(266 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of an incise drape with antibacterial activity, with no mention of AI or ML.
Yes.
The device is indicated for use as an incise drape with continuous antibacterial activity and provides antibacterial activity to help reduce the risk of bacterial contamination in the surgical wound. This directly affects the body's structure or function for a medical purpose.
No
This device is an incise drape used to provide a sterile barrier during surgery and to reduce bacterial contamination. It does not diagnose any condition or disease.
No
The device description clearly states it is a sterile adhesive film with an acrylic adhesive containing CHG, which is a physical material applied to the skin. The performance studies also focus on physical and chemical properties of the drape.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as an incise drape applied to the skin during surgery to provide a sterile barrier and antibacterial activity. This is a topical application for a surgical procedure.
- Device Description: The description details a sterile adhesive film applied to the skin. It does not involve testing samples of human origin (like blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
- Lack of Diagnostic Information: The device's function is to provide a physical barrier and antibacterial activity on the skin during surgery, not to diagnose a condition or provide information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is indicated for use as an incise drape with continuous antibacterial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.
Product codes
KKX
Device Description
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a sterile adhesive film that is applied pre-operatively to skin. It adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The Chlorhexidine Gluconate (CHG) contained in the adhesive provides antibacterial activity to help reduce the risk of bacterial contamination in the surgical wound.
The drape consists of a transparent, conformable, barrier film coated with an acrylic adhesive containing 2% w/w CHG. The adhesive drape is delivered on a release liner that is discarded after application.
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)
Bench Testing and biocompatibility testing were completed to demonstrate substantial equivalence of the submission device, the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG), to the predicate device.
The device performance was verified through the following tests, all of which passed:
- Barrier Performance (AAMI PB70:2012 using ASTM F1670 Resistance to Synthetic Blood Penetration)
- Force at 25% Elongation (Based on PSTC-131, ASTM D882, ASTM D3759)
- Assessment of Tear Resistance (N/A, Rationalization Provided)
- Flammability (16 CFR 1610)
- Moisture Vapor Transmission Rate (Based on ASTM E96)
- in vitro Direct Time Kill and Minimum Effective Concentration (Based on ASTM E2315)
- CHG Release Kinetics (3M CHG Kinetic Release Test Method)
- Ethylene Oxide Residuals (ISO 10993-7: 2008; Amd 1: 2019)
Biocompatibility tests performed in accordance with ISO 10993-1 included:
- Chemical Characterization and Toxicology Risk Assessment of Extractables
- Hemolysis
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
Clinical testing was not provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 18, 2023
3M Company Hilary Hovde Regulatory Affairs Specialist 2510 Conway Ave. Building 275-5W-06 St. Paul, Minnesota 55144
Re: K222578
Trade/Device Name: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: April 14, 2023 Received: April 14, 2023
Dear Hilary Hovde:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K222578
Device Name
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
Indications for Use (Describe)
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is indicated for use as an incise drape with continuous antibacterial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary for 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578
3M Company 3M Health Care 2510 Conway Ave. 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Hilary B. Hovde Regulatory Affairs Specialist hbhovde(@mmm.com
Submission Date: May 18, 2023
4
Device Name and Classification
| Trade Name: | 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape
(contains 2% w/w CHG) |
|------------------------|------------------------------------------------------------------------------|
| Common/Usual Name: | Surgical drape |
| Device Classification: | Class II |
| Classification Name: | Surgical drape and drape accessories
[21 CFR § 878.4370, KKX] |
Predicate Device
3MTM Steri-Drape™ CHG Antimicrobial Incise Drape, K140250
Indications for Use
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is indicated for use as an incise drape with continuous antibacterial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.
Description of Device
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a sterile adhesive film that is applied pre-operatively to skin. It adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The Chlorhexidine Gluconate (CHG) contained in the adhesive provides antibacterial activity to help reduce the risk of bacterial contamination in the surgical wound.
The drape consists of a transparent, conformable, barrier film coated with an acrylic adhesive containing 2% w/w CHG. The adhesive drape is delivered on a release liner that is discarded after application.
5
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
| | Submission Device: | Predicate Device
(K140250): | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | 3MTM IobanTM
CHG Chlorhexidine
Gluconate Incise Drape
(contains 2% w/w CHG) | 3MTM Steri-DrapeTM
CHG Antimicrobial
Incise Drape | Comparison |
| Classification
Name | Surgical drape and drape
accessories | Surgical drape and
drape accessories | Identical |
| Regulation | 21 CFR 878.4370 | 21 CFR 878.4370 | Identical |
| Product Code | KKX | KKX | Identical |
| Classification | Class II | Class II | Identical |
| Committee | General Hospital | General Hospital | Similar |
| Indications for use | 3MTM IobanTM CHG
Chlorhexidine Gluconate
Incise Drape (contains 2%
w/w CHG) is indicated for
use as an incise drape with
continuous antibacterial
activity based on in vitro time
kill data out to 90 minutes. It
is intended for external use
only. | 3MTM Steri-DrapeTM
CHG Antimicrobial
Incise Drape is
indicated for use as
an incise drape with
continuous
antimicrobial activity
based on in vitro time
kill data out to 90
minutes. It is
intended for external
use only. | Both the
submission and
predicate devices
are intended to be
used as an incise
drape. The testing
of the submission
device supports
that the drape is
antibacterial rather
than antimicrobial.
