(381 days)
Not Found
No
The device description and performance studies focus on the antimicrobial properties and clinical efficacy of a physical dressing, with no mention of AI or ML technology.
Yes
The device is intended to reduce local infections, catheter related blood stream infections (CRBSI), and skin colonization of microorganisms, which are therapeutic actions.
No
The device description and intended use clearly state that it is a wound dressing intended to absorb exudate, cover wounds, and reduce infections and skin colonization. It does not mention diagnosing any conditions.
No
The device description clearly states it is an "absorptive foam with chlorhexidine gluconate," indicating a physical, hardware-based medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a dressing applied externally to a wound site around percutaneous medical devices. It aims to absorb exudate, cover the wound, and reduce local infections and catheter-related blood stream infections. This is a direct therapeutic and preventative action on the patient's body.
- Device Description: The device is described as an absorptive foam with an antiseptic agent. This aligns with a topical dressing, not a diagnostic test performed on samples taken from the body.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or determine compatibility. The device's action is physical (absorption) and chemical (antimicrobial).
- Performance Studies: The performance studies focus on the reduction of infections and skin colonization, which are clinical outcomes related to the device's direct action on the patient, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
BIOPATCH* Antimicrobial Dressing containing Chlorhexidine gluconate is intended for use as a hydrophilic wound dressing that is used to absorb exudate and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: Vascular Devices IV Catheters Central Venous Lines Arterial Catheters Dialysis Catheters Peripherally Inserted Coronary Catheters Mid-Line Catheters Non-vascular percutaneous devices Drains Chest Tubes Externally Placed Orthopedic Pins Epidural Catheters. It is also intended to reduce local infections, catheter related blood stream infections (CRBSI), and skin colonization of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
BIOPATCH* Antimicrobial Dressing is an absorptive foam with chlorhexidine gluconate, a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity.
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)
A controlled, randomized, clinical trial consisting of 687 subjects with 1699 central venous or arterial catheter insertion sites was conducted at two centers. Results of this study demonstrated: use of BIOPATCH Antimicrobial Dressing resulted in a statistically significant 44% reduction in the incidence of local infection (p ≤ 0.0001). use of BIOPATCH Antimicrobial Dressing resulted in a statistically significant 60% reduction in the incidence of catheter related blood stream infections (p = 0.026). use of BIOPATCH Antimicrobial Dressing resulted in statistically significant reduction in skin colonization of microorganisms commonly associated with CRBSI (p ≤ 0.05). Patients randomized to the BIOPATCH Antimicrobial Dressing Treatment Group experienced no serious device-related adverse events.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reduction in incidence of local infection, reduction in incidence of catheter related blood stream infections, reduction in skin colonization of microorganisms.
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
N/A
0
100 - 100 - 100 - 100 -
510(k) SUMMARY K003229
| Submitter's Name: | Integra LifeSciences Corporation |
|---|---|
| Submitter's Address: | 105 Morgan Lane |
| Plainsboro, NJ 08536 | |
| Submitter's Phone Number: | (609) 936-2311 |
| Submitter's Fax Number: | (609) 897-0645 |
| Name of Contact Person: | Sergio J. Gadaleta, Ph.D. |
| Johnson & Johnson Wound Management, | |
| a Division of ETHICON, Inc. | |
| Somerville, N.J. | |
| (908) 218-2893 | |
| Date of Preparation: | October 18, 2001 |
| Name of Device: | |
| Trade Name: | BIOPATCH* Antimicrobial Dressing |
| Common Name: | Dressing |
| Classification Name: | Unclassified |
| Legally Marketed Device to Which Equivalency | |
| is Being Claimed: | The proposed BIOPATCH* Antimicrobial Dressing |
| is the same (material type, manufacturing methods, | |
| sterilization type) as the existing BIOPATCH* | |
| Antimicrobial Dressing (K895920). | |
| Description of the Device: | BIOPATCH* Antimicrobial Dressing is an |
| absorptive foam with chlorhexidine gluconate, a | |
| well-known antiseptic agent with broad spectrum | |
| antimicrobial and antifungal activity. | |
| Intended Use of the Device: | BIOPATCH* Antimicrobial Dressing containing |
| Chlorhexidine gluconate is intended for use as a | |
| hydrophilic wound dressing that is used to absorb | |
| exudate and to cover a wound caused by the use of | |
| vascular and non-vascular percutaneous medical | |
| devices such as: | |
| Vascular DevicesIV CathetersCentral Venous LinesArterial CathetersDialysis CathetersPeripherally Inserted Coronary CathetersMid-Line CathetersNon-vascular percutaneous devicesDrainsChest TubesExternally Placed Orthopedic PinsEpidural Catheters | |
| It is also intended to reduce local infections, | |
| catheter related blood stream infections (CRBSI), | |
| and skin colonization of microorganisms commonly | |
| related to CRBSI, in patients with central venous or | |
| arterial catheters. | |
| Summary of Technological Characteristics | |
| Compared to the Predicate Device: | The proposed BIOPATCH* Antimicrobial Dressing |
| is the same (material type, manufacturing methods, | |
| sterilization type) as the existing BIOPATCH* | |
| Antimicrobial Dressing. | |
| Brief Discussion of Nonclinical Tests: | No new nonclinical tests were required to support the change. |
| Brief Discussion of Clinical Tests: | A controlled, randomized, clinical trial consisting of 687 subjects with 1699 central venous or arterial catheter insertion sites was conducted at two centers. Results of this study demonstrated: |
| use of BIOPATCH Antimicrobial Dressing resulted in a statistically significant 44% reduction in the incidence of local infection (p ≤ 0.0001). use of BIOPATCH Antimicrobial Dressing resulted in a statistically significant 60% reduction in the incidence of catheter related blood stream infections (p = 0.026). use of BIOPATCH Antimicrobial Dressing resulted in statistically significant reduction in skin colonization of microorganisms commonly associated with CRBSI (p ≤ 0.05). Patients randomized to the BIOPATCH Antimicrobial Dressing Treatment Group experienced no serious device-related adverse events. | |
| Conclusions Drawn for the Nonclinical and Clinical Tests: | See "Brief Discussion" of Clinical Tests above. |
| Other Information Deemed Necessary by FDA: | Not Applicable |
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Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
OCT 2 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sergio J. Gadaleta, Ph.D. Senior Project Manager, Regulatory Affairs Johnson & Johnson Wound Management A Division of Ethicon Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K003229
Trade/Device Name: BIOPATCH Antimicrobial Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 8, 2001 Received: August 10, 2001
Dear Dr. Gadaleta:
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 application (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 such 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 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.
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Page 2 - Sergio J. Gadaleta, Ph.D.
This letter will allow you to begin 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Wall, is
fa
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
KOO3229
510(k) Number (if known): K003229
Device Name: BIOPATCH Antimicrobial Dressing
Indications for Use:
BIOPATCH* Antimicrobial Dressing containing Chlorhexidine gluconate is intended for use as BIOPATCH ' Antimicronal Dressing containty our a wound cause and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis cathers, peripherally inserted coronary catherers. It s Venous intel, diverial catherels, charysis duardson pins, and epidural cathers. It is a also intended to reduce local infections, catheter related blood stream infections (CRBS), and also intellection of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
SR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K003229