(49 days)
No
The description focuses on the physical characteristics and performance testing of a mechanical dilator, with no mention of AI or ML capabilities.
No
The device is described as facilitating the placement of other therapeutic or diagnostic devices, rather than directly providing therapy.
No
Explanation: The device is described as facilitating the placement of other therapeutic or diagnostic devices, but it is not itself performing a diagnostic function. Its intended use is to dilate puncture sites or catheter tracts.
No
The device description explicitly states it consists of physical components like dilators, entry needles, and wire guides, and the performance studies focus on physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dilat[e] puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications". This describes a physical intervention on the body to facilitate the insertion of other devices.
- Device Description: The device is described as a "single dilator or a group of components that are used percutaneously to dilate puncture sites or catheter tracts". This is a mechanical device used for physical manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs are typically used in vitro (outside the body) to analyze biological samples.
The device described is a medical device used for a procedural purpose (dilation) to facilitate other medical procedures. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DRE, FGE
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous, arterial, biliary and renal systems, natural body space (e.g., the peritoneal cavity, an artery or vein)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
- Lubricity Testing Tested in accordance with an approved study protocol. The pre-determined acceptance criterial were met.
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.
Key Metrics
Not Found
Predicate Device(s)
Medcomp® Vessel Dilator (Medcomp®, K162389), PBN Dilators (Medical Device Technologies, Inc., K990808)
Reference Device(s)
Peel-Away Introducer Set (Cook Inc., K170020), Royal Flush Catheter (Cook Inc., K171264), CrossCath Support Catheter (Cook Inc., K161801)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
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.(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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
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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 |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x102309 |
| Contact Fax Number: | (812) 332-0281 |
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).