(206 days)
Not Found
No
The summary describes a physical medical device (catheter) and its intended use and performance testing, with no mention of AI or ML technology.
Yes
Explanation: The device is indicated for use in hemodialysis and apheresis, which are therapeutic treatments. It also facilitates other medical interventions like infusion and medication administration, all contributing to the treatment or management of a patient's condition.
No
The device is a Triple Lumen Catheter used for vascular access, hemodialysis, apheresis, and infusion, not for diagnosing conditions.
No
The device description clearly states it is a physical catheter made of thermosensitive polyurethane with multiple lumens, indicating it is a hardware medical device. The performance studies also focus on physical properties and biocompatibility of the material.
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 directly into a patient's vein for vascular access. Its primary functions are for hemodialysis, apheresis, infusion, power injection of contrast media, and central venous pressure monitoring. These are all procedures performed in vivo (within the living body), not in vitro (in a test tube or lab setting).
- Lack of Diagnostic Testing: The description focuses on the physical characteristics and intended uses of the catheter for accessing the vascular system and delivering or removing substances. There is no mention of the device being used to analyze samples or provide diagnostic information based on those analyses.
Therefore, the Trio-CT™ Triple Lumen Catheter is a medical device used for therapeutic and procedural purposes, 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 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
Hospital and/or Dialysis Center
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)
Bench/Performance Data/ Non-Clinical Testing:
- ISO 10555-1: Intravascular catheters -- sterile and single-use intravascular catheters -- part 1: general requirements. Performance Testing: Air Leak, Liquid Leak, Peak Tensile Force, Gravity Flow, Power Injection.
- ISO 11607-1: Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging systems [including: amendment 1 (2014)]. Performance Testing: Shipping and Shelf Life testing.
- ISO 11607-2: Packaging for terminally sterilized medical devices - part 2: validation requirements for forming, sealing and assembly processes [including: amendment 1 (2014)]. Performance Testing: Shipping and Shelf Life testing.
- ISO 594-1: conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - part 1: general requirements. Performance Testing: Gauging.
- ISO 594-2: Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - part 2: lock fittings. Performance Testing: Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding Stress Cracking.
Biocompatibility:
- Conducted in accordance with FDA guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process" and International Standard ISO 10993-1 "Biocompatibility Evaluation of Medical Devices - Part 1 Evaluation and Testing Within a Risk Management Process".
- Met biocompatibility requirements for externally communicating device with tissue and circulating blood contact for a prolonged (, Biological Reactivity Tests, In Vitro.
- SENSITIZATION: ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization, OECD 406 Guideline for Testing of Chemical, Test No. 406, Skin Sensitization.
- IRRITATION: ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for irritation and Skin Sensitization.
- ACUTE SYSTEMIC TOXICITY: ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests for c Systemic Toxicity, United States Pharmacopeia 40. National Formulary 35 (USP). General Chapter . Pyrogen test.
- SUBCHRONIC TOXICITY: ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Test for o Systemic Toxicity, OECD 407 Guidelines for the Testing of Chemical, Test No. 407, Repeated O Dose 28-Day Oral Toxicity Study in Rodents.
- GENOTOXICITY: ISO 10993-3 Biological Evaluation of Medical Devices Part 3: Tests for O Genotoxicity, Carcinogenicity, and Reproductive Toxicity, OECD 471 Guidelines for Testing of Chemicals, Test No. 471, Bacterial o Reverse Mutation Test, OECD 490 Guidelines for the Testing of Chemicals, Test No. 490. In Vitro o Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene.
- IMPLANTATION: ISO 10993-6 Biological Evaluation of Medical Devices Part 6: Tests for Local Effects After Implantation, United States Pharmacopeia 40, National Formulary 35 (USP), General Chapter , Biological Reactivity Tests, In Vivo, Implantation Test, Table 6: Evaluation of Encapsulation in the Implantation Test.
- HEMOCOMPATIBILITY: ASTM F756 Standard Practice for Assessment of Hemolytic Properties of o Materials, ISO 10993-4 Biological Evaluation of Medical Devices Part 4 Selection of o Tests for Interactions with Blood.
Key Results: The proposed device, Trio-CT™ Triple Lumen Catheter, is considered substantially equivalent to the predicate device, T3 CT (K123292) as demonstrated through non-clinical testing performed.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs in the United States.
June 14, 2019
Medical Components, Inc. (dba MedComp) Courtney Nix Regulatory Affairs Director, North America and Europe 1499 Delp Drive Harleysville, PA 19438
Re: K183219 Trade/Device Name: Trio-CTTM Triple Lumen Catheter Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: NIE Dated: May 16, 2019 Received: May 17, 2019
Dear Courtney Nix:
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 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 located 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 kits/trays 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 kits/trays. 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 kits contain Lidocaine and Chloroprep 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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. 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).
2
Sincerely,
Carolyn Y. Neuland, Ph.D. Assistant Division 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183219
Device Name Trio-CTTM Triple Lumen Catheter
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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See PRA Statement below.
