(263 days)
The Merit Centros and CentrosFLO Long-Term Hemodialysis Catheter for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. This catheter is indicated for > 30 days, (long-term) placement.
The Centros and CentrosFLO Long-Term Hemodialysis Catheters are dual lumen, 15FR catheters available in lengths ranging from 15 to 31 cm (cuff-to-tip). The catheter comes with a stiffening stylet that can be used for over-the-wire placement. The catheter lumens are D-shaped and made from radiopaque polyurethane. The distal end design is a fixed length pre-formed split-tip, with (CentrosFLO) or without (Centros) side-holes. The distal venous lumen extends past the arterial lumen, and includes a guide wire slit for insertion by the optional over-the-wire placement technique. The proximal device contains a fixed polyester cuff, an integrated bifurcation, suture wing, and extension legs with color coded occlusion clamps and Luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on ID tags within the occlusion clamps. The trade name and cuff-to-tip length are printed on the catheter bifurcation. The catheter is a single-use device provided sterile via ethylene oxide for long-term (> 30 days) use. The Centros and CentrosFLO Long-Term Hemodialysis Catheters are marketed with any of the following components, depending on the product configuration: stylet, introducer, dilator(s), tunneler with sheath, introducer needle, scalpel, guide wire, adhesive wound dressings,
I am sorry, but the provided text is a Formal document from the FDA (Food and Drug Administration) about a 510(k) premarket notification for a medical device. It does not provide information about acceptance criteria and how a study proves a device meets those criteria. The document mainly discusses the substantial equivalence of the "Merit Centros® and CentrosFLO® Long-Term Hemodialysis Catheter" to a predicate device and outlines the regulatory framework.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth, or training set details from the given text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2016
Merit Medical Systems, Inc. Susan Christensen Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095
Re: K151967
Trade/Device Name: Merit Centros® and CentrosFLO® Long-Term Hemodialysis Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Catheter, Hemodialysis, Implanted Regulatory Class: II Product Code: MSD Dated: February 24, 2016 Received: February 25, 2016
Dear Susan Christensen,
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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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
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found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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
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Indications for Use
510(k) Number (if known) K151967
Device Name
Merit Centros/CentrosFLO Long-Term Hemodialysis Catheter
Indications for Use (Describe)
The Merit Centros and CentrosFLO Long-Term Hemodialysis Catheter for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. This catheter is indicated for > 30 days, (long-term) placement.
| 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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510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4789(801) 253-6919Susan ChristensenJuly 15, 20151721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Merit Centros® and CentrosFLO® Long-TermHemodialysis CatheterImplanted Hemodialysis CatheterCatheter, Hemodialysis, ImplantedIIMSD876.5540Gastroenterology/Urology |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | Merit Centros®/CentrosFLO® Long-TermHemodialysis CatheterCatheter, Hemodialysis, ImplantedK141363Merit Medical Systems, Inc.This predicate has not been subject to a design-related recall |
| ReferenceDevice | No reference devices were used in this submission. | |
| DeviceDescription | The Centros and CentrosFLO Long-Term Hemodialysis Catheters aredual lumen, 15FR catheters available in lengths ranging from 15 to 31cm (cuff-to-tip). The catheter comes with a stiffening stylet that can beused for over-the-wire placement. The catheter lumens are D-shapedand made from radiopaque polyurethane. The distal end design is afixed length pre-formed split-tip, with (CentrosFLO) or without (Centros)side-holes. The distal venous lumen extends past the arterial lumen,and includes a guide wire slit for insertion by the optional over-the-wireplacement technique. The proximal device contains a fixed polyestercuff, an integrated bifurcation, suture wing, and extension legs withcolor coded occlusion clamps and Luer connectors (red and blue for thearterial and venous lumens respectively). The lumen priming volumesare printed on ID tags within the occlusion clamps. The trade name andcuff-to-tip length are printed on the catheter bifurcation. The catheter isa single-use device provided sterile via ethylene oxide for long-term(> 30 days) use.The Centros and CentrosFLO Long-Term Hemodialysis Catheters aremarketed with any of the following components, depending on theproduct configuration: stylet, introducer, dilator(s), tunneler with sheath,introducer needle, scalpel, guide wire, adhesive wound dressings, | |
