(180 days)
Not Found
No
The summary describes a powered suction pump for wound care and explicitly states that the notification is for labeling changes only with no significant design modifications. There is no mention of AI, ML, or related concepts.
Yes
The device is described as promoting wound healing and removing infectious material/fluids from wounds, which are therapeutic actions.
No.
The document states that the device is a powered suction pump intended for wound healing and fluid removal, not for diagnosing conditions.
No
The device description explicitly states it is a "powered suction pump," which is a hardware device. The 510(k) is for labeling changes only, not a new software-only 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 the device as a "powered suction pump" used for "wound healing" and "vacuum assisted drainage and removal of infectious material or other fluids from wounds." This is a therapeutic and wound management function, not a diagnostic one performed on in vitro samples.
- Device Description: The description confirms it's a "powered suction pump" and focuses on labeling changes related to wound types. There is no mention of analyzing biological samples outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on in vitro analysis.
The V.A.C. PLUS is a medical device used for wound therapy and management, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The V.A.C. PLUS is a powered suction pump 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. PLUS is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.
Product codes
OMP
Device Description
This notification for The V.A.C. Plus device is for labeling changes only, as have evolved over time. There have been no significant modifications or design changes to the presently cleared and marketed V.A.C. Plus device, 510(k) No. K945062.
The labeling changes have not been fully itemized, but include changes in the listing of specific wound types addressed.
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)
Clinical studies are provided to support these claims.
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 Statement Submitter:
Kinetic Concepts, Inc. P.O. Box 659508 San Antonio, TX 78265 Judith A. Harbour 210-255-4468 210-255-4440 FAX
Date of Submittal:
Name of Device:
Classification Name:
July 1, 1999
V.A.C. PLUS
Powered Suction Pump (per 21 CFR 878.4780)
Substantial Equivalence:
V.A.C. Plus, 510(k) No. 945062
Device Description:
This notification for The V.A.C. Plus device is for labeling changes only, as have evolved over time. There have been no significant modifications or design changes to the presently cleared and marketed V.A.C. Plus device, 510(k) No. K945062.
The labeling changes have not been fully itemized, but include changes in the listing of specific wound types addressed.
Indications for Use:
The V.A.C. Plus is "a powered suction pump 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 (also referred to as intermittent) suction pressures."
Within this broad application of the therapy to all wound types, acute, chronic, traumatic, subacute and dehisced wounds and ulcers are but only a few types of wounds that fall within the cleared intended use of the V.A.C. Plus.
Clinical Studies to Support Labeling Claims:
A wound is defined as "(1) trauma to any of the tissues of the body, especially that caused by physical means and with interruption of continuity and (2) a surgical incision." See Stedman's Medical Dictionary (26th ed.). The adjectives used to describe wounds, such as "acute" (a brief health effect, sometimes severe); chronic (lasting a long time); traumatic (a wound caused by trauma); subacute (a wound of moderate duration or severity), dehisced (burst open or split along suture lines) and diabetic and pressure ulcers
1
K992448
(wounds that appear in pressure areas of skin overlying a body prominence in debilitated patients confined to bed or otherwise immobilized, due to a circulatory defect) help define the origin of the wound and assist the health care professional to prescribe the necessary wound treatment protocol. Clinical studies are provided to support these claims.
2
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 eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
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: K992448 Trade/Device Name: V.A.C. Plus Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: September 28, 1999 Received: October 20, 1999
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of January 18, 2000.
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.
Fe. Peter Ramez
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): K992448
Device Name: V.A.C. PLUS
Indications for Use:
The V.A.C. PLUS is a powered suction pump 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. PLUS is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, 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)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number __________ |
| Prescription Use | ✓ | OR | Over-The-Counter Use __________ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |