(232 days)
No
The description focuses on the physical characteristics and intended use of a catheter, with no mention of AI or ML.
Yes
The device is indicated for use in attaining short-term vascular access for hemodialysis and apheresis, which are therapeutic procedures.
No
The device is a vascular access catheter for hemodialysis, apheresis, and infusion, including power injection of contrast media and central venous pressure monitoring; it does not diagnose medical conditions.
No
The device description clearly details a physical catheter made of polyurethane with specific lumen configurations, extensions, and a hub. This is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "attaining short-term vascular access for hemodialysis, apheresis," and for "infusion, power injection of contrast media and central venous pressure monitoring." These are all procedures performed on the patient, not on samples taken from the patient to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into a vein to facilitate fluid exchange and monitoring within the patient's circulatory system. This is consistent with a medical device used for treatment and monitoring, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information.
Therefore, the Medcomp® T3 T catheter is a medical device used for therapeutic and monitoring purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medcomp® T3 T catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.
Product codes
NIE
Device Description
The T3 CT is a triple lumen catheter with a designated lumen for power injection, infusion or pressure monitoring. Each catheter lumen terminates through an extension to a female luer- lock connector. Each extension has an in-line clamp to control fluid flow and the clamp I.D. Ring is marked with the priming volume plus power injection rate is printed on the center clamp. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size, lumen length and both the company and catheter design name. The outer extensions are clear and marked with "Do Not Power Inject" and the center extension is a translucent purple pigment printed with "Power Injectable". The catheter is available with either straight or curved out extensions.
The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material with barium sulfate for radiopacity. At bodv temperature the catherer lumen becomes softer to reduce the risk of vessel trauma.
The catheter hub and extensions are molded from soft pliable polyurethane to increase patient comfort. The suture wing is flexible with suture holes for catheter securement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular, femoral or subclavian 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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K121848, K091953, K020465, K981125, K091586, K070003, K072509, K053345
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
| K123292 | |||
|---|---|---|---|
| pg 1 of 2 | |||
| Section 5 | 510(k) SUMMARY | Traditional 510K | |
| Submitter Information: | JUN 1 1 2013 | ||
| Submitter: | MEDCOMP® | ||
| 1499 Delp Drive | |||
| Harleysville, PA 19438 | |||
| (215) 256-4201 Telephone | |||
| (215) 256-9191 Fax | |||
| 1499 Delp Drive | |||
| Harleysville, PA 19438 | Contact: | Timothy Holwick, Regulatory Associate | |
| Date Prepared: | October 15, 2012 | ||
| Tel: 215-256-4201 | Device Name: | T3 CT | |
| Fax: 215-256-1787 | Common Name: | ||
| Classification Name: | Catheter, Hemodialysis, Triple-Lumen, Non-implanted | ||
| Blood Access device and accessories (a)(2)(b)(2) | |||
| www.medcompnet.com | C.F.R. Section: | 876.5540 | |
| Classification Panel: | |||
| Class: | Gastroenterology and Urology | ||
| II, 78 NIE | |||
| Predicate Devices: | |||
| Primary: | K033570, T3 concurrence date September 16, 2004. Class II CFR §876.5540 | ||
| K083675, Power-Trialysis™ Short Term Dialysis Catheter, concurrence date March 19, 2009. Class II CFR §876.5540 | |||
| K102605, MAHURKAR™ Triple Lumen Catheter, concurrence date December 22, 2000. Class II CFR §876.5540 | |||
| Secondary: | K121848, SCIII Chronoflex, concurrence date September 21, 2012. Class III CFR §876.5540 | ||
| K091953, Pro-Picc CT, concurrence date September 16, 2009. Class II CFR §876.5970 | |||
| K020465, Ash Split Cath II, concurrence date May 22, 2002. Class III CFR §876.5540 | |||
| K981125, Silicone Tesio, concurrence date February 26, 1999. Class III CFR §876.5540 | |||
| K091586, Vascu-Picc and Midline Catheters, concurrence date July 23, 2009. Class II CFR §876.5970 | |||
| K070003, Power Injectable Implantable Port concurrence date May 15, 2007. Class II CFR §876.5965 | |||
| K072509, Pro- Picc CT, concurrence date November 22, 2007. Class II CFR§876.5970 | |||
