Arterial Pressure Monitoring Set/Tray

K180792 · Cook Incorporated · DQO · Nov 30, 2018 · Cardiovascular

Device Facts

• Record ID: K180792
• Device Name: Arterial Pressure Monitoring Set/Tray
• Applicant: Cook Incorporated
• Product Code: DQO · Cardiovascular
• Decision Date: Nov 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients. - 5.0 French catheters are intended for patients aged 12 years and older

Device Story

Arterial Pressure Monitoring Set/Tray facilitates arterial blood pressure monitoring and blood sampling. Device includes single-lumen nylon catheter, stainless steel wire guide, access needle, and syringe; optional convenience accessories (e.g., lidocaine, antiseptic). Catheter inserted percutaneously via Seldinger technique. Used in clinical settings by healthcare professionals. Provides continuous pressure monitoring and access for blood sampling. Benefits include reliable vascular access for hemodynamic monitoring and diagnostic sampling. Sterilized via ethylene oxide; single-use.

Clinical Evidence

No clinical data. Bench testing performed: catheter shaft and hub-to-shaft tensile strength (BS EN ISO 10555-1:2013), liquid/air leakage (BS EN ISO 10555-1), kink resistance (BS EN 13868), gravity flow rate, and dimensional analysis. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility.

Technological Characteristics

Single-lumen intravascular catheter; nylon tubing; 5.0 French diameter; 15 cm length; 0.035 inch endhole. Stainless steel wire guide (0.035 inch OD, 50 cm length). Features 1 cm incremental ink markings. Sterilized via ethylene oxide (SAL 10^-6). Testing standards: BS EN ISO 10555-1:2013 (tensile, leakage, flow), BS EN 13868 (kink).

Indications for Use

Indicated for arterial blood pressure monitoring and blood sampling in adult and pediatric patients; 5.0 French catheters indicated for patients aged 12 years and older.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Cook Pressure Monitoring Catheter (K002254)

Submission Summary (Full Text)

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November 30, 2018

Cook Incorporated Johnathan Liu Regulatory Affairs Team Lead 750 Daniels Way Bloomington, Indiana 47404

Re: K180792

Trade/Device Name: Arterial Pressure Monitoring Set/Tray Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: October 19, 2018 Received: October 22, 2018

Dear Johnathan Liu:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Stephen C. Browning -S5

- for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180792

#### Device Name

Arterial Pressure Monitoring Set/Tray

Indications for Use (Describe)

The Arterial Pressure Monitoring Set Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients.

- 5.0 French catheters are intended for patients aged 12 years and older

Type of Use (Select one or both, as applicable)

| <span></span> | <span></span> |
|---------------|---------------|
| <span></span> | <span></span> |

| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background. The bottom red background is angled.

#### 2.0 510(k) SUMMARY

#### K180792 Arterial Pressure Monitoring Set/Tray 21 CFR §807.92 Date Prepared: October 19, 2018

#### Submitted By:

| Submission: | Traditional 510(k) Premarket Notification |
|-----------------------|---------------------------------------------------------------|
| Applicant: | Cook Incorporated |
| Applicant Address: | Cook Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 |
| Contact: | Johnathan Liu<br>Chelsea Woods |
| Secondary Contact: | Andrew Breidenbach, PhD, RAC |
| Email: | [e-mail] |
| Contact Phone Number: | [phone] x104509 |
| Contact Fax Number: | [phone] |

#### Device Information:

| Trade Name: | Arterial Pressure Monitoring Set/Tray |
|-----------------------|---------------------------------------|
| Common Name: | Catheter, Intravascular, Diagnostic |
| Classification Name: | Diagnostic intravascular catheter |
| Regulation: | 21 CFR §870.1200 |
| Product Code: | DQO |
| Device Class: | II |
| Classification Panel: | Cardiovascular |

#### Predicate Device:

The Arterial Pressure Monitoring Set/Tray is substantially equivalent to the following device: Cook Pressure Monitoring Catheter (K002254, Cook Incorporated) cleared on March 16, 2001.

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#### Device Description:

The Arterial Pressure Monitoring Set/Tray consists of a pressure monitoring catheter, wire guide, access needle, and syringe. The catheter is inserted into the vasculature using the Seldinger technique. The subject device is sterilized by ethylene oxide and intended for one-time use.

The subject device catheter is a single lumen intravascular catheter manufactured from nylon tubing and is designed with a pre-molded proximal winged hub. The catheter is 5.0 French with a length of 15 centimeters and has an endhole diameter of 0.035 inches. Additionally, the catheter is manufactured with one-centimeter incremental ink markings along the shaft. The wire guide is manufactured from stainless steel, has an outer diameter of 0.035 inches, and a length of 50 centimeters. The access needle is manufactured from stainless steel. Additional set configurations may contain convenience accessories, including lidocaine, PVP ointment, silk suture, Monoject needles, thumb scalpel, gauze, drapes, a filter straw, and ChloraPrep antiseptic.

