(19 days)
The Vaxcel™ Plus Chronic Dialysis Catheter Tunneler is indicated to assist in tunneling and insertion of Vaxcel™ Plus Chronic Dialysis Catheters of corresponding size (19, 23, 28 cm).
The Vaxcel Plus Chronic Dialysis Catheter Tunneler is a slender, cylindrical device made of biocompatible stainless steel or delrin. The tunneler is designed to assist in tunneling the Vaxcel Plus Chronic Dialysis Catheters through subcutaneous tissue during catheter implantation. It has a tapered end, which is used to tunnel through subcutaneous tissue, and a barbed end for attachment of the dialysis catheter tip prior to tunneling.
The provided text describes a 510(k) submission for the Vaxcel™ Plus Chronic Dialysis Catheter Tunneler. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a detailed study like those for AI/ML-driven devices.
Therefore, the document does not contain the information required to populate the fields in your request regarding acceptance criteria, study details, expert involvement, or specific performance metrics. It primarily states that the device is substantially equivalent to a predicate device.
Here's why the information you're asking for isn't present in this type of document:
- Acceptance Criteria and Reported Device Performance: 510(k)s for non-AI devices typically don't present acceptance criteria in the format you described (e.g., Sensitivity, Specificity, AUC). Instead, they demonstrate that the new device meets the same safety and performance characteristics as a predicate device through various means (e.g., material testing, mechanical testing, functional testing if applicable, and comparison of design, manufacturing, and sterilization processes). The document states: "All performance characteristics are substantially equivalent to currently marketed devices."
- Sample Size, Ground Truth, Experts, Adjudication, MRMC studies, Standalone studies, Training Set: These concepts are relevant for studies evaluating the performance of AI/ML algorithms, especially in diagnostic imaging or similar fields. The Vaxcel™ Plus Chronic Dialysis Catheter Tunneler is a physical medical device (a catheter tunneler), not an AI algorithm. Therefore, these types of studies and methodologies are not applicable to its regulatory submission.
Summary based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The underlying acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device in terms of safety and effectiveness. This implies that the device must perform similarly to the predicate device in its intended use.
- Reported Device Performance: "All performance characteristics are substantially equivalent to currently marketed devices." No specific quantitative metrics (e.g., sensitivity, specificity, accuracy) are provided, as this is a physical device, not a diagnostic algorithm.
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Sample size used for the test set and the data provenance: Not applicable. This document pertains to a physical medical device, not an AI/ML algorithm requiring a test set of data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
Explanation of the "Study" mentioned in the document:
The "study" or assessment performed for this device, as implied by the 510(k) submission, involved demonstrating that its "design characteristics, manufacturing, and sterilization processes are identical to the predicate devices" and that "all performance characteristics are substantially equivalent to currently marketed devices." This typically involves:
- Design comparison: Reviewing specifications, materials, dimensions, and functionality against the predicate device.
- Material biocompatibility: Ensuring materials are safe for human contact.
- Mechanical/Functional testing: If applicable, demonstrating the device can withstand expected forces or perform its mechanical function (e.g., strength of the tunneler, secure attachment of the catheter).
- Sterilization validation: Ensuring the sterilization process is effective.
These are not "studies" in the context of clinical trials or performance assessments for AI algorithms, but rather engineering and regulatory compliance evaluations.
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<040492 PAGE 1 OF 1
MAR 1 6 2004
Traditional 510(k) Vaxcel™ Plus Chronic Dialysis Catheter Tunneler February 25, 2004
Summary of Safety and Effectiveness
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
| GeneralInformation | Submitter: Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760508-652-5003 |
|---|---|
| Contact Person: Nicholas Condakes | |
| GeneralProvisions | Trade Name: Vaxcel™ Plus Chronic Dialysis Catheter TunnelerClassification Name: Catheter Tunneler, Hemodialysis |
| Name ofPredicateDevices | Vaxcel™ Plus Chronic Dialysis Catheter Tunneler |
| Classification | Class II |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act |
| Intended Useand DeviceDescription | The Vaxcel Plus Chronic Dialysis Catheter Tunneler is a slender, cylindricaldevice made of biocompatible stainless steel or delrin. The tunneler isdesigned to assist in tunneling the Vaxcel Plus Chronic Dialysis Cathetersthrough subcutaneous tissue during catheter implantation. It has a taperedend, which is used to tunnel through subcutaneous tissue, and a barbed endfor attachment of the dialysis catheter tip prior to tunneling. The Vaxcel™Plus Chronic Dialysis Catheter Tunneler is indicated to assist in tunneling andinsertion of Vaxcel™ Plus Chronic Dialysis Catheters of corresponding size(19, 23, 28 cm). |
| Summary ofSubstantialEquivalence | All design characteristics, manufacturing, and sterilization processes areidentical to the predicate devices. All performance characteristics aresubstantially equivalent to currently marketed devices. No new issues ofsafety or efficacy have been raised. |
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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 features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2004
Mr. Nicholas Condakes Regulatory Affairs Specialist Boston Scientific Corporation, Oncology One Boston Scientific Place NATICK MA 01760-1573
Re: K040492
Trade/Device Name: Vaxcel™ Plus Chronic Dialysis Catheter Tunneler Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: 78 MSD Dated: February 25, 2004 Received: March 2, 2004
Dear Mr. Condakes:
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. 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.
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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his lotel vill and my Jour of Substantial equivalence of your device of your device to a legally prematication. " 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 our labeling regulation (21 CFR Part 801), please It you desire of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrfv/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
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
| 510(k) Number (if known) | K040492 |
|---|---|
| Device Name: | Vaxcel™ Plus Chronic Dialysis Catheter Tunneler |
| Indications for Use | The Vaxcel™ Plus Chronic Dialysis Catheter Tunneler is indicated to assist in tunneling and insertion of Vaxcel™ Plus Chronic Dialysis Catheters of corresponding size (19, 23, 28 cm). |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devi :510(k) Number
Confidential Boston Scientific Corporation
§ 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.