(85 days)
No
The summary describes a physical medical device (catheter) and its intended use, without any mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device facilitates the insertion and guidance of other interventional devices and acts as a conduit for retrieval devices, rather than directly treating a condition.
No
The device is a distal access catheter used to facilitate the insertion and guidance of interventional devices and for retrieving devices, not for diagnosing conditions.
No
The device description clearly describes a physical catheter with a lumen, shaft, coating, radiopaque marker, and luer hub, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a catheter used to facilitate the insertion and guidance of other devices within blood vessels in the peripheral and neurovascular systems. It is a tool used within the body for interventional procedures.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information based on biological specimens. Its function is purely procedural and mechanical.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
Product codes
QJP, DQY
Device Description
The Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter comes in Straight (with no shaping of the catheter tip) and Curved (curved catheter tip) models based on the distal end. The catheter shaft has a hydrophilic coating on the distal end of the shaft to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neurovascular systems (blood vessel)
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
Non-Clinical Performance Testing: Bench testing was performed including Dimensional Verification, Tip Configuration, Surface Integrity, Tip Buckling, Luer Connector Tests, Flexural Fatigue, Trackability, Catheter Lubricity and Durability, Particulate and Coating Integrity Test, Tensile Strength Test, Air Leakage, Liquid Leakage, Torque Resistance, Kink Resistance Test, Catheter Tip and Lumen Integrity, Corrosion Resistance Test, Tip Flexibility Test, Radiopacity, Static Burst Pressure, Compatibility Test, and Flow Rate. All tests passed.
Biocompatibility: The following tests were conducted: Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity Test, Acute Toxicity, Rabbit Pyrogen, Complement Activation, In Vivo Thromboresistance, ASTM Hemolysis, Bacterial Reverse Mutation, In Vitro Mammalian Cell Mutation, Partial Thromboplastin Time Study. All tests passed.
Sterilization and Shelf Life: Ethylene Oxide (EO) sterilization process validated to achieve a sterility assurance level (SAL) of 10-6. EO and Ethylene Chlorohydrin (ECH) residuals were below specified limits. Bacterial Endotoxin Levels were below 2.15 EU/device. Baseline and accelerated shelf-life testing supports a 2-year shelf-life.
Clinical Performance Testing: No clinical studies were necessary to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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December 22, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shanghai HeartCare Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K233205
Trade/Device Name: Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: September 25, 2023 Received: September 28, 2023
Dear Diana Hong:
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
Your device is also subject to, among other requirements, the Quality System (OS) 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,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K233205
Device Name Distal Access Catheter
The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
| 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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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of 21 CFR 807.92.
510(k) Number: K233205
Date of Preparation: 12/19/2023
Sponsor Identification 1.
Shanghai HeartCare Medical Technology Co., Ltd.
590 Ruiging Rd, Building 4, Suite 201, East Zhangjiang High-Tech Park, Shanghai, P.R. China
Contact Person: Hong Tianrong
Position: Senior RA Manager
Tel: +86-13671683981
Email: trhong@heartcare.com.cn
Designated Submission Correspondent 2.
Ms. Diana Hong (Primary Contact Person)
Ms. Tingting Su (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850,
Fax: 360-925-3199
Email: info@mid-link.net
Identification of Proposed Device 3.
Trade Name: Distal Access Catheter Common Name: Percutaneous Catheter Regulatory Information Primary Product Code: QJP Classification Name: Catheter, Percutaneous, Neurovasculature Classification: II Regulation Number: 21 CFR 870.1250
4
Review Panel: Neurology
Secondary Product Code: DQY Classification Name: Catheter, Percutaneous Classification: II Regulation Number: 21 CFR 870.1250 Review Panel: Cardiovascular
4. Identification of Predicate and Reference Devices
Predicate Device: K151667 Device Name: AXS Catalyst™ Distal Access Catheter
Reference Device: K183463 Device Name: AXS Catalyst Distal Access Catheter (AXS Catalyst 7)
5. Device Description
The Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter comes in Straight (with no shaping of the catheter tip) and Curved (curved catheter tip) models based on the distal end. The catheter shaft has a hydrophilic coating on the distal end of the shaft to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end.
