(62 days)
No
The device description and performance studies focus on the material properties and antimicrobial agent, with no mention of AI or ML.
No.
The device is described as a sterile wound dressing, which primarily functions to cover and protect wounds, not to provide active therapy or treatment.
No
The device is described as a "wound dressing" for various tube and catheter sites, and its purpose is to provide antimicrobial protection. There is no indication or mention of it being used to diagnose conditions or process diagnostic data.
No
The device description clearly states it is a "sterile, single use wound dressing consisting of nonwoven material treated with Cosmocil®CQ," which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "Primary dressing for IV sites, tracheostomy tube sites, chest tube sites, catheter and drain sites." This clearly indicates a topical application for wound care and site management, not for testing samples of human origin in vitro to provide diagnostic information.
- Device Description: The description details a sterile, single-use wound dressing with an antimicrobial agent. This aligns with a medical device used for direct patient care, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition in vitro.
Therefore, this device falls under the category of a medical device used for wound and site management, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Excilon® A.M.D. Antimicrobial Sponges are intended for use as primary dressings for IV sites, Tracheostomy tube sites, chest tube sites, catheter sites and drain sites. The antimicrobial activity of the PHMB in Excilon® A.M.D. helps to resist bacterial colonization of the dressing and inhibit bacterial penetration through the dressing. The barrier function of the dressing may help reduce infections in partial and full thickness wounds.
Product codes
EFQ
Device Description
The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is a sterile, single use wound dressing consisting of nonwoven material treated with Cosmocil®CQ. Polyhexamethylene Biguanide Hydrochloride (PHMB) is the active ingredient in Cosmocil ®CQ. The sponges have a slit cut in them from the center of one side up through the midpoint wher a T-cut is formed. The dressing is packaged in a paper paper pouch and will be available in 2" x 2" and 4" x 4" sponge form.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
IV sites, Tracheostomy tube sites, chest tube sites, catheter sites and drain sites.
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)
Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
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
N/A
0
AUG 2 2 2001
EXHIBIT # 12
510(k) Summary
Kendall Excilon® A.M.D. Antimicrobial Sponges
In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
The Kendall Company / Division of Tyco Healthcare 15 Hampshire Street Mansfield, MA 02048 June 20, 2001 Date Prepared:
-
Contact Person 1.
Michael P. Spears Regulatory Affairs Specialist Phone - (508) 261-8155 -(508) 261-8461 Fax -
- Name of Medical Device
Proprietary Name: Common Name: Classification Name:
- Name of Medical Device
Excilon® A.M.D. Antimicrobial Sponges wound dressing dressing
-
- Identification of Legally Marketed Device
The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is substantially equivalent in intended use, function and composition to the Kendall Kerlix AMD Antimicrobial Gauze, 510(k) No. K990530 and the Acticoat® Primary Antimicrobial Dressing, 510(k) No. K992221.
- Identification of Legally Marketed Device
-
- Device Description
1 - 1 - 1 - 1 -
- Device Description
The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is a sterile, single use wound dressing consisting of nonwoven material treated with Cosmocil®CQ. Polyhexamethylene Biguanide Hydrochloride (PHMB) is the active ingredient in Cosmocil ®CQ. The sponges have a slit cut in them from the center of one side up through the midpoint wher a T-cut is formed. The dressing is packaged in a paper paper pouch and will be available in 2" x 2" and 4" x 4" sponge form.
1
0 11941
5. Device Intended Use
Excilon® A.M.D. Antimicrobial Sponges are intended for use as primary dressings for IV sites, Tracheostomy tube sites, chest tube sites, catheter sites and drain sites. The antimicrobial activity of the PHMB in Excilon® A.M.D. helps to resist bacterial colonization of the dressing and inhibit bacterial penetration through the dressing. The barrier function of the dressing may help reduce infections in partial and full thickness wounds.
റ്. Product Comparison
The Kendall Excilon® A.M.D. Antimicrobial Sponge is equivalent to the referenced predicate devices in that they are intended to be used as wound dressings. They each contain an ingredient that enhances the bacterial barrier function of the dressings and each has a broad spectrum of antimicrobial activity.
7. Nonclinical Testing
Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
9200 Corp
Rockville
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael P. Spears Regulatory Affairs Specialist The Kendall Company Division of Tyco Healthcare Group 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K011941
Trade/Device Name: Excilon A.M.D. Antimicrobial Sponge Regulatory Class: Unclassified Product Code: EFQ Dated: June 20, 2001 Received: June 21, 2001
Dear Mr. Spears:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becall be (x) =e is substantially equivalent (for the indications for use above and we nave acteriired predicate devices marketed in interstate commerce Stated in the encreate, to regary inte Medical Device Amendments, or to devices that pror to may 20, 1978, and and with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmone Act (ree). Tot may) and controls provisions of the Act include requirements for annual provisions of the Fee. "The general smanufacturing practice, labeling, and prohibitions against misbranding and adulteration.
AUG 2 2 2001
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 (1 remarter ripped any 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 mspotions, the Four and Lation 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.
3
Page 2 - Mr. Michael P. Spears
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis lotter will and it your ding 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) 594-4659. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mountactor on your respons and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely vours.
for Mark N. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page_1_of_1
K011941 510(k) Number (if Known):
Device Name: Excilon A.M.D. Antimicrobial Sponge
Indications For Use:
Primary dressing for IV sites, tracheostomy tube sites, chest tube sites, catheter and drain sites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K011941 |
|---|---|
| --------------- | --------- |
| Prescription Use | X (Per 21 CFR 801.109) |
|---|---|
| OR | |
| Over-The-Counter Use | (Optional Format 1-2-96) |