(375 days)
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No
The provided text describes a chronic dialysis catheter and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is a Chronic Dialysis Catheter used for hemodialysis, which is a medical treatment.
No
The device is a catheter designed for hemodialysis and apheresis, which are treatment procedures, not diagnostic ones. There is no indication from the provided text that it acquires information used to diagnose a disease or condition.
No
The intended use clearly describes a physical catheter, which is a hardware medical device. There is no mention of software as the primary or sole component.
Based on the provided information, the Vaxcel Chronic Dialysis Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "chronic hemodialysis and apheresis." These are procedures performed directly on a patient's body to filter blood or remove specific blood components.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing information about a patient's health status, diagnosis, or disease state based on sample analysis.
- Using reagents or test kits.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Vaxcel Chronic Dialysis Catheter is a device used for a therapeutic procedure performed in vivo (within the body).
N/A
Intended Use / Indications for Use
The Vaxcel Chronic Dialysis Catheter is designed for chronic hemodialysis and apheresis.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Image /page/0/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 bars representing its wings, and it is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is oriented to the left, and the text is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration Food and Dreg Boulevard Rockville MD 20850
JUL 1.2 1999
Ms. Laura Mondano Manager, Regulatory Affairs Manager, Rogger, Corporation One Boston Scientific Place One Do Massachusetts 01760
Re: K982326
Boston Scientific Vascular (BSV) Oston Scientino ic Dialysis Catheter Regulatory Class: III Regulatory Class: Dated: May 14, 1999 Received: May 17, 1999
Dear Ms. Mondano:
Dear MS. Montano.
We have reviewed your Section 510(k) notification of intent to market the device referenced We have teviewed your Section 510(k) notification of intent the cover seems of cuse we and we have determined the devices is substantially equivalent (on the marketed in interstate commerce
stated in the enclosure) to legally marketed prodicate devices marke stated in the enclosure) to legally marketed predical Device Amendment of to dees that
prior to May 28, 1976, the enatiment date of the Medical Device American of the Seat o stated May 28, 1976, the enatment date of the Medical Device I hood on the Federal Food, Drug, and
have been reclassion in accordance with the provisions of the Federal Contr profes to the Joy - and in the provisions of the reviews of the reacles for the general controls
Cosmetic Act (Act). You may, therefore, market the devices and Cosmetic Act (Act). You wer, you are responsible to devermine that the motion of the motion by the section of the Comises of the Act. However, you are responsible to determindly equivelent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to
premarket notification process (Section 510(k) of the act), or were legally premarket notification process (Section 510(K) of the act, of were in J. S. (1976)
May 28, 1976, the enactment date of the Medical Device Americal (e.g., sterilize May 28, 1976, the enactment in bulk (i.e., unfinished) and finitims. Trocess (e.g., sterilize)
purchase your device components in bulk (i.e., unfinished) and fither process ( purchase your device components in bulk (i.e., unimalsed) and har more in the (eneral
you must submit a new 510(k) before including these components in your kiti. The general you must submit a new 510(k) before including these controllents in the of devices,
controls provisions of the Act include requirements for annual registration, listing of de controls provisions of the Act include requirements for animal viges.
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
n and the supportunity on and control isset to such additional controls. Exist If your device is classified (see above) into entrely . Existing major regulations
(Premarket Approval) it may be subject to subject to subjections, Title 21, Parts 800 to (Premarket Approval) it may be subject to such additions, Title 21, Parts 800 to
affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to affecting your device can be tound in the Courses compliance with the Current Good
895. A substantially equivalent determs assumes compliance with the Current Regulation (QS) 895. A substantially equivalents, as set forth in the Quality System Regulation (QS) for
Manufacturing Practice requirements, as set forth in the Pool periodic QS Manufacturing Practice requirements, as set coral mat that , through periodic QS
Medical Devices: General regulation (21 CFR Part 820) and that , through periodic QS
. Medic Medical Devices: General regulation (21 CPK Part 620) and this the GMP regulation may
1
Page 2 - Ms. Laura Mondano
result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish fesuit in regulatory action. In addition, and readeral Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification . The FDA finding of substantial equivalence of your device to a legally marketed notification. The FDA inding of saconantar vour device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation proceed to the marker. If your assure op 10 for in vitro diagnostic devices), please contact the (21 CFR Far 801 and additionally 609 6 6. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act (21 OF IC 601:57). Other goivision of Small Manufacturers 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,
Ra- Phillips
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | K882326 |
|---|---|
| Device Name: | Chronic Dialysis Catheter |
| Indications for Use: | The Vaxcel Chronic Dialysis Catheter is |
| designed for chronic hemodialysis and | |
| apheresis. |
(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 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Ra-Phillips
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, ENT, and Radiological Dey 510(k) Number