6. Indications for Use
The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
5
7. Comparison of Technological Characteristics
| ITEM | Subject Device K233205
Distal Access Catheter | Predicate Device K151667
AXS Catalyst™ Distal Access Catheter | Reference Device K183463
AXS Catalyst Distal Access
Catheter (AXS Catalyst 7) | Remark |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Classification | II | II | II | Same |
| Regulation No. | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Same |
| Code | QJP, DQY | DQY | DQY | Same |
| Indication for Use | The Distal Access Catheter is indicated
for use in facilitating the insertion and
guidance of appropriately sized
interventional devices into a selected
blood vessel in the peripheral and
neurovascular systems. The Distal
Access Catheter is also indicated for use
as a conduit for retrieval devices. | The AXS Catalyst Distal Access Catheter
is indicated for use in facilitating the
insertion and guidance of appropriately
sized interventional devices into a
selected blood vessel in the peripheral and
neurovascular systems. The AXS Catalyst
Distal Access Catheter is also indicated
for use as a conduit for retrieval devices. | The AXS Catalyst Distal Access
Catheter is indicated for use in
facilitating the insertion and guidance
of appropriately sized interventional
devices into a selected blood vessel in
the peripheral and neurovascular
systems. The AXS Catalyst Distal
Access Catheter is also indicated for
use as a conduit for retrieval devices. | Same |
| Inner Diameter (ID) | 0.058 inch; 0.071 inch | 0.058 inch; 0.060 inch | 0.068 inch | Similar |
| Outer Diameter (OD) | 5.4F (0.071 inch); 6.3F (0.083 inch) | Distal: 5.3F (0.069 inch); 5.4F (0.071 inch)
Proximal: 5.6F (0.073 inch); 6F (0.079 inch) | Distal: 6.2F (0.082 inch)
Proximal: 6.3F (0.0825 inch) | Similar |
| Effective Length | 95 cm; 105 cm; 115 cm; 125 cm; 130 cm | 115 cm; 132 cm | 115 cm; 125 cm; 132 cm | Similar |
| Radiopaque Marker | Yes | Yes | Yes | Same |
| Single Use | Yes | Yes | Yes | Same |
| Accessories | None | Rotating Hemostasis Valve (RHV)
Tuohy Borst valve with sideport
Two peel away introducer sheaths | RHV
Tuohy Borst valve with sideport
Peel away introducer sheath | N/A |
| Maximum Guidewire
OD | 0.035 inch | 0.038 inch | 0.038 inch | Similar |
| Table 1: Comparison of Technological Characteristics | ||
|---|---|---|
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| Materials | ||||
|---|---|---|---|---|
| Shaft (Outer | ||||
| Surface) | Pebax; Nylon; Thermoplastic | |||
| Urethanes (TPU) | Pebax; Nylon; Tecoflex | Pebax; Nylon; Tecoflex | The differences | |
| do not raise new | ||||
| questions of | ||||
| safety or | ||||
| effectiveness. | ||||
| Shaft (Metal Braid) | Nickel-Titanium alloy | Stainless steel, Nitinol wire, and polymer | ||
| fiber | Nitinol wire and polymer fiber | |||
| Shaft (Inner Lumen) | Polytetrafluoroethylene (PTFE) | PTFE | PTFE | |
| Hydrophilic Coating | Polyvinylpyrrolidone (PVP) | Hydrophilic coating | Hydrophilic coating | The subject |
| device has been | ||||
| evaluated | ||||
| Marker | Platinum-Tungsten alloy | Platinum/Iridium | Platinum/Iridium | |
| Hub | Polycarbonate (PC) | Nylon | Nylon | through bench |
| Heat Shrink Tube | ||||
| and Stainless Steel | ||||
| Diffusion Tube | Polyolefin and 304 Stainless Steel | Thermoplastic rubber | ||
| (Santoprene) | Thermoplastic rubber | |||
| (Polyolefin) | and | |||
| biocompatibility | ||||
| testing. | ||||
| Sterilization | ||||
| Method | Ethylene Oxide (EO) sterilized | EO sterilized | EO sterilized | Same |
| Sterility Assurance | ||||
| Level (SAL) | 10-6 | 10-6 | 10-6 | Same |
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8. Non-Clinical Performance Testing
