(57 days)
Not Found
No
The document describes a physical medical device (catheter) and its intended use and features. There is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML.
No
The device is a catheter for vascular access and administration of various substances, which are supportive functions for medical procedures and monitoring, rather than directly treating a disease or condition.
No
The device is a catheter used for vascular access, hemodialysis, apheresis, and infusion, not for diagnosing medical conditions.
No
The device description clearly describes a physical catheter made of thermosensitive polyurethane with multiple lumens, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Trio-CT® Triple Lumen Catheter is a device inserted into a vein for vascular access. Its purpose is to facilitate procedures like hemodialysis, apheresis, infusion, and monitoring. It does not perform any diagnostic testing on samples taken from the body.
The device is a medical device used for treatment and access, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
- The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and 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 (comma separated list FDA assigned to the subject device)
NIE
Device Description
The Trio-CT® Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The catheter is available with straight or curved extensions in a variety of lengths to accommodate physician preference and clinical needs. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.
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
Adult
Intended User / Care Setting
qualified, licensed physician or other qualified health care professional under direction of a physician utilizing strict aseptic technique.
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)
Design validation performance testing was leveraged from the predicate device manufactured by Medical Components, Inc. Design verification performance testing was completed to confirm performance criteria of the subject device. Clinical testing was not required nor performed to support the substantial equivalence of these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 16, 2023
Medical Components Inc. (Dba MedComp) Danielle McKinney Regulatory Affairs Associate II 1499 Delo Drive Harleysville, Pennsylvania 19438
Re: K232945
Trade/Device Name: Trio-CT® Triple Lumen Catheter w/ Curved Extensions Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: Class II Product Code: NIE Dated: September 20, 2023 Received: September 20, 2023
Dear Danielle McKinney:
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 (the 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 the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 legally 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/tray. 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 found in the Code of
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
2
See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gema Gonzalez -S
Maura Rooney, MS Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232945
Device Name
Trio-CT® Triple Lumen Catheter w/ Curved Extensions
Indications for Use (Describe)
· The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------- | ----------------------------------------------- |
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U.S. Food and Drug Administration Center for Devices and Radiological Health Document Control Center (DCC) - W066-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
510(k) Summary Traditional 510(k): Original
1. Submitter Information:
510(k) Submitted By:
- Medical Components Inc. (Dba MedComp) 1499 Delp Drive Harleysville, PA 19438 United States of America
- Primary Correspondent: Danielle McKinney, Regulatory Affairs Associate II regulatory@medcompnet.com 843-467-5661
- Date Prepared: September 20, 2023
2. Subject Device Information:
| Trade Name: | Trio-CT® Triple Lumen Catheter w/ Curved Extensions |
|---|---|
| Common Name: | Triple Lumen Catheter |
| Regulation Name: | Blood Access Device and Accessories, |
| 21 CFR 876.5540 | |
| Device Class: | Class II |
| Classification Panel: | Gastroenterology/Urology |
| Product Code: | NIE |
3. Predicate Device Information:
| Trade Name (predicate): | Trio-CT™ Triple Lumen Catheter |
|---|---|
| Common Name (predicate): | Triple Lumen Catheter |
| Classification Regulation: | Catheter, Hemodialysis, Triple Lumen, Non-Implanted, |
| 21 CFR 876.5540 | |
| Device Class: | Class II |
| Classification Panel: | Gastroenterology/Urology |
| Product Code: | NIE |
| Predicate 510(k) Number: | 510(k) K183219 |
| Predicate 510(k) Owner: | Medical Components Inc. (Dba MedComp) |
5
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4. Device Description:
The Trio-CT® Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The catheter is available with straight or curved extensions in a variety of lengths to accommodate physician preference and clinical needs. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.
5. Indications for Use
- The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less . than 30 days) vascular access for hemodialysis and 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.
