(198 days)
The NEXUS™ MIDLINE CT CATHETER is indicated for short term (less than 30 days) peripheral access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The NEXUS™ MIDLINE CT CATHETER is suitable for use with power injectors.
The NEXUS™ MIDLINE CT Catheter is a family of peripherally inserted central catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access. The NEXUS™ MIDLINE CT Catheter is indicated for dwell times shorter than 30 days. The NEXUS™ MIDLINE CT Catheter product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The NEXUS™ MIDLINE CT Catheters are supplied in two lengths, approximately 10 and 20 cm long. All catheters are attached to an injectionmolded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
The provided text describes the Nexus Midline CT Catheter and its substantial equivalence to predicate devices, but it does not contain details of a clinical study or a multi-reader multi-case (MRMC) comparative effectiveness study. The information focuses on non-clinical bench testing to demonstrate performance and substantial equivalence.
Here's an analysis based on the provided text, addressing the points where information is available and indicating where it is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that various bench tests "met predefined acceptance criteria" and "demonstrated equivalence." However, it does not provide the specific numerical acceptance criteria or the numerical reported device performance for each test. It only lists the tests performed and states they were successful.
A qualitative summary of the performance claims based on the text:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength Test | Predefined acceptance criteria (details not provided) | Met predefined acceptance criteria |
| Power Injection Performance | Predefined acceptance criteria (details not provided) | Met predefined acceptance criteria |
| Dynamic Failure Test | Predefined acceptance criteria (details not provided) | Met predefined acceptance criteria |
| Static Pressure Test | Predefined acceptance criteria (details not provided) | Met predefined acceptance criteria |
| Static Burst Test | Predefined acceptance criteria (details not provided) | Met predefined acceptance criteria |
| Life Cycle Power Injection | Predefined acceptance criteria (details not provided) | Met predefined acceptance criteria |
| Catheter Flow Rate Test | Predefined acceptance criteria (details not provided) | Met predefined acceptance criteria |
| Air Leakage Test | Predefined acceptance criteria (details not provided) | Met predefined acceptance criteria |
| Liquid Leakage Test | Predefined acceptance criteria (details not provided) | Met predefined acceptance criteria |
| Biocompatibility | Requirements according to ISO-10993, Part 1, Test profiles for externally communicating, blood-contacting, long-term devices. | Test profiles were met |
| Sterilization | Requirements of ISO 11135:2007 | Requirements were met |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the sample size for any of the bench tests (e.g., number of catheters tested for tensile strength, burst pressure, etc.).
- Data Provenance: The data is described as "Nonclinical tests" and "bench test data" performed for "design verification testing." This suggests it's laboratory-based testing of the device itself, not data from human subjects or clinical settings. There is no mention of country of origin as it pertains to clinical data, as this is bench testing. The data is not described as retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the document describes non-clinical bench testing. There is no mention of human experts being involved in establishing "ground truth" for these engineering and material performance tests. The "ground truth" for such tests would typically be defined by engineering specifications and direct physical measurements.
4. Adjudication method for the test set
This question is not applicable as the document describes non-clinical bench testing. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus in interpreting images or clinical outcomes, which is not relevant here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or mentioned. The submission describes non-clinical bench testing for a physical medical device (catheter), not an AI algorithm or a diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done or mentioned. The device is a physical catheter, not a software algorithm.
7. The type of ground truth used
For the non-clinical bench testing, the "ground truth" refers to engineering specifications, direct physical measurements, and adherence to relevant international standards (e.g., ISO 11135:2007 for sterilization, ISO-10993 for biocompatibility). The document states that testing was performed "according to protocols based on the above-referenced guidance document recommendations and additional standards."
8. The sample size for the training set
This question is not applicable as the document describes non-clinical bench testing for a physical medical device. There is no mention of a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 9, 2020
Health Line International Corporation John Lincoln Principal Consultant Po Box 2786 St. George, Utah 84771-2786
Re: K140270
Trade/Device Name: Nexus Midline Ct Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ Dated: January 30, 2014 Received: February 3, 2014
Dear John Lincoln:
This letter corrects our substantially equivalent letter of August 20, 2014.
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. 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) 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.
