Cook Unimpregnated Central Venous Catheter

K182252 · Cook Incorporated · FOZ · May 17, 2019 · General Hospital

Device Facts

• Record ID: K182252
• Device Name: Cook Unimpregnated Central Venous Catheter
• Applicant: Cook Incorporated
• Product Code: FOZ · General Hospital
• Decision Date: May 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for: 1. Continuous or intermittent drug infusions 2. Central venous blood pressure monitoring (CVP) 3. Acute hyperalimentation 4. Blood sampling 5. Delivery of whole blood or blood products 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only The device is a short-term use catheter, intended for less than 30 days. The Cook dilator is used for dilating puncture sites or catheter tracts. The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations. The Cook Unimpregnated Central Venous Catheter with power injection is used for: 1. Continuous or intermittent drug infusions 2. Central venous blood pressure monitoring (CVP) 3. Acute hyperalimentation 4. Blood sampling 5. Delivery of whole blood or blood products 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only 7. Power injection of contrast media* *The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0, and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters. The device is a short-term use catheter, intended for less than 30 days. The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter. The Cook dilator is used for dilating puncture sites or catheter tracts. The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

Device Story

Single-use, sterile, intravascular catheter; inserted via Seldinger technique; tip positioned at SVC-RA junction. Configurations: single, dual, triple, or five-lumen; materials include polyethylene, ethylene-vinyl acetate, polyurethane. Used in clinical settings for drug delivery, blood monitoring, and hyperalimentation. Power-injectable versions allow contrast media delivery at defined flow rates (up to 10 mL/sec) and pressure limits (up to 325 psi). Includes accessories like dilators, inner catheters, and wire guides. Healthcare providers use the device to establish vascular access; output is the delivery of fluids or monitoring of venous pressure. Benefits include reliable short-term venous access for critical care and diagnostic imaging.

Clinical Evidence

Bench testing only. Performance testing included tensile strength (BS EN ISO 10555-1), liquid/air leakage, kink radius (BS EN 13868), gravity flow rate, static burst, and hub pressure for power injection. Biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, implantation, and hemocompatibility per ISO 10993-1.

Technological Characteristics

Materials: Polyethylene, ethylene-vinyl acetate, polyurethane (catheter); nylon (inner catheter). Dimensions: 2.5-10 French, 5-40 cm length. Sensing/Actuation: Passive fluid delivery/pressure monitoring. Connectivity: None. Sterilization: Ethylene oxide (EtO). Standards: BS EN ISO 10555-1, BS EN 13868, ISO 594-1/2, ISO 11135-1.

Indications for Use

Indicated for adult and pediatric patients requiring short-term (<30 days) vascular access for drug infusion, CVP monitoring, hyperalimentation, blood sampling, and blood product delivery. Power-injectable models are indicated for contrast media injection at specified flow/pressure limits. Contraindicated for power injection in non-power-injectable models.

Regulatory Classification

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.

Predicate Devices

• Cook Central Venous Catheters with or without Heparin (K081113)

Reference Devices

• Dilator Sets (K183036)
• Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) (K072625)

Submission Summary (Full Text)

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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

May 17, 2019

Cook Incorporated Chelsea Woods Regulatory Affairs Specialist 750 Daniels Way P.Box 489 Bloomington, Indiana 47404

Re: K182252

Trade/Device Name: Cook Unimpregnated Central Venous Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ, DRE Dated: April 15, 2019 Received: April 16, 2019

Dear Chelsea Woods:

We have reviewed vour 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/cfpmp/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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,

for Tina Kiang, Ph.D 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182252

Device Name

Cook Unimpregnated Central Venous Catheter

Indications for Use (Describe)

- The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:
- 1. Continuous or intermittent drug infusions
- 2. Central venous blood pressure monitoring (CVP)
- 3. Acute hyperalimentation
- 4. Blood sampling
- 5. Delivery of whole blood or blood products
- 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only

The device is a short-term use catheter, intended for less than 30 days.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# Indications for Use

510(k) Number (if known) K182252

Device Name

Cook Unimpregnated Central Venous Catheter

Indications for Use (Describe)

- The Cook Unimpregnated Central Venous Catheter with power injection is used for:
- 1. Continuous or intermittent drug infusions
- 2. Central venous blood pressure monitoring (CVP)
- 3. Acute hyperalimentation
- 4. Blood sampling
- 5. Delivery of whole blood or blood products
- 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only
- 7. Power injection of contrast media*

*The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0. 8.0. 9.0. and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters.

The device is a short-term use catheter, intended for less than 30 days.

The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span></span> | <span></span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo is white text on a red background. The word "COOK" is in large, bold letters, and the word "MEDICAL" is in smaller letters below it.

