(161 days)
The ChloraShield™ Antimicrobial Dressing is intended for use as a wound dressing to absorb exudate and to cover and protect catheter sites. Common applications include IV catheters, other intravascular catheters and percutaneous devices.
The ChloraShield™ Antimicrobial Dressing is intended to fill the need for a transparent primary catheter dressing that can be applied easily while surrounding the wound site. The dressing is an oval shaped dressing intended to cover and protect a catheter site and absorb exudates. The dressing is transparent and conformable allowing for easy visual and manual inspection of IV sites. The dressing is impregnated with Chlorhexidine Gluconate (CHG), a persistent, broad spectrum antimicrobial and antifungal activity against a wide range of gram positive and gram negative organisms. The antimicrobial agent protects the dressing from bacterial penetration and colonization. The patch complements other infection control measures by providing continued IV site protection while also allowing for good site visualization and inspection. ChloraShield has not been clinically tested for its ability to reduce local infections, catheter-related blood stream infections (CRBSI) or skin colonization of microorganisms commonly related to CRBSI. The product is sold in a sterile condition, opened in the operating field and then applied to the catheter site. Like the predicate devices, the ChloraShield ™ Dressing is easy to apply and easy to remove. The product offering includes: The product number is: # 410100 standard package - one dressing or patch per sterile package.
The provided text describes a 510(k) premarket notification for the ChloraShield™ Antimicrobial Dressing. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical and a limited clinical study assessing tolerability, rather than a comparative effectiveness study in the context of AI. Therefore, much of the requested information about AI-specific studies, such as multi-reader multi-case studies, effect sizes of AI assistance, standalone algorithm performance, and sample sizes for training sets (which are relevant for AI/ML models), is not applicable or present in this regulatory submission for a physical medical device.
However, I can extract information related to the acceptance criteria for the tolerability study, its methodology, and the reported performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Device Tolerability | Tolerability (frequency and severity of skin reactions) at skin sites across a wear period of seven days. | The tolerability of the proposed device was found to be equivalent to the predicate devices. The safety assessment aimed to evaluate if an exaggerated use model (one initial high dose exposure (7 times intended clinical use) on Day 1, followed by daily descending exposure of one patch each day over 7 days) would cause irritation or adverse events in normal healthy volunteers. The study results indicate that the device met this criterion by demonstrating equivalence to predicate devices under these conditions, without reporting significant irritation or adverse events. |
| Safety and Effectiveness | Device is safe and effective, and its performance is substantially equivalent to the two predicate devices. | The applicant concluded that the ChloraShield™ Antimicrobial Dressing is safe and effective, and its performance is substantially equivalent to the two predicate devices. This conclusion is based on both non-clinical tests (biocompatibility, sterility, packaging, and antimicrobial testing using CLSI standards) and the tolerability clinical study. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set (Clinical Study): 45 subjects
- Data Provenance: The document does not explicitly state the country of origin. The study was conducted as a "clinical study" involving "normal healthy volunteers." It can be inferred as a prospective study as it describes the methodology for patient enrollment and observation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The context of "experts" and "ground truth" typically applies to diagnostic devices where human interpretation is involved. For this device (an antimicrobial dressing), the primary outcome measured in the clinical study was "tolerability (frequency and severity of skin reactions)."
- Number of Experts: Not specified as "experts" in the clinical study sense for establishing a diagnostic ground truth. The assessment of skin reactions would have been performed by trained clinical personnel (e.g., nurses, doctors) observing the subjects.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
Not applicable in the context of skin reaction assessment in this type of tolerability study. Adjudication methods (like 2+1 or 3+1) are typically used for resolving discrepancies in expert interpretations of images or diagnostic findings, which is not the nature of this study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No.
This is a physical medical device, not an AI/ML algorithm. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done: No.
This product is a physical medical device. The concept of an "algorithm only" performance is not applicable.
7. The Type of Ground Truth Used (for the clinical study)
The "ground truth" for the clinical study was the observed and documented frequency and severity of skin reactions on the study participants under the specified exaggerated use model. This is an objective clinical observation, not a diagnostic pathology or outcome data in the traditional sense, but rather a direct measurement of the device's tolerability.
8. The Sample Size for the Training Set
No training set is mentioned as this device is a physical product and not an AI/ML model. The "training set" concept is relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML model.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CareFusion 213 LLC % Arlen Johnson Sr. Regulatory Affairs Specialist 1550 Northwestern Drive El Paso, Texas 79912
MAR 3 0 2011
Re: K103106
Trade/Device Name: ChloraShield™ Antimicrobial Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 17, 2011 Received: March 21, 2011
Dear Arlen Johnson:
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. 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.
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
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Page 2 – Arlen Johnson
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
A. B. R. h
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K 103106
Device Name: ChloraShield™ Antimicrobial Dressing
Indications for use:
The ChloraShield™ Antimicrobial Dressing is intended for use as a wound dressing to absorb exudate and to cover and protect catheter sites. Common applications include IV catheters, other intravascular catheters and percutaneous devices.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AND/OR
Prescription Use
X
Over-The-Counter Use
Daniel Kramer for MXM
(Division Sign Off)
(Division Sign-C Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K103106
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Image /page/3/Picture/1 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a small orange section in the upper left corner. The text is to the right of the circle.
