(30 days)
Not Found
No
The summary describes a wound therapy system and its components, focusing on mechanical function and material properties. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is described as a "Therapy System" intended to "promote wound healing" and is indicated for various wound types and conditions, which are therapeutic goals.
No
The device description clearly states its purpose is to create an environment that promotes wound healing and to collect wound exudates, which are therapeutic functions, not diagnostic.
No
The device description clearly describes a physical canister with gel packs, which is a hardware component, not 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 device used for wound healing by applying negative pressure therapy to the wound bed. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The device is a canister designed to collect wound exudates from a therapy unit. This is a component of a therapeutic system, not a device used to examine specimens from the human body in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device is used to treat a wound directly on the patient.
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 V.A.C.® ATS Large (1000 mL) Canister With Gel is a sterile, single use canister that is inserted into the V.A.C.® ATS Therapy Unit to collect wound exudates. The V.A.C.® ATS 1000 mL Canister has volume graduations every 100 mL and contains two gel packs (isolyzers) for solidification of wound exudates. The 1000 mL canister is identical to the 500 mL canister cleared under K032310 except for volume capacity, the number of gel packs within the canister, and labeling.
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 Found
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/0 description: The image shows the logo for KCI. The logo consists of a series of curved lines on the left and the letters "KCI" on the right. The curved lines are arranged in a parallel fashion, with each line slightly offset from the others. The letters "KCI" are in a bold, sans-serif font. There is a registered trademark symbol to the right of the I.
510(k) SUMMARY V.A.C.® ATS Large (1000 mL) Canister With Gel
DEC 1 3 2006
:
| Date prepared | November 10, 2006 |
|---|---|
| 510(k) Owner | |
| Name | KCI USA, Inc. |
| Address | 8023 Vantage Drive, San Antonio, Texas 78230 |
| Fax number | 210-255-6727 |
| Name of contact | |
| person | Véronique Smith, Sr. Regulatory Affairs Specialist |
| Name of the device | |
| Trade or | |
| proprietary name | V.A.C.® ATS Large (1000 mL) Canister With Gel |
| Common or usual | |
| name | Negative pressure wound therapy device |
| Classification | |
| name | Powered suction pump |
| Legally marketed | |
| device to which | |
| equivalence is | |
| claimed | The predicate product is the 500 mL V.A.C.® ATS Canister With |
| Gel, described under K032310. This canister is a component of | |
| the V.A.C.® ATS Therapy Unit which was included in the V.A.C.® | |
| Family of Products 510(k) K032310 and the V.A.C.® Therapy | |
| System 510(k) K062227. | |
| Device description | The V.A.C.® ATS Large (1000 mL) Canister With Gel is a sterile, |
| single use canister that is inserted into the V.A.C.® ATS Therapy | |
| Unit to collect wound exudates. The V.A.C.® ATS 1000 mL | |
| Canister has volume graduations every 100 mL and contains two | |
| gel packs (isolyzers) for solidification of wound exudates. The | |
| 1000 mL canister is identical to the | |
| 500 mL canister cleared under K032310 except for volume | |
| capacity, the number of gel packs within the canister, and | |
| labeling. | |
| 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 for the device has not changed from the |
| predicate. |
1
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
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: K063426
Trade/Device Name: V.A.C.® ATS large Canister with Gel (1000ml) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: November 10, 2006 Received: November 13, 2006
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of December 13, 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
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 (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,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): Device Name: V.A.C.® ATS Large (1000 mL) Canister With Gel 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, fraumatic, 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.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| 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)
Page 1 of 1
(Posted November 13, 2003)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K063426 |
|---|---|
| --------------- | --------- |