(176 days)
The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep™ Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextStep™ Antegrade catheter is intended for use in adult patients.
The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is a 15 Fr, 2 lumen, one piece Carbothane catheter with a preloaded stylet and step tip designed for antegrade placement. The catheter is available in multiple lengths. The procedure kit includes the necessary accessories to correctly insert the catheter.
The provided 510(k) summary for the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238) does not describe a study that uses AI/algorithm performance. Instead, it focuses on demonstrating the substantial equivalence of a medical device (a catheter) to a predicate device through traditional engineering and biological performance testing.
Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context.
Here's a breakdown of the information that is available based on your request, adapted for a medical device rather than an AI/algorithm:
Acceptance Criteria and Device Performance for Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238)
This submission describes a medical device, a chronic hemodialysis catheter, and its performance is assessed through laboratory testing to demonstrate substantial equivalence to a predicate device, not through an AI/algorithm performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria / Purpose | Reported Device Performance |
|---|---|---|
| Flow Rate Tests | To ensure the catheter provides adequate blood flow for hemodialysis. (Specific criteria not detailed in summary). | Tests were performed to demonstrate substantial equivalence. (Specific numerical results not detailed in summary). |
| Recirculation Test | To evaluate the degree of recirculation of blood flow within the catheter, which can reduce dialysis efficiency. (Specific criteria not detailed in summary). | Tests were performed to demonstrate substantial equivalence. (Specific numerical results not detailed in summary). |
| Leak Tests | To ensure the catheter integrity and prevent fluid leakage. (Specific criteria not detailed in summary). | Tests were performed to demonstrate substantial equivalence. (Specific numerical results not detailed in summary). |
| Biocompatibility Tests | To ensure the materials used in the device are safe for contact with human tissue and blood as per ISO 10993. (Specific criteria not detailed in summary). | Tests were performed to demonstrate substantial equivalence. (Specific results confirming biocompatibility per standards not detailed in summary). |
| Tensile Test | To evaluate the mechanical strength of the catheter, particularly its resistance to breaking under tension. (Specific criteria not detailed in summary). | Tests were performed to demonstrate substantial equivalence. (Specific numerical results not detailed in summary). |
Conclusion from Submission: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. Based on the indications for use, design, safety and performance testing, the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheters met the requirements that are considered adequate for its intended use and is substantially equivalent to the predicate devices."
The following points are not applicable (N/A) as the submission describes a physical medical device and not an AI/algorithm:
2. Sample size used for the test set and the data provenance: N/A (This was a physical device performance study, not a data-driven test set.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth is not relevant for physical device testing this context; performance is measured against physical standards/benchmarks.)
4. Adjudication method for the test set: N/A (Not applicable for physical device testing.)
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (This is not an AI-assisted device.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is not an algorithm.)
7. The type of ground truth used: N/A (For physical devices, performance is measured against engineering specifications, industry standards, and predicate device performance, not "ground truth" derived from expert consensus or pathology in the sense of an AI model.)