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 18, 2010 |
|---|---|
| Submitter: | CareFusion 213 LLC1550 Northwestern DriveEl Paso, TX 79912 |
| Primary Contact Person: | Arlen JohnsonSr. Regulatory Affairs SpecialistPhone: (913) 345-3570Fax: (614)757-6080arlen.johnson@carefusion.com |
| Alternate Contact: | Frank Pokrop6550 Lusk Blvd.San Diego, CA 92121858-617-4364frank.pokrop@carefusion.com |
| Device Trade Name: | ChloraShield™ Antimicrobial Dressing |
| Common Trade Name: | Antimicrobial Dressing |
| Classification: | Unclassified |
| Panel: | General, Restorative, and Neurological Devices |
| Product Code (Primary): | FRO |
| Predicate Devices: | Two predicate devices are identified in this submission |
| 510(k) # | Date of Clearance | Company | |
|---|---|---|---|
| 1 | K003229 | 10-26-2001 | IntegraLifesciences |
| 2 | K063458 | 4-5-2007 | 3M |
The ChloraShield™ Antimicrobial Dressing is intended to Device Description: fill the need for a transparent primary catheter dressing that can be applied easily while surrounding the wound site.
The dressing is an oval shaped dressing intended to cover and protect a catheter site and absorb exudates.
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Image /page/4/Picture/1 description: The image contains the logo for CareFusion. The logo consists of an orange circle with a white shield inside. The shield has a small orange triangle in the upper right corner. To the right of the circle is the text "CareFusion" in a dark gray sans-serif font.
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Device Description: | The dressing is transparent and conformable allowing for easy visual and manual inspection of IV sites.The dressing is impregnated with Chlorhexidine Gluconate (CHG), a persistent, broad spectrum antimicrobial and antifungal activity against a wide range of gram positive and gram negative organisms. The antimicrobial agent protects the dressing from bacterial penetration and colonization. The patch complements other infection control measures by providing continued IV site protection while also allowing for good site visualization and inspection.ChloraShield has not been clinically tested for its ability to reduce local infections, catheter-related blood stream infections (CRBSI) or skin colonization of microorganisms commonly related to CRBSI.The product is sold in a sterile condition, opened in the operating field and then applied to the catheter site.Like the predicate devices, the ChloraShield TM Dressing is easy to apply and easy to remove.The product offering includes: The product number is: # 410100 standard package - one dressing or patch per sterile package. |
|---|---|
| Intended Use: | The ChloraShield TM Antimicrobial Dressing is intended for use as a wound dressing to absorb exudate and to cover and protect catheter sites. Common applications include IV catheters, other intravascular catheters and percutaneous devices. |
| Technology: | The proposed device is similar to the predicate devices and uses biocompatible materials that are merged into a dressing that is breathable, transparent and easy to apply and remove. The device consists of a polypropylene mesh that holds or has been imbibed with a proprietary hydrogel that contains the active ingredient. The product is supplied in a sterile condition with one product per foil laminate pouch. |
| Determination of Substantial Equivalence: | Summary of Non-Clinical Tests: A variety of non-clinical tests were conducted to show the safety and effectiveness of the proposed device including |
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Image /page/5/Picture/1 description: The image contains the logo for CareFusion. The logo consists of an orange circle with a white shield inside. The shield has a small orange corner at the top right. To the right of the circle is the text "CareFusion" in a gray sans-serif font.
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Determination of SubstantialEquivalence: | Summary of Clinical Tests:A clinical study was conducted which compared thetolerability (frequency and severity of skin reactions) atskin sites across a wear period of seven days. Forty-fivesubjects participated in the study (15 subjects pertreatment group).The safety assessment in the clinical study was designedto evaluate if an exaggerated use model would causeirritation or adverse events in normal healthy volunteerswhen receiving multiple test article applications over aseven-day duration of exposure. The study designemployed an initial high dose exposure, (7 times theexposure of the intended clinical use), on Day 1 and dailydescending exposure of one patch each day over the 7day wear period.The tolerability of the proposed device was found to beequivalent to the predicate devices and additional detail isprovided in the submission. the use of placebos and, comparisons against thepredicate devices including tests on mice, rabbits andguinea pigs. Standardized test methods from ASTM andISO were used in this testing and are described in thesubmission. |
| Standards Used in theTesting and Development ofthis Product: | ISO 11607-2:2006. Packaging for terminallysterilized medical devices -- Part 2: Validationrequirements for forming, sealing and assemblyprocesses ISO 11135-1:2007. Sterilization of health careproducts -- Ethylene oxide -- Part 1: Requirementsfor development, validation and routine control ofa sterilization process for medical devices ISO 10993-7:1995 (R) 2001. Biological evaluationof medical devices -- Part 7: Ethylene oxidesterilization residuals ASTM D4169 - 09 Standard Practice for PerformanceTesting of Shipping Containers and Systems |
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Image /page/6/Picture/0 description: The image shows the text "ChloraShield™ Antimicrobial Dressing". The text is in a sans-serif font and is black. The word "ChloraShield" is followed by the trademark symbol. The text is centered in the image.
Image /page/6/Picture/1 description: The image contains the logo for CareFusion. The logo consists of an orange circle with a white shield inside. The shield has an orange accent on the top left corner. To the right of the circle is the text "CareFusion" in a gray, sans-serif font.
In accordance with 21 CFR 807.92 the following summary of information is provided:
-
. ASTM D4728 - 06 Standard Test Method for Random Vibration Testing of Shipping Containers
Standards Used in the Testing and Development of this Product: CLSI (Clinical and Laboratory Standards Institute): -
. Performance Standards for Antimicrobial Disk Susceptibility Tests: Approved Standard - Ninth Edition; M2-A9: Sept. 2006
-
. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Tenth Edition; M2-A10: Jan 2009
-
The applicant considers the ChloraShield™ Antimicrobial Conclusion: Dressing to be safe and effective, and its performance is substantially equivalent to the two predicate devices.
N/A