(74 days)
No
The summary describes a negative pressure wound therapy device with feedback control based on pressure measurement, with no mention of AI or ML terms or concepts.
Yes
The device is described as "negative pressure devices used to help promote wound healing," directly indicating a therapeutic purpose.
No
The device is a negative pressure device used to promote wound healing by draining and removing fluids and infectious material. It measures the level of negative pressure at the wound site for feedback control, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the devices consist of a "vacuum control unit with an integrated collection canister and power supply," indicating 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 device used to promote wound healing by applying negative pressure to the wound site. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The description details a vacuum control unit with a collection canister and power supply, consistent with a medical device used for wound therapy.
- 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 treatment. IVDs are used in vitro (outside the body) to analyze samples.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The V.A.C.® family of devices are feedback-controlled negative pressure devices used to help promote wound healing, through means including vacuum assisted drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent suction pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site.
Product codes
OMP
Device Description
All models of the VAC family of devices, including the V.A.C.® ATS™, mini V.A.C.®, and the V.A.C.® Freedom™, consist of a vacuum control unit with an integrated collection canister and power supply.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wound site
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)
Verification and validation testing of the V.A.C. family of devices, including functional performance testing and electrical leakage testing, was conducted in accordance with established design control procedures.
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
OCT 1 0 2003
Kψ32310 (P, 1of2)
510(K) SUMMARY: V.A.C® Therapy family of devices.
| I. Name of Device: | V.A.C.® ATS™™, mini V.A.C.®,
V.A.C.® Freedom™™ |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| 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. Plus
510(k) No.K992448
Ambulatory V.A.C.
510(k) No.K971548 |
V. Description of Device
All models of the VAC family of devices, including the V.A.C.® ATS™, mini V.A.C.®, and the V.A.C.® Freedom™, consist of a vacuum control unit with an integrated collection canister and power supply.
VI. Intended Use of the Device
The V.A.C.® family of devices are feedback-controlled negative pressure devices used to help promote wound healing, through means including vacuum assisted drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent suction pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site.
VII.Summary of the technological characteristics of the device compared to the predicate device.
Each of the devices in the V.A.C. family of devices consists of the same basic technology, and do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness. Each device consists of a vacuum control unit with an integrated collection canister and power supply (battery or AC). The primary differences in these models relate to size and weight. All models of the V.A.C. family of devices are designed to help promote wound healing, through the application of controlled negative pressure to the surface and margins of the wound. This negative pressure therapy is applied to the V.A.C. foam dressing positioned in the wound cavity or over a flap or graft. This pressure distributing foam dressing helps remove fluids from the wound. The devices are designed to treat wounds such as chronic, acute, traumatic, subacute and dehisced wounds; partial-thickness burns; ulcers (such as diabetic or pressure); flaps; and grafts.
1
ψ3231φ (P,2.0fa
V.A.C. Family of Devices Page 2
VIII. Testing
Verification and validation testing of the V.A.C. family of devices, including functional performance testing and electrical leakage testing, was conducted in accordance with established design control procedures.
IX. Conclusions
Based upon the testing and comparison to the predicate devices, the V.A.C. family of devices has the same intended uses, with similar technological characteristics. The system performs as intended and raises no new safety or effectiveness issues.
2
Image /page/2/Picture/1 description: The image shows the seal of the United States Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR -7 2009
KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230
Re: K032310
Trade/Device Name: The V.A.C.® family of devices:
mini V.A.C.®, V.A.C. ® Freedom™, V.A.C.® ATSTM
Regulation Number: 21 CFR 878.4780
Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP
Dated: July 21, 2003
Received: August 4, 2003
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of October 10, 2003.
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
3
Page 2 - Ms. Christy Oviatt
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); 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.
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,
For Pete Romano
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
Page 1 of 1
510(k) Number (if known): 大922310
Device Name:
The V.A.C.® family of devices: mini V.A.C.®, V.A.C.® Freedom™, V.A.C.® ATSTM
Indications For Use:
The V.A.C.® family of devices with woundsite feedback control are negative pressure devices used to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site.
(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) | OR
mirian C. Provos | Over the Counter Use:
, (Optional Format 1-2-96) |
|-------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------|
| | (Division Sign-Off)
Division of General, Restorative
and Neurological Devices | |
| | 510(k) Number _ | K0232316 |