(64 days)
No
The 510(k) summary describes a physical medical device (catheter) and its intended use and performance testing, with no mention of AI or ML capabilities.
Yes.
The device facilitates hemodialysis and apheresis treatments, which are medical therapies for conditions that would otherwise cause disease or death.
No
The device is a catheter for vascular access for hemodialysis and apheresis, and for intravenous therapy, blood draws, and medication infusion. It is used for treatment and access, 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The description clearly states the device is a catheter used for vascular access for procedures like hemodialysis and apheresis. It is inserted into the body (specifically, veins) to facilitate the flow of blood for treatment.
- Intended Use: The intended use is for "attaining Short-Term vascular access," not for performing diagnostic tests on samples.
Therefore, the 12F Tri-Flow Triple Lumen Catheter is a therapeutic device used for treatment, not a diagnostic device used for testing.
N/A
Intended Use / Indications for Use
The 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein as required. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days.
Product codes (comma separated list FDA assigned to the subject device)
NIE
Device Description
The 12F Tri-Flow Triple Lumen Catheter is a short term 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 (clear) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, blood draws and infusion of medications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, subclavian vein, and femoral vein
Indicated Patient Age Range
adult patient
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: Air Leak, Catheter Leak, Extension-Hub, Extrusion-Hub, Gravity Flow
ISO 11607-1: Shipping and Shelf Life testing
ISO 11607-2: Shipping and Shelf Life testing
ISO 594-1: Gauging
ISO 594-2: Liquid Leakage Air Leakage Separation Force Unscrewing Torque Ease of Assembly Resistance to Overriding Stress Cracking
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.
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). 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.
July 5, 2018
Medical Components Inc. (Dba Medcomp) Courtney Nix Regulatory Affairs Manager, North America and Europe 1499 Delo Drive Harleysville, PA 19438
Re: K181175
Trade/Device Name: 12F Tri-Flow Triple Lumen Catheter Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: NIE Dated: April 18, 2018 Received: May 2, 2018
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. 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 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); 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for
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
2
Indications for Use
510(k) Number (if known) K181175
Device Name 12F Tri-Flow Triple Lumen Catheter
Indications for Use (Describe)
The 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein as required. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days.
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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3
K181175
Page 1 of 6
Medcomp®: 12F Tri-Flow Triple Lumen Catheter
| | Section 6
510(k) SUMMARY | Traditional 510K |
|--|-----------------------------|------------------------------------------------------------------------------------------------|
| | A. Submitter Information | |
| | Submitter Name: | Medical Components Inc.
(dba Medcomp®) |
| | Address: | 1499 Delp Drive
Harleysville, PA 19438
Tel (215) 256-4201 X 2285
Fax (215) 256-9191 |
| | Registration Number: | 2518902 |
| | Contact Person: | Courtney Nix
Cnix@Medcompnet.com
Regulatory Affairs Manager,
North America and Europe |
| | Date of Preparation: | 04/18/2018 |
| | B. Subject Device | |
| | Trade Name: | 12F Tri-Flow Triple Lumen Catheter |
| | Device: | Catheter, Hemodialysis, Triple Lumen, Non-
Implanted |
| | Regulation Description: | Blood Access Device and Accessories |
| | Product Code: | NIE |
| | 21 CFR Regulation: | 876.5540 |
| | Class: | 2 |
| | Review Panel: | Gastroenterology/Urology |
| | C. Predicate Device | |
| | Predicate Trade Name: | MEDCOMP® T-3 |
| | 510(k) Number: | K033570 |
| | 510(k) Holder: | Medical Components Inc. |
| | Device: | Catheter, Hemodialysis, Triple Lumen, Non-
Implanted |
| | Regulation Description: | Blood Access Device and Accessories |
| | Product Code: | NIE |
| | 21 CFR Regulation: | 876.5540 |
| | Class: | 2 |
| | Review Panel: | Gastroenterology/Urology |
| | D. Reference Device | |
| | Predicate Trade Name: | T-3 CT |
| | 510(k) Number: | K123292 |
| | 510(k) Holder: | Medical Components Inc. |
4
K181175 Page 2 of 6
Image /page/4/Picture/1 description: The image shows the logo for medCOMP. The logo consists of a stylized letter "G" in pink, with the word "medCOMP" written in a combination of pink and black below it. The "med" portion of the word is in pink, while the "COMP" portion is in black.
