(167 days)
The Symetrex™ Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and aphersis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.
The Symetrex™ Long Term Hemodialysis Catheter is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to arochr the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.
The provided document is a 510(k) premarket notification for a medical device called the Symetrex Long Term Hemodialysis Catheter. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, and thus does not contain information about an AI/ML powered medical device. As such, the requested information regarding acceptance criteria, study details, ground truth, and training data for an AI/ML device cannot be extracted.
The document discusses the substantial equivalence of the new device to a predicate device (K140884), focusing on design, materials, manufacturing, and performance testing against established medical device standards (e.g., ISO, ASTM) for safety and basic functionality.
Therefore, I cannot provide the answer in the requested format because the input document does not pertain to an AI/ML medical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font and is placed within a blue square.
November 16, 2017
Medcomp (DBA Medical Components, Inc.) Courtney Nix Regulatory Affairs Manager, North America and EU 1499 Delp Drive Harleysville, PA 19438
Re: K171618
Trade/Device Name: Symetrex Long Term Hemodialysis Catheter Regulation Number: 21 CFR& 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: MSD Dated: October 6, 2017 Received: October 11, 2017
Dear Courtney Nix:
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 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. 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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 medical devices and radiation-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,
Benjamin R. Fisher -S
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
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Indications for Use
510(k) Number (if known) K171618
Device Name
Symetrex Long Term Hemodialysis Catheter
Indications for Use (Describe)
The Symetrex™ Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and aphersis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral 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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Image /page/3/Picture/1 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape above the word "medCOMP". The word "med" is in red and the word "COMP" is in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
| Section 6 | 510(k) SUMMARYK171618 | Traditional 510K | |
|---|---|---|---|
| 1. | Submitter Information: | ||
| Submitter: | Medical Components Inc.Dba Medcomp®1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201, x 2285Fax: (215) 256-9191 | ||
| Registration Number: | 2518902 | ||
| Contact: | Courtney NixCnix@Medcompnet.comRegulatory Affairs Manager: North America and EU | ||
| Date Prepared: | 05/30/2017 | ||
| 2. | Proposed or Subject Device Information: | ||
| Trade Name: | Symetrex™ Long Term Hemodialysis Catheter | ||
| Device: | Catheter, Hemodialysis, Implanted | ||
| Product Code: | MSD | ||
| Regulation Description: | Blood access device and accessories | ||
| C.F.R. Section: | 21 CFR 876.5540 | ||
| Class: | II (Special Controls) | ||
| Regulation Medical Specialty and Review Panel: | Gastroenterology/Urology | ||
| 3. | Predicate Device Information: | ||
| 510(k) Number: | K140884 | ||
| 510(k) Holder: | Medcomp® | ||
| Trade Name: | Symetrex™ Long Term Hemodialysis Catheter | ||
| Device: | Catheter, Hemodialysis, Implanted | ||
| Product Code: | MSD |
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Image /page/4/Picture/1 description: The image shows a logo for medCOMP. The logo consists of a red geometric shape above the word "med" in red and "COMP" in black. The geometric shape is an abstract design, possibly representing a stylized letter or symbol.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
| Regulation Description: | Blood access device and accessories |
|---|---|
| C.F.R Section: | 21 CFR 876.5540 |
| Class: | II (Special Controls) |
| Regulation MedicalSpecialty and ReviewPanel: | Gastroenterology/Urology |
4. Device Description:
The Symetrex™ Long Term Hemodialysis Catheter is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to arochr the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.
5. Indications for Use:
The Symetrex™ Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and aphersis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.
6. Intended Use:
Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.
7. Comparison to Predicate Devices:
Symetrex™ Long Term Hemodialysis Catheter is substantially equivalent to the predicate device, Symetrex™ Long Term Hemodialysis Catheter (K140884), in terms of indications for use, intended use, anatomical location, basic design, performance, manufacturing process and method of sterilization.
The difference or changes between the Symetrex™ Long Term Hemodialysis Catheter and the predicate, Symetrex™ Long Term Hemodialysis Catheter (K140884), are the revisions to the labeling (e.g. Instructions for Use), sterilization site, and expanding the componentry.
