(129 days)
Not Found
No
The device is a physical barrier cap with an antimicrobial coating. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as reducing microbial colonization and incidences of central-line associated bloodstream infections (CLABSI), which is a preventive therapeutic effect, even if it is not treating existing infections.
No.
The ClearGuard HD Antimicrobial Barrier Cap is a treatment device designed to reduce microbial colonization and prevent infections, specifically Central Line-Associated Bloodstream Infections (CLABSI), in hemodialysis catheter hubs by releasing an antimicrobial agent. It does not diagnose conditions.
No
The device description clearly states it is a physical cap made of polypropylene and nylon, incorporating an antimicrobial agent. It is a hardware device, not software.
Based on the provided text, the ClearGuard HD Antimicrobial Barrier Cap is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to be used with hemodialysis catheter hubs to reduce microbial colonization and subsequently reduce the incidence of central-line associated bloodstream infections (CLABSI). This is a direct intervention on a medical device (the catheter hub) to prevent infection in the patient.
- Mechanism of Action: The device works by releasing an antimicrobial agent (chlorhexidine acetate) into the catheter lock solution within the hub. This agent directly kills microorganisms.
- Lack of Diagnostic Purpose: The device does not perform any tests on samples taken from the body (like blood, urine, or tissue) to diagnose a disease or condition. It is a preventative measure applied to a medical device.
- Focus on Clinical Outcome: The performance studies focus on reducing the rate of positive blood cultures (PBCs) and CLABSIs, which are clinical outcomes related to infection prevention, not diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The ClearGuard HD cap does not fit this definition. It is a medical device used to prevent infection in a specific clinical setting.
N/A
Intended Use / Indications for Use
ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter hubs.
Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
Using post-market clinical surveillance data, use of the ClearGuard HD Antimicrobial Barrier Cap has been shown to reduce the incidence of central-line associated bloodstream infections (CLABSI) in hemodialysis patients. Note: CLABSI was defined as a positive blood culture (PBC) not related to an alternative source of infection per the National Healthcare Safety Network (NHSN) surveillance definition. Alternative sources were excluded if dialysis sites attributed the PBC to vascular access on the dialysis event form. The actual reduction in CLABSI rates may be less substantial as the evaluation for alternative PBC sources was not pre-specified, nor standardized between patients and clinical sites, and supplemental data evaluating for alternative sources were not available for review.
The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only present within the hub of the catheter and does not migrate to distal portions of the catheter.
Product codes
PEH
Device Description
The ClearGuard HD Antimicrobial Barrier Cap (hereinafter also referred to as the ClearGuard HD cap) is a single-use male luer lock cap that incorporates an antimicrobial treatment on its surfaces.
The ClearGuard HD cap consists of 1) a polypropylene polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine acetate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD cap is inserted into a liquid-filled catheter, CHA elutes from the rod into the catheter lock solution. This CHA solution is designed to kill microorganisms in the hemodialysis catheter hub, which results in a reduction in Central Line-Associated Bloodstream Infection (CLABSI) rates.
The catheter extension line pinch clamps are used to maintain the lock solution within the catheter lumens to minimize the risk of air embolism and maintain catheter patency. These clamps, which are closed when the catheter is not in use, mechanically confine the CHA and prevent diffusion of CHA toward the catheter tip and the patient's bloodstream.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hemodialysis catheter hubs
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
A 13-month, prospective, cluster-randomized, multi-arm, unblinded clinical study with a control was conducted at 40 dialysis facilities throughout the United States only. Facilities were pairmatched and randomly assigned to treatment or control group. The treatment group received the ClearGuard HD Antimicrobial Barrier Cap and the control group received the Tego® Connector with the Curos™ Disinfecting Cap. The primary study endpoint was PBC rate. There were no other primary study endpoints but an ad hoc exploratory analysis of CLABSI was also conducted. 1,671 subjects participated in the study during the primary and exploratory analyses, accruing approximately 183,000 CVC-days in the primary analysis. The study demonstrated that use of the ClearGuard HD Antimicrobial Barrier Caps resulted in a statistically significant reduction in the rate of PBCs (63% reduction) compared to the use of Tego connector plus Curos cap. The CLABSI analysis demonstrated that using ClearGuard HD Antimicrobial Barrier Caps resulted in a reduction in the rate of CLABSIs (66% reduction) compared to the control. There was no formal safety endpoint associated with this clinical study. There were no device-associated adverse events reported.