| K053345-Pro-Line CT-Power-Injectable-CVC. concurrence date March 17, 2006 - Class II - CFR §880.5970 | |||
| Device Description: | |||
| The T3 CT is a triple lumen catheter with a designated lumen for power injection, infusion or pressure monitoring. Each catheter lumen terminates through an extension to a female luer- lock connector. Each extension has an in-line clamp to control fluid flow and the clamp I.D. Ring is marked with the priming volume plus power injection rate is printed on the center clamp. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size, lumen length and both the company and catheter design name. The outer extensions are clear and marked with "Do Not Power Inject" and the center extension is a translucent purple pigment printed with "Power Injectable". The catheter is available with either straight or curved out extensions. | |||
| Medcomp T3 CT Summary | Page 1 of 2 |
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K123292
pg 2 of 2
Image /page/1/Picture/2 description: The image shows a logo for medCOMP. The logo consists of a stylized geometric shape above the word "medCOMP." The geometric shape is made up of black and white lines and angles, creating a modern and abstract design. The word "medCOMP" is written in a lowercase, italicized font.
1499 Delp Drive
Harlevsville. PA 19438
Tel: 215-256-4201
Fax: 215-256-1787
The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material with barium sulfate for radiopacity. At bodv temperature the catherer lumen becomes softer to reduce the risk of vessel trauma.
The catheter hub and extensions are molded from soft pliable polyurethane to increase patient comfort. The suture wing is flexible with suture holes for catheter securement.
Intended Used:
This is a hemodialysis catheter with power injection. infusion and pressure monitoring canabilities through one designated lumen.
Indications for Use:
The Medcomp® T3 " catheter is a triple lumen catherer indicated for use in attaining shortterm vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
The catheter is intended to be inserted in the jugular. femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.
Comparison to Predicate Devices:
The T3 " catheter is substantially equivalent to the predicate devices in terms of intended use, materials. anatomical location, basic design, performance, labeling, manufacturing process and method of sterilization.
Performance Standards:
Performance standards have not been established by the FDA under section 514 of the Federal Food. Drug and Cosmetic Act.
Biocompatibility:
Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993. All materials have been cleared under past approved 510K's. .
Technological Characteristics:
The principles of operation are the same as the predicate devices. There are no new questions raised regarding the safer or effectiveness of the device.
Summary of Substantial Equivalence:
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
The proposed device meets the performance criteria of design verification as specified by ISO standards. guidance documents and test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three overlapping curved lines, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is printed in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2013
Medcomp® % Mr. Timothy Holwick Regulatory Associate 1499 Delp Drive HARLEYSVILLE PA 19438
Re: K123292
Trade/Device Name: T3CT Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II . Product Code: NIE Dated: May 1, 2013 Received: May 2, 2013
Dear Mr. Holwick:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, 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 have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it · may be subject to additional controls. Existing major regulations affecting your device can be
3
Page 2 - Mr. Timothy Holwick
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 kit contains Lidocaine and Chloraprep 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 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 (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
4
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K123292
Device Name: __ T3 CT
Indications for Use:
The Medcomp® T3 T catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.
X Over-The-Counter Use Prescription Use AND/OR (21-CFR 801-Subpart C) (Part 21-CFR-801-Subpart D)-
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/9 description: The image shows the name Benjamin R. Fisher -S, followed by the date and time 2013.06.11 18:14:40 -04'00'. The text appears to be a timestamp or record of some kind. The text is black and the background is white.
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123292 510(k) Number
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