(311 days)
Not Found
No
The device description and intended use focus on the physical components and function of delivery catheters and systems for introducing devices into the left heart. There is no mention of AI, ML, image processing for analysis, or any software-driven decision-making or analysis. The performance studies are focused on device integrity and physical characteristics.
No.
The device is a delivery system intended to introduce other transvenous devices and leads, contrast medium, or pacing/defibrillator leads and catheters; it does not itself provide therapy.
No
The device descriptions and intended uses clearly state that these devices are delivery systems or catheters designed to introduce or facilitate delivery of other transvenous devices, leads, or contrast medium. They are tools for accessing and navigating anatomy to place other medical devices, not for diagnosing conditions or diseases.
No
The device description explicitly details physical components such as catheters, dilators, guide wires, and slitters, all constructed from materials like Polyether Block Amide and Polyethylene. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a delivery system for introducing transvenous devices and leads into the left heart via the coronary sinus. This is a surgical/interventional procedure, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details catheters, dilators, guide wires, and related components used for physically delivering other devices within the body. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is designed for facilitating the placement of other medical devices within the body, which is the function of an interventional or surgical device, not an IVD.
N/A
Intended Use / Indications for Use
- Attain CommandTM + SureValve™ Left Heart Delivery System; Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery: The left-heart delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
- Attain Select™ II + SureValve™ Delivery Catheter System: The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer guide catheters.
- C315 Delivery Catheter: The C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
Product codes (comma separated list FDA assigned to the subject device)
DOY, DQY
Device Description
The Medtronic C315 Delivery Catheter contains one catheter and one dilator constructed of Polyether Block Amide and Polyethylene respectively. It is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. There are seven models in the Medtronic C315 Delivery Catheter product family, all of which have the same inner and outer diameter (5.4Fr and 7.0Fr respectively). The models differ in useable length, which varies from 20cm to 43cm. Proximally, the C315 is equipped with a hemostatic valve, and the distal tip is radiopaque to facilitate imaging under fluoroscopy. The C315 is designed to be slittable, thereby allowing its removal after device placement. A variety of curves are available to accommodate various anatomies and different lead locations.
The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus. The Attain Command™ + SureValve™ Left-Heart Delivery System kits each contain two outer guide catheters with an integrated hemostasis valve (SureValve™), up to two valve tools, one dilator, one guide wire, and one slitter. The Attain Command™ + Sure Valve™ Left-Heart Delivery System is available in two models:
- Attain Command™ + SureValve™ 6250VC Left Heart Delivery System
- Attain Command™ + SureValve™ 6250VS Left Heart Delivery System
With the exception of the two guide catheters, all system components packaged in each kit are identical. Each guide catheter model is different with respect to the guide catheter shape and length.
The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery individual packs each contain one guide catheter with an integrated hemostasis valve (SureValve™), up to two valve tools, and one dilator. The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are available in 12 models:
- Attain Command™ + SureValve™ 6250V-45S Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-50S Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-57S Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-AM Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-EH Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-EHXL Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-MB2 Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-MB2X Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-MP Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-MPR Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-MPX Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-3D Guide Catheter for Left Heart Delivery
Each model is different with respect to the guide catheter shape and length and dilator length.
The Attain Select™ II + SureValve™ delivery catheter system is designed to facilitate left-heart lead delivery to a desired cardiac vein. The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer guide catheters. Together, the catheters function as a telescoping system that can provide additional sub selecting capabilities.
The delivery catheter system consists of a delivery catheter with an integrated hemostasis valve (SureValve™), an inner catheter, and up to two valve tools. The Attain Select™ II + SureValve™ delivery catheter system is available in 8 models:
- Attain Select™ II + SureValve™ 6248V-90 Delivery Catheter System
- Attain Select™ II + SureValve™ 6248V-90S Delivery Catheter System
- Attain Select™ II + SureValve™ 6248V-90L Delivery Catheter System
- Attain Select™ II + SureValve™ 6248V-130 Delivery Catheter System
- Attain Select™ II + SureValve™ 6248V-130L Delivery Catheter System
- Attain Select™ II + SureValve™ 6248V-90P Delivery Catheter System
- Attain Select™ II + SureValve™ 6248V-90SP Delivery Catheter System
- Attain Select™ II + SureValve™ 6248V-130P Delivery Catheter System
The Attain Select™ II + SureValve™ inner catheter is identical for all configurations. Each model is different with respect to delivery catheter shape and length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
the distal tip is radiopaque to facilitate imaging under fluoroscopy.