Key Metrics
PBC Rate, ClearGuard HD: 0.28 per 1,000 CVC-days
PBC Rate, Tego+Curos: 0.75 per 1,000 CVC-days
Incidence Rate Ratio (IRR): 0.37
Reduction in PBC Rate: 63%
P value: 0.001
CLABSI Rate, ClearGuard HD: 0.17 per 1,000 CVC-days
CLABSI Rate, Tego+Curos: 0.50 per 1,000 CVC-days
Incidence Rate Ratio (IRR): 0.34
Reduction in CLABSI Rate: 66%
Predicate Device(s)
K131060 ClearGuard HD End Cap
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
May 25, 2018
Pursuit Vascular, Inc. Laurie E. Lynch, Ph.D. Director of Quality/Regulatory/Clinical 6901 East Fish Lake Road, Suite 166 Maple Grove, MN 55369
Re: K180111
Trade/Device Name: ClearGuard® HD Antimicrobial Barrier Cap Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: PEH Dated: April 27, 2018 Received: April 30, 2018
Dear Laurie E. Lynch:
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.
1
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); 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180111
Device Name ClearGuard HD Antimicrobial Barrier Cap
Indications for Use (Describe)
ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter hubs.
Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
Using post-market clinical surveillance data, use of the ClearGuard HD Antimicrobial Barrier Cap has been shown to reduce the incidence of central-line associated bloodstream infections (CLABSI) in hemodialysis patients. Note: CLABSI was defined as a positive blood culture (PBC) not related to an alternative source of infection per the National Healthcare Safety Network (NHSN) surveillance definition. Alternative sources were excluded if dialysis sites attributed the PBC to vascular access on the dialysis event form. The actual reduction in CLABSI rates may be less substantial as the evaluation for alternative PBC sources was not pre-specified, nor standardized between pafients and clinical sites, and supplemental data evaluating for alternative sources were not available for review.
The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only present within the hub of the catheter and does not migrate to distal portions of the catheter.
| 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
Date Prepared: 21-May-2018
Submitter's Name / Contact Person
| Manufacturer | Contact Person |
|---|---|
| Pursuit Vascular, Inc. | Laurie Lynch, PhD |
| 6901 E. Fish Lake Road, Suite 166 | Director of Quality/Regulatory/Clinical |
| Maple Grove, MN 55369 | Phone: (952) 221-2468 |
| Fax: (763) 592-8202 | |
| Email: llynch@pursuitvascular.com | |
| General Information | |
| Trade Name | ClearGuard® HD Antimicrobial Barrier Cap |
| Common / Usual Name | Hemodialysis Catheter Luer End Cap |
| Regulation Name | 21 CFR 876.5540; Blood Access Device and Accessories |
| Product Code | PEH; Hemodialysis Catheter Luer End Cap |
| Device Class | II |
| Predicate Devices | K131060 ClearGuard HD End Cap |
Device Description
The ClearGuard HD Antimicrobial Barrier Cap (hereinafter also referred to as the ClearGuard HD cap) is a single-use male luer lock cap that incorporates an antimicrobial treatment on its surfaces.
The ClearGuard HD cap consists of 1) a polypropylene polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine acetate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD cap is inserted into a liquid-filled catheter, CHA elutes from the rod into the catheter lock solution. This CHA solution is designed to kill microorganisms in the hemodialysis catheter hub, which results in a reduction in Central Line-Associated Bloodstream Infection (CLABSI) rates.
The catheter extension line pinch clamps are used to maintain the lock solution within the catheter lumens to minimize the risk of air embolism and maintain catheter patency. These clamps, which are closed when the catheter is not in use, mechanically confine the CHA and prevent diffusion of CHA toward the catheter tip and the patient's bloodstream.
Intended Use / Indications for Use
ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter hubs.
Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA),
4
Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
Using post-market clinical surveillance data, use of the ClearGuard HD Antimicrobial Barrier Cap has been shown to reduce the incidence of central-line associated bloodstream infections (CLABSI) in hemodialysis patients with catheters. Note: CLABSI was defined as a positive blood culture (PBC) not related to an alternative source of infection per the National Healthcare Safety Network (NHSN) surveillance definition. Alternative sources were excluded if dialysis sites attributed the PBC to vascular access on the dialysis event form. The actual reduction in CLABSI rates may be less substantial as the evaluation for alternative PBC sources was not prespecified, nor standardized between patients and clinical sites, and supplemental data evaluating for alternative sources were not available for review.
