(196 days)
Not Found
No
The summary describes a physical catheter device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
Explanation: The device is intended for short-term vascular access for hemodialysis, which is a life-sustaining treatment, but the catheter itself does not directly treat a disease or promote healing in the way a therapeutic device typically would. It is a tool for accessing the vascular system to facilitate a therapeutic process performed by another machine (hemodialysis).
No
Explanation: The device is intended for vascular access for hemodialysis, which is a treatment, not a diagnostic purpose. Its description and intended use focus on the physical facilitation of blood flow for treatment, with no mention of diagnosing conditions.
No
The device description clearly describes a physical catheter with lumens, extension tubes, clamps, and luer lock adapters, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "short-term vascular access for hemodialysis." This is a procedure performed directly on the patient's body to facilitate a medical treatment (hemodialysis).
- Device Description: The device is a catheter designed to be inserted into a vein. This is a physical device used for accessing the circulatory system.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis on specimens.
The device is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Kendal! Dual Lumen Catheters are intended for use as short-term vascular access for hemodialysis. The catheters can be inserted in the femoral, subclavian or jugular vein as required.
Product codes
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Device Description
The Kendall Dual Lumen Catheters are single use, sterile devices. The single radiopaque cannula catheters have two distinct lumina which provide simultaneous "arterial" outflow and "venous" return. The catheters have two extension tubes, sach with a color-coded in-line clamp (red for arterial outflow, blue for venous return) and luer lock adapter. The catheters are sold in 8.5, 10.0 and 11.0 Fr sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, subclavian or jugular 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Non-Clinical Tests - Comparative testing of the Kendall Dual Lumen Catheters with the predicate device found similar physical and functional properties. Such criteria included flow rate, hemolysis and recirculation studies. Biocompatibility testing of the catheter components has also been performed.
Clinical Tests - No clinical testing was performed.
Test Conclusions - Biocompatibility testing of the Kendall Dual Lumen Catheters has demonstrated that they contain no bioactive components. Comparative testing of the Kendall product and predicate device have found them similar in design, physical and functional attributes.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
963446
Exhibit 10
510(k) Summary
In accordance with section 513(1)(3) of the SMDA and as described in 21 CFR Part 807.92 interim rule dated April 28, 1992, this summary is submitted by:
Kendall Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 Date: August 28, 1996
Contact Person 1.
David A. Olson, Regulatory Affairs Telephone: (508) 261-8530
2. Name of the Device
Hemodialysis System and Accessories Classification Name: Common or Usual Name: Vascular Access Catheters Kendall CURITY Dual Lumon Subclavian Proprietary Name: Catheters
3. Statement of Substantial Equivalence
The Kendall Dual Lumen Catheters are substantially equivalent in form, fit, function and intended use to the commercially available Neostar Dual Lumen Catheters, 510(k) No. K941851.
Description of Device ব
The Kendall Dual Lumen Catheters are single use, sterile devices. The single radiopaque cannula catheters have two distinct lumina which provide simultaneous "arterial" outflow and "venous" return. The catheters have two extension tubes, sach with a color-coded in-line clamp (red for arterial outflow, blue for venous return) and luer lock adapter. The catheters are sold in 8.5, 10.0 and 11.0 Fr sizes.
റ് Intended Use of the Device
The Kendal! Dual Lumen Catheters are intended for use as short-term vascular access for hemodialysis. The catheters can be inserted in the femoral, subclavian or jugular vein as required.
1
Product Comparison 6.
The Kendall Dual Lumen catheters are equivalent to the referenced predicate device in that they are the same design (single cannula, dual fumen), fabricated from similar materials and have equivalent indications for use.
7. Performance Data
Non-Clinical Tests - Comparative testing of the Kendall Dual Lumen Catheters with the predicate device found similar physical and functional properties. Such criteria included flow rate, hemolysis and recirculation studies. Biocompatibility testing of the catheter components has also been performed.
Clinical Tests - No clinical testing was performed.
Test Conclusions - Biocompatibility testing of the Kendall Dual Lumen Catheters has demonstrated that they contain no bioactive components. Comparative testing of the Kendall product and predicate device have found them similar in design, physical and functional attributes.