K181175 · Medical Components, Inc. (dba MedComp) · NIE · Jul 5, 2018 · Gastroenterology, Urology
Device Facts
Record ID
K181175
Device Name
12F Tri-Flow Triple Lumen Catheter
Applicant
Medical Components, Inc. (dba MedComp)
Product Code
NIE · Gastroenterology, Urology
Decision Date
Jul 5, 2018
Decision
SESK
Submission Type
Traditional
Regulation
21 CFR 876.5540
Device Class
Class 2
Attributes
Therapeutic
Indications for 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.
Device Story
The 12F Tri-Flow Triple Lumen Catheter is a short-term, non-implanted dialysis catheter constructed from thermosensitive polyurethane. It features three independent lumens: two (venous/arterial) for hemodialysis and apheresis, and one (middle/clear) for intravenous therapy, blood draws, and medication infusion. The device is used in hospitals or dialysis centers by clinicians. It is inserted percutaneously, primarily into the internal jugular vein, with alternate access via the subclavian or femoral vein. The catheter tip is positioned near the junction of the superior vena cava and the right atrium. By providing multi-lumen access, the device enables simultaneous dialysis and infusion therapy, potentially reducing the need for multiple venous access points in patients requiring short-term treatment.
Clinical Evidence
Bench testing only. Testing included air leak, gravity flow, and mechanical integrity (leakage, separation force, unscrewing torque) per ISO 10555-1, ISO 594-1, and ISO 594-2. Biocompatibility was evaluated per ISO 10993-1 for externally communicating devices with blood contact for prolonged duration (>24h to 30 days), covering cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, and hemocompatibility.
Technological Characteristics
Thermosensitive polyurethane catheter; three-lumen design; 12F size; step-tip configuration. EO sterilized. Complies with ISO 10555-1, ISO 11607-1/2, ISO 594-1/2, and ISO 10993 series. No software or electronic components.
Indications for Use
Indicated for short-term vascular access for hemodialysis and apheresis in adult patients. Percutaneous insertion primarily in the internal jugular vein; alternate sites include subclavian or femoral vein. Intended for use <30 days.
Regulatory Classification
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).
Special Controls
*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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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.
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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
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## 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)
| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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K181175
Page 1 of 6
Medcomp®: 12F Tri-Flow Triple Lumen Catheter
| | Section 6<br>510(k) SUMMARY | Traditional 510K |
|--|-----------------------------|------------------------------------------------------------------------------------------------|
| | A. Submitter Information | |
| | Submitter Name: | Medical Components Inc.<br>(dba Medcomp®) |
| | Address: | 1499 Delp Drive<br>Harleysville, PA 19438<br>Tel (215) 256-4201 X 2285<br>Fax (215) 256-9191 |
| | Registration Number: | 2518902 |
| | Contact Person: | Courtney Nix<br>Cnix@Medcompnet.com<br>Regulatory Affairs Manager,<br>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-<br>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-<br>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. |
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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
www.medcompnet.com
| Medcomp®: 12F Tri-Flow Triple Lumen Catheter | | | |
|----------------------------------------------|--|--|--|
|----------------------------------------------|--|--|--|
| Device: | Catheter, Hemodialysis, Triple Lumen, Non-<br>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<br>12F Tri-Flow Triple Lumen<br>Catheter | Predicate Device<br>Medcomp® T-3<br>(K033570) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription | Prescription Use | Prescription Use |
| Indications for Use | The 12F Tri-Flow Triple<br>Lumen Catheter is indicated<br>for use in attaining Short-<br>Term vascular access for<br>Hemodialysis and Apheresis.<br>It may be inserted<br>percutaneously and is<br>primarily placed in the<br>internal jugular vein of an | The Medcomp® T-3 is<br>indicated for use in attaining<br>Short-Term vascular access<br>for Hemodialysis, Apheresis,<br>and Infusion.It may be<br>inserted percutaneously and<br>is primarily placed in the<br>internal jugular vein of an<br>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
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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
www.medcompnet.com
| | | adult patient. Alternate<br>insertion sites include<br>subclavian vein or femoral<br>vein as required. The 12F<br>Tri-Flow Triple Lumen<br>Catheter is intended to be<br>used less than (30) days. | insertion sites include the<br>subclavian vein. The<br>Medcomp® T-3 is intended<br>to be used less than (30)<br>days. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Tip Design | Step | | Step |
| General Purpose of<br>Device | Hemodialysis and Apheresis | | Hemodialysis and Apheresis |
| Location of Use | Hospital and/or Dialysis<br>Center | | Hospital and/or Dialysis<br>Center |
| French Size | 12F | | 15F |
| Lengths | Curved Extensions:<br>15 and 20cm<br>Straight Extension:<br>15, 20, & 24 cm | | Curved Extensions:<br>15 and 20cm<br>Straight Extension:<br>15, 20, & 24 cm |
| Duration of Use | Short Term (<30 Days) | | Short Term |
| Catheter Type | Hemodialysis | | Hemodialysis |
| Sterilization | EO Sterilized | | EO Sterilized |
| Number of Lumens | Three | | Three |
| Patient Population | Adult | | Adult |
| Insertion Site | Internal jugular vein,<br>subclavian vein, and<br>femoral vein* | | Internal jugular vein and<br>subclavian vein |
| Proper Placement of<br>Tip | The distal tip should be<br>located just before the<br>junction of the superior<br>vena cava and the right<br>atrium | | The distal venous tip<br>should be located just<br>before the junction of the<br>superior vena cava and<br>the right atrium. |
| Priming Volume (cc) | | | |
| | | Curved | |
| | | Length P D M | Length P D |
| | | 15cm 1.26 0.40 1.27 | 15cm 1.5 1.5 |
| | | 20cm 1.38 0.46 1.45 | 20cm 1.7 1.7 |
| | | Straight | 24cm 1.8 1.8 |
| | | Length P D M | 32cm 2.1 2.1 |
| | | 15cm 1.06 0.35 1.07 | |
| | | 20cm 1.20 0.45 1.26 | |
| | | 24cm 1.23 0.48 1.34 | |
*The reference device, T-3 CT (K123292), is used being used for the femoral insertion site.
