(225 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a device with a long history on the market with no significant design changes mentioned in this submission.
Yes
The device is described as promoting wound healing and treating various types of wounds and ulcers, which are therapeutic functions.
No
The V.A.C. System is described as a powered suction pump intended for wound healing and removal of fluids, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "powered suction pump system," indicating it is a hardware device, not software-only. The notification is for a labeling change only, not a new software 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 system that applies suction to wounds to promote healing and remove fluids. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The description confirms it's a powered suction pump system.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body to diagnose a condition, monitor a treatment, or screen for diseases. IVDs are used to perform tests on biological specimens.
Therefore, the V.A.C. System, as described, is a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The V.A.C. System is a powered suction pump system that is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound* healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.
- The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers, flaps and grafts.
Product codes
OMP
Device Description
This notification for The V.A.C. device is for labeling change only, to include an additional indication. There have been no significant modifications or design changes to the currently cleared and marketed V.A.C. device, 510(k) No.K992448.
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)
Since the V.A.C.® System was placed on the market in 1995, KCI has worked through non-KCI clinicians to gather date to establish the safety and effectiveness of the V.A.C. System. V.A.C. units have been used internationally treating well over 20,000 acute and chronic wound patients. Major burn centers have been using V.A.C. therapy to assist with healing burns for several years. We believe the findings of the clinical studies, cases reported in the literature, as well as informal reports by clinicians warrants the additional claim that V.A.C. treatment assists in healing partial-thickness burns.
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: V.A.C.
| I. Name of Device: | V.A.C.® (Vacuum Assisted Closure™) |
|---|---|
| II. Classification Name: | Powered Suction Pump |
| 21 CFR 878.4780 | |
| III. 510(k) Applicant: | Kinetic Concepts, Inc. (KCI) |
| 8023 Vantage Drive | |
| San Antonio, TX 78265-8508 | |
| Contact: Judith Harbour 1-800-275-4524 | |
| IV. Substantial Equivalence: | V.A.C. |
| 510(k) No.K945062 |
V.A.C. PLUS
510(k) No.K992448
V. Description of Device
This notification for The V.A.C. device is for labeling change only, to include an additional indication. There have been no significant modifications or design changes to the currently cleared and marketed V.A.C. device, 510(k) No.K992448.
V. Indications for Use
The V.A.C. System is a powered suction pump system that is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound* healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.
- The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers, flaps and grafts.
VI. Clinical Studies to Support Labeling Claims
Since the V.A.C.® System was placed on the market in 1995, KCI has worked through non-KCI clinicians to gather date to establish the safety and effectiveness of the V.A.C. System. V.A.C. units have been used internationally treating well over 20,000 acute and chronic wound patients. Major burn centers have been using V.A.C. therapy to assist with healing burns for several years. We believe the findings of the clinical studies, cases reported in the literature, as well as informal reports by clinicians warrants the additional claim that V.A.C. treatment assists in healing partial-thickness burns.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The logo is black and white.
Public Health Service
APR -7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230
Re: K021500
Trade/Device Name: Vacuum Assisted Closure (VAC) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: October 7, 2002 Received: October 10, 2002
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of December 20, 2002.
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 vour 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
2
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,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K021500
Device Name: The V.A.C.® System
Indications For Use:
The V.A.C. System is a powered suction pump system that is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound* healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.
*The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers, flaps and grafts.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ × (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)
Page
Miriam C. Provost
OR
: Vision Sign-Off Civision of General, Restorative and Neurological Devices