6. Summary of Technological Characteristics
The subject device has similar technological characteristics as the predicate device. The Trio-CT® Triple Lumen Catheters facilitate hemodialysis, intravenous administration of fluids or medications, and power injection of contrast media in patients in whom immediate central venous vascular access for short-term hemodialysis is deemed necessary based on the direction of a qualified, licensed physician. The catheter is not intended for use in pediatric patients. The Trio-CT® Triple Lumen Catheters utilize a symmetric/tapered tip design which facilitates insertion without a peelable introducer. The Trio-CT® Triple Lumen Catheters are made from medical-grade chemically-stable materials and are provided sterile and nonpyrogenic. The catheters can be inserted via the internal jugular vein, femoral vein or subclavian vein. While there are differences in the anatomic reference points utilized for properly identifying the insertion site and risks associated with each site, once the insertion site is identified, the implantation process utilizes the Seldinger insertion method to place the catheter. Regardless of insertion point selected, Trio-CT® Triple Lumen Catheters are to be inserted, manipulated and removed by a qualified, licensed physician or other qualified health care professional under direction of a physician utilizing strict aseptic technique. Based on the similarity of these technological characteristics, there are no changes that affect the safety or effectiveness of the Trio-CT® Triple Lumen Catheter w/ Curved Extensions.
7. Substantial Equivalence Discussion
The Substantial Equivalence Comparison Table (Table 2) below provides evidence to facilitate the substantial equivalence determination between the Trio-CT® Triple Lumen Catheter w/ Curved Extensions to the predicate device Trio-CT™ Triple Lumen Catheter.
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K232945 Page 3 of 5
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Table 2: Substantial Equivalence Comparison
| Description | Subject Device | Predicate Device | ||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device Trade | ||||||||||||||||||||||||||||||||||||||||||||||
| Name | Trio-CT® Triple Lumen Catheter w/ Curved | |||||||||||||||||||||||||||||||||||||||||||||
| Extensions | Trio-CT™ Triple Lumen Catheter | |||||||||||||||||||||||||||||||||||||||||||||
| 510(k) | ||||||||||||||||||||||||||||||||||||||||||||||
| submitter/holder | Medical Components Inc. (Dba MedComp) | Medical Components Inc. (Dba MedComp) | ||||||||||||||||||||||||||||||||||||||||||||
| 510(k) Number | K###### | K183219 | ||||||||||||||||||||||||||||||||||||||||||||
| Indications for | ||||||||||||||||||||||||||||||||||||||||||||||
| Use | The Trio-CT® Triple Lumen Catheter is indicated | |||||||||||||||||||||||||||||||||||||||||||||
| for use in attaining short-term (less than 30 days) | ||||||||||||||||||||||||||||||||||||||||||||||
| vascular access for hemodialysis and 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. | The Trio-CT® Triple Lumen Catheter is indicated | |||||||||||||||||||||||||||||||||||||||||||||
| for use in attaining short-term (less than 30 days) | ||||||||||||||||||||||||||||||||||||||||||||||
| vascular access for hemodialysis and 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. | ||||||||||||||||||||||||||||||||||||||||||||||
| Prescription/Over | ||||||||||||||||||||||||||||||||||||||||||||||
| -the-Counter Use | Prescription Use | Prescription Use | ||||||||||||||||||||||||||||||||||||||||||||
| Target Population | Adult | Adult | ||||||||||||||||||||||||||||||||||||||||||||
| Duration of Use | Short Term | Short Term | ||||||||||||||||||||||||||||||||||||||||||||
| Sterilization | ||||||||||||||||||||||||||||||||||||||||||||||
| Method | 1x and/or 2x EO Sterilized | 1x and/or 2x EO Sterilized | ||||||||||||||||||||||||||||||||||||||||||||