The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only present within the hub of the catheter and does not migrate to distal portions of the catheter.
Substantial Equivalence Comparison
The predicate device is the Pursuit Vascular, Inc. ClearGuard HD End Cap, K131060.
In regard to the technological characteristics, the predicate and subject devices are both antimicrobial coated hemodialysis catheter caps manufactured by the same company, Pursuit Vascular, Inc. See comparison of the subject and predicate device in Table 1 below.
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K180111 | K131060 |
| Classification | Class II; PEH; 21 CFR 876.5540; Blood | |
| access device and accessories | Class II; PEH; 21 CFR 876.5540; Blood | |
| access device and accessories | ||
| Indications for | ||
| Use | ClearGuard HD Antimicrobial Barrier | |
| Cap is indicated for use with | ||
| hemodialysis catheter hubs. | ||
| Using in vitro methods, the antimicrobial | ||
| treatment on the ClearGuard HD | ||
| Antimicrobial Barrier Cap has been | ||
| shown to be effective at reducing | ||
| microbial colonization in hemodialysis | ||
| catheter hubs against the following | ||
| microorganisms: Enterococcus faecium | ||
| (VRE), Enterococcus faecalis (VRE), | ||
| Acinetobacter baumannii, Escherichia | ||
| coli, Staphylococcus aureus (MRSA), | ||
| Staphylococcus aureus, Staphylococcus | ClearGuard HD is indicated for use as an | |
| end cap for use with hemodialysis | ||
| catheter hubs. | ||
| The antimicrobial treatment on the | ||
| ClearGuard HD end cap has been shown | ||
| to be effective at reducing microbial | ||
| colonization in hemodialysis catheter | ||
| hubs against the following | ||
| microorganisms: Enterococcus faecium | ||
| (VRE), Enterococcus faecalis (VRE), | ||
| Acinetobacter baumannii, Escherichia | ||
| coli, Staphylococcus aureus (MRSA), | ||
| Staphylococcus aureus, Staphylococcus | ||
| epidermidis (MRSE), Pseudomonas | ||
| Subject Device | Predicate Device | |
| aeruginosa, Candida albicans and | ||
| Candida parapsilosis and has not been | ||
| shown to be effective against Candida | ||
| paratropicalis and Klebsiella | ||
| pneumoniae. |
Using post-market clinical surveillance
data, use of the ClearGuard HD
Antimicrobial Barrier Cap has been
shown to reduce the rate of central line-
associated bloodstream infections
(CLABSI) in hemodialysis patients with
catheters. Note: CLABSI was defined as
a positive blood culture (PBC) not related
to an alternative source of infection per
the National Healthcare Safety Network
(NHSN) surveillance definition.
Alternative sources were excluded if
dialysis sites attributed the PBC to
vascular access on the dialysis event
form. The actual reduction in CLABSI
rates may be less substantial as the
evaluation for alternative PBC sources
was not pre-specified, nor standardized
between patients and clinical sites, and
supplemental data evaluating for
alternative sources were not available for
review.
The subject device is not intended to be
used for the treatment of existing
infections. The antimicrobial is only
present within the hub of the catheter and
does not migrate to distal portions of the
catheter. | Candida parapsilosis and has not been
shown to be effective against Candida
paratropicalis and Klebsiella
pneumoniae.
