(198 days)
Not Found
No
The provided text describes a physical medical device (a catheter) and its intended use and performance testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is used for access to the peripheral venous system for infusion and therapy but does not directly provide therapy itself. It is a delivery/sampling device, not a therapeutic one.
No
The device is used for infusion, intravenous therapy, and blood sampling (therapeutic and collection for later analysis), not for diagnosing a condition.
No
The device description clearly states it is a physical catheter made from biocompatible medical grade materials, with various sizes and lengths, and includes accessories for introduction. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "peripheral access to the peripheral venous system for infusion, intravenous therapy and blood sampling." This describes a device used in vivo (within the body) for delivering substances and collecting samples directly from the bloodstream.
- Device Description: The description details a catheter designed for insertion into the peripheral venous system. This is a physical device used for accessing the circulatory system.
- Lack of IVD Characteristics: An IVD is a device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any such use or analysis of specimens outside the body.
Therefore, the NEXUS™ MIDLINE CT CATHETER is a medical device used for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FOZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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
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.
Key Metrics
Not Found
Predicate Device(s)
K101329, K130034, K091586, K121073
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
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.
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
2
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 Flow
Rate (ml/sec)* | Max Internal Catheter
Pressure at Max Flow Rate
(psi) | Rated Burst
Pressure
(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. | | | | |
| 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
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, double |
| and triple lumen | |
| Classification Panel: | General Hospital |
| Regulatory Class: | Class II |
| Product Code: | L J S |
| Regulation Number: | 21 CFR 880.5970 |
4
| Proprietary Name: | UNI-PICCC™ (K130034) |
|---|---|
| Regulation Name: | Percutaneous, Implanted, Long-term Intravascular Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC), single, double |
| and 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 and |
| Triple 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.
5
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 Flow
Rate (ml/sec)* | Max Internal Catheter
Pressure at Max Flow Rate
(psi) | Rated Burst
Pressure
(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.
6
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.
7
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).