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Image /page/5/Picture/1 description: The image shows the logo for medComp. The logo consists of a red geometric shape above the word "med" in red and "COMP" in black. The geometric shape is abstract and appears to be a stylized letter or symbol.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
| Device | Proposed Device:Symetrex™ Long TermHemodialysis Catheter | Predicate Device:Symetrex™ Long TermHemodialysis Catheter(K140884) |
|---|---|---|
| Design | Symmetric Tip, Dual KidneyShaped Lumen Catheter | Symmetric Tip, Dual KidneyShape Lumen Catheter |
| Lengths | 19cm-42cm | 19cm-42cm |
| Indicationsfor Use | The Symetrex™ Long TermHemodialysis Catheter is asymmetric tip dual lumencatheter designed forchronic hemodialysis andaphersis. It may be insertedpercutaneously of by cutdown. Catheters withgreater than 37cm implantlength are indicated forfemoral placement. | The Symetrex™ Long TermHemodialysis Catheter is asymmetric tip dual lumencatheter designed forchronic hemodialysis andaphersis. It may be insertedpercutaneously of by cutdown. Catheters withgreater than 37cm implantlength are indicated forfemoral placement. |
| CatheterO.D. | 15.5FR | 15.5FR |
| SterilizationMethod | EO Sterilization | EO Sterilization |
| Materials | Hub (Green):Carbothane w/ 20% BaSO4Lumen (White):Carbothane w/ 20% BaSO4Cuff:Polyester FeltExtension (Clear):PellethaneBarbed Luer (Green) :IsoplastID Ring (White with redink):ABSID Ring (White with blueink):ABSClamp (White):Polypropylene | Hub (Green):Carbothane w/ 20% BaSO4Lumen (White):Carbothane w/ 20% BaSO4Cuff:Polyester FeltExtension (Clear):PellethaneBarbed Luer (Green) :IsoplastID Ring (White with redink):ABSID Ring (White with blueink):ABSClamp (White):Polypropylene |
| Components | Dilator, Stylet, Tunneler,Valved Introducer, andGuidewire | Dilator, Stylet, ValvedIntroducer and TunnelerGuidewire |
Table 6.1: 510(K) Summary: Design Comparison Matrix
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Image /page/6/Picture/1 description: The image shows a logo with a red geometric shape at the top and the text "medCOMP" at the bottom. The geometric shape is a stylized letter "G" or a house-like structure with an open roof. The word "med" is in red, matching the color of the geometric shape, while "COMP" is in black. The logo appears to be for a company or organization named medCOMP.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
| PackagingSystems | Clamshell tray for cathetersunder 33cmTranslumbar tray forcatheters for 33 cm andgreaterClamshell:One unit gets a snap lidone unit is sealed into aheader bag5 Header bags are placedin a shipping cartonTranslumbar tray:One unit gets a snap lidOne unit is sealed into aheader bag.5 units are placed into ashipping carton. | Symetrex Tray (Predicate)One units gets a snap lidOne unit is sealed in apouchOne sealed unit is placedinto an SBS Shelf Box15 are placed into ashipping carton | ||
|---|---|---|---|---|
| PerformanceTesting | Priming Volume: | Priming Volume: | ||
| Tip to CuffLength | LumenVolume | Tip to CuffLength | LumenVolume | |
| 19cm | 2.1cc | 19cm | 2.1cc | |
| 23cm | 2.3cc | 23cm | 2.3cc | |
| 28cm | 2.5cc | 28cm | 2.5cc | |
| 33cm | 2.6cc | 33cm | 2.6cc | |
| 37cm | 2.8cc | 37cm | 2.8cc | |
| 42cm | 3.2cc | 42cm | 3.2cc | |
| Recirculation:SymetrexTM Long TermHemodialysis Catheter hasless than 1% recirculation inforward and reverse flowwhen tested in vitro | Recirculation:SymetrexTM Long TermHemodialysis Catheter hasless than 1% recirculation inforward and reverse flowwhen tested in vitro |
8. Bench / Performance Data / Non-Clinical Testing:
The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Symetrex™ Long Term Hemodialysis Catheter, is equivalent to the predicate device, Symetrex™ Long Term Hemodialysis Catheter (K140884). The performance testing was performed in accordance with the following standards:
Table 6.2: Performance Standards
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Image /page/7/Picture/1 description: The image contains a logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "M" or an abstract design. Below the geometric shape, the word "medCOMP" is written in a combination of red and black letters. The "med" portion is in red, while the "COMP" portion is in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
| Standard | Standard Title | Revision/ Date | PerformanceTesting |
|---|---|---|---|
| ISO 10555-1 | Intravascularcatheters --sterile and single-useintravascularcatheters -- part1: generalrequirements. | Second Edition2013-06-15 | Air Leak, CatheterLeak, Extension-Hub, Extrusion-Hub, Gravity Flow |
| ISO 11607-1 | Packaging forterminallysterilized medicaldevices - part1: requirementsfor materials,sterile barriersystems andpackagingsystems[including:amendment 1(2014)]. | First Edition2006-04-15 | V-10712:15.5F SymetrexCatheter - ShippingTests - 32cmClamshell Trayw/PackagingEnvelopeV-10713:15.5F SymetrexCatheter - ShippingTest |
| ISO 11607-2 | Packaging forterminallysterilized medicaldevices - part2: validationrequirements forforming, sealingand assemblyprocesses[including:amendment 1(2014)]. | First Edition2006-04-15 | V-10712:15.5F SymetrexCatheter - ShippingTests - 32cmClamshell Trayw/PackagingEnvelopeV-10713:15.5F SymetrexCatheter - ShippingTest |
| ISO 594-1 | conical fittingswith a 6% (luer)taper forsyringes, needlesandcertain othermedicalequipment - part1: generalrequirements. | First edition1986-06-15, | Gauging |
| ISO 594-2 | Conical fittingswith a 6% (luer) | Second Edition1998-09-01 | Liquid LeakageAir Leakage |
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Image /page/8/Picture/1 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "G" or an abstract building. Below the geometric shape, the word "medCOMP" is written in a combination of red and black letters, with "med" in red and "COMP" in black.