# 510(k) SUMMARY

# K182252 Cook Unimpregnated Central Venous Catheter 21 CFR §807.92 Date Prepared: May 16, 2019

| Submission: | Traditional 510(k) Premarket Notification |
|-----------------------|-------------------------------------------|
| Applicant: | Cook Incorporated |
| Applicant Address: | Cook Incorporated |
| | 750 Daniels Way |
| | Bloomington, IN 47404 |
| Primary Contact: | Chelsea Woods |
| Secondary Contact: | Ram Iyer, Ph.D. RAC |
| Email: | [e-mail] |
| Contact Phone Number: | [phone] x104707 |
| Contact Fax Number: | [phone] |

# Device Information:

| Trade Name: | Cook Unimpregnated Central Venous Catheter |
|-----------------------|-----------------------------------------------------------------------|
| Common Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than<br>30 Days |
| Classification Name: | Intravascular catheter |
| Regulation: | 21 CFR §880.5200 |
| Product Code: | FOZ; DRE |
| Device Class: | II |
| Classification Panel: | General Hospital |

# Predicate Device:

The Cook Unimpregnated Central Venous Catheter is substantially equivalent to the following devices:

- Cook Central Venous Catheters with or without Heparin (K081113, Cook -Incorporated) cleared on July 30, 2008

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Cook Incorporated - Traditional 510(k) Cook Unimpregnated Central Venous Catheter May 16, 2019

#### Device Description:

The Cook Unimpregnated Central Venous Catheter is a single use sterile intravascular catheter designed to be inserted into a patient's vascular system. The CVC is inserted into the vasculature using the Seldinger technique. The tip of the catheter is then advanced until it is above the superior vena cava-right atrium (SVC-RA) junction. The CVC configurations include a single, dual, triple, or five-lumen shaft manufactured from polyethylene, ethylene-vinyl acetate, or polyurethane tubing. The CVC is manufactured with an outside diameter between 2.5 and 10 French and has a length between 5 and 40 centimeters dependent on the configuration. Single lumen CVCs are designed with a premolded winged hub on the proximal end. Dual, triple, and five-lumen CVCs are designed with a manifold assembly, which is comprised of a winged manifold connected to extension tubes. Each extension tube has a slide clamp and is manufactured with a proximal winged hub. Certain CVC configurations are power injectable. The CVC may be packaged as a convenience kit with various other components which may include a dilator, inner catheter, wire guide, access needle, injection caps, clamps, catheter securement device, connecting tube, and other convenience accessories. The subject device inner catheter, supplied with the 9 and 10 French subject device catheters, is used to assist advancement of the main catheter over the wire guide. The inner catheter, manufactured from nylon, is designed to lock with the hub of the polyurethane catheter. The subject device dilator, used to dilate the access site during the procedure, is designed with a radiopaque extruded polyethylene shaft and a pre-molded polyethylene proximal hub. It is manufactured with an outside diameter ranging from 3.5 to 12.0 French and has a length between 6 and 11 centimeters. For non-power injectable catheters, the 2.5 French, 3.0 French and 4.0 French catheters are recommended for patients from birth and older (or weighing at least 2.4 kilograms), the 5.0 French catheters are recommended for patients aged 2 years and older (or weighing at least 10 kilograms), the 6.0 French and 6.3 French catheters are recommended for patients aged 4 years and older (or weighing at least 13 kilograms), and the 7.5 French catheters are recommended for patients aged 10 years and older (or weighing at least 50 kilograms). For power injectable catheters, the 4.0 French catheters are recommended for patients from birth and older (or weighing at least 2.4 kilograms), the 5.0 French catheters are recommended for patients aged 2 years and older (or weighing at least 10 kilograms), the 7.0 French and 8.0 French catheters are recommended for patients aged 10 years and older (or weighing at least 50 kilograms),

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and the 9.0 French and 10.0 French catheters are recommended for patients aged 21 years and older (adults only).

The Cook Unimpregnated Central Venous Catheter is a short-term device, sterilized by ethylene oxide, and intended for single use.

## Indications for Use (Non-Power Injectable):

The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:

- 1. Continuous or intermittent drug infusions
- 2. Central venous blood pressure monitoring (CVP)
- 3. Acute hyperalimentation
- 4. Blood sampling
- 5. Delivery of whole blood or blood products
- 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only

The device is a short-term use catheter, intended for less than 30 days.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Cook unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

## Indications for Use (Power Injectable):

The Cook Unimpregnated Central Venous Catheter with power injection is used for:

- 1. Continuous or intermittent drug infusions
- 2. Central venous blood pressure monitoring (CVP)
- 3. Acute hyperalimentation
- 4. Blood sampling
- 5. Delivery of whole blood or blood products
- 6. Simultaneous, separate infusion of drugs for multi-lumen catheters only
- 7. Power injection of contrast media*

*The flow rate may not exceed 3 mL/sec 4.0Fr and 5.0Fr catheters and 10 mL/sec for 7.0, 8.0, 9.0, and 10.0Fr catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters.

The device is a short-term use catheter, intended for less than 30 days.