-Bench/Performance Data/ Non-Clinical Testing:
| Standard | Standard Title | Revision/ Date | Performance Testing |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------------------------------------------------------------------------------------|
| ISO 10555-1 | Intravascular | Second Edition | Air Leak, Catheter |
| | catheters --<br>sterile and single-<br>use<br>intravascular<br>catheters -- part<br>1: general<br>requirements. | 2013-06-15 | Leak, Extension-<br>Hub, Extrusion-<br>Hub, Gravity Flow |
| ISO 11607-1 | Packaging for<br>terminally<br>sterilized medical<br>devices - part<br>1: requirements<br>for materials,<br>sterile barrier<br>systems and<br>packaging<br>systems<br>[including:<br>amendment 1<br>(2014)]. | First Edition<br>2006-04-15 | Shipping and Shelf<br>Life testing |
| ISO 11607-2 | Packaging for<br>terminally<br>sterilized medical<br>devices - part<br>2: validation<br>requirements for<br>forming, sealing<br>and assembly<br>processes<br>[including:<br>amendment 1<br>(2014)]. | First Edition<br>2006-04-15 | Shipping and Shelf<br>Life testing |
| ISO 594-1 | conical fittings<br>with a 6% (luer)<br>taper for<br>syringes, needles<br>and<br>certain other<br>medical<br>equipment - part<br>1: general<br>requirements. | First edition<br>1986-06-15, | Gauging |
| ISO 594-2 | Conical fittings<br>with a 6% (luer)<br>taper for<br>syringes, needles<br>and<br>certain other | Second Edition<br>1998-09-01 | Liquid Leakage<br>Air Leakage<br>Separation Force<br>Unscrewing Torque<br>Ease of Assembly<br>Resistance to |
Medcomp®: 12F Tri-Flow Triple Lumen Catheter Section 6: 510(k) Site Summary
Medcomp®: 12F Tri-Flow Triple Lumen Catheter
6-3
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Image /page/6/Picture/1 description: The image shows a logo for medCOMP. The logo features a stylized letter "G" in a bold, red color. The word "medCOMP" is written in a smaller font below the symbol, with "med" in red and "COMP" in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
www.medcompnet.com
Medcomp®: 12F Tri-Flow Triple Lumen Catheter Section 6: 510(k) Site Summary
Medcomp®: 12F Tri-Flow Triple Lumen Catheter
6-4
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Image /page/7/Picture/31 description: The image shows the logo for medCOMP. The logo features a stylized, geometric shape in pink, resembling a house or building structure. Below the geometric shape, the word "medCOMP" is written, with "med" in pink and "COMP" in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
www.medcompnet.com
#### Medcomp®: 12F Tri-Flow Triple Lumen Catheter
| medical | equipment - part<br>2: lock fittings. | Overriding<br>Stress Cracking |
|---------|---------------------------------------|-------------------------------|
|---------|---------------------------------------|-------------------------------|
#### J. Biocompatibility
The biocompatibility evaluation for the 12F Tri-Flow Triple Lumen Catheter was conducted in accordance with the FDA quidance 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", as recognized by the FDA. The 12F Tri-Flow Triple Lumen Catheter met the biocompatibility requirements for an externally communicating device with tissue and circulating blood contact for prolong (>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 < 87>, 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 <151>. 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
www.medcompnet.com
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 < 88> 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.
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Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