| Technical Specifications | ||||||||||||||||||||||||||||||||||||||||||||||
| Catheter French | ||||||||||||||||||||||||||||||||||||||||||||||
| Size | 13.5F | 13.5F | ||||||||||||||||||||||||||||||||||||||||||||
| Inner Diameters | Venous - 0.088" nominal | |||||||||||||||||||||||||||||||||||||||||||||
| Arterial – 0.088" nominal | ||||||||||||||||||||||||||||||||||||||||||||||
| Infusion - 0.042" nominal | Venous - 0.088" nominal | |||||||||||||||||||||||||||||||||||||||||||||
| Arterial - 0.088" nominal | ||||||||||||||||||||||||||||||||||||||||||||||
| Infusion - 0.042" nominal | ||||||||||||||||||||||||||||||||||||||||||||||
| Number of | ||||||||||||||||||||||||||||||||||||||||||||||
| Lumens | Three (3) | Three (3) | ||||||||||||||||||||||||||||||||||||||||||||
| Catheter Lengths | 12cm, 15cm, 20cm and 24cm | 12cm, 15cm, 20cm, 24cm and 30cm | ||||||||||||||||||||||||||||||||||||||||||||
| Priming Volume | ||||||||||||||||||||||||||||||||||||||||||||||
| (cc) | Length Center Arterial Venous 12cm 0.4 cc 1.4 cc 1.4 cc 15cm 0.4 cc 1.5 cc 1.5 cc 20cm 0.5 cc 1.7 cc 1.7 cc 24cm 0.5 cc 1.9 cc 1.9 cc | Length Center Arterial Venous 12cm 0.4 cc 1.2 cc 1.2 cc 15cm 0.4 cc 1.3 cc 1.3 cc 20cm 0.5 cc 1.5 cc 1.5 cc 24cm 0.5 cc 1.6 cc 1.6 cc 30cm 0.6 cc 1.9 cc 1.9 cc | ||||||||||||||||||||||||||||||||||||||||||||
| Power Injection | ||||||||||||||||||||||||||||||||||||||||||||||
| Pressure (psi) | Max | |||||||||||||||||||||||||||||||||||||||||||||
| Indicated | ||||||||||||||||||||||||||||||||||||||||||||||
| Power | ||||||||||||||||||||||||||||||||||||||||||||||
| Injection | ||||||||||||||||||||||||||||||||||||||||||||||
| Flow-Rate Average | ||||||||||||||||||||||||||||||||||||||||||||||
| Max | ||||||||||||||||||||||||||||||||||||||||||||||
| Catheter | ||||||||||||||||||||||||||||||||||||||||||||||
| Pressure | ||||||||||||||||||||||||||||||||||||||||||||||
| During Max | ||||||||||||||||||||||||||||||||||||||||||||||
| Indicated | ||||||||||||||||||||||||||||||||||||||||||||||
| Power | ||||||||||||||||||||||||||||||||||||||||||||||
| Injection | ||||||||||||||||||||||||||||||||||||||||||||||
| Flow Rate Average | ||||||||||||||||||||||||||||||||||||||||||||||
| Max Burst | ||||||||||||||||||||||||||||||||||||||||||||||
| Pressure Range of | ||||||||||||||||||||||||||||||||||||||||||||||
| Max Burst | ||||||||||||||||||||||||||||||||||||||||||||||
| Pressures 5 ml/sec 92 psi 314 psi 277-425 | ||||||||||||||||||||||||||||||||||||||||||||||
| psi | Max | |||||||||||||||||||||||||||||||||||||||||||||
| Indicated | ||||||||||||||||||||||||||||||||||||||||||||||
| Power | ||||||||||||||||||||||||||||||||||||||||||||||
| Injection | ||||||||||||||||||||||||||||||||||||||||||||||
| Flow-Rate Average | ||||||||||||||||||||||||||||||||||||||||||||||
| Max | ||||||||||||||||||||||||||||||||||||||||||||||
| Catheter | ||||||||||||||||||||||||||||||||||||||||||||||
| Pressure | ||||||||||||||||||||||||||||||||||||||||||||||
| During Max | ||||||||||||||||||||||||||||||||||||||||||||||
| Indicated | ||||||||||||||||||||||||||||||||||||||||||||||
| Power | ||||||||||||||||||||||||||||||||||||||||||||||
| Injection | ||||||||||||||||||||||||||||||||||||||||||||||
| Flow Rate Average | ||||||||||||||||||||||||||||||||||||||||||||||
| Max Burst | ||||||||||||||||||||||||||||||||||||||||||||||
| Pressure Range of | ||||||||||||||||||||||||||||||||||||||||||||||
| Max Burst | ||||||||||||||||||||||||||||||||||||||||||||||
| Pressures 5 ml/sec 84 psi 420 psi 332-446 | ||||||||||||||||||||||||||||||||||||||||||||||
| psi |
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K232945 Page 4 of 5
Image /page/7/Picture/1 description: The image shows the logo for MedComp. The logo consists of a red abstract shape on the left, followed by the word "med" in red and the word "COMP" in black. There is a period after the word "COMP".