#### Indications for Use:

The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients.

- -5.0 French catheters are intended for patients aged 12 years and older
#### Comparison to Predicate Device:

The Arterial Pressure Monitoring Set/Tray is substantially equivalent to the predicate device, Cook Pressure Monitoring Catheter (K002254), in that these devices are identical in intended use, principle of operation, catheter design (single lumen, straight tip), and packaging. The differences between the subject device and the predicate device, including pediatric indication, materials, and dimensions, do not raise different questions of safety and/or effectiveness when compared to the predicate. The substantial equivalence comparison of the subject device to the predicate is provided in the table below.

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| | | PREDICATE DEVICE | SUBJECT DEVICE |
|--------------------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Cook Pressure Monitoring Catheter<br>(K002254) | Arterial Pressure Monitoring Set/Tray |
| Regulation | | 21 CFR §870.1200 | IDENTICAL TO PREDICATE |
| | Product Code | DQO – Catheter, Intravascular, Diagnostic | IDENTICAL TO PREDICATE |
| | Classification | II | IDENTICAL TO PREDICATE |
| Indications for Use | | The Cook Pressure Monitoring Catheter is<br>used for arterial pressure monitoring and<br>blood sampling. It is provided sterile in<br>peel-open packages and intended for one-<br>time use. | The Arterial Pressure Monitoring Set/Tray<br>is intended for arterial blood pressure<br>monitoring and blood sampling in adult and<br>pediatric patients.<br>5.0 French catheters are intended for<br>patients aged 12 years and older. |
| Device is for One-<br>time use | | Yes | IDENTICAL TO PREDICATE |
| Catheter Placement<br>Method | | Percutaneously via Seldinger technique | IDENTICAL TO PREDICATE |
| | Shaft<br>Material | Polyurethane | Nylon |
| | Hub<br>Material | Polyurethane | Nylon |
| | Outer<br>Diameter | 3.0 French | 5.0 French |
| Catheter | Length | 2.5, 5.0, 7.5, 8.0, 12.0, 22.0 cm | 15 cm |
| | Number of<br>Lumens | Single Lumen | IDENTICAL TO PREDICATE |
| | Distal Tip<br>Design | Straight Tip | IDENTICAL TO PREDICATE |
| | Ink<br>Markings | Yes | IDENTICAL TO PREDICATE |
| Packaging | | Tray w/ Tyvek lidstock | IDENTICAL TO PREDICATE |
| Sterilization<br>Method | | EtO | IDENTICAL TO PREDICATE |
| Sterility Assurance<br>Level | | 10-6 | IDENTICAL TO PREDICATE |

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## Technological Characteristics:

The subject device, Arterial Pressure Monitoring Set/Tray was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:

## Performance Testing:

- . Catheter Shaft Tensile (Aged) – The peak tensile load for the shaft section of the catheter shall be greater than or equal to 10 N in accordance with BS EN ISO 10555-1:2013. The acceptance criterion was met.
- Catheter Hub-to-Shaft Tensile (Aged) The peak tensile load for the hub-to-shaft . section of the catheter shall be greater than or equal to 10 N in accordance with BS EN ISO 10555-1:2013. The acceptance criterion was met.
- Catheter Liguid Leakage (Aged) No part of the catheter shall leak liquid when . tested in accordance with Annex C of BS EN ISO 10555-1. The acceptance criterion was met.
- . Catheter Air Leakage (Aged) – No air shall enter the hub when tested in accordance with Annex D of BS EN ISO 10555-1. The acceptance criterion was met.
- Catheter Kink Length (Aged) The catheter shall not kink (flowrate reduced by 50%) . at a specified kink (circumferential) length when tested in accordance with Annex B of BS EN 13868. The acceptance criterion was met.
- Catheter Gravity Flow Rate (Time-Zero) The flow rate shall be a minimum of 90% . of the flow rate stated by the manufacturer when tested in accordance with Annex E of BS EN ISO 10555-1. The acceptance criterion was met.
- Visual Inspection & Dimensional Analysis (Aged) Test was conducted to . demonstrate that the catheter dimensions are within the specified tolerances and the catheter and wire guide are compatible.

Biocompatibility Testing:

- Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, . intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility were performed to ensure the biocompatibility of the subject device set.

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#### Conclusion:

The results of these tests confirm that the Arterial Pressure Monitoring Set/Tray meets the design input requirements based on the intended use and support the conclusion that this device does not raise different questions of safety and/or effectiveness and is substantially equivalent to the predicate device, the Cook Pressure Monitoring Catheter (K002254).