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).
Sincerely,
Sapana Patel -S
for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K140270
Device Name Nexus™ Midline CT Catheter
Indications for Use (Describe)
The NEXUS™ MIDLINE CT CATHETER is indicated for short term (less than 30 days) peripheral access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The NEXUS™ MIDLINE CT CATHETER is suitable for use with power injectors. For maximum flow rate and maximum pressure that can be used during power injection, please refer to the following:
| Catheter Size | Priming Volume(ml) | Max Labeled FlowRate (ml/sec)* | Max Internal CatheterPressure at Max Flow Rate(psi) | Rated BurstPressure(psi)** |
|---|---|---|---|---|
| 3Fr Single Lumen | 0.29 | 1 | 167 | 251 |
| 4Fr Single Lumen | 0.37 | 5 | 164 | 299 |
| 4Fr Dual Lumen | 0.35/0.35 | 3 | 173/173 | 299 |
| 5Fr Single Lumen | 0.38 | 5 | 112 | 300 |
| 5 Fr Dual Lumen | 0.37/0.37 | 5 | 179/179 | 299 |
| * Pressurized flow rates are determined with pump safety cut-off at 300 psi using viscous fluid at 11.8centipoise (cP) and represents approximate flow capability of power injection of contrast media. | ||||
| ** Max Burst Pressure is the static burst pressure failure point of the catheter when the lumen iscompletely occluded. WARNING: Power injector machine pressure limiting feature may not preventover pressurization of an occluded catheter. |
| 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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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for NEXUS™ MIDLINE CT CATHETER
SUBMITTER:
Health Line International Corporation 803 N. 1250 W. - STE 1 Centerville, Utah 84014
ESTABLISHMENT REGISTRATION NUMBER:
3006097687
CONTACT:
Nola L. Benstog QA/RA Director Telephone: 801-773-7798 Fax: 855-228-1336 Email: nbenstog@hlic.net
DATE PREPARED:
January 30, 2014
NAME OF MEDICAL DEVICE:
| Proprietary Name: | NEXUS™ MIDLINE CT CATHETER |
|---|---|
| Regulation Name: | Intravascular Catheter |
| Common/Usual Name: | Midline Catheter, single and double lumen |
DEVICE CLASSIFICATION:
| Classification Panel: | General Hospital |
|---|---|
| Regulatory Class: | Class II |
| Product Code: | FOZ |
| Regulation Number: | 21 CFR 880.5200 |
PREDICATE DEVICES:
| Proprietary Name: | SYNERGY™ CT PICC (K101329) |
|---|---|
| Regulation Name: | Percutaneous, Implanted, Long-term Intravascular Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC), single, doubleand triple lumen |
| Classification Panel: | General Hospital |
| Regulatory Class: | Class II |
| Product Code: | L J S |
| Regulation Number: | 21 CFR 880.5970 |
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| Proprietary Name: | UNI-PICCC™ (K130034) |
|---|---|
| Regulation Name: | Percutaneous, Implanted, Long-term Intravascular Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC), single, doubleand triple lumen |
| Classification Panel: | General Hospital |
| Regulatory Class: | Class II |
| Product Code: | L J S |
| Regulation Number: | 21 CFR 880.5970 |
| Proprietary Name: | Vascu-PICC® and Midline Catheters, Single, Double andTriple Lumen (K091586) |
| Regulation Name: | Percutaneous, Implanted, Long-term Intravascular Catheter |
| Common/Usual Name: | Catheter, Intravascular, Therapeutic, Long-Term |
| Classification Panel: | General Hospital |
| Regulatory Class: | Class II |
| Product Code: | L J S |
| Regulation Number: | 21 CFR 880.5970 |
| Proprietary Name: | PowerGlide Midline Catheter (K121073) |
| Regulation Name: | Intravascular Catheter |
| Common/Usual Name: | Intravascular Catheter |
| Classification Panel: | General Hospital |
| Regulatory Class: | Class II |
| Product Code: | FOZ |
| Regulation Number: | 21 CFR 880.5200 |
DEVICE DESCRIPTION:
The NEXUS™ MIDLINE CT Catheter is a family of peripherally inserted central catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access.