| Description | Subject Device | Predicate Device | ||||||
|---|---|---|---|---|---|---|---|---|
| Flow Rate (ml/min) | Flow Rate (ml/min) | |||||||
| 200 | 300 | 400 | 200 | 300 | 400 | |||
| Flow (ml/min) vs | ||||||||
| Pressure (mmHg) | 12CM Venous | 20 | 41 | 61 | 12CM Venous | 20 | 30 | 51 |
| Arterial | -29 | -44 | -69 | Arterial | -21 | -40 | -60 | |
| 15CM Venous | 21 | 40- | 59 | 15CM Venous | 20 | 40 | 63 | |
| Arterial | -30 | -45 | -70 | Arterial | -26 | -46 | -70 | |
| 20CM Venous | 30 | 45 | 72 | 20CM Venous | 21 | 40 | 62 | |
| Arterial | -30 | -49 | -74 | Arterial | -30 | -50 | -70 | |
| 24CM Venous | 30 | 46 | 71 | 24CM Venous | 30 | 50 | 76 | |
| Arterial | -30 | -50 | -80 | Arterial | -33 | -50 | -80 | |
| 30CM Venous | 30 | 51 | 84 | |||||
| Arterial | -33 | -59 | -90 | |||||
| Principles of Operation | ||||||||
| Insertion Site | Jugular, femoral or subclavian vein | Jugular, femoral or subclavian vein |
8. Summary of Non-Clinical Testing and Standards
8.1 Biocompatibility
A biocompatibility evaluation was performed in accordance with the FDA Guidance 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Based on this evaluation, the following tests were conducted:
- ISO Muscle Implantation Study in Rabbits 4 Weeks ●
- USP Rabbit Pyrogen Study, Material Mediated ●
- ASTM Hemolysis Study ●
- SC5b-9 Complement Activation Assay ●
- ISO Guinea Pig Maximization Sensitization Test ●
- ISO Intracutaneous Study in Rabbits ●
- Cytotoxicity Study Using the ISO Elution Method
- ISO Acute Systemic Toxicity Study in Mice ●
- ISO Systemic Toxicity Study in the Rat, Repeated Parenteral Administration of Two ● Extracts, 28 Days
- Bacterial Reverse Mutation Study ●
- Genotoxicity: Mouse Lymphoma Assay ●
- Infrared Spectroscopy ●
- Mechanical Hemolysis Testing of Triple Lumen Catheters ●
- In Vivo GLP 30 Day Thromboresistance Study in Sheep- Jugular Vein
8.2 Performance Testing
Design validation performance testing was leveraged from the predicate device manufactured by Medical Components, Inc. Design verification performance testing was completed to confirm performance criteria of the subject device. Clinical testing was not required nor performed to support the substantial equivalence of these devices.
8
9. Conclusion
In conclusion, based on the non-clinical testing performed, the subject device Trio-CT® Triple Lumen Catheter w/ Curved Extensions is substantially equivalent to the predicate device Trio-CT™ Triple Lumen Catheter [510(k) K183219] and does not raise any concern for the safety and effectiveness of the subject device.