(82 days)
Not Found
Not Found
No
The summary describes a surgical instrument wipe and contains no mention of AI, ML, or related technologies.
No
The device is described as an "instrument wipe" for use during surgical procedures, which cleans instruments rather than directly treating a disease or condition.
No
Explanation: The device, the INVOTEC CLEAN PAD, is described as an "instrument wipe" for use during surgical procedures. Its function is to clean instruments, which is a supportive role in a medical procedure, not a diagnostic one. Diagnostic devices are used to identify the presence, nature, or cause of a disease or condition.
No
The provided 510(k) summary describes a physical instrument wipe ("CLEAN PAD") used during surgery, which is a hardware device, not software.
Based on the provided information, the INVOTEC CLEAN PAD is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an instrument wipe during any surgical procedure." This describes a device used on instruments, not for testing samples taken from the body (which is the core function of an IVD).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
The INVOTEC CLEAN PAD appears to be a surgical accessory used for cleaning instruments, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
THE INVOTEC CLEAN PAD may be used during any surgical procedure as an instrument wipe.
Product codes
EFQ
Device Description
Not Found
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
any surgical procedure
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/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 three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1997
Mr. Jeffrey L. Aull President Invotec International, Inc. 11243-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K973580 Trade Name: Clean Pad Regulatory Class: Unclassified Product Code: EFQ Dated: September 17, 1997 Received: September 19, 1997
Dear Mr. Aull:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Jeffrey L. Aull
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
focoeef
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
- Recel ved Nov-21-97 01:27pm 301 594 2358 - INVOTEC INT'L INC.
CDRR CDRR One page
from , 11/21/97 14:12 2801 594
| Page | of |
|---|---|
| Property of the program and | |
| 1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 510(k) Number (if known): | K973580 |
|---|---|
| Device Name: | INVOTEC CLEAN PAD |
Indications For Use:
THE INVOTEC CLEAN PAD may be used during any surgical procedure as an instrument wipe.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IP NEBOED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Inside Sign-Off
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973580
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formst 1-2-96)