(99 days)
No
The document describes a medical device for percutaneous catheter introduction, consisting of mechanical components like a steerable sheath, dilator, and handle. There is no mention of any AI, DNN, or ML technologies in the "Mentions AI, DNN, or ML" section or within the device description and performance studies. The testing conducted focuses on mechanical and biological performance, not AI model evaluation.
No.
The Global Introducer is designed to facilitate percutaneous access for other devices into the vasculature and heart chambers, not to directly treat a condition.
No
The device is an introducer sheath, which is used to facilitate access for other medical instruments. Its purpose is to create a pathway into the body, not to diagnose a condition or disease.
No
The device is a physical medical instrument (a steerable introducer sheath with hardware components like a handle, steering knob, and dilator) intended for direct physical interaction with the human body for catheter introduction. It is not described as being composed solely of software.
No
This device is an introducer sheath designed to facilitate percutaneous access to the vasculature and heart chambers. It is used to introduce other catheters into the body, not to perform any diagnostic testing on in vitro samples.
N/A
Intended Use / Indications for Use
The Globe Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum.
Product codes
DRA
Device Description
The Globe® Introducer is a single use, ethylene oxide sterilized medical device used to facilitate percutaneous access to the vasculature and into the heart chambers. The device consists of a 16 Fr (5.3 mm) inner diameter (ID) steerable sheath with a hydrophilic coating, a dilator compatible with 0.89 mm (0.035 in) guidewires, and a dilator loader.
The proximal end of the sheath includes a handle with an integrated steering knob for bidirectional deflection control of the sheath tip, a steering indicator, and a slider. The slider contains a loader connection port for the dilator loader and a compatible catheter loader. The slider provides a hemostatic seal and a saline flushing line with a standard Luer fitting stopcock, for air removal and management.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted to support the determination of substantial equivalence between the Globe Introducer and the predicate device:
- Biocompatibility Testing
- Sterilization Validation
- Packaging Validation
- Shelf-Life Testing
- Bench Testing
- Particulate Test
- Deployment-Retraction Force Test
- Flushing Test
- Pressure Withstand Test
- Corrosion Resistance Test
- ISO 80369 Luer Test
- Introducer Health Check Test
- Dimensional Inspection Test
- Steering Knob Torque Test
- Sheath Tensile Test
- Mechanical Performance Test
- Torque Test
- Lubricity Test
- Radiopacity Test
- Dilator Performance Test
- Air Egress Test
Bench Testing was performed following the applicable principles and recommendations of relevant FDA-recognized consensus standards and guidance documents. The test results demonstrate that the Globe Introducer meets the performance criteria for its intended use and does not raise new questions on safety or effectiveness compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
FARADRIVE™ Steerable Sheath (K233248)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - Globe® Introducer
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 3, 2025
Kardium Inc.
Ricardo Romero
Vice President, RA&QA
8518 Glenlyon Parkway, Unit 155
Burnaby, BC V5J 0B6
Canada
Re: K250529
Trade/Device Name: Globe® Introducer
Regulation Number: 21 CFR 870.1280
Regulation Name: Steerable Catheter
Regulatory Class: Class II
Product Code: DRA
Dated: May 5, 2025
Received: May 6, 2025
Dear Ricardo Romero:
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 (the 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 available 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.
Page 2
K250529 - Ricardo Romero
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250529 - Ricardo Romero
Page 3
assistance/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,
Aneesh S. Deoras -S
Aneesh Deoras
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250529
Device Name: Globe® Introducer
Indications for Use (Describe):
The Globe Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary
per 21 CFR §807.92
| Sponsor | Kardium Inc.
155-8518 Glenlyon Parkway
Burnaby, British Columbia V5J 0B6
Canada |
|-------------|-------------------------------------------------------------------------------------------|
| Contact Name and Information | Ricardo Romero
Vice President, RA&QA
Kardium Inc.
Tel: +1 604.248.8891 |
| Date Prepared by | February 21st, 2025 |
| Proprietary Name | Globe® Introducer |
| Common Name | Steerable catheter |
| Product Code | DRA |
| Classification | Class II, 21 CFR Part 870.1280 |
| Predicate Device | FARADRIVE™ Steerable Sheath (K233248) |
| Device Description | The Globe® Introducer is a single use, ethylene oxide sterilized medical device used to facilitate percutaneous access to the vasculature and into the heart chambers. The device consists of a 16 Fr (5.3 mm) inner diameter (ID) steerable sheath with a hydrophilic coating, a dilator compatible with 0.89 mm (0.035 in) guidewires, and a dilator loader.
