(207 days)
No
The summary describes a modified wound therapy device with controlled delivery of solutions, and there is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions, for chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts, which are all therapeutic actions.
No
Explanation: The device is described as a treatment device for wounds, specifically for vacuum-assisted drainage and controlled delivery of topical wound treatments. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description explicitly states it is a "modified V.A.C. device" and combines technologies and features of previously cleared V.A.C. devices, which are hardware-based vacuum-assisted closure systems. The description focuses on the physical device and its function of delivering solutions, not solely on software.
Based on the provided information, the V.A.C. Instillamat device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for vacuum assisted drainage and controlled delivery of topical wound treatments over the wound bed. This is a direct treatment applied to the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a modified V.A.C. device that combines features for wound treatment and delivery of solutions. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The V.A.C. Instillamat device's function is therapeutic, focused on wound management and treatment delivery.
N/A
Intended Use / Indications for Use
The V.A.C. Instillamat device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.
Product codes
OMP
Device Description
The V.A.C. Instillamat device is a modified V.A.C. device manufactured by Kinetic Concepts Inc. The V.A.C. Instillamat device combines technologies and features of the V.A.C. Plus device previously cleared by the FDA in 1999 [510(k) No. K992448] and the Ambulatory V.A.C. device previously cleared by the FDA in 1997 [510(k) No. K971548] with the additional modifications to provide a controlled delivery system for applying secondary wound treatments to a wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound bed
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)
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
November 18, 2002
510(K) SUMMARY: V.A.C. Instillamat Device
| I. Name of Device: | V.A.C.® Instillamat Device | DEC 02 2002 |
|---|---|---|
| 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
The V.A.C. Instillamat device is a modified V.A.C. device manufactured by Kinetic Concepts Inc. The V.A.C. Instillamat device combines technologies and features of the V.A.C. Plus device previously cleared by the FDA in 1999 [510(k) No. K992448] and the Ambulatory V.A.C. device previously cleared by the FDA in 1997 [510(k) No. K971548] with the additional modifications to provide a controlled delivery system for applying secondary wound treatments to a wound.
VI. Indications for Use
The V.A.C. Instillamat device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.
VII. Substantial Equivalence
The V.A.C. Instillamat device has essentially the same technologies and features as the previously cleared predicate devices and has been independently tested and successfully approved to the following medical safety standards:
- UL2601-1, The Standard for Safety of Medical Electrical Equipment, 15 Edition 1994 .
- . IEC 60601-1-1. Medical Electrical Equipment - Part 1: General Requirements for Safety; 1. Collateral Standard: Safety Requirements for Medical Electrical Systems
- IEC 60601-1-2, Medical Electrical Equipment Part 1: General Requirements for Safety; . 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-4, Medical Electrical Equipment Part 1; General Requirements for Safety; . 4. Collateral Standard: Programmable Electrical Medical Systems
1
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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: K021501
Trade/Device Name: Vacuum Assisted Closure Instillamat Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: August 31, 2002 Received: September 2, 2002
Dear Ms. Oviatt:
This letter corrects our substantially equivalent letter of December 2, 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 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 (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 vours.
For Pete Moore
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
510(k) Number (if known): K021501
Device Name: V.A.C. Instillamat®
Indications For Use:
:
The V.A.C. Instillamat device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C. 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)
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
110(k) Number ________________________________________________________________________________________________________________________________________________________________