(219 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.
No
The device is described as a microcatheter designed to assist in the placement and exchange of guidewires, and delivery of contrast media, not to directly treat a condition.
No
The device description and intended use indicate that the Teleport XT microcatheter is used for facilitating the placement and exchange of guidewires, and for delivery of contrast media, all of which are interventional or procedural support functions, not diagnostic ones.
No
The device description clearly outlines a physical catheter with various material components, dimensions, and performance characteristics related to its physical structure and function within the body. There is no mention of software as the primary or sole component.
Based on the provided information, the Teleport XT microcatheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for supporting and facilitating guidewire placement, exchanging guidewires, and delivering contrast media into blood vessels. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter designed to be inserted into the vasculature, which is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Anatomical Site: The specified anatomical sites (coronary, peripheral, and abdominal vasculature) are all locations within the human body, further indicating in vivo use.
Therefore, the Teleport XT microcatheter is a medical device used for interventional procedures within the body, not an IVD device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Teleport XT microcatheters are indicated for:
- · supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature.
- · exchanging guidewires in the coronary and peripheral vasculature.
- · the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
Teleport XT Microcatheter is a single lumen OTW catheter offered in one size (2.1F, distal OD) with working lengths of 90cm, 135cm or 150cm, designed for use in the coronary and peripheral vasculature. The shaft profile gradually changes from 2.8F (0.0370") to 2.1F (0.0280"). The catheter consists of five primary sections: hub, body shaft, proximal section, distal section, and a radiopaque tip. The distal most 60cm of the outer surface is coated with hydrophilic polymer to increase lubricity and the lumen of the catheter is lined with fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014-inch (0.36mm) guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature, abdominal vasculature
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 performance data were provided in support of the substantial equivalence determination.
Sterilization Shelf-Life Performance Testing
Particulate Evaluation
Visual Inspection
Dimension Inspection
Media Flow Rate
Simulated Use
Vacuum Leakage
Shaft Burst Pressure
Guidewire Compatibility
Coating Integrity
Flexibility and Kinking
Corrosion Resistance
Torque Strength
Tensile
Radiopacity
Pouch Integrity
Pouch Burst
Seal Strength
The Teleport XT microcatheter test results met all acceptance criteria and were similar to the predicate and reference devices.
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
§ 870.1250 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 7, 2024
OrbusNeich Medical (Shenzhen) Co., Ltd. Jerry Cheung Senior Director of Regulatory Affairs No.1 Jinkui Road, Futian Free Trade Zone Shenzhen, Guangdong 518038 China
Re: K231608
Trade/Device Name: Teleport XT Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 8, 2023 Received: December 8, 2023
Dear Jerry Cheung:
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.
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).
1
Page 2
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 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-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 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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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, Lydia S. Glaw -S
Digitally signed by Lydia S. Glaw -S Date: 2024.01.07 10:56:35 -05'00'
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K231608
Device Name Teleport XT Microcatheter
Indications for Use (Describe)
The Teleport XT microcatheters are indicated for:
- · supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature.
- · exchanging guidewires in the coronary and peripheral vasculature.
- · the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.
| 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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FORM FDA 3881 (6/20)
3
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR 807.92.
| Submitter: | OrbusNeich Medical (Shenzhen) Co., Ltd.
No.1 Jinkui Road
Futian Free Trade Zone
Shenzhen 518038, China |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: +86-755-83580181-8330
Fax: +86-755-83580169 |
| Contact Person: | Name: Jerry Cheung
Job Title: Senior Director of Regulatory Affairs
Email: jcheung@orbusneich.com |
| Date Prepared: | May 31, 2023 |
| Device: | Name of Device: Teleport XT Microcatheter
Common Name: Microcatheter
Classification Name: Percutaneous catheter (21
CFR
870.1250)
Regulatory Class: II
Product Code: DQY |
| Predicate Device: | Teleport Microcatheter (K182360, DQY, cleared Nov 09,
2018)
This predicate has not been subject to a design-related recall. |
| Reference Devices: | ASAHI Corsair Pro XS (K182420, DQY, cleared Dec 20,
2018)
Turnpike LP Catheter (K191560, DQY, cleared Aug 09,
2019)
Mamba Flex Microcatheter (K171452, DQY, cleared Aug
21, 2017) |
| Device Description: | Teleport XT Microcatheter is a single lumen OTW catheter
offered in one size (2.1F, distal OD) with working lengths of
90cm, 135cm or 150cm, designed for use in the coronary and
peripheral vasculature. The shaft profile gradually changes
from 2.8F (0.0370") to 2.1F (0.0280"). The catheter consists
of five primary sections: hub, body shaft, proximal section,
distal section, and a radiopaque tip. The distal most 60cm of
the outer surface is coated with hydrophilic polymer to |
| | increase lubricity and the lumen of the catheter is lined with fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014-inch (0.36mm) guidewire. |
| Indications For Use: | The Teleport XT microcatheters are indicated for:
supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature. exchanging guidewires in the coronary and peripheral vasculature. the delivery of contrast media into the coronary, peripheral, and abdominal vasculature. |
| Technological
Characteristics: | The subject device has the following similarities to the predicate devices:
Same indications for use Same catheter design Similar materials of construction Same hydrophilic coating 0.014" guidewire compatibility 4F guiding catheter compatibility Maximum allowable pressure of 300 psi Same method of EO sterilization The following technological differences exist between the subject and predicate device: specific materials selected exact dimensions of components catheter working length |
| Performance Data: | The following performance data were provided in support of the substantial equivalence determination.
Sterilization Shelf-Life Performance Testing Particulate Evaluation Visual Inspection Dimension Inspection Media Flow Rate Simulated Use Vacuum Leakage |
4
-
Shaft Burst Pressure
5
- Guidewire Compatibility >
- Coating Integrity >
- Flexibility and Kinking >
-
Corrosion Resistance
-
Torque Strength
-
Tensile
-
Radiopacity
- Pouch Integrity >
-
Pouch Burst
-
Seal Strength
The Teleport XT microcatheter test results met all acceptance criteria and were similar to the predicate and reference devices.
Conclusion: This information supports a determination of substantial equivalence between the Teleport XT microcatheter and the predicate device described above.