| Indications forUse | The Merit Centros and CentrosFLO Long-Term Hemodialysis Catheterare indicated for use in attaining long-term vascular access forhemodialysis and apheresis. It may be inserted percutaneously and isprimarily placed in the internal jugular vein of an adult patient. Thiscatheter is indicated for > 30 days, (long-term) placement.There is no change in the Indications for Use Statement from thepredicate to the subject device. | |
| Providing long-term vascular access for hemodialysis and apheresis isthe technological principle for both the subject and predicate device. | ||
| Comparison toPredicateDevice | At a high level, the subject and predicate devices are based on thefollowing same technological elements: | |
| DesignIndications for UseKit ComponentsPackagingLabelingSterilization | ||
| The following technological differences exist between the subject andpredicate devices: | ||
| The material formulations are different.The design of the bifurcation is changing slightly.Addition of spacer component to the full kit configuration. | ||
| PerformanceData | FDA guidance and recognized performance standards have beenestablished for Implanted Blood Access Devices for Hemodialysisunder Section 514 of the Food, Drug and Cosmetic Act. A battery oftests was performed based on the requirements of the belowrecognized performance standards and draft guidance, as well asbiocompatibility, sterilization, and labeling standards and guidance.Conformity to these standards demonstrates that the proposed MeritCentros/CentrosFLO Long-Term Hemodialysis Catheter met thestandards' established acceptance criteria applicable to the safety andefficacy of the device. Performance testing was conducted based onthe risk analysis and based on the requirements of the followinginternational standards/documents: | |
| • FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, 1995• FDA Draft Guidance for Industry and Food and Drug AdministrationStaff - Class II Special Controls Guidance Document Implanted BloodAccess devices for Hemodialysis June 28, 2013• ISO 10555-1:2013, Sterile, Single-Use Intravascular Catheters, Part 1:General Requirements.• ISO 10555-3:2013, Sterile, Single-Use Intravascular Catheters, Part 3:Central Venous Catheters.• ISO 594-1:1986, Conical Fittings with 6% (Luer) Taper for Syringes,Needles and Certain Other Medical Equipment - Part 1: GeneralRequirements.• ISO 594-2:1998, Conical Fittings with 6% (Luer) Taper for Syringes,Needles and Certain Other Medical Equipment – Part 2: Lock fittings | ||
| PerformanceData cont. | ISO 11135:2014, Sterilization of health care products -Ethylene oxide-Requirements for validation and routine control of a sterilization processfor medical devices ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1:Evaluation and Testing within a risk management process FDA guidance Required Biocompatibility Training and ToxicologyProfiles for Evaluation of Medical Devices, May 1, 1995 ISO 10993-3:2003, Biological Evaluation of Medical Devices – Part 3:Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medicaldevices - Part 4: Selection of tests for interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices – Part 5:Tests for in vitro cytotoxicity ISO 10993-6:2007, Biological evaluation of medical devices – Part 6:Tests for local effects after implantation ISO 10993-7:2008, Biological evaluation of medical devices – Part 7:Ethylene oxide sterilization residuals ISO 10993-10:2010, Biological evaluation of medical devices – Part 10:Tests for irritation and skin sensitization ISO 10993-11:2006, Biological evaluation of medical devices – Part 11:Tests for systemic toxicity ISO 10993-18:2005, Biological evaluation of medical devices – Part 18:Chemical characterization of materials ASTM F756-08:2008, Standard Practice for Assessment of HemolyticProperties of Materials United States Pharmacopeia 36, National Formulary 31, 2013 <151>Pyrogen Test The biocompatibility evaluation for the Merit Centros/CentrosFLO Long-Term Hemodialysis Catheter was conducted in accordance with theFDA Blue Book Memorandum #G95-1 "Use of International StandardISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluationand Testing,'" May 1, 1995, and International Standard ISO 10993-1"Biological Evaluation of Medical Devices - Part 1: Evaluation andTesting Within a Risk Management Process," as recognized by FDA.The Merit Centros/CentrosFLO Long-Term Hemodialysis Catheter metthe biocompatibility requirements for externally communicating devicewith circulating blood contact for a permanent (> 30 days) duration.The results of the testing demonstrated that the subject MeritCentros/CentrosFLO Long-Term Hemodialysis Catheter met theacceptance criteria applicable to the safety and efficacy of the device. | |
| Summary ofSubstantialEquivalence | Based on design qualification through safety and performance testing,the subject Merit Centros/CentrosFLO Long-Term HemodialysisCatheter meets the requirements that are considered essential for itsintended use and supports substantial equivalence to the predicatedevice, the Merit Centros/CentrosFLO Long-Term HemodialysisCatheter, K141363. |
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§ 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.