 Rediological Health (CDRH) (Signature)