(64 days)
Not Found
No
The description focuses on the physical design and intended use of a catheter, with no mention of AI or ML capabilities. The performance studies described are bench-top functional tests, not related to algorithmic performance.
Yes
The device is described as a catheter used for hemodialysis, apheresis, and infusion, which are medical procedures performed to treat or manage a patient's health condition.
No
The device description and intended use indicate it is a catheter for hemodialysis, apheresis, and infusion, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly details a physical catheter with a shaft, lumens, luer adapters, extension tubes, clamps, a hub assembly, suture wings, a cuff, and a distal tip. This is a hardware medical device.
Based on the provided text, 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 procedures performed directly on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The description details a catheter designed for insertion into the vasculature. This is a medical device used for treatment and access, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is clearly designed for therapeutic and access purposes within the body.
N/A
Intended Use / Indications for Use
The Palindrome™ RT Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral insertion.
Product codes
MSD
Device Description
The Palindrome™ RT Chronic Catheter is supplied with a detached "proximal end" allowing for the catheter tip to be positioned in the vasculature before the catheter shaft is pulled through the patient's subcutaneous tunnel tract in a retrograde manner. The fully assembled Palindrome™ RT Chronic Catheter has a 15.0 Fr. radiopaque shaft with two large inner lumens designed in an opposing "double D" configuration. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the hub assembly which includes suture wings. The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical distal tip configuration.
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
Bench top functional testing was completed to support substantial equivalence between the modified device and the current device. The test protocol evaluated the device's Catheter to Tunneler Attachment Strength and Catheter to Tunneler Retention Strength. The results of the performance testing show that the modified device continues to meet the relevant product specifications. These results support the determination of substantial equivalence.
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
K111817
page 1 of 2
AUG 3 0 2011
510(K) SUMMARY
1. 510(k) Owner:
Covidien 15 Hampshire Street Mansfield, MA 02048
Contact: Mr. Wing Ng Title: Manager, Regulatory Affairs Telephone: (508) 261 - 6596 Fax: (508) 261 - 8149 Date Prepared: June 23, 2011
2. Device:
Trade Names: Palindrome™ RT Chronic Catheter Common Name: Hemodialysis Catheter Classification Name: Implanted Hemodialysis Catheter Regulation Number: 21 CFR 876.5540 Product Code: MSD Classification: Class III
3. Predicate Devices:
Palindrome™ RT Chronic Catheter (K092205 and K111372)
4. Device Description:
The Palindrome™ RT Chronic Catheter is supplied with a detached "proximal end" allowing for the catheter tip to be positioned in the vasculature before the catheter shaft is pulled through the patient's subcutaneous tunnel tract in a retrograde manner. The fully assembled Palindrome™ RT Chronic Catheter has a 15.0 Fr. radiopaque shaft with two large inner lumens designed in an opposing "double D" configuration. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the hub assembly which includes suture wings. The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical distal tip configuration.
1
5. Intended Use:
The Palindrome™ RT Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral insertion.
6. Technological Characteristics:
The modified device has the same technological characteristics as compared to the predicate device.
7. Performance Data:
Bench top functional testing was completed to support substantial equivalence between the modified device and the current device. The test protocol evaluated the device's Catheter to Tunneler Attachment Strength and Catheter to Tunneler Retention Strength. The results of the performance testing show that the modified device continues to meet the relevant product specifications. These results support the determination of substantial equivalence.
8. Conclusion:
Based on non-clinical testing results, Covidien has demonstrated that the modified Palindrome™ RT Chronic Catheter is substantially equivalent to the existing Palindrome™ RT Chronic Catheter (K092205 and K111372).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of an eagle or bird-like figure. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Wing Ng Manager, Regulatory Affairs Covidien Vascular Therapies 15 Hampshire Street MANSFIELD MA 02048
File 3 0 2011
Re: K111817
KTT1617
Trade/Device Name: Palindrome™ RT Chronic Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: August 7, 2011 Received: August 12, 2011
Dear Mr. Ng:
We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 3 i0(x) pecifically equivalent to legally marketed
referenced above and have determined the device is substantially equivalent date of referenced above and have determined the device is substantials and the enatment date of predicate devices marketed in metstate colimients por weeks ified in accordance with the the Medical Device Amendments of to devices intentions of therefore, market the provisions of the Federal Food, Drug, and Cosment Free Act. However, you are responsible to
device, subject to the general controls provisions of the Act. However, you are r device, subject to the general controls of the Act how hit have either been determined
determine that the medical devices you use as components in the kit have and determine that the medical devices you use as conficulion process (Section 510(k) of the act),
as substantially equivalent under the premarket notification process (Section 5 as substantially equivalent uner the promation proosts (are of the Medical Device
or were legally on the market prior to May 28, 1976, the enament in bulk (i.e., unfinished) or were legally on the market prob to May 26, 1970, the enamments in bulk (i.e., unfinished)
Amendments. Please note: If you purchase your device including these Amendments. Please not? II you purchase your as now 510(k) before including these and further process (e.g., sterlize) you must submit it its (records) of the Act include requirements for
components in your kit. The general controls provisions of the Act components in your kif. The general controls be novacious be not labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
Cass III (See above), and entire Firsting major regulations affecting yo If your device is classified (see above) into entre regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affecting y it may be subject to additional controls. Existing major regardo of 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 800 in the Fe found in the Code of Federal Regulations, This 20, C
publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Wing Ng
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substition with other requirements of the Act
that FDA has made a determination that your device Ederal For must that FDA has made a determination in a your are over Federal agencies. You must
or any Federal statutes and regulations administered by other its registration and listin or any Federal statutes and regulations and institution of registration and listing (21
comply with all the Act's requirements, including, but not answering of medical comply with all the Act s requirements, includes to and the reporting of medical
CFR Part 807); labeling (21 CFR Part 200); medical device requirements as CFR Part 807); labeling (21 CFK Parl 807); good manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practice requiremen device-related adverse evenis) (21 CFR Pat 200): age if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QS) regulation (DF Of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r (15809 html (1588) by (11) (1) CDRLL(CDRHOffices/wcm) 15809 htm for If you desire specific advice for your devices offices/ucm1/158/ucm1/15809.html for the go to http://www.fda.gov/AboutrDA/CCMcr3O116cs Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH) starket notifiestion" (21CFR Part the Center for Devices and Radiological Treams of comments incitition." (2) CFR Part
note the regulation entitled, "Misbranding by reference versear veder the MDR regulation note the regulation entitled, "Misolanding by reference to promations of the MDR regulation (21)
807.97). For questions regarding the reporting of adverse events under the M CFR Part 803), please go to
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.html for the CDRH's Office http://www.ida.gov/wiedicalles/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general informational and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its toll-(800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Helene Lemay
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Section 4 Indications for Use Statement
510(k) Number (if known): To Be Determined
Device Name: Palindrome™ RT Chronic Catheter
Indications for Use:
The Palindrome™ RT Chronic Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral insertion.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard Lewis
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111817