(55 days)
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.
The V.A.C. ATS® and V.A.C. Freedom® canisters are provided with a sterile fluid path for single use with the V.A.C. ATS® and V.A.C. Freedom® therapy units.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the K063590 device:
The provided text describes a 510(k) summary for V.A.C. Freedom® and V.A.C. ATS® Therapy Device Canisters. It focuses on the manufacturing change to maintain sterility of the fluid path in these canisters compared to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance (Study Conclusion) |
|---|---|
| Maintain integrity of the fluid path sterile barriers | Verification through accelerated aging, distribution simulation, and microbial aerosol challenge testing. |
| Ensure sterility assurance level (SAL) of 10^-6 for the fluid path | The sterility assurance level of the sterile fluid path of the canisters can be assured to a level of 10^-6. |
| Device is as safe and effective as the predicate device | The modified V.A.C. ATS® and V.A.C. Freedom® canisters with the sterile fluid path are safe and effective for their intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the "accelerated aging, distribution simulation, and microbial aerosol challenge testing." It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The studies performed (accelerated aging, distribution simulation, microbial aerosol challenge testing) are generally laboratory-based performance tests rather than studies requiring expert clinical assessment for ground truth.
4. Adjudication Method
This information is not applicable and therefore not provided. The studies conducted are performance tests, not clinical evaluations requiring adjudication from experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, and therefore, there is no information on the effect size of human readers improving with or without AI assistance. This device is a medical device accessory and its evaluation did not involve AI or human interpretation in that context.
6. Standalone (Algorithm Only) Performance
A standalone performance study was not conducted. This device is not an algorithm or AI-based system, so this type of study is not relevant.
7. Type of Ground Truth Used
The ground truth used for these tests would be based on objective performance measurements of the physical and microbiological integrity of the sterile fluid path. For example:
- Accelerated aging: Measuring the package integrity and sterility after simulated aging.
- Distribution simulation: Assessing package integrity after simulating shipping and handling stress.
- Microbial aerosol challenge testing: Direct measurement of the ability of the sterile barrier to prevent microbial ingress, verifying the 10^-6 SAL.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is not an AI/ML algorithm that requires a training set. The "training set" concept is not relevant to the nonclinical tests described for this physical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for KCI. The logo consists of a stylized graphic to the left of the letters "KCI". The graphic is made up of several curved lines that are stacked on top of each other. The letters "KCI" are in a bold, sans-serif font, and there is a registered trademark symbol to the right of the "I".
JAN 2 5 7007 14 - 1 - 510(k) SUMMARY - 510(k) SUMMARY
Product Name: V.A.C. Freedom® and V.A.C. ATS® Therapy Device Canisters
| Date prepared | November 30, 2006 |
|---|---|
| 510(k) Owner | |
| Name | KCI USA, Inc. |
| Address | 8023 Vantage Dr., San Antonio, TX 78230 |
| Fax number | (210) 255-6727 |
| Name of contact person | Christy Hubbard Oviatt, Sr. Regulatory Affairs Specialist |
| Name of the device | |
| Trade or proprietaryname | • V.A.C. 300 ml Canister (with Gel) for V.A.C. Freedom®• 500 ml Canister (with Gel) for V.A.C. ATS®• 500 ml Canister for V.A.C. ATS® |
| Common or usualname | Accessory to Negative Pressure Wound Therapy Device |
| Classification name | Accessory to Powered Suction Pump |
| Legally marketed deviceto which equivalence isclaimed | The canisters are proposed to be substantially equivalentto canisters currently marketed in sterile barrierpackaging. These canisters were included in the V.A.C.Family of Devices 510(k) K032310.• V.A.C. 300 ml Canister (with Gel) for V.A.C. Freedom®• 500 ml Canister (with Gel) for V.A.C. ATS®• 500 ml Canister for V.A.C. ATS® |
| Device description | The V.A.C. ATS® and V.A.C. Freedom® canisters areprovided with a sterile fluid path for single use with theV.A.C. ATS® and V.A.C. Freedom® therapy units. |
| Device function | The V.A.C. ATS® and V.A.C. Freedom® canisters functionas reservoirs to collect fluids and wound exudatesremoved from the wounds during treatment with thenegative pressure therapy devices. |
| Device design | The canisters are molded plastic devices designed toinsert into the V.A.C. Freedom® or V.A.C. ATS® Therapyunits. |
| Differences indevice designfrom predicatedevice | The only difference between the proposed and the predicatedevices is the means by which sterility of the fluid path of thedevice is maintained. The predicate products are packaged withsterile barrier packaging while the modified canisters aredesigned with sterile barriers at the open ends of the fluid path ofthe product to maintain the sterility prior to use. |
| Intended use of thedevice | The V.A.C. Therapy System is intended to create an environmentthat promotes wound healing by secondary or tertiary (delayedprimary) intention by preparing the wound bed for closure,reducing edema, promoting granulation tissue formation andperfusion, and by removing exudate and infectious material. It isindicated for patients with chronic, acute, traumatic, subacuteand dehisced wounds, partial-thickness burns, ulcers (such asdiabetic or pressure), flaps and grafts. |
| The V.A.C.® GranuFoam® Silver™ Dressing is an effectivebarrier to bacterial penetration and may help reduce infection inthe above wound types. | |
| Differences inintended usefrom thepredicate | The intended use of the devices has not changed from theintended use of the predicate devices. |
| Summary of thetechnologicalcharacteristics ofthe device | The modified and unmodified V.A.C. ATS® and V.A.C. Freedom®canisters have molded-in graduation markings on the side of thecanister to aid in estimation of fluid removal. Hydrophobicmembranes secured to the side of the canisters during themanufacturing process isolate the collected fluid from thevacuum pump in each case. A gel packet is included in theV.A.C. Freedom® canister and in one model of the V.A.C. ATS®canisters to solidify the wound fluid in the canister. |
| Summary ofnonclinical tests | Verification of the integrity of the fluid path sterile barriers of themodified design was through accelerated aging, distributionsimulation, and microbial aerosol challenge testing. |
| Conclusions drawnfrom thenonclinical teststhat demonstratethat the device isas safe, aseffective, andperforms as well asor better than thepredicate device | The modified V.A.C. ATS® and V.A.C. Freedom® canisters withthe sterile fluid path are safe and effective for their intended use.The sterility assurance level of the sterile fluid path of thecanisters can be assured to a level of 10-6. |
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K063590 page 2/2
Image /page/1/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 bold, sans-serif font. There is a small circle with an R inside of it to the right of the I.
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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 eagle with its wings forming three curved lines. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
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: K063590
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: January 4, 2007 Received: January 5, 2007
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of January 25, 2007.
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
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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
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INDICATIONS FOR USE
510(k) Number (if known): 1063590 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), 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 X AND/OR Over-The-Counter Use _______
(Part 21 CFR 801 Subpart D) (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, I
(Posted November 16, 2005) and Neurological Devices
| 510(k) Number: | 12063590 |
|---|---|
| ---------------- | ---------- |
Page 1 of 1
§ 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.