(56 days)
Not Found
No
The summary describes a physical medical device (catheter) with coatings and a sleeve for reducing platelet adhesion and microbial colonization. There is no mention of software, algorithms, data analysis, or any other components that would suggest the use of AI or ML. The performance studies are based on bench and animal testing of the physical properties and effects of the coatings and sleeve.
Yes
The device is intended for acute and chronic hemodialysis, apheresis, and infusion, which are therapeutic procedures. Additionally, the heparin coating and silver-impregnated sleeve are designed to provide therapeutic benefits by reducing platelet adhesion and microbial colonization, respectively.
No
The device is a chronic hemodialysis catheter, used for treatment (hemodialysis, apheresis, and infusion), not for diagnosing conditions.
No
The device description clearly outlines a physical catheter with specific material properties (polyurethane, silicone), coatings (heparin), and an impregnated sleeve (silver). The performance studies focus on the physical and biological interactions of this hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Kendall 14.5 Fr Chronic Hemodialysis Catheter is an implantable medical device designed to be inserted into a patient's veins for procedures like hemodialysis, apheresis, and infusion. It directly interacts with the patient's circulatory system.
- Intended Use: The stated intended use is for performing medical procedures on a patient, not for analyzing samples taken from a patient.
- Device Description: The description details the physical components of the catheter and its coatings, all of which are designed for direct patient contact and function within the body.
- Performance Studies: The performance studies focus on the catheter's ability to reduce platelet adhesion and microbial colonization on the catheter surface while implanted in the body or in simulated in-vivo conditions. These are not studies related to analyzing patient samples.
In summary, the device is a therapeutic and procedural device, not a diagnostic one that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.
The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.
The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.
Product codes
MSD
Device Description
The proposed Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. The proposed catheter also contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data for the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is compared to that of the predicate device identified in this 510(K) summary.
The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by:
- A two hour circulating blood loop test demonstrating a 60% reduction in platelet adhesion on the catheter surface at p
§ 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
K062671 fige 1.t'4
Special 510(k) : Device Modification Special 14.5 Fr Chronic Hounteanon
Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™)
510(k) Summary
| Date Summary
| Was Prepared: | November 1, 2006 | NOV - 3 2006 |
|---|---|---|
| Submitter's | ||
| Information: | Kendall, a Division of Tyco Healthcare Group LP | |
| 15 Hampshire Street | ||
| Mansfield, MA 02048 | ||
| Phone: 508-261-8000 | ||
| Fax: 508-261-6644 | ||
| Contact: | Keith Martin | |
| Manager, Regulatory Affairs | ||
| Kendall, a Division of Tyco Healthcare Group LP | ||
| Telephone: 508-261-8440 | ||
| Fax: 508-261-8461 | ||
| Device Trade | ||
| Name: | 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating | |
| and Silver Impregnated Sleeve (Palindrome™ Sapphire™) | ||
| Device Common | ||
| Name: | Catheter, Hemodialysis, Implanted, Coated | |
| Classification Panel: | Gastroenterology |
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is substantially equivalent to Kendall's 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating (Palindrome™ Emerald™, K060509) in intended use, materials, physical characteristics, and performance characteristics. The modification attributed to the predicate device is the addition of a silver impregnated sleeve to the external surface of the catheter from the hub to the cuff to reduce catheter colonization in the subcutaneous tunnel tract. This silver impregnated sleeve is the same sleeve used on the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) cleared for marketing via K060972 on August 4, 2006. K060972 is within the same device classification regulation (876.5540) as the unmodified predicate device, and has the same intended use. No other modifications have been made to either the silver impregnated sleeve or the predicate device, including the heparin coating.
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Special 510(k) : Device Modification Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™)
Device Description:
The proposed Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™) Sapphire™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. The proposed catheter also contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.
Indications / Intended Use:
The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days was supported by bench and animal testing.
Performance Data:
Performance data for the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is compared to that of the predicate device identified in this 510(K) summary. Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device.
Test Summary:
The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by:
- A two hour circulating blood loop test demonstrating a 60% reduction in platelet adhesion on the catheter surface at p