(267 days)
No
The device description and performance studies focus on the physical characteristics and functionality of a catheter infusion set, with no mention of AI or ML.
No.
The device is intended to administer therapeutic solutions, but it is not itself a therapeutic device; it is a delivery system.
No
The device is an infusion set intended to administer therapeutic solutions and contrast media. It is not designed to diagnose a medical condition or disease.
No
The device description clearly outlines physical components like a catheter, Luer lock adapter, shaft, tip occluder, and check valve, indicating it is a hardware device. The performance studies also focus on physical properties and performance of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer infusions of various therapeutic solutions and contrast media into the peripheral vasculature." This describes a device used in vivo (within the body) for treatment or imaging, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a catheter and associated components for delivering substances into the bloodstream. This is consistent with an in vivo medical device.
- Anatomical Site: The anatomical site is the "Peripheral vasculature," which is within the body.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the catheter for its intended in vivo use (biocompatibility, leakage, tensile strength, radiopacity, simulated use). These are not studies related to analyzing biological specimens.
IVD devices are used to examine specimens such as blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. This device's function is to deliver substances into the body, which is a therapeutic or diagnostic procedure performed on the patient, not an analysis of a specimen from the patient.
N/A
Intended Use / Indications for Use
The Multi-Sideport Catheter Infusion Set is intended to administer infusions of various therapeutic solutions and contrast media into the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Multi-Sideport Catheter Infusion Set is available in the 5.0 Fr size and is manufactured in lengths of 40, 65, 100 and 130 centimeters. The catheter is compatible with a 0.035 inch wire guide. The infusion segment lengths are 7, 15 or 20 centimeters and come with 14, 30 or 40 sideports. Each subject device set includes a catheter with a Luer lock adapter and a single lumen shaft, a tip occluder and Tuohy-Borst large bore clear plastic side adapter, and a dual check valve with a 1 ml syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 201 Subpart D)
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)
The Multi-Sideport Catheter Infusion Set, subject of this submission, was subjected to the applicable testing listed below to assure reliable design and performance under the testing parameters. Performance and biocompatibility testing were conducted in accordance with applicable standards and FDA guidance documents to confirm the reliable performance of critical device characteristics.
- Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subchronic toxicity, genotoxicity, implantation, hemocompatibility, complement activation, partial thromboplastin time and in vivo thrombogenicity) demonstrated that the subject device is biocompatible for the intended use. In conformance with the applicable sections of ANSI AAMI ISO 10993- 1:2009(R)2013, the predetermined acceptance criteria were met.
- Air Leakage Testing – Testing verified that, under proper clinical use of the subject device, there will be no air leakage when tested in accordance with the methods described in BS EN ISO 10555-1:2013, Annex D. The predetermined acceptance criterion was met.
- Compatibility Testing – Testing verified that the compatibility requirements of the subject device are within a specified tolerance. The predetermined acceptance criteria were met.
- Corrosion Testing – Tested in accordance with Annex B of ISO 11070:2014. The predetermined acceptance criteria were met.
- Dimensional Verification Testing - Testing was completed in accordance with an approved study protocol. The predetermined acceptance criteria were met.
- Liquid Leakage Testing - Testing verified that, under proper clinical use of the subject device, there will be no liquid leakage when tested in accordance with the methods described in BS EN ISO 10555-1:2013, Annex C. The predetermined acceptance criterion was met.
- Tuohy Stress Cracking – Testing verified the requirements of no signs of leakage or stress cracking when tested in accordance with ISO 80369-7:2016. The predetermined acceptance criteria were met.
- Tensile Testing of the Hub-to-Shaft Bond – Testing verified that, under proper clinical use of the subject device, the peak load value of the hub-to-shaft connection is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Tensile Testing of the Marker Band to Shaft Bond – Testing was completed in accordance with an approved study protocol. The predetermined acceptance criterion was met.
- Tensile Testing of the Sideported Area – Testing verified that, under proper clinical use of the subject device, the peak load value of the sideported area of the shaft is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Radiopacity Testing – The results verified, under the proper clinical use of the subject device, the test articles were visible when imaged under fluoroscopy. The predetermined acceptance criterion was met.
