(38 days)
Not Found
No
The summary describes a physical medical device (a catheter) and its intended use, materials, and performance testing based on equivalence to a predicate device. There is no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as providing access to the peripheral venous system for infusion, intravenous therapy, and blood sampling, which are diagnostic or supportive functions, not directly therapeutic.
No
The device is a catheter used for infusion, intravenous therapy, and blood sampling, which are therapeutic and access functions, not diagnostic ones. While blood sampling can contribute to diagnostics, the device itself is for obtaining the sample, not diagnosing.
No
The device description clearly states it is a family of peripherally inserted peripheral catheters made from physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "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 or collecting samples directly from the bloodstream.
- Device Description: The description details a "peripherally inserted peripheral catheter" designed for "vascular access." This further confirms its use within the circulatory system.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information about a person's health. The provided text does not mention any analysis or testing of specimens outside the body.
Therefore, the HEALTH LINE CT MIDLINE CATHETER is a medical device used for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HEALTH LINE CT MIDLINE CATHETER is indicated for short term (less than 30 days) access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The HEALTH LINE CT MIDLINE CATHETER is suitable for use with power injectors.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The HEALTH LINE CT MIDLINE CATHETER is a family of peripherally inserted peripheral catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous micro introducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access.
The HEALTH LINE CT MIDLINE CATHETER is indicated for dwell times shorter than 30 days. The HEALTH LINE CT MIDLINE CATHETER product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The HEALTH LINE CT MIDLINE CATHETER's 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
Adults
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device is identical to the predicate device (K140270) in its final finished form. Therefore, the biocompatibility and performance data were leveraged from the predicate device. The subject device complies with FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95.
The subject device complies with sterilization requirements of ISO 11135-1:2007, Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. It also complies with AAMI TIR 28, Product adoption and process equivalence for ethylene oxide sterilization.
A risk analysis was performed with respect to these changes and no risks were identified with these changes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 contains 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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 12, 2020
Health Line International Corporation Aaron Faulkner RA Director 5675 W 300 S Salt Lake City, Utah 84104
Re: K200263
Trade/Device Name: Health Line CT Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: January 6, 2020 Received: February 3, 2020
Dear Aaron Faulkner:
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.
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
1
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.
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) K200263
Device Name Health Line CT Midline Catheter
Indications for Use (Describe)
The HEALTH LINE CT MIDLINE CATHETER is indicated for short term (less than 30 days) access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The HEALTH LINE CT MIDLINE CATHETER is suitable for use with power injectors.
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 HEALTH LINE CT MIDLINE CATHETER (K200263)
SUBMITTER: Health Line International Corporation 5675 W 300 S Salt Lake City, Utah 84104
ESTABLISHMENT REGISTRATION NUMBER:
3010882065
CONTACT:
Aaron G. Faulkner Director Engineering Telephone: 801-773-7798 Fax: 855-228-1336 Email: agfaulkner@hlic.net
DATE PREPARED:
December 20, 2019
NAME OF MEDICAL DEVICE:
| Proprietary Name: | HEALTH LINE CT MIDLINE CATHETER (K200263) |
|---|---|
| Regulation Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| 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 DEVICE:
| Proprietary Name: | NEXUS MIDLINE CT (K140270) |
|---|---|
| Regulation Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Common/Usual Name: | Midline Catheter, single and double lumen |
4
| Classification Panel: | General Hospital |
|---|---|
| Regulatory Class: | Class II |
| Product Code: | FOZ |
| Regulation Number: | 21 CFR 880.5200 |
DEVICE DESCRIPTION:
The HEALTH LINE CT MIDLINE CATHETER is a family of peripherally inserted peripheral catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous micro introducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access.
The HEALTH LINE CT MIDLINE CATHETER is indicated for dwell times shorter than 30 days. The HEALTH LINE CT MIDLINE CATHETER product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The HEALTH LINE CT MIDLINE CATHETER's 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.
| Catheter Size | Priming
Volume (ml) | Max 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.
INTENDED USE
The HEALTH LINE CT MIDLINE CATHETER is intended to be used by medical professionals for short term percutaneous access to the peripheral venous system for infusion, intravenous therapy and for blood sampling.
5
INDICATIONS FOR USE:
The HEALTH LINE CT MIDLINE CATHETER is indicated for short term (less than 30 days) access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The HEALTH LINE CT MIDLINE CATHETER is suitable for use with power injectors.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
The HEALTH LINE CT MIDLINE CATHETER is technologically identical to the, NEXUS MIDLINE CT CATHETER (K140270), predicate device in all aspects. The Health Line CT Midline Catheter is identical to the predicate device in all aspects except for: a name change, priming instructions added to the instructions for use, and a catheter trim tool was added to the device kit. Below is a summary table comparing the HEALTH LINE CT MIDLINE Catheter to the predicate NEXUS MIDLINE CT CATHETER (K140270).
| Technological
Comparison
Area | Subject Device
HEALTH LINE CT MIDLINE CATHETER
(K200263) | Predicate Device
Nexus Midline CT Catheter
(K140270) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Indications for Use: | The HEALTH LINE CT MIDLINE CATHETER is
indicated for short term (less than 30 days)
access to the peripheral venous system for
infusion, intravenous therapy and blood
sampling. The HEALTH LINE CT MIDLINE
CATHETER is suitable for use with power
injectors. | 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. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intended Use: | Intended to be used by medical professionals
for short term peripheral access to the venous
system for infusion, intravenous therapy,
blood sampling and power injection of
contrast media. | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Target Population | Adults | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Duration of Use | Less than 30 days | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Insertion Method | Seldinger Technique | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sizes | 3Fr, 4Fr, 5Fr Single Lumen, 4Fr & 5Fr Dual
Lumen | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Biocompatibility | ISO-10993 | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sterilization Method | EtO (SAL 10-6) | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Materials | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Female Luer connectors | Rigid PVC | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Hub | Polyurethane | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Catheter Tubing | Polyurethane | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Summary of Technological Comparison of Subject Device to Predicate Devices
6
| Extension Leg Tubing | Polyurethane | Identical |
|---|---|---|
| Pinch Clamps | Acetal | Identical |
| Informational Clamp | ||
| Inserts | ABS | Identical |
PERFORMANCE TESTING
The subject device is identical to the predicate device (K140270) in its final finished form. Therefore, the biocompatibility and performance data were leveraged from the predicate device. The subject device complies with FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95.
The subject device complies with sterilization requirements of ISO 11135-1:2007, Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. It also complies with AAMI TIR 28, Product adoption and process equivalence for ethylene oxide sterilization.
A risk analysis was performed with respect to these changes and no risks were identified with these changes.
CONCLUSION
Based on FDA's decision tree the HEALTH LINE CT MIDLINE CATHETER is substantially equivalent to the, Nexus Midline CT Catheter (K140270), predicate device.