1499 Delp Drive
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
| Medcomp®: 12F Tri-Flow Triple Lumen Catheter | |||
|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- |
| Device: | Catheter, Hemodialysis, Triple Lumen, Non-
Implanted |
|-------------------------|---------------------------------------------------------|
| Requlation Description: | Blood Access Device and Accessories |
| Product Code: | NIE |
| 21 CFR Regulation: | 876.5540 |
| Class: | 2 |
| Review Panel: | Gastroenterology/Urology |
E. Device Description:
The 12F Tri-Flow Triple Lumen Catheter is a short term 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 (clear) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, blood draws and infusion of medications.
F. Indications For Use:
The 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein or femoral vein as required. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days.
G. Intended Use
The 12F Tri-Flow Triple Lumen Catheter with a third internal lumen for Infusion is indicated for use in attaining short-term vascular access for hemodialysis and apheresis. The third lumen allows infusion of fluids, medications, and/or when nutritional therapy is prescribed.
H. Comparison to Predicate Device(s):
| Attribute | Subject Device
12F Tri-Flow Triple Lumen
Catheter | Predicate Device
Medcomp® T-3
(K033570) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription | Prescription Use | Prescription Use |
| Indications for Use | The 12F Tri-Flow Triple
Lumen Catheter is indicated
for use in attaining Short-
Term vascular access for
Hemodialysis and Apheresis.
It may be inserted
percutaneously and is
primarily placed in the
internal jugular vein of an | The Medcomp® T-3 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 |
Table 6.1: 510(k) Summary Design Comparison Matrix
Medcomp®: 12F Tri-Flow Triple Lumen Catheter Section 6: 510(k) Site Summary
5
Image /page/5/Picture/1 description: The image shows the logo for medCOMP. The logo features a stylized, geometric shape in pink, resembling a house or building outline. Below the shape, the word "medCOMP" is written, with "med" in a cursive, pink font and "COMP" in a bold, black font.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
| | | adult patient. Alternate
insertion sites include
subclavian vein or femoral
vein as required. The 12F
Tri-Flow Triple Lumen
Catheter is intended to be
used less than (30) days. | insertion sites include the
subclavian vein. The
Medcomp® T-3 is intended
to be used less than (30)
days. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Tip Design | Step | | Step |
| General Purpose of
Device | Hemodialysis and Apheresis | | Hemodialysis and Apheresis |
| Location of Use | Hospital and/or Dialysis
Center | | Hospital and/or Dialysis
Center |
| French Size | 12F | | 15F |
| Lengths | Curved Extensions:
15 and 20cm
Straight Extension:
15, 20, & 24 cm | | Curved Extensions:
15 and 20cm
Straight Extension:
15, 20, & 24 cm |
| Duration of Use | Short Term (24 h to 30 days) duration. The biological endpoints that were met as are follows:
CYTOTOXICITY
- ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for In O Vitro Cytotoxicity
- United States Pharmacopeia 40, National Formulary 35 (USP), General O Chapter , Biological Reactivity Tests, In Vitro
SENSITIZATION
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for 0 Irritation and Skin Sensitization
- OECD 406 Guideline for Testing of Chemical, Test No. 406, Skin 0 Sensitization
IRRITATION
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for 0 irritation and Skin Sensitization
ACUTE SYSTEMIC TOXICITY
- ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests for 0 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 0 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
Medcomp®: 12F Tri-Flow Triple Lumen Catheter Section 6: 510(k) Site Summary
6-5
8
Image /page/8/Picture/1 description: The image shows the logo for medCOMP. The logo consists of a pink geometric shape that resembles a stylized letter "M" or an arrow pointing upwards. Below the geometric shape, the word "medCOMP" is written in a combination of pink and black letters. The "med" portion is in pink, while the "COMP" portion is in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: 12F Tri-Flow Triple Lumen Catheter
- 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
- o 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
- o ISO 10993-4 Biological Evaluation of Medical Devices Part 4 Selection of Tests for Interactions with Blood
K. Summary of Substantial Equivalence
In conclusion, the proposed device, 12F Tri-Flow Triple Lumen Catheter, is considered substantially equivalent to the predicate device, Medcomp® T-3 (K033570) as demonstrated through non-clinical testing performed and T-3 CT (K123292) for the femoral insertion site.