- Simulated Use Testing – The results verified, under simulated clinical use of the subject device, the test articles can be loaded, advanced, flushed and withdrawn as intended, without kinks or material separation. The predetermined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
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April 25, 2019
Cook Incorporated Reuben Lidster Regulatory Affairs Specialist P.O. Box 489, 750 Daniels Way Bloomington, Indiana 47402
Re: K182071
Trade/Device Name: Multi-Sideport Catheter Infusion Set Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: March 14, 2019 Received: March 15, 2019
Dear Mr. Lidster:
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 and Part 809); 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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory 2019.04.25 10:03:51 -04'00' O'Connell 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) K182071
Device Name Multi-Sideport Catheter Infusion Set
Indications for Use (Describe)
The Multi-Sideport Catheter Infusion Set is intended to administer infusions of various therapeutic solutions and contrast media into the peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
COOK INCORPORATED 750 DANIELS WAY OOMINGTON, WW.COOKMEDICI
Multi-Sideport Catheter Infusion Set
Traditional 510(k) Summary 21 CFR §807.92
Submitter Information
| Applicant: | Cook Incorporated |
|---|---|
| Address: | 750 Daniels Way |
| Bloomington, IN 47404 | |
| Contact: | Reuben G. Lidster |
| Email: | RegSubmissions@CookMedical.com |
| Contact Phone Number: | 812-335-3575 ext. 104866 |
| Contact Fax Number: | 812-332-0281 |
| Date Prepared: | 31 July 2018 |
Device Information
| Trade Name: | Multi-Sideport Catheter Infusion Set |
|---|---|
| Common Name: | Continuous flush catheter |
| Classification Name: | Catheter, Continuous, Flush |
| KRA (21 CFR §870.1210) |
Predicate Device
The predicate device is the Merit Medical Systems Inc. Fountain Infusion System cleared under 510(k) number K991619. The predicate device is manufactured in a diameter of 5.0 French and in lengths of 45 - 135 centimeters. The catheter is compatible with a 0.035 inch wire guide. The infusion segment lengths are 5 - 50 centimeters and come with 40 to 400 sideports.
Reference Device
The reference device is the AngioDynamics SpeedLyser™ (K170258), which is available in
4
shorter lengths than the predicate.
Comparison to Predicate Device
The subject device, Multi-Sideport Catheter Infusion Set has a similar indication for use, duration of use, principles of operation, fundamental technological characteristics, and insertion method as the predicate device (K991619). Minor differences between the subject device and the predicate device include materials and dimensions. The differences between the subject device and the predicate device do not raise new questions of safety and effectiveness as demonstrated by the biocompatibility and performance testing.
Device Description
The Multi-Sideport Catheter Infusion Set is available in the 5.0 Fr size and is manufactured in lengths of 40, 65, 100 and 130 centimeters. The catheter is compatible with a 0.035 inch wire guide. The infusion segment lengths are 7, 15 or 20 centimeters and come with 14, 30 or 40 sideports. Each subject device set includes a catheter with a Luer lock adapter and a single lumen shaft, a tip occluder and Tuohy-Borst large bore clear plastic side adapter, and a dual check valve with a 1 ml syringe.
Intended Use
The Multi-Sideport Catheter Infusion Set is intended to administer infusions of various therapeutic solutions and contrast media into the peripheral vasculature.
Test Data
The Multi-Sideport Catheter Infusion Set, subject of this submission, was subjected to the applicable testing listed below to assure reliable design and performance under the testing parameters. Performance and biocompatibility testing were conducted in accordance with applicable standards and FDA guidance documents to confirm the reliable performance of critical device characteristics.
- . Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subchronic toxicity, genotoxicity, implantation, hemocompatibility, complement activation, partial thromboplastin time and in vivo thrombogenicity) demonstrated that the subject device is biocompatible for the intended use. In conformance with the applicable sections of ANSI AAMI ISO 10993- 1:2009(R)2013, the predetermined acceptance criteria were met.
- Air Leakage Testing Testing verified that, under proper clinical use of the .
5
subject device, there will be no air leakage when tested in accordance with the methods described in BS EN ISO 10555-1:2013, Annex D. The predetermined acceptance criterion was met.
- Compatibility Testing Testing verified that the compatibility . requirements of the subject device are within a specified tolerance. The predetermined acceptance criteria were met.
- Corrosion Testing Tested in accordance with Annex B of ISO 11070:2014. The . predetermined acceptance criteria were met.
- . Dimensional Verification Testing - Testing was completed in accordance with an approved study protocol. The predetermined acceptance criteria were met.
- . Liquid Leakage Testing - Testing verified that, under proper clinical use of the subject device, there will be no liquid leakage when tested in accordance with the methods described in BS EN ISO 10555-1:2013, Annex C. The predetermined acceptance criterion was met.
- Tuohy Stress Cracking Testing verified the requirements of no signs of leakage . or stress cracking when tested in accordance with ISO 80369-7:2016. The predetermined acceptance criteria were met.
- Tensile Testing of the Hub-to-Shaft Bond Testing verified that, under proper . clinical use of the subject device, the peak load value of the hub-to-shaft connection is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Tensile Testing of the Marker Band to Shaft Bond Testing was completed in . accordance with an approved study protocol. The predetermined acceptance criterion was met.
- Tensile Testing of the Sideported Area Testing verified that, under proper . clinical use of the subject device, the peak load value of the sideported area of the shaft is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Radiopacity Testing The results verified, under the proper clinical use of the . subject device, the test articles were visible when imaged under fluoroscopy. The predetermined acceptance criterion was met.
6
- K182071
- Simulated Use Testing The results verified, under simulated clinical use of the . subject device, the test articles can be loaded, advanced, flushed and withdrawn as intended, without kinks or material separation. The predetermined acceptance criteria were met.
Conclusion
The results of testing support a conclusion that the Multi-Sideport Catheter Infusion Set met the design input requirements based on the intended use and support the conclusion that the modifications do not raise new questions of safety or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the Merit Medical Fountain Infusion Catheter (K991619).