4
Image /page/4/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "C" or a square with missing corners. Below the geometric shape, the word "med" is written in red, followed by "COMP" in black. The logo has a clean and modern design.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
| Section 6 | 510(k) SUMMARY | Traditional 510K |
|---|---|---|
| A. Submitter Information | ||
| Submitter Name: | Medical Components Inc. | |
| (dba Medcomp®) | ||
| Address: | 1499 Delp Drive | |
| Harleysville, PA 19438 USA | ||
| Registration Number: | 2518902 | |
| Contact Person: | Courtney Nix | |
| Regulatory Affairs Manager, | ||
| North America and EU | ||
| Date of Preparation: | 11/19/2018 | |
| B. Subject Device | ||
| Trade Name: | Trio-CT™ Triple Lumen Catheter | |
| Device: | Catheter, Hemodialysis, Triple Lumen | |
| Non-Implanted | ||
| Regulation Description: | Blood Access Device and Accessories | |
| Product Code: | NIE | |
| Regulation Number: | 876.5540 | |
| Class: | II | |
| Review Panel: | Gastroenterology/Urology | |
| C. Predicate Device | ||
| Predicate Trade Name: | MEDCOMP® T-3 CT | |
| 510(k) Number: | K123292 | |
| 510(k) Holder: | Medical Components Inc. | |
| Device: | Catheter, Hemodialysis, Triple Lumen | |
| Non-Implanted | ||
| Regulation Description: | Blood Access Device and Accessories | |
| Product Code: | NIE | |
| Regulation Number: | 876.5540 | |
| Class: | II | |
| Review Panel: | Gastroenterology/Urology | |
| D. 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
Medcomp®: Trio-CTTM Triple Lumen Catheter Section 6: 510(k) Site Summary
K183219 Page 1 of 5
6-1
5
Image /page/5/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized house or building, with the word "medCOMP" written in a combination of red and black below it. The "med" portion of the word is in red, while the "COMP" portion is in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Trio-CTTM Triple Lumen Catheter
media, central venous pressure monitoring, blood draws and infusion of medications. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.
E. Indications For Use
The Trio-CT™ Triple Lumen Catheter is indicated for use in attaining shortterm (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.
F. Intended Use
The Trio-CT™ Triple Lumen Catheter is a hemodialysis catheter that also has power iniection. infusion and pressure monitoring capabilities through one designated lumen
G. Comparison to Predicate Device(s):
| Attribute | Subject Device
Trio-CT™ Triple Lumen
Catheter | Predicate Device
T3 CT
(K123292) |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription
Indications for
Use | Prescription 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. | Prescription Use
The Medcomp® T3 CT
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 | 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 |
Table 6.1: 510(k) Summary Design Comparison Matrix
Medcomp®: Trio-CTTM Triple Lumen Catheter Section 6: 510(k) Site Summary
6
Image /page/6/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized house or building, with the word "med" in red and "COMP" in black underneath. The geometric shape is made up of thick red lines, creating a modern and abstract design.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Trio-CT™ Triple Lumen Catheter
| Definition
(From Product
| Code) | of contrast media. | of contrast media. | ||||||
|---|---|---|---|---|---|---|---|---|
| Short-term (, Biological Reactivity Tests, In Vitro |
SENSITIZATION
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for o Irritation and Skin Sensitization
- OECD 406 Guideline for Testing of Chemical, Test No. 406, Skin o Sensitization
IRRITATION
Medcomp®: Trio-CTTM Triple Lumen Catheter Section 6: 510(k) Site Summary
8
Image /page/8/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "C" or a partial square with an open side. Above the shape are two red triangles that form an arc. Below the shape, the word "medCOMP" is written in a lowercase, italicized font, with "med" in red and "COMP" in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Trio-CT™ Triple Lumen Catheter
- o ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for irritation and Skin Sensitization
ACUTE SYSTEMIC TOXICITY
- ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests for c Systemic Toxicity
- United States Pharmacopeia 40. National Formulary 35 (USP). General o Chapter . Pyrogen test
SUBCHRONIC TOXICITY
- ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Test for o Systemic Toxicity
- OECD 407 Guidelines for the Testing of Chemical, Test No. 407, Repeated O Dose 28-Day Oral Toxicity Study in Rodents
GENOTOXICITY
- ISO 10993-3 Biological Evaluation of Medical Devices Part 3: Tests for O Genotoxicity, Carcinogenicity, and Reproductive Toxicity
- OECD 471 Guidelines for Testing of Chemicals, Test No. 471, Bacterial o Reverse Mutation Test
- OECD 490 Guidelines for the Testing of Chemicals, Test No. 490. In Vitro o Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene
IMPLANTATION
- · ISO 10993-6 Biological Evaluation of Medical Devices Part 6: Tests for Local Effects After Implantation
- United States Pharmacopeia 40, National Formulary 35 (USP), General o Chapter , Biological Reactivity Tests, In Vivo, Implantation Test, Table 6: Evaluation of Encapsulation in the Implantation Test
HEMOCOMPATIBILITY
- ASTM F756 Standard Practice for Assessment of Hemolytic Properties of o Materials
- ISO 10993-4 Biological Evaluation of Medical Devices Part 4 Selection of o Tests for Interactions with Blood
J. Summary of Substantial Equivalence
In conclusion, the proposed device, Trio-CT™ Triple Lumen Catheter, is considered substantially equivalent to the predicate device, T3 CT (K123292) as demonstrated through non-clinical testing performed.
Medcomp®: Trio-CT™ Triple Lumen Catheter Section 6: 510(k) Site Summary
K183219 Page 5 of 5