(30 days)
The Arrow® integral catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The integral 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 integral catheter is intended for use in adult patients.
The Arrow integral hemodialysis catheter consists of a double lumen catheter with a molded juncture hub and two extension lines. This allows the catheter tip to be precisely positioned within the vein, similar to single lumen, dual catheters.
The provided text describes a 510(k) premarket notification for the Arrow® Integral Hemodialysis Catheter (K070260) from 2004. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with predetermined acceptance criteria.
Therefore, the document does not contain information on acceptance criteria for a clinical study or a study directly proving the device meets such criteria. Instead, it details various performance tests conducted to show equivalence to a predicate device.
Here's a breakdown of the information that is available, and what is not:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified, as this is a 510(k) submission not requiring new clinical performance acceptance criteria. | Performance tests were conducted to demonstrate substantial equivalence, including: - Chemical compatibility tests - Flow rate tests - Biocompatibility tests - Leak tests - Hemolysis tests - Tensile tests - Flex tests The conclusion states: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices." |
2. Sample Size Used for the Test Set and the Data Provenance:
- Not applicable/Not provided. This submission relies on laboratory performance tests, not a clinical "test set" in the context of human data. The performance tests would have used various samples of the device itself.
- The data provenance is implicitly from internal Arrow International, Inc. laboratory testing in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable/Not provided. Ground truth, in the sense of expert assessment for a clinical test set, is not relevant to the laboratory performance tests described.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. This is not a clinical study involving human readers or adjudicated outcomes.
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:
- Not applicable/Not provided. This device is a physical medical device (catheter), not an AI algorithm. Therefore, an MRMC study or AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. As stated above, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
- For the performance tests, the "ground truth" would be established by the validated methods and specifications for each laboratory test. For example, a "flow rate test" would have a defined standard for measuring flow, and the results would be compared against the performance of the predicate device or a pre-defined engineering specification.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable/Not provided. As there is no training set.
Summary based on the document:
The 510(k) submission for the Arrow® Integral Hemodialysis Catheter primarily relies on bench testing and laboratory performance assessments to demonstrate substantial equivalence to a legally marketed predicate device (Arrow Cannon Catheter K010399). The device's performance was evaluated across chemical compatibility, flow rate, biocompatibility, leak, hemolysis, tensile, and flex tests. The report concludes that these tests demonstrate the device is "as safe and effective as the legally marketed predicate devices." No clinical studies with new acceptance criteria or human reader performance assessments are detailed in this 510(k) summary.
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Page 1 of 1
MAR - 5 2004
510(k) Summary ARROW International, Inc. Submitter: 2400 Bernville Road Reading, PA 19605-9607 USA Brandon Epting, Regulatory Affairs Associate Contact person: Phone: 610-378-0131, ext. 8498 610-374-1160 Fax: Email: brandon.epting@arrowintl.com February 3, 2004 Date summary prepared: Integral hemodialysis catheter Device trade name: Chronic hemodialysis catheter Device common name: MSD, Class III, 21 CFR 876.5540, Catheter, Hemodialysis, Device classification name: Implanted Arrow Cannon Catheter (K010399). Legally marketed devices to which the device is substantially equivalent: The Arrow integral hemodialysis catheter consists of a double Description of the lumen catheter with a molded juncture hub and two extension lines. device: This allows the catheter tip to be precisely positioned within the vein, similar to single lumen, dual catheters. The Arrow® integral catheter is indicated for use in attaining long-Intended use of the term vascular access for hemodialysis and apheresis. The integral device: catheter is inserted percutaneously and is preferentially placed into the internal juqular (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 integral catheter is intended for use in adult patients. The proposed device has the same technological characteristics as Technological the predicate device(s). characteristics: Tests were performed to demonstrate substantial equivalence in the Performance tests: following areas: - Chemical compatibility tests - Flow rate tests - Biocompatibility tests - Leak tests - Hemolysis tests - Tensile tests - Flex tests The results of the laboratory tests demonstrate that the device is as Conclusions: safe and effective as the legally marketed predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2004
Mr. Brandon Epting Regulatory Affairs Associate ARROW® INTERNATIONAL P.O. Box 6306 READING PA 19610
Re: K040260
Trade/Device Name: Integral chronic hemodialysis catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: February 3, 2004 Received: February 4, 2004
Dear Mr. Epting:
We have reviewed your Section 510(k) premarket notification of intent to narket the nevice the indicati we nave reviewed your bection 310(t) premier is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the Chelosure for regarry manating the Medical Device Ameral Esea Drug commerce prior to May 26, 1776, the enaoment and of the Federal Food. Drug, devices that nave occa recrassified in accessed no the the device, subject to the general controls and Cosmedic Act (Act). " Fourmal), alerermine that the medical devices you provisions of the Act. Tronever, you are responsers.
use as components in the kit have either been determined as substantially with wise the right use as components in the Kir have ettiler been act), or were legally on the market prior to premarket notification process (Securent Predical Device Amendments. Please note: If your May 26, 1970, the chaomient and of the A.e., unfinished) and further process (e.g., sterilize) purchase your device components in ound uling these components in your kit. The general you must submit a new 916(x) before annual registration, listing of devices, controls provisions of the free 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), If your device is classified (see above) in existing major regulations affecting your device can be It may of Subject to additions, 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 - Mr. Brandon Epting
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition with other requirements of the Act
that FDA has made a determination that your device forcepcies. Your must that FDA has made a decemination that your accred by other federal agencies. You must or any Federal statutes and regulations andudines and of other aggistration (21 CFR Part
comply with all the Act's requirements, including and montacturing practice comply with all the Act 3 requirences, mort 801); good manufacturing practice 807); listing (21 CFR Part 807); laocing (21 Cr (CF areas) 382 (CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Pat 820); and i requirements as set form in the quality Systems (20) regarates (2006) - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin makemig your averies as wasnee of your device to a legally
premarket notification. The FDA finding of substantial end the permits vour premarket notification. The PDA Industing of backer and thus, permits your device on the labeli marketed predicate device results In a classine specific advice for your device on the labeling
device to proceed to the market. If you desire specific advice for your device device to proceed to the marker in you desire operate (301) 594-4616. Also, please note the regulation, please contact the Office of Compilance at (e) notification' (21 CFF Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification the As regulation entitled, "Misoranuing of Pricerence our responsibilities under the Act from the You may obtain other general information on Jour respear.
Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Bigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Indications for Use:
Integral hemodialysis catheter
The Arrow® integral catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The integral 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 integral catheter is intended for use in adult patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
K040260
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices
510(k) Number K04626
§ 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.