(63 days)
Not Found
No
The description focuses on mechanical and software-controlled negative pressure therapy, with no mention of AI or ML capabilities. The "software-controlled" aspect and "T.R.A.C.® technology" for monitoring pressure are standard control systems, not indicative of AI/ML.
Yes
The device is intended to promote wound healing, reduce edema, promote granulation tissue formation, and remove exudate and infectious material, all of which are therapeutic effects.
No
The V.A.C. Therapy System is described as a treatment device that promotes wound healing by applying negative pressure and removing exudate, not a device used to diagnose medical conditions.
No
The device description explicitly states that the system includes hardware components such as a Therapy Unit, foam dressings, tubing, and a canister, in addition to software.
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 wound healing by applying negative pressure to the wound bed. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The description details components like foam dressings, a therapy unit, tubing, and a canister, all designed to physically interact with the wound and manage exudate.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The V.A.C. Therapy 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
The V.A.C.® GranuFoam® Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The components of the V.A.C.® Therapy System work as an integrated product to optimize both the delivery and the benefits of negative pressure. An open pore foam (reticulated polyurethane foam (GranuFoam®, GranuFoam® Silver, and Abdominal Dressings, etc.) or polyvinyl alcohol foam (Vers-Foam™ Dressing)] is cut to fit the wound, then covered with a semi-permeable adhesive drape. The software-controlled Therapy Unit applies negative pressure to the wound bed. The user can select continuous or intermittent therapy, depending upon wound type and the needs of each patient. The open cells of the foam enable equal distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. T.R.A.C.® (Therapeutic Regulated Accurate Care) technology monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing.
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
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 applicable; no new nonclinical tests were performed for the purposes of this submission.
Not applicable; no new clinical tests were performed for the purposes of this submission, except as described in the submitted literature.
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.
K032310, K021501, K053627, K022011
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
K062227 Page 1/2
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 a bold, sans-serif font. A registered trademark symbol is located to the right of the "I".
OCT - 4 2006
| Date prepared | September 27, 2006 | |
|---|---|---|
| 510(k) Owner | ||
| Name | KCI USA, Inc. | |
| Address | 8023 Vantage Drive San Antonio, TX 78230 | |
| Fax number | 210 255-6727 | |
| Name of contact | ||
| person | Margaret Marsh; Senior Manager, Regulatory Affairs | |
| Name of the device | ||
| Trade or | ||
| proprietary name | V.A.C.® Therapy System | |
| Common or usual | ||
| name | Negative pressure wound therapy device | |
| Classification | ||
| name | Powered suction pump | |
| Legally marketed | ||
| device to which | ||
| equivalence is | ||
| claimed | Because the V.A.C.® Therapy System has not been modified | |
| for the purposes of this submission, the predicate products | ||
| are the V.A.C.® Therapy Family of Products (Therapy Units | ||
| ATS, Freedom and Instill and their associated disposable | ||
| components), which were most recently cleared under | ||
| 510(k)s: K032310 (V.A.C.® ATS and V.A.C.® Freedom® | ||
| Therapy Units), K021501 (V.A.C.® Instill Therapy Unit), | ||
| K053627 (V.A.C.® GranuFoam® Silver Protection Dressing) | ||
| and K022011 (V.A.C.® Abdominal Dressing). | ||
| Device description | The components of the V.A.C.® Therapy System work as an | |
| integrated product to optimize both the delivery and the | ||
| benefits of negative pressure. An open pore foam (reticulated | ||
| polyurethane foam (GranuFoam®, GranuFoam® Silver, and | ||
| Abdominal Dressings, etc.) or polyvinyl alcohol foam (Vers- | ||
| Foam™ Dressing)] is cut to fit the wound, then covered with a | ||
| semi-permeable adhesive drape. The software-controlled | ||
| Therapy Unit applies negative pressure to the wound bed. | ||
| The user can select continuous or intermittent therapy, | ||
| depending upon wound type and the needs of each patient. | ||
| The open cells of the foam enable equal distribution of the | ||
| negative pressure across the surface of the wound, while the | ||
| tubing transfers accumulated fluids to the canister. T.R.A.C.® | ||
| (Therapeutic Regulated Accurate Care) technology monitors | ||
| and maintains target pressure and alarms as needed to help | ||
| assure target pressure is maintained and constant therapy is | ||
| delivered. The safety features of the system include | ||
| additional alarms, such as those that signal for tubing | ||
| blockages, a full or missing collection canister, inactive | ||
| therapy, low battery, and leaks in the seal of the dressing. | ||
| Intended use of the device | The V.A.C. Therapy 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. It is indicated for patients with chronic, | ||
| acute, traumatic, subacute and dehisced wounds, partial- | ||
| thickness burns, ulcers (such as diabetic or pressure), flaps | ||
| and grafts. | ||
| The V.A.C.® GranuFoam® Silver™ Dressing is an effective | ||
| barrier to bacterial penetration and may help reduce infection | ||
| in the above wound types. | ||
| Differences in | ||
| intended use from the | ||
| predicate | The intended use of the device has not changed. | |
| Summary of the | ||
| technological | ||
| characteristics of the | ||
| device compared to | ||
| the predicate device | Design | Same as predicates |
| Materials | Same as predicates | |
| Energy | ||
| Source | Same as predicates | |
| Summary of | ||
| nonclinical tests | Not applicable; no new nonclinical tests were performed for | |
| the purposes of this submission. | ||
| Summary of clinical | ||
| tests | Not applicable; no new clinical tests were performed for the | |
| purposes of this submission, except as described in the | ||
| submitted literature. | ||
| Conclusions | Published literature documenting the effective use of the | |
| V.A.C.® Therapy System in a variety of wound types and | ||
| clinical situations support the following revision to the | ||
| Indications for Use statement. | ||
| The V.A.C.® Therapy 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. It is indicated for patients with chronic, | ||
| acute, traumatic, subacute and dehisced wounds, | ||
| partial-thickness burns, ulcers (such as diabetic or | ||
| pressure), flaps and grafts. | ||
| The V.A.C.® GranuFoam® Silver™ Dressing is an | ||
| effective barrier to bacterial penetration and may help | ||
| reduce infection in the above wound types. |
1
K062227 page 2/2
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ekci.
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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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
APR -7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230
Re: K062227
Trade/Device Name: V.A.C.® Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: July 31, 2006 Received: August 2, 2006
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of October 4, 2006.
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. Christy Oviatt
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 (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.
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,
foe Dott
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: K062227 Device Name: V.A.C. ® Therapy System Indications for Use:
The V.A.C. Therapy 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flans and grafts.
The V.A.C.® GranuFoam® Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
| Prescription Use
| (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 Services
(Posted November 13, 2003)
Page ___ of ___
510(k) Number L062227