The NEXUS™ MIDLINE CT Catheter is indicated for dwell times shorter than 30 days. The NEXUS™ MIDLINE CT Catheter product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The NEXUS™ MIDLINE CT Catheters are supplied in two lengths, approximately 10 and 20 cm long. All catheters are attached to an injectionmolded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
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INTENDED USE:
The NEXUS™ MIDLINE CT Catheter is intended to be used by medical professionals for shortterm percutaneous access to the venous system for infusion, intravenous therapy and for blood sampling.
The intended use for the NEXUS™ MIDLINE CT Catheter has not changed from that of the SYNERGY™ CT PICC (K101329) and UNI-PICC™ (K130034) predicate devices.
INDICATIONS FOR USE:
The NEXUS™ MIDLINE CT CATHETER is indicated for short term (less than 30 days) peripheral access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The NEXUS™ MIDLINE CT CATHETER is suitable for use with power injectors. For maximum flow rate and maximum pressure that can be used during power injection, please refer to the following:
| Catheter Size | Priming Volume(ml) | Max Labeled FlowRate (ml/sec)* | Max Internal CatheterPressure at Max Flow Rate(psi) | Rated BurstPressure(psi)** |
|---|---|---|---|---|
| 3Fr Single Lumen | 0.29 | 1 | 167 | 251 |
| 4Fr Single Lumen | 0.37 | 5 | 164 | 299 |
| 4Fr Dual Lumen | 0.35/0.35 | 3 | 173/173 | 299 |
| 5Fr Single Lumen | 0.38 | 5 | 112 | 300 |
| 5 Fr Dual Lumen | 0.37/0.37 | 5 | 179/179 | 299 |
Pressurized flow rates are determined with pump safety cut-off at 300 psi using viscous fluid at 11.8 centipoise (cP) and represents approximate flow capability of power injection of contrast media.
-
- Max Burst Pressure is the static burst pressure failure point of the catheter when the lumen is completely occluded. WARNING: Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
New device is compared to Marketed Device? Yes. It is compared to four legally marketed predicate devices.
Does the new device have the same indication statements? Yes the indications for use statement is basically the same as the SYNERGY™ CT PICC (K101329) and the UNI-PICC™ (K130034) predicate devices.
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Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e., deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended effect of the device.
Does the new device have the same technological characteristics, e.g. design, material, etc.? Yes. The device of this submission, the NEXUS™ MIDLINE CT CATHETER, is identical to that of the predicate devices. In fact, the SYNERGY™ CT PICC and the UNI-PICC™ are manufactured by the same company, Health Line International Corporation, the submitter of this submission. The basic fundamental scientific technology of the device has not changed. There may be minor variations in the contents of the introduction kit components.
Could the new characteristics affect safety or effectiveness? No.
Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.
Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.
The FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 was used to determine the appropriate methods for evaluating the device's performance.
Sterilization requirements of ISO 11135:2007, Sterilization of Health Care Products -Requirements for Validation and Routine Control -- Ethylene Oxide Sterilization.
Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Test profiles for externally communicating, bloodcontacting, long-term devices will be met.
These and other standards were used to determine the appropriate methods for evaluating the device's performance.
Are performance data available to assess effects of new characteristics? Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards.
Nonclinical tests submitted included appropriate biocompatibility tests, as well as performance bench testing. Bench test data including Tensile Strength Test, Power Injection Performance Test, Dynamic Failure Test, Static Pressure Test, Static Burst Test, Life Cycle Power Injection Test, Catheter Flow Rate Test, Air Leakage Test and Liquid Leakage Test all met predefined acceptance criteria, and supported the substantial equivalence determination.
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Do performance data demonstrate equivalence? Yes. Performance data gathered in design verification testing demonstrated that the NEXUS™ MIDLINE CT Catheter is substantially equivalent to the noted predicate devices.
CONCLUSION
The NEXUS™ MIDLINE CT Catheter met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the NEXUS™ MIDLINE CT Catheter is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the SYNERGY™ CT PICC (K101329), UNI-PICC™ (K130034), Vascu-PICC® and Midline Catheters, Single, Double and Triple Lumen (K091586) and PowerGlide Midline Catheter (K121073).
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).