(244 days)
Not Found
Arrow Antimicrobial Pressure Injectable PICC
No
The device description and performance studies focus on the mechanical and antimicrobial properties of the end cap, with no mention of AI or ML.
No
Explanation: The device is an end cap for hemodialysis catheter hubs designed to reduce microbial colonization, not to treat existing infections or provide direct therapeutic intervention. Its primary function is preventive, not curative.
No
The device is an end cap designed to reduce microbial colonization in hemodialysis catheter hubs, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical end cap made of polymer and nylon with an antimicrobial coating, not software.
Based on the provided information, the ClearGuard HD device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is as an end cap for hemodialysis catheter hubs to reduce microbial colonization. This is a device used on a medical device (the catheter) to prevent infection, not a device used to test a sample from the body to diagnose a condition.
- Mechanism of Action: The device releases an antimicrobial agent (chlorhexidine acetate) into the catheter hub to reduce microorganisms. This is a direct antimicrobial action within the catheter, not a diagnostic test.
- Performance Evaluation: The performance studies described focus on the antimicrobial effectiveness using in vitro methods and the safety and sealing capabilities of the end cap. There is no mention of testing patient samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typical of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (biomarkers, pathogens, etc.)
- Providing diagnostic information about a patient's health status.
The device is a medical device designed to prevent infection in a specific clinical setting (hemodialysis). While it has an antimicrobial component evaluated in vitro, its primary function is not diagnostic.
N/A
Intended Use / Indications for Use
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.
The antimicrobial treatment on the ClearGuard HD 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.
The antimicrobial effectiveness was evaluated using in vitro methods and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. It 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.
Product codes (comma separated list FDA assigned to the subject device)
PEH
Device Description
The ClearGuard HD end cap is male lucr lock end cap that incorporates an antimicrobial treatment on its surfaces. It is designed to reduce microbial colonization within a hemodialysis catheter hub.
The ClearGuard HD end cap consists of 1) a copolyester polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine actate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD end cap is inserted into a liquid-filled catheter, CHA clutes into the catheter lock solution. This CHA solution is designed to reduce the number of microorganisms in the hemodialysis catheter hub.
The catheter extension line pinch clamps are used to maintain the lock solution within the catheter lumens and minimize the risk of air embolism. 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
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)
The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested.
Results of design verification and validation testing demonstrate that the ClearGuard HD end cap is safe for use with hemodialysis catheters and reliably seals catheter hubs. It also demonstrates that the chlorhexidine antimicrobial agent effectively reduces the number of microorganisms in hemodialysis catheter hubs as does the reference Arrow PICC and introduces no new or increased safety concerns. The risk assessment results, together with the results of design verification and validation testing presented in this submission, confirm that the ClearGuard HD end cap raises no new questions of safety or effectiveness compared to the predicate and reference devices.
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.
Boston Scientific Corporation Vaxcel™ Plus Chronic Dialysis Catheter
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.
Arrow Antimicrobial Pressure Injectable PICC
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
§ 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
Pursuit Vascular, Inc. Traditional 510(k): K131060
i
:
510(k) Summary
Summary of Safety and Effectiveness for the ClearGuard HD
General Information
| Submitter
Pursuit Vascular, Inc.
6901 E. Fish Lake Road, Suite 166
Maple Grove, MN 55369 | Contact Person
Laurie Lynch, PhD
Director of Quality/Regulatory/Clinical
Phone: (612) 424-9006
Fax : (763) 592-8202
Email : llynch@pursuitvascular.com |
|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Provisions | |
| Trade Name | ClearGuard HD |
| Common/Usual Name | Hemodialysis Catheter Luer End Cap |
| Classification Name | 21 CFR 880.5540 |
| Predicate Devices | Boston Scientific Corporation Vaxcel™ Plus
Chronic Dialysis Catheter |
Device Description
The ClearGuard HD end cap is male lucr lock end cap that incorporates an antimicrobial treatment on its surfaces. It is designed to reduce microbial colonization within a hemodialysis catheter hub.
The ClearGuard HD end cap consists of 1) a copolyester polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine actate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD end cap is inserted into a liquid-filled catheter, CHA clutes into the catheter lock solution. This CHA solution is designed to reduce the number of microorganisms in the hemodialysis catheter hub.
The catheter extension line pinch clamps are used to maintain the lock solution within the catheter lumens and minimize the risk of air embolism. 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 is indicated for use as an end cap for use with hemodialysis catheter hubs.
Pursuit Vascular Confidential Information
DEC 16 2013
1
| Pursuit Vascular, Inc. | Page 2 of 2 |
|---|---|
| Traditional 510(k): K131060 | December 10, 2013 |
K131060 Page 2 of 2
The antimicrobial treatment on the ClearGuard HD 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.
The antimicrobial effectiveness was evaluated using in vitro methods and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. It 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.
Substantial Equivalence Comparison
The ClearGuard HD end cap is substantially equivalent to a legally marketed 510(k) cleared device in intended use, indications for use, principles of operation, hub compatibility, and the fact that they are both provided as sterile, non-pyrogenic, single use devices. The predicate device is a chronic hemodialysis catheter that contains end caps. The technological differences between ClearGuard HD end caps and the end caps of the predicate device include 1) the use of an antimicrobial agent on the end cap and 2) a rod extending 1.8 cm (0.7 in) from the luer region. The antimicrobial agent on the ClearGuard HD end cap is the same agent used on the Arrow Antimicrobial Pressure Injectable PICC reference device. This reference device has two versions of chlorhexidine applied to the catheter surfaces, chlorhexidine base and chlorhexidine acctate. The ClearGuard HD end cap has chlorhexidine acetate applied to the cap surfaces.
Results of design verification and validation testing demonstrate that the ClearGuard HD end cap is safe for use with hemodialysis catheters and reliably seals catheter hubs. It also demonstrates that the chlorhexidine antimicrobial agent effectively reduces the number of microorganisms in hemodialysis catheter hubs as does the reference Arrow PICC and introduces no new or increased safety concerns. The risk assessment results, together with the results of design verification and validation testing presented in this submission, confirm that the ClearGuard HD end cap raises no new questions of safety or effectiveness compared to the predicate and reference devices. The ClearGuard HD end cap has, therefore, been shown to be substantially equivalent to a legally marketed device for the purpose of 510(k) clearance.
Summary of Non-Clinical Testing
The ClearGuard HD end caps have been tested and compared to the predicate device. All data gathered demonstrate this device is substantially equivalent. No new or increased safety risks or efficacy issues have been raised.
Summary of Clinical Performance Data
Not applicable - no clinical data was needed to demonstrate substantial equivalence to its predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo of the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2013
Pursuit Vascular, Inc. Laurie E. Lynch, Ph.D. Director Quality/Regulatory/Clinical 6901 E. Fish Lake Road, Suite 166 Maple Grove, MN 55369
Re: K131060
Trade/Device Name: ClearGuard HD End Cap Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: PEH Dated: December 5, 2013 Received: December 6, 2013
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.
3
Page 2 - Laurie E. Lynch, Ph.D.
... ... ..
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 (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -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
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131060
Device Name ClearGuard HD End Cap
Indications for Use (Describe)
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.
The antimicrobial treatment on the ClearGuard HD has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus foecolis (VRE), Acinetobocter baumannii, Escherichia coli, Staphylococus aureus, Staphylococus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candidosis 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.
Herbert P. Lerner
2013.12.13 16:19:25 -05:00'
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
PROPERT STORE FREE STATE AND A FOR FDATUSE ONLY CONLY CONTRACT AT S Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)