8. The sample size for the training set: N/A (This is not an AI/algorithm that requires a training set.)
9. How the ground truth for the training set was established: N/A (Not applicable.)
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| 510(k) Summary | |
|---|---|
| Submitter: | ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA |
| Contact person: | Suzanne Schorle, Regulatory Affairs SpecialistPhone: 610-378-0131, ext. 3443Fax: 610-478-3183Email: suzanne.schorle@teleflexmedical.com |
| Date summary prepared: | October 5, 2010 |
| FEB - 1 2011 | |
| Device trade name: | Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter |
| Device common name: | Chronic hemodialysis catheter |
| Device classification name: | MSD, Class III, 21 CFR Part 876.5540, Catheter, Hemodialysis, Implanted |
| Legally marketed devices to which the device is substantially equivalent: | Integral Chronic Hemodialysis Catheter (K040260) |
| Description of the device: | The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is a 15 Fr, 2 lumen, one piece Carbothane catheter with a preloaded stylet and step tip designed for antegrade placement. The catheter is available in multiple lengths. The procedure kit includes the necessary accessories to correctly insert the catheter. |
| Intended use of the device: | The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextStep™ Antegrade Catheter is intended for use in adult patients. |
| Technological characteristics: | The proposed device has the same technological characteristics as the predicate device. |
| Performance tests: | Tests were performed to demonstrate substantial equivalence in the following areas:- Flow rate tests - Recirculation test- Leak tests - Biocompatibility tests- Tensile test |
| Conclusions: | The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.Based on the indications for use, design, safety and performance testing, the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheters met the requirements that are considered adequate for its intended use and is substantially equivalent to the predicate devices. |
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Arrow International: Page 12 of 16
:
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KIT CERTIFICATION
We certify that all of the medical components of the subject kit are either 1) legally marketed pre-amendment devices, 2) exempt from premarket notification (consistent with the exemption criteria described in the classification regulations and the limitations of exemptions from Section 510(k) of the Act (e.g., 21 CFR Part 862.9), or 3) have been. found to be substantially equivalent through the premarket notification process for the use(s) for which it is intended (i.e. not claiming or causing a new use for the components). Refer to Table 8 below for a list of kit components.
We further certify that Arrow International, Inc. purchases all device components either in packaged and labeled form consistent with their pre-amendments, exemption, or premarket notification criteria and status, or as bulk non-labeled and non-sterile components, also consistent with their pre-amendments, exemption, or premarket notification criteria and status.
The kit version of the device utilizes packaging that consists of a vacuum-formed tray in a poly and Tyvek® pouch. All components are placed in the tray and pouch, sealed, EtO sterilized and then packed in corrugated shipping cartons. No components are "reprocessed" as a result of the sterilization. Final processing of the kit has no effect on the functionality (i.e., safety and effectiveness) of any of the kit components.
| Component | DeviceClassification | Regulation | Certification |
|---|---|---|---|
| Spring wire guide with ArrowAdvancerTM | Class II, DQX 21 | CFR 870.1330 | K914531 |
| SmartSealTM2 Hemostatic DialysisSheath | Class II, DYB | CFR 870.1340 | K043438 |
| Introducer Needle 18 ga. X 2-12/"(6.35 cm) | Class II, DQY | 21 CFR870.1250 | K862056 |
| Tunneler with tunneling sheath | Class II | 21 CFR876.5540 | K040260 |
| Non vented male dust cap | Class II | 21 CFR870.5540 | K040260 |
| Dressing: Tegaderm® | Class I, KGX | 21 CFR880.5240 | K973036 |
| Tissue Dilator 12 FrTissue Dilator 14 Fr | Class II, DYB | 21 CFR870.1310 | K780532 |
| Arrow® SharpsAway IITM LockingDisposal Cup | Class II, FMI | 21 CFR878.4800 | K041153 |
| Safety Scalpel | Class I, GDX | 21 CFR878.4800 | Exempt |
| CSR Wraps | Class II, FRG | 21 CFR880.6850 | K800123 |
Arrow International: Page 11, of 16
Oct. 2010
08
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written in a circle around the eagle. The eagle is facing to the right, and its wings are slightly raised. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Suzanne Schorle Regulatory Affairs Specialist Arrow International, Inc. a division of Teleflex Medical. Inc. 2400 Bernville Road READING PA 19605
FEB - 1 2011
Re: K102238
Trade/Device Name: Arrow® NextStep" Antegrade Chronic Hemodialysis Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: December 30, 2010 Received: January 3, 2011
Dear Ms. Schorle:
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 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). 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, and labeling, and prohibitions against misbranding and adulteration.
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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Page 2 - Ms. Suzanne Schorle
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Loni M. Whig
( nHerbert P. Lerner, M.D., Director (Acting) 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 Statement
| 510(k) Number: | K102238 |
|---|---|
| Device Name: | Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter |
| Indications for Use: | The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep™ Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextStep™ Antegrade catheter is intended for use in adult patients. |
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Division of Reproductive. Gastro-Renal and
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K1022387
Arrow International Special 510(k): Page 23 of 157
§ 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.