(205 days)
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No
The provided text describes a physical medical device (a catheter) and its intended use and testing. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts.
No.
The device is a hemodialysis catheter, which is a tool used to provide vascular access for therapy, but it is not the therapeutic device itself. The therapy (hemodialysis and apheresis) is performed through the device.
No
The device is a hemodialysis catheter used for vascular access, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter made of polyurethane with lumens and a cuff, which are hardware components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that the TruFlow™ catheters are inserted into the body (internal jugular, subclavian, or femoral vein) for the purpose of hemodialysis and apheresis. These are procedures that directly interact with the patient's circulatory system.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze samples or provide diagnostic information based on those samples. Its function is to facilitate the process of dialysis and apheresis.
Therefore, based on the provided information, the TruFlow™ Long-term and Short-term Dual-lumen Hemodialysis Catheters are not IVDs. They are medical devices used for therapeutic procedures.
N/A
Intended Use / Indications for Use
TruFlow™ Long-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis. The TruFlow™ Short-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires acute hemodialysis and apheresis.
TruFlow™ Long-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.
TruFlow™ Short-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.
Product codes (comma separated list FDA assigned to the subject device)
78 MPB, 78 MSD
Device Description
The catheters are long- and short-term dual lumen polyurethane dialysis catheters with D-shaped inner lumens and a staggered tip. Long-term catheters include a pre-attached in-growth cuff. Various product configurations will be offered, including IJ, straight and pre-curved catheters. Catheters will be offered in multi-unit packaging and with accessory components.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
internal jugular, subclavian vein, femoral vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Functional Testing: In-vitro testing was conducted on the TruFlow™ Dialysis Catheters. Biocompatibility testing was also conducted on the catheters. The results of the testing indicated that the TruFlow™ Dialysis Catheters function according to specifications and the materials used in the device are biocompatible. Therefore, this product is considered acceptable for human use.
Clinical Studies: Clinical studies were not deemed necessary regarding the TruFlow™ Dialysis Catheters due to their similarity in materials, design and function to the Medcomp Dialysis Catheters.
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.
Not Found
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.
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Page 1 of 2
JAN 3 0 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
TruFlow™ Dialysis Catheters
July 8, 2002
I. GENERAL INFORMATION
| Applicant's Name and Address: | Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa J. Stone
Manager, Regulatory Affairs |
| Common/Usual Name: | Dialysis Catheter |
| Proprietary Name: | TruFlowTM Long-term and Short-term Dual-lumen Dialysis Catheters |
| Equivalence Device Comparison: | MedComp Hemo-FlowTM Dual Lumen Dialysis
Catheter and MedComp Duo-FlowTM Dual
Lumen Catheter |
II. DEVICE DESCRIPTION
The catheters are long- and short-term dual lumen polyurethane dialysis catheters with D-shaped inner lumens and a staggered tip. Long-term catheters include a pre-attached in-growth cuff. Various product configurations will be offered, including IJ, straight and pre-curved catheters. Catheters will be offered in multi-unit packaging and with accessory components.
III. INTENDED USE OF THE DEVICE
TruFlow™ Long-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis. The TruFlow™ Short-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires acute hemodialysis and apheresis.
IV. DEVICE COMPARISON
The technological characteristics of the TruFlow™ Dialysis Catheters are substantially equivalent to the predicate device in terms of intended use, instructions for use, material type, device specification, manufacturing process and method of sterilization.
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K.022221
Page 2 of 2
SUMMARY OF STUDIES V.
Functional Testing A.
In-vitro testing was conducted on the TruFlow™ Dialysis Catheters.
Biocompatibility testing was also conducted on the catheters.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the TruFlow™ Dialysis Catheters due to their similarity in materials, design and function to the Medcomp Dialysis Catheters.
Conclusions Drawn from the Studies C.
The results of the testing indicated that the TruFlow™ Dialysis Catheters function according to specifications and the materials used in the device are biocompatible. Therefore, this product is considered acceptable for human use.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2003
Ms. Lisa Stone Manager, Regulatory Affairs Deltec, Inc. 1265 Grey Fox Road ST PAUL MN 55112
Re: K022221
Trade/Device Name: TruFlow™ Long-term and Short-term Dual-lumen Dialysis Catheters Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: 78 MPB Regulatory Class: III Product Code: 78 MSD Dated: October 31, 2002 Received: November 1, 2002
Dear Ms. Stone:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 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, 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
3
Page 2 - Ms. Lisa Stone
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.
In addition, we have determined that your device kit contains Iodine Swabsticks, Povidone Iodine Ointment, and Lidocaine HCl, which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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 our 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/dsma/dsmamain.html
Sincerely yours.
David A. Ingram
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): no22222
Device Name: TruFlow™ Long-term and Short-term Dual-lumen Dialysis Catheters
Indications for Use:
"TruFlow™ Long-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis. The TruFlow™ Short-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires short-term vascular access for acute hemodialysis and apheresis.
TruFlow™ Long-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.
TruFlow™ Short-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use l. (Per 21 CFR 801.109)
OR Over-The Counter Use
Daniel K. Lyon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022221