(113 days)
Not Found
No
The summary describes a physical medical device (a catheter) and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on the physical characteristics and equivalence to predicate devices.
Yes.
The device is used for hemodialysis and infusion, which are therapeutic interventions.
No
Explanation: The device is a chronic hemodialysis catheter, intended for treatment (dialysis, apheresis, infusion) rather than diagnosing a condition.
No
The device description clearly details physical components such as a polyurethane shaft, lumens, hub assembly, extension sets, and insertion stylets, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "acute and chronic hemodialysis, apheresis, and infusion." These are all procedures performed on the patient's body, not on samples taken from the patient's body for diagnostic purposes.
- Device Description: The description details a catheter designed for insertion into the body, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, or other biological samples, nor is there any mention of diagnostic purposes.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device is a therapeutic and access device used directly on the patient.
N/A
Intended Use / Indications for Use
The 14.5 Fr Chronic Hemodialysis Catheter with Insertion Stylets is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down.
Product codes
MSD
Device Description
The 14.5 Fr Chronic Hemodialysis Catheter has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The tip of the Maxid catheter is staggered, while the Palindrome is symmetrical. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The insertion stylets are polyethylene, and extend the full length of the catheter and protrude from the tip. The purpose of the insertion stylet is to provide the clinician with an additional option for catheter placement.
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
Performance data for the insertion stylets of the 14.5 Fr Chronic Hemodialysis Catheters is compared to the design requirements of the predicate devices identified in this 510(K) summary. Results of verification / validation demonstrate that the new catheter/insertion stylet configuration is substantially equivalent to the legally marketed device.
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
K051584 page. 2 of 2
OCT 6 - 2005
15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 • (508) 261-8000
510(k) Premarket Notification 14.5Fr Chronic Hemodialysis Catheter with insertion stylets
Section B - 510(K) Summary
| Date Summary
| Was Prepared: | June 9, 2005 |
|---|---|
| Submitter's | |
| Information: | Kendall |
| a Division of Tyco Healthcare Group LP | |
| 15 Hampshire Street | |
| Mansfield, MA 02048 | |
| Phone: 508-261-8000 | |
| Fax: 508-261-8461 | |
| Contact: | James Welsh |
| Vice President, Regulatory Affairs | |
| Kendall | |
| a Division of Tyco Healthcare Group LP | |
| Telephone: 508-261-8532 | |
| Fax: 508-261-6694 | |
| Device Trade | |
| Name: | 14.5 Fr Chronic Hemodialysis Catheter with insertion stylets |
| Device Common | |
| Name: | Catheter, Hemodialysis, Apheresis, Intravascular |
Classification Panel: Gastroenterology
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
The new configurations of 14.5 Fr Chronic Hemodialysis Catheters are substantially equivalent to the existing Maxid™ and Palindrome™ 14.5 Fr Chronic Hemodialysis Catheters in intended use, materials, physical characteristics, and performance characteristics. The modification attributed to the predicate device is the addition of insertion stylets for use during catheter placement.
1
KENDALL 16 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 · (508) 261-8000
510(k) Premarket Notification 14.5Fr Chronic Hemodialysis Catheter with insertion stylets
Section B - 510(K) Summary
Device Description:
The 14.5 Fr Chronic Hemodialysis Catheter has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The tip of the Maxid catheter is staggered, while the Palindrome is symmetrical. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The insertion stylets are polyethylene, and extend the full length of the catheter and protrude from the tip. The purpose of the insertion stylet is to provide the clinician with an additional option for catheter placement.
Intended Use:
The 14.5 Fr Chronic Hemodialysis Catheters are intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.
Performance Data: Performance data for the insertion stylets of the 14.5 Fr Chronic Hemodialysis Catheters is compared to the design requirements of the predicate devices identified in this 510(K) summary. Results of verification / validation demonstrate that the new catheter/insertion stylet configuration is substantially equivalent to the legally marketed device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers, and a wavy line below that suggests a body or tail.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 - 2005
Mr. James Welsh Vice President, Regulatory Affairs Tyco Healthcare/Kendall 15 Hampshire Street MANSFIELD MA 02048
Re: K051584
Trade/Device Name: 14.5 Fr. Chronic Hemodialysis Catheter with Insertion Stylets Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: September 2, 2005 Received: September 7, 2005
Dear Mr. James Welsh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beenen overy promotive is substantially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce ass stated in the encreated of the Medical Device Amendments or to devices that prov to May 20, 1970, and enclance with the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in aberefore, 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, tray and sport pack (mini kit) have either been determined as substantially equivalent under the kit, the spert paces (Section 510(k) of the act), or were on the market prior to May the promation necessariant date of the Medical Device Amendments. Please note: If you purchase 20, 1770, the enatinent uno ult (i.e., unfinished) and further process (e.g., sterilize) you must your device components in outs (no, atese components in your kit, tray and sport pack (mini kit). Submit a new 910(x) between and the Act include requirements for annual registration, listing of I ne general conances 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 rr your de rice to additional controls. Existing major regulations affecting your device can be found inay of Subject to additional other 2007 - Internations of the 2006. 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 I least be advised that i Dr is issualled or device complies with other requirements of the Act or any I DA has made a decommistered by other Federal agencies. You must comply with all
3
Page 2 - Mr. James Welsh
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 tray contains lidocaine, 1%, and povidone-iodine swab sticks, 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 (240) 276-0115. 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/cdrh/industry/support/index.html.
Sincerely vours,
David W. Ayres
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 · (508) 261-8000
510(k) Premarket Notification 14.5Fr Chronic Hemodialysis Catheter with insertion stylets
Appendix 1
Indications for Use Statement
Device Name:
14.5 Fr Chronic Hemodialysis Catheter with Insertion Stylets
Indications for Use:
The 14.5 Fr Chronic Hemodialysis Catheter with Insertion Stylets is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down.
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_
David R. Jesson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number