The antimicrobial effectiveness was
evaluated using in vitro methods, and
correlation between in vitro antibacterial
activity and any clinical effectiveness has
not been tested. The subject device is not
intended to be used for the treatment of
existing infections. The antimicrobial is
only effective within the hub of the
catheter, and does not migrate to distal
portions of the catheter. |
| Materials/Design | | |
| Maximum
amount of
chlorhexidine
on the device | 2.53 mg | 2.43 mg |
| Maximum
amount of
chlorhexidine
that is
potentially
released to the
patient | 0.6 mg | 0.6 mg |
| Lock Ring | Nylon with red or blue dye | Nylon with red or blue dye |
| | Subject Device | Predicate Device |
| Plug | • Polypropylene with new white colorant
• Specify minimum and maximum
surface roughness
• Fins to prevent lock ring from rotating | • Polyester with white colorant
• Specify maximum luer surface
roughness
• No fins, lock ring freely rotates |
| Shield | • Polypropylene with white colorant | • Polyester with white colorant |
| Packaging, Sterilization, Shelf Life | | |
| Packaging | Foil pouch | Foil pouch |
| Sterilization | Gamma, SAL 10-6 | Gamma, SAL 10-6 |
| Device shelf
life | 3 years | 11 months |
Table 1. Comparison of Subject and Predicate Devices
5
6
Summary of Non-Clinical Testing
The ClearGuard HD Antimicrobial Barrier Caps have been found to be safe and effective for their intended use. Finished sterile ClearGuard HD Antimicrobial Barrier Caps have been subjected to biocompatibility testing and found to be non-hemolytic, non-cytotoxic, nonirritating, non-sensitizing, non-mutagenic, non-toxic and non-pyrogenic under intended use conditions. The ClearGuard Antimicrobial Barrier Caps have also met their requirements for liquid leakage, disassembly torque, plug, shield and pouch integrity, and for antimicrobial quantity, effectiveness, elution and solubility, initially, and after 3 years real time shelf life.
Biocompatibility testing was conducted in compliance with ISO 10993-1:2009/TC1 2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Package integrity was conducted in compliance with ASTM D3078-02(2013) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission.
Clinical Trial Results
A 13-month, prospective, cluster-randomized, multi-arm, unblinded clinical study with a control was conducted at 40 dialysis facilities throughout the United States only. Facilities were pairmatched and randomly assigned to treatment or control group. The treatment group received the ClearGuard HD Antimicrobial Barrier Cap and the control group received the Tego® Connector with the Curos™ Disinfecting Cap. The primary study endpoint was PBC rate. There were no other primary study endpoints but an ad hoc exploratory analysis of CLABSI was also conducted. 1,671 subjects participated in the study during the primary and exploratory analyses, accruing approximately 183,000 CVC-days in the primary analysis.1 The subject enrollment is shown in Table 2 and the subject demographics are shown in Table 3.
| Stage | Investigation Device
Arm
(ClearGuard HD) | Control Device
Arm
(Tego+Curos) | Total in
Both Arms |
|-------------------|------------------------------------------------|---------------------------------------|-----------------------|
| Subjects enrolled | 951 | 960 | 1911 |
Table 2. Subject Enrollment During the Intervention Period
7
| Stage | Investigation Device
Arm
(ClearGuard HD) | Control Device
Arm
(Tego+Curos) | Total in
Both Arms |
|-----------------------------------------------------|------------------------------------------------|---------------------------------------|-----------------------|
| Subjects excluded for history
of heparin allergy | 9 | 0 | 9 |
| Subjects receiving treatment | 942 | 960 | 1902 |
| Subjects excluded due to
treatment ≤21 days | 116 | 115 | 231 |
| Subjects in primary and
exploratory analyses | 826 | 845 | 1671 |
Table 3. Subject Demographics During the Intervention Period
| Characteristic | All | Treatment
Group | Control
Group | P-Value |
|---------------------|-------------|--------------------|------------------|---------|
| No. of Facilities | 40 | 20 | 20 | |
| No. of CVC Subjects | 1671 | 826 | 845 | |
| Age, y | 62.8 ± 14.9 | 63.7 ± 14.4 | 62.0 ± 15.3 | 0.02 |
| Gender (% Male) | 856 (51) | 421 (51) | 435 (51) | 0.8 |
| Race | | | | |
| Caucasian | 778 (47) | 414 (50) | 364 (43) | |
| African American | 621 (37) | 267 (32) | 354 (42) | 1 Brunelli, SM MD, MSCE, Van Wyck, DB MD, Njord, L PhD, Killion, DP MBA, Lynch, LE, PhD and Ziebol, RJ BS. Cluster-Randomized Trial of Devices to Prevent Catheter-Related Bloodstream Infection. J Am Soc Nephrol: 29:1336-1343, 2018.
ର Centers for Disease Control and Prevention (CDC): National Healthcare Safety Network (NHSN) Patient Safety Component Manual, January 2018. Bloodstream Infection Event. Chapter 4 Device-associated Module: Central Line-Associated Bloodstream Infection and Non-central Line Associated Bloodstream Infection). https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual current.pdf. Accessed Apr 23, 2018.
ന https://www.cdc.gov/nhsn/forms/57.502_DIAL_BLANK.pdf. Accessed Apr 23, 2018.
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