The proximal end of the sheath includes a handle with an integrated steering knob for bidirectional deflection control of the sheath tip, a steering indicator, and a slider. The slider contains a loader connection port for the dilator loader and a compatible catheter loader. The slider provides a hemostatic seal and a saline flushing line with a standard Luer fitting stopcock, for air removal and management. |
| Indications for Use | The Globe Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. |
Page 6
Predicate Comparison
Table 1: Comparison of Technological Characteristics with the Predicate Device
| Characteristics | Subject Device: Globe® Introducer | Predicate Device: FARADRIVE™ Steerable Sheath (K233248) | Comparison |
|---|---|---|---|
| Product Code | DRA | DRA | Identical |
| Intended Use / Indications for Use | The Globe Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. | The FARADRIVE Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. | Same Intended Use / Indications for Use |
| Design Features | Steering knob that rotates in the plane of the handle | Actuator knob that rotates coaxially to the handle | Differences in the steering mechanism do not alter the fundamental scientific technology or pose an added safety risk. |
| Bi-directional shaft deflection clockwise ≥90° counterclockwise ≥45° | Unidirectional shaft deflection from 0°to 180° | The range of motion has been shown to be sufficient for anatomical placement of compatible catheters. The differences do not raise new questions of safety or effectiveness. | |
| Integrated hemostatic seal, slider port, and flush line with three-way stopcock | Integrated hemostasis valve and side flush line with three-way stopcock | The differences in design do not alter the fundamental scientific technology or raise new questions about device performance or safety. |
Page 7
| Characteristics | Subject Device: Globe® Introducer | Predicate Device: FARADRIVE™ Steerable Sheath (K233248) | Comparison |
|---|---|---|---|
| Distal vent holes | Distal vent holes | Distal vent holes | Same design characteristics |
| Radiopaque tip marker | Radiopaque tip marker | Radiopaque tip marker | Same design characteristics |
| Dimensions | Sheath size: | ||
| – Inner diameter: 16 F | |||
| – Usable length: 71 cm | |||
| – Sheath outer diameter: 21 F | Sheath size: | ||
| – Inner diameter: 13 F | |||
| – Usable length: 74 cm | |||
| – Sheath outer diameter: 17.4 F | The differences in sheath dimensions ensure compatibility with prescribed catheters under identical intended uses of the sheath. | ||
| Dilator size: | |||
| – Dilator usable length: 102 cm (40.24 in) | |||
| – Dilator inner diameter: 0.9 mm (0.035 in) | |||
| – Dilator outer diameter: 5.2 mm (0.205 in) | Dilator size: | ||
| – Dilator usable length: 94 cm (36.85 in) | |||
| – Dilator inner diameter: 0.9 mm (0.037 in) | |||
| – Dilator outer diameter: 4.4 mm (0.172 in) | The differences in dilator dimensions do not alter the fundamental scientific technology nor do they raise new questions about device performance or safety. | ||
| Guidewire Compatibility | Maximum diameter: 0.89 mm (0.035 in) | Maximum diameter: 0.89 mm (0.035 in) | Same guidewire compatibility. |
| Materials | This device contains: | ||
| – Hydrophilic coated (polyvinylpyrrolidone) polyether block amide (PEBAX) | |||
| – Nylon | |||
| – Polytetrafluoroethylene (PTFE) liner | |||
| – Silicone rubber | |||
| – Polycarbonate | |||
| – Polyethylene | |||
| – Polyvinyl Chloride (PVC) | |||
| – Acetal | |||
| – Rilsan | This device contains: | ||
| – Polyether block amide (PEBAX) | |||
| – Nylon | |||
| – Stainless steel | |||
| – Hydrophilic coated PEBAX liner | |||
| – Silicone rubber | |||
| – Polycarbonate | |||
| – Polyethylene | The subject and predicate devices are constructed of equivalent materials. Any differences have been qualified through biological safety and performance testing. | ||
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same sterilization method. |
Page 8
| Characteristics | Subject Device: Globe® Introducer | Predicate Device: FARADRIVE™ Steerable Sheath (K233248) | Comparison |
|---|---|---|---|
| Single Use | Yes | Yes | Same limitations on use. |
| Packaging | Tyvek nylon/polyethylene pouch with a protective tray | Tyvek nylon/polyethylene pouch | Same sterile barrier system. Minor differences in packaging do not raise new questions about device performance or safety, as demonstrated by preclinical and packaging validation testing. |
Non-clinical Performance Data
The following testing was conducted to support the determination of substantial equivalence between the Globe Introducer and the predicate device:
- Biocompatibility Testing
- Sterilization Validation
- Packaging Validation
- Shelf-Life Testing
- Bench Testing
- Particulate Test
- Deployment-Retraction Force Test
- Flushing Test
- Pressure Withstand Test
- Corrosion Resistance Test
- ISO 80369 Luer Test
- Introducer Health Check Test
- Dimensional Inspection Test
- Steering Knob Torque Test
- Sheath Tensile Test
- Mechanical Performance Test
- Torque Test
- Lubricity Test
- Radiopacity Test
- Dilator Performance Test
- Air Egress Test
Bench Testing was performed following the applicable principles and recommendations of relevant FDA-recognized consensus standards and guidance documents. The test results demonstrate that the Globe Introducer meets the performance criteria for its intended use and does not raise new questions on safety or effectiveness compared to the predicate device.
Page 9
Statement of Equivalence
The Globe Introducer and predicate device have identical or equivalent intended use, indications for use, technological characteristics, and performance. Differences in design do not raise any new or different questions of safety and effectiveness. Based on this and the results of performance testing, the Globe Introducer is substantial equivalent to the predicate device.