Dilator Sets

K183036 · Cook Incorporated · DRE · Dec 20, 2018 · Cardiovascular

Device Facts

• Record ID: K183036
• Device Name: Dilator Sets
• Applicant: Cook Incorporated
• Product Code: DRE · Cardiovascular
• Decision Date: Dec 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Indications for Use

Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems.

Device Story

Cook Dilator Sets consist of single dilators or kits (including entry needle and wire guide) used to dilate puncture sites or catheter tracts; facilitates percutaneous placement of diagnostic or therapeutic devices into body spaces (e.g., peritoneal cavity, arteries, veins). Used in clinical settings for vascular and non-vascular applications. Dilators range from 3.0 to 26.0 French in diameter and 6 to 65 cm in length. Operated by clinicians to expand access sites for subsequent device insertion. Single-patient use; supplied sterile. Benefits include enabling minimally invasive access for various medical procedures.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1:2009), dilator hub-to-shaft tensile strength (ISO 11070:2014), compatibility, dimensional verification, radiopacity (ASTM F640-12), tip rollback (ISO 11070:2014), kink radius (ISO 11070:2014), and lubricity. All pre-determined acceptance criteria were met.

Technological Characteristics

Dilators range 3.0-26.0 Fr diameter, 6-65 cm length. Materials tested per ISO 10993-1:2009. Mechanical performance tested per ISO 11070:2014 (tensile, tip rollback, kink radius). Radiopacity tested per ASTM F640-12. Supplied sterile for single-patient use.

Indications for Use

Indicated for patients requiring percutaneous placement of devices into venous, arterial, biliary, or renal systems; used for dilating puncture sites or catheter tracts.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Medcomp® Vessel Dilator (K162389)
• PBN Dilators (K990808)

Reference Devices

• Peel-Away Introducer Set (K170020)
• Royal Flush Catheter (K171264)
• CrossCath Support Catheter (K161801)

Submission Summary (Full Text)

{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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

January 10, 2019

Cook Incorporated David Lehr Regulatory Affairs Manager 750 Daniels Way Bloomington, Indiana 47404

Re: K183036

Trade/Device Name: Dilator Sets Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE, FGE Dated: December 21, 2018 Received: December 26, 2018

Dear Mr. Lehr:

This letter corrects our substantially equivalent letter of December 20, 2018.

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/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 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,

# Misti L. Malone -S

For

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

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K183036

Device Name Dilator Sets

Indications for Use (Describe)

Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### 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 [e-mail]

"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."

{3}------------------------------------------------

#### 510(k) Summary

# As required by 21 CFR §807.92 Date Prepared: December 21, 2018

| Submitted By: | |
|-----------------------|---------------------------------------------------------------|
| Applicant: | Cook Incorporated |
| Contact: | David Lehr, RAC |
| Applicant Address: | Cook Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 |
| Contact Phone Number: | [phone] x102309 |
| Contact Fax Number: | [phone] |

#### Device Information:

Trade Name: Common Name:

Classification Panel: Regulation: Product Code:

# Dilator Sets Dilator, vessel, for percutaneous catheterization/ Stents, drains and dilators for the biliary ducts Cardiovascular/Gastroenterology/Urology 21 CFR §870.1310, 21 CFR §876.5010 DRE, FGE

### Predicate Devices:

- Medcomp® Vessel Dilator (Medcomp®, K162389) l
- l PBN Dilators (Medical Device Technologies, Inc., K990808)

### Reference Devices:

- Peel-Away Introducer Set (Cook Inc., K170020)
- l Royal Flush Catheter (Cook Inc., K171264)
- I CrossCath Support Catheter (Cook Inc., K161801)

# Device Description:

Cook Dilator Sets may consist of either a single dilator or a group of components that are used percutaneously to dilate puncture sites or catheter tracts, thereby facilitating the placement of other therapeutic or diagnostic devices into a natural body space (e.g., the peritoneal cavity, an artery or vein) for various vascular or non-vascular clinical applications. Some Dilator Set configurations may also include an entry needle and wire guide. The dilator component of the Dilator Sets is available in diameters ranging from 3.0 to 26.0 French and in lengths ranging from 6 to 65 cm. The broad range of dilator sizes accommodates the variation in the size of the

{4}------------------------------------------------

devices that could be inserted through the initial access site. All configurations of the Dilator Sets are supplied as packaged, sterile devices, intended for single-patient use.

## Intended Use:

Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems.

## Comparison of Technological Characteristics to Predicate:

The Dilator Sets and the predicate devices have the same basic intended use. The subject device is similar in technological characteristics (i.e., design and materials) to those of the predicate devices, with the addition of a smaller dilator diameter of 3.0 Fr and a broader scope of lengths (6 to 65 cm) as compared to the predicate devices, which have a combined scope of lengths ranging from 15 to 35 cm. Some configurations of the subject device are also supplied with additional kit components (i.e., entry needle and wire guide) as compared to the predicate devices.

# Technological Characteristics:

The subject device. Dilator Sets, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests performed are listed below:

- Biocompatibility Tested in accordance with ISO 10993-1:2009. The pre-determined . acceptance criteria were met.
- Dilator Hub to Shaft Tensile Tested in accordance with ISO 11070:2014. The pre-. determined acceptance criteria were met.
- . Compatibility Testing – Tested in accordance with an approved study protocol. The predetermined acceptance criterial were met.
- Dimensional Verification Testing Tested in accordance with an approved study . protocol. The pre-determined acceptance criteria were met.
- Radiopacity Evaluation Tested in accordance with ASTM F640-12. The pre-determined . acceptance criteria were met.
- Dilator Tip Rollback Testing Tested in accordance with ISO 11070:2014, Annex A.3. . The pre-determined acceptance criteria were met.
- Kink Radius Testing Tested in accordance with ISO 11070:2014, Annex A. The pre-■ determined acceptance criteria were met.

{5}------------------------------------------------

- Lubricity Testing Tested in accordance with an approved study protocol. The pre-. determined acceptance criterial were met.
### Conclusion:

The results of these tests support a conclusion that the Dilator Sets, subject of this submission, met the design input requirements based on the devices' intended use and support the conclusion these devices do not raise new questions of safety and/or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate devices, the Medcomp® Vessel Dilator (Medcomp®, K162389) and the PBN Dilators (Medical Device Technologies, Inc., K990808).