Anatomical Site
left heart, coronary sinus, left-heart venous anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Device integrity testing was performed to support the equivalency of the tip material change of the applicable devices device to the predicate devices. Testing included mechanical, functional, sterilization and biocompatibility testing. The devices listed below met all specified design and performance requirements.
- C315 Delivery Catheter (K101885, cleared on September 9, 2010)
- Attain Select™ II + SureValve™ delivery catheter system (K123153, cleared on April 9, 2013)
- Attain Command™ + SureValve™ Product families (Left Heart Delivery System and Guide Catheters for Left Heart Delivery) (K123153, cleared on April 9, 2013)
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.
Not Found
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
August 3, 2020
Medtronic, Inc. Nicola Reidy Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland
Re: K192712
Trade/Device Name: Attain Select™ II + SureValve™ Delivery Catheter System, Attain Command™ + SureValve™ Left Heart Delivery System, Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery, C315 Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: July 2, 2020 Received: July 6, 2020
Dear Nicola Reidy:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K192712
Device Name
Attain CommandTM + SureValve™ Left Heart Delivery System; Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery
Indications for Use (Describe)
The left-heart delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
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 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."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
Indications for Use
510(k) Number (if known) K192712
Device Name
Attain Select™ II + SureValve™ Delivery Catheter System
Indications for Use (Describe)
The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer guide catheters.
Type of Use (Select one or both, as applicable)
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 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."
FORM FDA 3881 (7/17)
Page 1 of 1
EF PSC Publishing Services (301) 443-6740
4
Indications for Use
510(k) Number (if known) K192712
Device Name C315 Delivery Catheter
Indications for Use (Describe)
The C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters.
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 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."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
5
510(k) Summary per 21 CRF 807.92
Date Prepared:
26 September 2019
Applicant:
Medtronic Ireland Parkmore Business Park West Galway Ireland
Official Correspondent:
Nicola Reidy Regulatory Affairs Specialist Medtronic Ireland Parkmore Business Park West Galway Ireland Phone: (+353) 91 750772 Fax: (+353) 91 708672 Email: nicola.m.reidy@medtronic.com
Common Name:
- . C315 Delivery Catheter
- Attain Select™ II + SureValve™ delivery catheter system
- Attain Command™ + SureValve™ Product families (Left Heart Delivery System ● & Guide Catheters for Left Heart Delivery)
Device Classification:
II
Regulation Number:
21 CFR 870.1250
Classification Name:
Percutaneous Catheter
Product Code:
DQY
6
Device Description:
The Medtronic C315 Delivery Catheter contains one catheter and one dilator constructed of Polyether Block Amide and Polyethylene respectively. It is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. There are seven models in the Medtronic C315 Delivery Catheter product family, all of which have the same inner and outer diameter (5.4Fr and 7.0Fr respectively). The models differ in useable length, which varies from 20cm to 43cm. Proximally, the C315 is equipped with a hemostatic valve, and the distal tip is radiopaque to facilitate imaging under fluoroscopy. The C315 is designed to be slittable, thereby allowing its removal after device placement. A variety of curves are available to accommodate various anatomies and different lead locations.
The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus. The Attain Command™ + SureValve™ Left-Heart Delivery System kits each contain two outer guide catheters with an integrated hemostasis valve (SureValve™), up to two valve tools, one dilator, one guide wire, and one slitter. The Attain Command™ + Sure Valve™ Left-Heart Delivery System is available in two models:
- Attain Command™ + SureValve™ 6250VC Left Heart Delivery System .
- Attain Command™ + SureValve™ 6250VS Left Heart Delivery System
With the exception of the two guide catheters, all system components packaged in each kit are identical. Each guide catheter model is different with respect to the guide catheter shape and length.
The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery individual packs each contain one guide catheter with an integrated hemostasis valve (SureValve™), up to two valve tools, and one dilator. The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are available in 12 models:
- . Attain Command™ + SureValve™ 6250V-45S Guide Catheter for Left Heart Delivery
- Attain Command™ + SureValve™ 6250V-50S Guide Catheter for Left Heart Delivery ●
- Attain Command™ + SureValve™ 6250V-57S Guide Catheter for Left Heart Delivery ●
- Attain Command™ + SureValve™ 6250V-AM Guide Catheter for Left Heart Delivery ●
- Attain Command™ + SureValve™ 6250V-EH Guide Catheter for Left Heart Delivery .