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The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

## Comparison to Predicate Device:

The Cook Unimpregnated Central Venous Catheter is substantially equivalent to the predicate device, Cook Central Venous Catheters with or without Heparin (K081113, Cook Incorporated), cleared on July 30, 2008. The subject device is identical to the predicate device in intended use, principle of operation, and fundamental technologies. The differences between the subject device and the predicate device (K081113), including pediatric indication, materials, lumen number, and dimensions do not raise any different questions of safety and/or effectiveness. The substantial equivalence comparison of the subject device to the predicate devices is provided in the table below. To further support the safety and effectiveness of the subject device dilators, Dilator Sets cleared under K183036 are provided as a reference device.

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| | PREDICATE DEVICE | SUBJECT DEVICE | |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| | Cook Central Venous Catheters with or<br>without Heparin<br>(K081113) | Cook Unimpregnated Central Venous<br>Catheter | |
| Regulation | 21 CFR §880.5200 | IDENTICAL TO PREDICATE | |
| Product Code | FOZ<br>Catheter, Intravascular, Therapeutic, Short-<br>Term Less Than 30 Days | IDENTICAL TO PREDICATE | |
| Classification | II | IDENTICAL TO PREDICATE | |
| Indications for<br>Use | The Cook Central Venous Catheter is used<br>for:<br>- Continuous or intermittent drug<br>infusions<br>- Central venous blood pressure<br>monitoring (CVP)<br>- Acute hyperalimentation<br>- Blood sampling<br>- Delivery of whole blood or blood<br>products<br>- Power injection of contrast media*<br>The device is a short-term use catheter.<br>*The flow rate of the Cook Central Venous<br>Catheters may not exceed 10 mL/sec. | The Cook Unimpregnated Central Venous<br>Catheter (Non-Power Injectable) is used for:<br>1. Continuous or intermittent drug infusions<br>2. Central venous blood pressure monitoring<br>(CVP)<br>3. Acute hyperalimentation<br>4. Blood sampling<br>5. Delivery of whole blood or blood<br>products<br>6. Simultaneous, separate infusion of drugs<br>for multi-lumen catheters only<br><br>The device is a short-term use catheter,<br>intended for less than 30 days.<br><br>The Cook dilator is used for dilating puncture<br>sites or catheter tracts.<br><br>The Cook unimpregnated Central Venous<br>Catheter (Non-Power Injectable) is intended<br>for adult and pediatric populations | |
| | | The Cook Unimpregnated Central Venous | |
| | | Catheter with power injection is used for: | |
| | | 1. Continuous or intermittent drug infusions | |
| | | 2. Central venous blood pressure monitoring | |
| | | (CVP) | |
| | | 3. Acute hyperalimentation | |
| | | 4. Blood sampling | |
| | | 5. Delivery of whole blood or blood | |
| | | products | |
| | | 6. Simultaneous, separate infusion of drugs<br>for multi-lumen catheters only | |
| | | 7. Power injection of contrast media* | |
| | | *The flow rate may not exceed 3 mL/sec for | |
| | | 4.0 and 5.0 French catheters and 10 mL/sec | |
| | | for 7.0, 8.0, 9.0, and 10.0 French catheters | |
| | | Verify prior to use that the maximum safety | |
| | | cut-off pressure limit is set at or below 250 psi | |
| | | for 4.0 and 5.0 French catheters and 325 psi | |
| | | for 7.0, 8.0, 9.0, and 10.0 French catheters. | |
| | | The device is a short-term use catheter, | |
| | | intended for less than 30 days. | |
| | | The 9.0 and 10.0 French catheters include an | |
| | | inner catheter to facilitate insertion of the | |
| | | main catheter. | |
| | | The Cook dilator is used for dilating puncture | |
| | | sites or catheter tracts. | |
| | | The Cook Unimpregnated Central Venous | |
| | | Catheter with power injection is intended for | |
| | | adult and pediatric populations. | |
| | | Catheter Size | Recommended Minimum<br>Age / Weight |
| Patient Population | Not specified | 2.5Fr | Birth / < 2.4 kg |
| | | 3.0Fr | Birth / 2.4 kg |
| | | 4.0Fr | |
| | | 5.0Fr | 2 yrs / 10 kg |
| | | 6.3Fr | 4 yrs / 13 kg |
| | | 7.0Fr | |
| | | 7.5Fr | 10 yrs / 50 kg |
| | | 8.0Fr | |
| | | 9.0Fr | 21 yrs (adult only) |
| | | 10.0Fr | |
| Device is for One-<br>Time Use | Yes | IDENTICAL TO PREDICATE | |
| Catheter<br>Placement Method | Percutaneous via Seldinger technique | IDENTICAL TO PREDICATE | |
| Catheter Tip<br>Target Anatomy | SVC-RA junction | IDENTICAL TO PREDICATE | |
| Catheter Tip<br>Location<br>Confirmation<br>Method | | | |
| Catheter Distal<br>End Configuration | Straight and tapered | IDENTICAL TO PREDICATE | |
| Catheter Ink<br>Markings | Yes | IDENTICAL TO PREDICATE…