Similar |
| Design/Materials | Antibacterial impregnated
adhesive coated on breathable
film with silicone-coated
release liner. | Antimicrobial
impregnated adhesive
coated on breathable
film with silicone-
coated release liner. | Similar
Some minor
modifications
were made to the
adhesive
formulation,
adhesive coat
weight, and film
of the submission
device as
compared to the
predicate device. |
| Active Ingredient | Chlorhexidine Gluconate
(2% w/w CHG) | Chlorhexidine
Gluconate
(2% w/w CHG) | Identical |
| Sterilization | Modality: Ethylene Oxide
SAI : 10-6 | Modality: Ethylene
Oxide | Identical |
| | Submission Device: | Predicate Device
(K140250): | |
| Feature | 3MTM IobanTM
CHG Chlorhexidine
Gluconate Incise Drape
(contains 2% w/w CHG) | 3MTM Steri-DrapeTM
CHG Antimicrobial
Incise Drape | Comparison |
| Packaging | Film/Tyvek pouch | Film/Tyvek pouch | Identical |
| Principles of
Operation | The 3MTM IobanTM CHG
Chlorhexidine Gluconate
Incise Drape (contains 2%
w/w CHG) is considered a
non-invasive device
containing an
antimicrobial/antibacterial
agent (chlorhexidine
gluconate) in the adhesive.
The primary mode of action
of this device is to provide a
sterile barrier during surgical
procedures. The secondary
mode of action, based on the
CHG containing adhesive, is
to provide continuous
antibacterial activity and to
reduce the risk of surgical site
contamination due to skin
flora. Surgical incisions can
be made directly through the
Ioban incise film which
creates a sterile surface all the
way to the wound edge. | The 3MTM Steri-
DrapeTM CHG
Antimicrobial Drape
is a sterile adhesive
film that is applied
pre-operatively to
skin. The film
adheres and conforms
to the body contours,
providing a sterile
surface on top of the
skin prior to surgery.
The surgeon incises
through the adhesive
film and skin,
ensuring a sterile film
barrier all the way to
the edge of the
incision. The CHG
contained in the
adhesive provides
additional
antimicrobial activity
to reduce the risk of
microbial
contamination of the
surgical wound. | Identical |
| Performance
Characteristics | • Barrier performance per
AAMI PB70:2012 using
ASTM 1670 Resistance to
Synthetic Blood Penetration
• Force at 25% Elongation
• Assessment of Tear
Resistance | SAL: 10-6
• Barrier
performance per
AAMI PB70:2012
using ASTM 1670
Resistance to
Synthetic Blood
Penetration | The same testing
was completed to
assess the barrier,
mechanical and
antimicrobial
properties of the
subject device in |
| | Submission Device: | Predicate Device
(K140250): | |
| Feature | 3MTM IobanTM
CHG Chlorhexidine
Gluconate Incise Drape
(contains 2% w/w CHG) | 3MTM Steri-DrapeTM
CHG Antimicrobial
Incise Drape | Comparison |
| | • Flammability testing per 16
CFR 1610
• Moisture Vapor
Transmission Rate
• In vitro Direct Time Kill
• Minimum Effective
Concentration
• CHG Release Kinetics | • Tensile and
Elongation
• Flammability
testing per 16 CFR
1610
• Moisture Vapor
Transmission Rate
• In vitro Direct Time
Kill
• Minimum Effective
Concentration
• CHG Release
Kinetics | addition to an
assessment of tear
resistance. |
| Biocompatibility | Not cytotoxic, slight irritant,
not a potential skin sensitizer,
not pyrogenic, not acutely
systemically toxic, non-
hemolytic | Non cytotoxic, slight
irritant, not a
potential skin
sensitizer | Duration and type
of contact are
identical.
Additional
endpoints tested
are in alignment
with updates to
ISO 10993. |
| Clinical Testing | None provided | Adhesion to skin
study | No clinical testing
was provided to
support substantial
equivalence since
this was a minor
change. Adhesion
was assessed
through bench
testing. |
Comparison of Technological Characteristics with the Predicate Device
6
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
7
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
8
Summary of Non-Clinical Testing
Bench Testing and biocompatibility testing were completed to demonstrate substantial equivalence of the submission device, the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG), to the predicate device.
| Test | Test Method
Description | Acceptance Criteria | Results |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------|---------|
| Barrier
Performance | AAMI PB70:2012 using
ASTM F1670 Resistance
to Synthetic Blood
Penetration | Level 4 | PASS |
| Force at 25%
Elongation | Based on PSTC-131,
ASTM D882,
ASTM D3759 | 400 g/m²/24 hours | PASS |
| in vitro Direct
Time Kill and
Minimum
Effective
Concentration | Based on ASTM E2315 | > 4 log reduction at 90 minutes | PASS |
| CHG Release
Kinetics | 3M CHG Kinetic Release
Test Method | > 0.0% after 90 minute extraction | PASS |
| Ethylene Oxide
Residuals | ISO 10993-7: 2008;
Amd 1: 2019 | Per ISO 10993-7: 2008;
Amd 1: 2019 | PASS |
The device performance was verified through the following tests:
9
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1. Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process as recognized by FDA. The 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is categorized as a surface contacting device, with breached or compromised skin contact of limited duration in accordance with ISO 10993-1 and FDA Guidance, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." The battery of tests included the following:
- Chemical Characterization and Toxicology Risk Assessment of Extractables ●
- . Hemolysis
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Acute Systemic Toxicity ●
- . Material-Mediated Pvrogenicity
Summary of Clinical Testing
Clinical testing was not provided to support substantial equivalence.
Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K140250.