(60 days)
The Arrow® Step-Tip Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It is inserted percutaneously in internal jugular or subclavian vein. It is intended to be used only in adult patients.
The Step-Tip Catheter consists of a double lumen catheter with a detached connector assembly. This allows the arterial port at the catheter tip to be precisely positioned within the right atrium and the venous port to be positioned within the superior vena cava. After the catheter has been positioned, the proximal end of the catheter is tunneled retrograde to the exit site. The connector assembly is then fastened to the proximal end of the catheter using a compression sleeve and compression cap.
The provided text describes a 510(k) premarket notification for the "Step-Tip chronic hemodialysis catheter." This document is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study reporting performance against specific acceptance criteria in the way an AI/ML medical device submission would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of regulatory submission for a traditional medical device like a catheter. The device's performance is established through bench testing and a comparison to a predicate device, not through an AI algorithm's diagnostic accuracy.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance (as inferred from the 510(k) Summary)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to the predicate device (Arrow Cannon Catheter™ II Plus) in terms of safety and effectiveness. | "The results of the laboratory and in-vivo tests demonstrate that the device is as safe and effective as the legally marketed predicate devices." |
| Functional performance characteristics (e.g., adequate flow rate). | "Tests were performed to demonstrate substantial equivalence in the following areas: - Flow rate tests" |
| Biocompatibility and safety (e.g., minimal red blood cell damage). | "Tests were performed to demonstrate substantial equivalence in the following areas: - Hemolysis tests" |
| Efficiency of dialysis (e.g., minimizing recirculation of blood). | "Tests were performed to demonstrate substantial equivalence in the following areas: - Recirculation tests" |
| Identical technological characteristics to the predicate device. | "The proposed device has the same technological characteristics as the predicate device." |
Detailed Study Information
- Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated through laboratory and in-vivo tests, not a clinical "test set" in the context of an AI/ML algorithm. The document doesn't specify the sample sizes for these tests or their provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device, so there's no diagnostic "ground truth" to be established by experts for a test set.
- Adjudication method for the test set: Not applicable.
- 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. This is a physical medical device (catheter), not an AI algorithm.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used: Not applicable in the context of diagnostic accuracy. For a physical device, "ground truth" would relate to engineering specifications, validated test methods (e.g., hemolysis standards, flow rate measurements), and comparison to the predicate device's established performance.
- The sample size for the training set: Not applicable. This device does not involve a "training set" as it's not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
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K040666
Page 1 of 1
MAY 1 4 2004
| 510 (K) SUMMARY | |
|---|---|
| Submitter: | ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA |
| Contact person: | Brandon Epting, Regulatory Affairs AssociatePhone: 610-378-0131, ext. 8498Fax: 610-374-1160Email: brandon.epting@arrowintl.com |
| Date summary prepared: | March 11, 2004 |
| Device trade name: | Step-Tip chronic hemodialysis catheter |
| Device common name: | Chronic hemodialysis catheter |
| Device classificationname: | MSD, Class III, 21 CFR Part 876.5540, Catheter, Hemodialysis,Implanted |
| Legally marketed devicesto which the device issubstantially equivalent: | Arrow Cannon Catheter™ II Plus (K040078). |
| Description of the device: | The Step-Tip Catheter consists of a double lumen catheter with adetached connector assembly. This allows the arterial port at thecatheter tip to be precisely positioned within the right atrium andthe venous port to be positioned within the superior vena cava.After the catheter has been positioned, the proximal end of thecatheter is tunneled retrograde to the exit site. The connectorassembly is then fastened to the proximal end of the catheterusing a compression sleeve and compression cap. |
| Intended use of thedevice: | The Arrow® Step-Tip Catheter is indicated for use in attaininglong-term vascular access for hemodialysis and apheresis. It isinserted percutaneously in internal jugular or subclavian vein. It isintended to be used only in adult patients. |
| Technologicalcharacteristics: | The proposed device has the same technological characteristicsas the predicate device. |
| Performance tests: | Tests were performed to demonstrate substantial equivalence inthe following areas:- Flow rate tests- Hemolysis tests- Recirculation tests |
| Conclusions: | The results of the laboratory and in-vivo tests demonstrate thatthe device is as safe and effective as the legally marketedpredicate 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2004
Mr. Brandon Epting Regulatory Affairs Associate Arrow International, Inc. 2400 Bernville Road READING PA 19605-9607
Re: K040666
Trade/Device Name: Step-Tip chronic hemodialysis catheter; Models CS-15242-ST, CS-15282-ST, CS-15322-ST, and CS-15362-ST Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: March 11, 2004 Received: March 15, 2004
Dear Mr. Epting:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been mind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the environment date of 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 and Cosmone free (100). "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 ass us voluptions in arecess (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 May 20, 1970, the endemponents in bulk (i.e., unfinished) and further process (e.g., sterilize) parenase your it a new 510(k) before including these components in your kit. The general fou must bacinit a now 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 - Mr. Brandon Epting
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 (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation, please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). 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) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David A. Syrom
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
K040666 510(k) Number (if known): Step-Tip chronic hemodialysis catheter Device Name: The Arrow® Step-Tip Catheter is indicated for use in Indications for Use: rne Arrow - erm vascular access for hemodialysis and apheresis. The Step-Tip Catheter is inserted and upnoneously and is preferentially placed into the internal jugular (IJ) vein. It may be placed into the subclavian vein also. The Step-Tip Catheter is intended to be used only in adult patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AMOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Bergman
(Division Sign-Off) (Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
§ 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.