- 1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
| Medcomp®: Symetrex™ Long Term Hemodialysis Catheter | ||||
|---|---|---|---|---|
| ----------------------------------------------------- | -- | -- | -- | -- |
| taper forsyringes, needlesandcertain othermedicalequipment - part2: lock fittings. | Separation ForceUnscrewing TorqueEase of AssemblyResistance toOverridingStress Cracking |
|---|
9. Biocompatibility:
Biocompatibility was performed for the Symetrex™ Long Term Hemodialysis Catheter per ISO 10993-1 for a blood implant device with prolonged exposure (i.e. > 24 hours < 30 days). Biocompatibility was performed on the final, finished device. The biological end points include:
- Hemocompatibility: 0
- o ISO 10993-4 Biological Evaluation Of Medical Devices Part 4: Selection Of Tests For Interaction With Blood
- ASTM F 756-08, Standard Practice for Assessment of Hemolytic Properties O of Materials, 2008
- Genotoxicity: O
- ISO 10993-3, Biological Evaluation of Medical Devices Part 3: Tests for O Genotoxicity, Carcinogenicity and Reproductive Toxicity.
- 0 Cytotoxicity:
- o AAMI / ANSI / ISO 10993-5: Biological evaluation of medical devices part 5: tests for in vitro cytotoxicity.
- 0 Irritation/Intracutaneous:
- o ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization.
- 0 Acute Systemic Toxicity:
- o ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity
- 0 Implantation:
- ISO 10993-6 Biological Evaluation of Medical Devices Part 6: Tests for O Local Effects after Implantation.
- ASTM F763-04 Standard Practice For Short-Term Screening of Implant O Materials.
- ASTM F981-04 Standard Practice For Assessment of Compatibility of O Biomaterials for Surgical Implants With Respect To Effect of Materials on Muscle and Bone.
- Additional Testing: .
- o ISO 10993-18 Biological Evaluation of Medical Devices Part 18: Chemical Characterization of Materials
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Image /page/9/Picture/1 description: The image shows the MedComp logo. The logo consists of a red geometric shape that resembles a stylized letter "G" or an abstract medical symbol. Below the geometric shape, the word "medCOMP" is written in a combination of red and black letters. The "med" portion is in red, while "COMP" is in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Symetrex™ Long Term Hemodialysis Catheter
- o ASTM D4128-06 Standard Guide for Identification of Quantitation of Organic Compounds in Water by Combined Gas Chromatography and Electron Impact Mass Spectrometry
- o ASTM D1971-11 Standard Practices for Digestion of Water Samples for Determination of Metals by Flame Atomic Absorption, Graphite Furnace Atomic Absorption, Plasma Emission Spectroscopy, or Plasma Mass Spectroscopy
- ISO 10993-17 Biological Evaluation of Medical Devices Part 17: o Establishment of Allowable Limits for Leachable Substances
10. Summary of Substantial Equivalence:
In conclusion, the proposed device, Symetrex™ Long Term Hemodialysis Catheter, is considered substantially equivalent to the predicate device, Symetrex™ Long Term Hemodialysis (K140884) as demonstrated through non-clinical testing performed.
§ 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.