(309 days)
K/DEN number and list them here in a comma separated list exactly as they appear in the text:
K020089
No
The device description and performance studies focus on the physical properties and in-vitro performance of a vascular catheter, with no mention of AI or ML technologies.
Yes
The device is indicated for use in attaining short-term vascular access for hemodialysis, apheresis, and infusion, all of which are medical treatments or procedures.
No
The Medcomp® T-3 catheter is used for vascular access for hemodialysis, apheresis, and infusion, which are therapeutic and access functions, not diagnostic ones.
No
The device description clearly details a physical catheter made of polyurethane with lumens, extensions, hubs, and clamps, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "attaining short-term vascular access for hemodialysis, apheresis and infusion." This involves direct interaction with the patient's circulatory system for therapeutic and access purposes.
- Device Description: The description details a catheter designed for insertion into veins to facilitate blood removal and return, and fluid infusion. This is a medical device used in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs typically involve tests performed on samples like blood, urine, or tissue outside the body.
The device described is a vascular access catheter, which is a type of medical device used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
THE MEDCOMP® T-3 CATHETER IS INDICATED FOR USE IN ATTAINING SHORT-TERM VASCULAR ACCESS FOR HEMODIALYSIS, APHERESIS AND INFUSION.
IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN OF AN ADULT PATIENT. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN.
THE MEDCOMP® T-3 CATHETER IS INDICATED FOR A DURATION LESS THAN (30) DAYS.
Product codes
NIE
Device Description
The Medcomp® T-3 catheter is a 15.5 polyurethane, triple lumen catheter used to remove and return blood with a third internal lumen for infusion. The Medcomp® T-3 catheter is comprised of a soft thermosensitive, radiopaque polyurethane material that is rigid upon insertion and once it reaches body temperature becomes soft to reduce vessel trauma. The lumens are connected to the extensions via a soft pliable hub with a suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. The luers and clamps are color coded, red for arterial, blue for venous and a clear luer for infusion of drugs, TPN or fluid administration.
The catheters are available in 15.5F. The catheter is offered in 28 and 32cm.
The Medcomp® T-3 catheter is packaged with the necessary accessories to facilitate catheter insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Internal Jugular Vein, Subclavian Vein
Indicated Patient Age Range
Adult patient
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)
In-vitro performance data for the Medcomp® T-3 catheter including force at break, air and liquid leakage, recirculation, and flow performance demonstrate that this device is substantially equivalent to the legally marketed predicate devices. In vitro testing was performed on the Medcomp® T-3 catheter to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3.
Clinical safety and effectiveness is addressed in 510(K)020089.
Biocompatibility testing on the Medcomp® T-3 catheter demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
020089
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
K03357-D
SEP 16 2004
510(k) SUMMARY
A. Submitter Information:
| Submitter: | MEDCOMP®
1499 Delp Drive
Harleysville, PA 19438
(215) 256-4201 Telephone
(215) 256-9191 Fax |
|-----------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Jean Callow
Regulatory Specialist |
| Date Prepared: | April 27, 2004 |
| Trade Name: | Medcomp® T-3 |
| Common Name: | Hemodialysis, Apheresis and
Infusion Catheter, Non-implanted |
| Classification: | NIE |
| C.F.R. Section: | 876.5540 |
C. Predicate Devices:
B.
K020089 Mahurkar8 Triple Lumen Catheter K973561 Medcomp® Tri-Flow™
Triple Lumen Catheter
D. Device Description:
The Medcomp® T-3 catheter is a 15.5 polyurethane, triple lumen catheter used to remove and return blood with a third internal lumen for infusion. The Medcomp® T-3 catheter is comprised of a soft thermosensitive, radiopaque polyurethane material that is rigid upon insertion and once it reaches body temperature becomes soft to reduce vessel trauma. The lumens are connected to the extensions via a soft pliable hub with a suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. The luers and clamps are color coded, red for arterial, blue for venous and a clear luer for infusion of drugs, TPN or fluid administration.
The catheters are available in 15.5F. The catheter is offered in 28 and 32cm.
The Medcomp® T-3 catheter is packaged with the necessary accessories to facilitate catheter insertion.
E. Intended Use:
The Medcomp® T-3 catheter with a third internal lumen for infusion is indicated for use in attaining short-term vascular access for hemodialysis
1
K033570 Page 2 of 2
and apheresis. The third lumen allows infusion of fluids, medications, and/or when nutritional therapy is prescribed.
This catheter may be inserted via the subclavian vein.
Comparison to Predicate Devices: F.
The Medcomp® T-3 catheter is substantially equivalent to the predicate devices in terms of its intended use, insertion method, anatomical location, design, material type, performance and method of sterilization.
G. Performance Data:
In-vitro performance data for the Medcomp® T-3 catheter including force at break, air and liquid leakage, recirculation, and flow performance demonstrate that this device is substantially equivalent to the legally marketed predicate devices. In vitro testing was performed on the Medcomp® T-3 catheter to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3.
Clinical safety and effectiveness is addressed in 510(K)020089.
Biocompatibility testing on the Medcomp® T-3 catheter demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
SEP 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jean Callow Regulatory Specialist MEDCOMP® 1499 Delp Drive HARLEYSVILLE PA 19438
Re: K033570
Trade/Device Name: Medcomp® T-3 Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: 78 NIE Dated: August 25, 2004 Received: September 7, 2004
Dear Ms. Callow:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector b re(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) is regard and date of the Medical Device Amendments or to commerce price to May 20, 1978, and encordance with the provisions of the Federal Food, Drug, devices may nave occh roomssined in acefore, market the device, subject to the general controls and Cosmede Hot (710). "Totallary interesponsible to determine that the medical devices you provisions of the ret. "10 nove bey your been determined as substantially equivalent under the use as components in the kir nave etates 10(k) of the act), or were legally on the market prior to premarket notification process (Section of the Medical Device Amendments. Please note: If you May 28, 1770, the onleanen and on bellk (i.e., unfinished) and further process (e.g., sterilize) purchase your de ried bonny before including these components in your kit. The general you must submit a now 9 rocts, octode requirements for annual registration, listing of devices, controls provibions of tictice, and 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 your device is classified (500 a00 v). Existing major regulations affecting your device can be it may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 – Ms. Jean Callow
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 or any I vith all the Act's requirements, including, but not limited to: registration (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bettronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms tetet notification. The FDA finding of substantial equivalence of your device to a legally premaind newice 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 the labeling de not to proobed to 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 I va may 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/dsma/dsmamain.html.
Sincerely yours,
Daniel A. Layman
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: K033570
Device Name: MEDCOMP® T-3
Indications for use:
THE MEDCOMP® T-3 CATHETER IS INDICATED FOR USE IN ATTAINING SHORT-TERM VASCULAR ACCESS FOR HEMODIALYSIS, APHERESIS AND INFUSION.
IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN OF AN ADULT PATIENT. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN.
THE MEDCOMP® T-3 CATHETER IS INDICATED FOR A DURATION LESS THAN (30) DAYS.
(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)
510(k) Number _
OR
Over-The-Counter
David R. Segerson
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices