(446 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of a catheter and its components, with no mention of AI or ML.
No.
The device is described as an arterial catheter used for short-term access to the peripheral arterial system. Its function is to permit access, not to provide therapy.
No
Explanation: The device is a catheter designed for short-term access to the peripheral arterial circulation system. Its intended use is to permit access, not to diagnose a condition.
No
The device description clearly details physical components such as a catheter, introducer needle, guidewire, and suture wing, and the performance studies focus on physical properties and functionality of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit access to the peripheral arterial circulation system for short-term access (less than 30 days)." This describes a device used for accessing the body's circulatory system, not for testing samples taken from the body.
- Device Description: The description details a catheter, needle, and guidewire designed for insertion into an artery. This is consistent with a device used for direct access to the body, not for in vitro testing.
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing samples (like blood, urine, etc.) outside of the body. There's no mention of reagents, test strips, analyzers, or any other elements typically associated with IVD devices.
- Anatomical Site: The device is inserted into an artery, which is a direct interaction with the patient's body, not an in vitro process.
In summary, the Medline Integrated Arterial Catheter is a device used for accessing the arterial system within the patient's body, which is the definition of an in vivo device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medline Integrated Arterial Catheter permits access to the peripheral arterial circulation system for short-term access (less than 30 days).
Product codes
DQX
Device Description
The Medline Integrated Arterial Catheter is a single-use device supplied sterile and nonpyrogenic; it will be packaged inside convenience kits alongside various components outside the scope of this 510(k) submission. The proposed device is a single lumen peripherally inserted catheter device designed to permit short-term access to the peripheral arterial circulatory for less than 30 days. The device assembly comprises a 20-Gauge catheter, 22-Gauge introducer needle, and a 0.018" guidewire with slide advancer. The catheter is made of radiopaque polyurethane tubing, echogenic needle, and removable stainless steel guidewire with slide advancer. The subject device has a kink-resistant catheter design. The device features dual flash with two distinct points of visualization, one with the clear introducer needle proximal hub and the second point at the notch cutout in the needle shaft. The final finished device is packaged with a suture wing (ALCS004). The suture wing is a Class I, 510(k) exempt device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Artery (blood vessel); typically inserted into the radial artery but can be placed in the elbow (brachial), groin (femoral), or foot (Dorsalis pedis).
Indicated Patient Age Range
general adult patient population
Intended User / Care Setting
Intended Users: Trained ICU physicians, intensivists, anesthesiologists, surgeons, and ICU nurses. Nurses and physicians (e.g., anesthesiology, surgery, critical care) with education ranging from undergraduate to graduate level. Intended users should have basic knowledge and training of catheter placement techniques, contraindications, and necessary precautions. Intended users should have experience with the modified Seldinger technique, and only minimal device-specific training is needed (e.g., reading and understanding the IFU).
Care Settings: Several hospital environments, including the ICU, OR, Anesthesiology, and Cath Lab.
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)
Non-clinical verification was conducted to evaluate performance and functionality. The results demonstrated the proposed device's substantial equivalence in accordance with relevant test methods, supporting a substantial equivalence determination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
May 17, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Centurion Medical Products Sheri Deisler Regulatory Affairs Manager 100 Centurion Way Williamston, Michigan 48895
Re: K210548
Trade/Device Name: Medline Integrated Arterial Catheter Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: April 18, 2022 Received: April 18, 2022
Dear Sheri Deisler:
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 Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210548/A001
Device Name Medline Integrated Arterial Catheter
Indications for Use (Describe)
The Medline Integrated Arterial Catheter permits access to the peripheral arterial circulation system for short-term access (less than 30 days).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Centurion Medical Products. The word "CENTURION" is written in large, bold, blue letters. Below the word "CENTURION" is a gray line, and below the line, the words "MEDICAL PRODUCTS" are written in smaller, gray letters.
SECTION 5 510(k) Summary [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Centurion Medical Products 100 Centurion Way Williamston, MI 48895 Registration Number: 3008403546
Contact Person(s)
Sheri Deisler Manager, Regulatory Affairs Phone: 517-545-1136 Email: SDeisler@medline.com
Amanda Baughman Regulatory Affairs Specialist Phone: 517-545-1119 Email: ABaughman@medline.com
Summary Preparation Date April 11, 2022
Type of 510(k) Submission Traditional 510(k)
Device Name / Classification
Proprietary Name: Medline Integrated Arterial Catheter Classification Name: Wire, Guide, Catheter Product Code: DQX Classification Panel: Cardiovascular Regulatory Class: II Regulation Number: 870.1330
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Primary Predicate Device
Health Line ARTLINE K160448
Secondary Predicate Device
Arrow Radial® Artery Catherization Set K810675
Device Description
The Medline Integrated Arterial Catheter is a single-use device supplied sterile and nonpyrogenic; it will be packaged inside convenience kits alongside various components outside the scope of this 510(k) submission. The proposed device is a single lumen peripherally inserted catheter device designed to permit short-term access to the peripheral arterial circulatory for less than 30 days. The device assembly comprises a 20-Gauge catheter, 22-Gauge introducer needle, and a 0.018" guidewire with slide advancer. The catheter is made of radiopaque polyurethane tubing, echogenic needle, and removable stainless steel guidewire with slide advancer. The subject device has a kink-resistant catheter design. The device features dual flash with two distinct points of visualization, one with the clear introducer needle proximal hub and the second point at the notch cutout in the needle shaft. The final finished device is packaged with a suture wing (ALCS004). The suture wing is a Class I, 510(k) exempt device.
Principle of Operation
After puncturing the skin and advancement into the artery, arterial cannulation is verified visually by observing blood flashback into the catheter shaft and the clear hub of the introducer needle. The introducer needle is then advanced a maximum of 1-2 mm further into the vessel. The user stabilizes the introducer needle and then advances the guidewire using the actuating lever until it coincides with the clear tube's black indicator line. After that, the guidewire is deployed into the artery. The catheter is then advanced over the guidewire into the artery using a slight rotating motion. The catheter is held in place, and the assembly is then pulled back, removing the guidewire. After pulsatile blood is confirmed, a sterile primed hemodynamic monitoring tube with a stopcock is secured to the catheter tube. The catheter position is secured to the patient with a removable suture wing, provided with the proposed device and suture or a suture-free securement device per hospital protocol.
5
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Proposed Conditions of Use
An arterial catheter is intended for use in the general adult patient population. It is primarily used for real-time, dynamic monitoring of blood pressure in patients, including those experiencing shock, hypertensive emergency, stroke, patients on titratable vasoactive medications, and those undergoing complex surgical procedures. The device provides access for frequent blood draws, including ABG's in ventilated patients, and for monitoring cardiac function in conjunction with separate technologies (i.e., pulse pressure variation). The proposed device will be used in several hospital environments, including the ICU, OR, Anesthesiology, and Cath Lab. These environments will typically be well lit and climatecontrolled. The Medline Integrated Arterial Catheter is a single-use device in which no reuse will occur, and sterile technique should be used during placement. The catheter may remain in place for up to 30 days and be utilized for continuous monitoring while therapy is being given or accessed intermittently for blood sampling.
Anatomical Location of Use and Description of Users
Arterial Catheters are inserted percutaneous into an artery (blood vessel); they are typically inserted into the radial artery but can be placed in the elbow (brachial), groin (femoral), or foot (Dorsalis pedis). Typical users of the proposed device include trained ICU physicians, intensivists, anesthesiologists, surgeons, and ICU nurses. Great care needs to be taken to avoid vessel wall puncture and inadvertent subarterial placement. Therefore, the intended users' will be nurses and physicians (e.g., anesthesiology, surgery, critical care) with education ranging from undergraduate to graduate level. Intended users should have basic knowledge and training of catheter placement techniques, contraindications, and necessary precautions. Intended users should have experience with the modified Seldinger technique, and only minimal device-specific training is needed (e.g., reading and understanding the IFU).
The Medline Integrated Arterial Catheter will be available as outlined below:
| Centurion Medical
| Products Item Number | Description | Gauge | Length |
|---|---|---|---|
| RA20G175* | Medline Integrated | ||
| Arterial Catheter | 20Ga | 1.75 inches |
The final finished device, RA20G175, is packaged with a Suture Wing (ALCS004).
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Indications for Use
The Medline Integrated Arterial Catheter permits access to the peripheral arterial circulation system for short-term access (less than 30 days).
Figure 1: Medline Integrated Arterial Catheter with protective tube (Photograph 1 of 3)
Image /page/6/Picture/5 description: The image shows a long, thin, clear plastic tube with a white tip on one end and a black piece attached to the other end. The tube is lying on a dark gray surface. The white tip appears to be a swab, and the black piece may be a handle or a marker.
Figure 2: Medline Integrated Arterial Catheter (Photograph 2 of 3)
Image /page/6/Picture/7 description: The image shows a medical catheter laying on a dark surface. The catheter is long and thin, with a needle at one end and a white cap at the other. There is a black piece attached to the catheter near the white cap. The catheter appears to be unused and sterile.
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Figure 3: Suture Wing (Photograph 3
Image /page/7/Picture/3 description: The image shows a small, light blue plastic clip with a unique design. It features two circular pads with holes, connected by a U-shaped bridge. The clip is placed on a textured, dark gray surface, possibly a foam or fabric material. The lighting highlights the clip's shape and the surface's texture, creating a clear contrast.
The final finished device, RA20G175, is packaged with a Suture Wing (ALCS004), pictured above.
Summary of Technological Characteristics
The Medline Integrated Arterial Catheter is similar in design and technological characteristics to the predicate devices. Minor differences from the predicate devices design are minor and do not raise any additional questions on safety and effectiveness.
Table 5-1 provides a side-by-side comparison of the key attributes with the proposed device, the Medline Integrated Arterial Catheter, and the predicate devices, the Health Line ARTLINE (K160448), and the Arrow Radial® Artery Catherization Set (K810675).
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Table 5-1: Proposed and Predicate Device(s) Comparison
| Device
Characteristics | Proposed Device
Medline Integrated Arterial
Catheter | Primary Predicate
Device
Health Line ARTLINE | Secondary Predicate
Device
Arrow Radial ® Artery
Catheterization Set | Comparative Analysis |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory History | New Device | K160448 | K810675 | Same clearance pathway |
| Classification Panel | Cardiovascular | Cardiovascular | Cardiovascular | Same |
| Classification Name | Guide, Wire, Catheter | Guide, Wire, Catheter
Catheter, Percutaneous | Guide, Wire, Catheter | Same |
| Device Class | Class II | Class II | Class II | Same |
| Device Code | DQX | DQX/DQY | DQX, | The proposed device and
secondary predicate have the
same device code. The primary
predicate device has two product
codes DQX/DQY. |
| Intended Use | The catheter is intended to
permit access to peripheral
vessels | The catheter is intended to
permit access to peripheral
vessels | The catheter is intended to
permit access to peripheral
vessels | Same |
| Indication for Use | The device permits access
to the peripheral arterial
circulation system for
short-term access (less than
30 days). | The ARTLINE device permits
access to the peripheral
arterial circulation system for
short-term access (less than 30
days). | The Arrow Arterial
Catheterization device
permits access to the
peripheral arterial
circulation or to other
small vessels. | The indications for use are the
same for the proposed device and
primary predicate. The secondary
predicate device varies slightly
but still fall under the same
intended use. |
| Device
Characteristics | Proposed Device
Medline Integrated Arterial
Catheter | Primary Predicate
Device
Health Line ARTLINE | Secondary Predicate
Device
Arrow Radial ® Artery
Catheterization Set | Comparative Analysis |
| Single Use Vs.
Disposable | Single-Use | Single-Use | Single-Use | Same |
| Sterile Vs. Non-Sterile | Sterile | Sterile | Sterile | Same |
| Non-Pyrogenic | Yes | Yes | Yes | Same |
| Accessories | Suture Wing | Suture Wing | Suture Wing | Same |
| Available in Sterile Kit
Configurations | Yes | Yes | Yes | Same |
| Sterilization Method | Ethylene Oxide Gas | Ethylene Oxide Gas | Ethylene Oxide Gas | Same |
| Shelf Life | 1 Year | 5 Year | Not indicated | N/A |
| Catheter body OD | 20 Ga | 20 Ga | 18, 20 Ga | All three devices feature 20 Ga
catheter body. |
| Catheter length | 1 ¾ inches (4.45 cm) | 1 ¾ inches (4.45 cm) | 1 ¾ inches (4.45 cm) | Same |
| Catheter body material | Polyurethane | Polyurethane | Polyurethane | Same |
| Dual blood flashback | Yes – clear introducer
needle proximal hub and
notch cutout in the needle
shaft | Yes – clear introducer needle
proximal hub and notch cutout
in the needle shaft | No - clear introducer
needle proximal hub | The proposed device and primary
predicate device feature dual
flash. The secondary predicate
device features one blood
flashback. |
| Echogenic needle | Yes | Yes | Not indicated | The proposed device and primary
predicate device feature an
echogenic needle. The secondary |
| Device
Characteristics | Proposed Device
Medline Integrated Arterial
Catheter | MEDICAL PRODUCTS
Primary Predicate
Device
Health Line ARTLINE | Secondary Predicate
Device
Arrow Radial ® Artery
Catheterization Set | Comparative Analysis |
| | | | | predicate device does not have
this feature. |
| Radiopaque single
lumen catheter | Yes | Yes | Yes | Same |
| Integrated Guidewire | Yes | Yes | Yes | Same |
| Removable Guidewire | Yes | Yes | No | The proposed device and primary
predicate device feature a
removable guidewire. The
secondary predicate device does
not have this feature. |
| Kink Resistant | Yes | Yes | Yes | Same |
| Guidewire material/size | Stainless Steel 0.018",
Straight, soft tip | Stainless Steel 0.018",
Straight, soft tip | Stainless Steel 0.018",
Straight, soft tip | Same |
9
CENTURION
MEDICAL PRODUCTS
10
CENTURION
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Shelf Life and Sterilization
The Medline Integrated Arterial Catheter is sterilized by Ethylene Oxide (EO). The method used to validate the sterilization cycle for this device was conducted in accordance with ISO 11135:2014, Sterilization of Health Care Products - Ethylene Oxide - Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices, to ensure that a Sterility Assurance Level (SAL) of 1 x 106 is achieved. The proposed device has also been evaluated for EO/ECH residuals in accordance with ISO-10993-7:2008, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
In accordance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, aging studies have been conducted to verify a oneyear shelf-life of the subject device and to ensure functionality and sterility are successfully maintained throughout the duration of this shelf life.
Summary of Testing
To evaluate performance and functionality, non-clinical verification of the Medline Integrated Arterial Catheter has been conducted. The results of these test have demonstrated the proposed devices' substantial equivalence in accordance with relevant test methods, and ultimately support a substantial equivalence determination.
Functional Performance Testing
Stress Cracking in accordance with ISO 80369-7 Positive Pressure Liquid Leakage in accordance with ISO 80369-7 Sub Atmospheric Pressure Air Leakage in accordance with ISO 80369-7 Resistance to Separation from Axial Load in accordance with ISO 80369-7 Resistance to Separation from Unscrewing in accordance with ISO 80369-7 Resistance to Overriding with ISO 80369-7 Kink Resistance Bend Stiffness Corrosion Resistance in accordance with ISO 11070 Guidewire Rebound Peak Tensile Force in accordance with ISO 11070 and ISO 10555 Fracture in accordance with ISO 11070
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Flex in accordance with ISO 11070 Insertion Force Loosening Force Ouick Flash Strength of Union in accordance with ISO 11070 Visual Inspection Simulated Use Testing Print Durability Freedom from Leakage in accordance with ISO 10555 Surface Inspection (Catheter Tube) in accordance with ISO 10555 Needle Bevel Interface Inspection in accordance with ISO 11070 Dimensional Verification Echogenicity
Biocompatibility Testing
The biological evaluation of the subject device was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of the Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process as recognized by the FDA. The proposed device is classified an externally communicating device with prolonged duration of use (>24 hours, to ≤ 30 days) contact with circulating blood.
Summary of Clinical Testing
Not applicable. No clinical testing was conducted on the proposed device.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification. Centurion Medical Products concludes that Medline Integrated Arterial Catheter is substantially equivalent to the predicate device, Health Line ARTLINE (K160448).