- Attain Command™ + SureValve™ 6250V-EHXL Guide Catheter for Left Heart ● Delivery
- Attain Command™ + SureValve™ 6250V-MB2 Guide Catheter for Left Heart ● Delivery
- Attain Command™ + SureValve™ 6250V-MB2X Guide Catheter for Left Heart ● Delivery
- Attain Command™ + SureValve™ 6250V-MP Guide Catheter for Left Heart Delivery ●
7
- Attain Command™ + SureValve™ 6250V-MPR Guide Catheter for Left Heart ● Delivery
- Attain Command™ + SureValve™ 6250V-MPX Guide Catheter for Left Heart ● Delivery
- Attain Command™ + SureValve™ 6250V-3D Guide Catheter for Left Heart Delivery ●
Each model is different with respect to the guide catheter shape and length and dilator length.
The Attain Select™ II + SureValve™ delivery catheter system is designed to facilitate leftheart lead delivery to a desired cardiac vein. The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer guide catheters. Together, the catheters function as a telescoping system that can provide additional sub selecting capabilities.
The delivery catheter system consists of a delivery catheter with an integrated hemostasis valve (SureValve™), an inner catheter, and up to two valve tools. The Attain Select™ II + SureValve™ delivery catheter system is available in 8 models:
- Attain Select™ II + SureValve™ 6248V-90 Delivery Catheter System ●
- Attain Select™ II + SureValve™ 6248V-90S Delivery Catheter System ●
- Attain Select™ II + SureValve™ 6248V-90L Delivery Catheter System
- Attain Select™ II + SureValve™ 6248V-130 Delivery Catheter System ●
- Attain Select™ II + SureValve™ 6248V-130L Delivery Catheter System ●
- Attain Select™ II + SureValve™ 6248V-90P Delivery Catheter System ●
- Attain Select™ II + SureValve™ 6248V-90SP Delivery Catheter System ●
- Attain Select™ II + SureValve™ 6248V-130P Delivery Catheter System ●
The Attain Select™ II + SureValve™ inner catheter is identical for all configurations. Each model is different with respect to delivery catheter shape and length.
Indications For Use:
The indications for use for each of the applicable devices is listed below;
-
C315 Delivery Catheter .
The device is indicated for the introduction of various types of pacing or defibrillator leads and catheters. -
Attain Command™ + SureValve™ Left Heart Delivery System ●
-
Attain Command™ & SureValve™ Guide Catheters for Left Heart Delivery: ●
8
The left-heart delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
- Attain Select™ II + SureValve™ Delivery Catheter System: ●
The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer guide catheters.
Substantially Equivalent Device:
The applicable device uses similar technology and has similar intended uses, function, materials and method of operation to the following predicate devices:
- C315 Delivery Catheter (K101885, cleared on September 9, 2010) .
- Attain Select™ II + SureValve™ delivery catheter system (K123153, cleared on April ● 9, 2013)
- Attain Command™ + SureValve™ Product families (Left Heart Delivery System and ● Guide Catheters for Left Heart Delivery) (K123153, cleared on April 9, 2013)
Summary of Technological Differences to the Predicate Device:
The difference to the predicate device is the change in the tip material.
| Current Tip Material | Proposed Tip Material | |
|---|---|---|
| Materials | Tungsten Carbide Pebax | |
| material | Tungsten Carbide Pebax material with addition | |
| of hydrolysis inhibitor stabilizer and a hindered | ||
| amine light stabilizer. |
Summary of Non-Clinical Data:
Device integrity testing was performed to support the equivalency of the tip material change of the applicable devices device to the predicate devices. Testing included mechanical, functional, sterilization and biocompatibility testing. The devices listed below met all specified design and performance requirements.
- C315 Delivery Catheter (K101885, cleared on September 9, 2010) ●
- Attain Select™ II + SureValve™ delivery catheter system (K123153, cleared on ● April 9, 2013)
- Attain Command™ + SureValve™ Product families (Left Heart Delivery System and ● Guide Catheters for Left Heart Delivery) (K123153, cleared on April 9, 2013)
Biocompatibility Information:
The biocompatibility evaluation completed for the devices listed below verifies that the applicable devices are biocompatible.
- C315 Delivery Catheter
- . Attain Select™ II + SureValve™ delivery catheter system
9
- Attain Command™ + SureValve™ Product families (Left Heart Delivery System and ● Guide Catheters for Left Heart Delivery)
The testing which supports the biocompatibility is consistent with International Standard ISO 10993-1: "Biological Evaluation of Medical devices- Part 1: Evaluation and Testing." When classified according to this standard, the catheter and dilator included in the applicable devices are external communicating devices with limited exposure (