The results of verification and validation testing conducted on the Distal Access Catheter demonstrate that it performs as designed and is substantially equivalent to the predicate. A summary of the tests performed is provided in the table below:
| Test | Test Method / Applicable Standard | Test
Results |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Dimensional
Verification | Verify dimensions using specified measurement tool. | Pass |
| Tip Configuration | Visually inspect distal tip at 10x magnification. | Pass |
| Surface Integrity | Inspect catheter surface. ISO 10555-1:2013 | Pass |
| Tip Buckling | Use a testing apparatus to measure the maximum force
required to cause a test sample to buckle at 5 mm, 10 mm
and 20 mm from distal tip. | Pass |
| Luer Connector Tests | ISO 80369-7: 2021 | Pass |
| Flexural Fatigue | After ten runs of the Distal Access Catheter with the accessories
in the simulated use model, remove the test sample and inspect
the sample for kinks or damage. | Pass |
| Trackability | Test the peak tracking force and the compatibility with the
ancillary devices during insertion and retraction of the catheter
in the simulated use model. | Pass |
| Catheter Lubricity and
Durability | Use friction tester to measure the frictional force of the test
samples when pulled between two clamped pads. Record the
peak frictional force over 5 cycles. | Pass |
| Particulate and Coating
Integrity Test | Measure the size and number of particulates generated during
simulated use and conduct visual inspection at 50x and 200x
magnification of the outer surface of the catheter after
simulated use. | Pass |
| Tensile Strength Test | ISO 10555-1:2013 | Pass |
| Air Leakage | ISO 10555-1:2013 | Pass |
| Liquid Leakage | ISO 10555-1:2013 | Pass |
| Torque Resistance | Fix the distal tip of the Distal Access Catheter and rotate the
proximal end until the Distal Access Catheter shows kink or
other signs of failure. | Pass |
| Kink Resistance Test | Visually inspect whether the Distal Access Catheter kinks or
not when wrapped around mandrels with diameters 1 mm
to 10 mm (in 1 mm increments). | Pass |
| Catheter Tip and
Lumen Integrity | After simulated use, aspirate test sample for 10 sec using a
60 cc syringe during retrieval device withdrawal. Visually
inspect the test sample to verify absence of tip or lumen
collapse. | Pass |
8
| Corrosion Resistance
| Test | ISO 10555-1:2013 | Pass |
|---|---|---|
| Tip Flexibility Test | Use a mechanical force meter to push the tip from left to | |
| right at 5 mm, 10 mm, and 20 mm from the distal tip. | Pass | |
| Radiopacity | ASTM F640-12 | Pass |
| Static Burst Pressure | ISO 10555-1:2013 | Pass |
| Compatibility Test | The compatibility of the Distal Access Catheter with a | |
| marketed introducer sheath, guide catheter, guidewire, micro | ||
| guidewire, microcatheter, and stent-retriever is evaluated. | Pass | |
| Flow Rate | Use a flow rate tester to measure the flow rate of the Distal Access | |
| Catheter. | Pass |
Biocompatibility
The Distal Access Catheter is categorized as Externally Communicating Device, Limited Contact (≤ 24 hours) with Circulating Blood, per ISO 10993-1, the following tests were conducted:
| Standard Utilized / | Test Results | |||
|---|---|---|---|---|
| Test | Section | Method | Acceptance Criteria | (Pass/Fail) |
| Cytotoxicity | ISO 10993-5: 2009 | MTT Method | Viability > 70% | Pass |
| Skin Sensitization | ISO 10993-10: 2010 | Guinea Pig Maximization Test | ||
| (GPMT) | Magnusson & Kligman grades . Both baseline and accelerated shelf-life testing were conducted demonstrating the device will perform as intended to support the proposed 2-year shelf-life. |
Clinical Performance Testing 9.
No clinical studies were necessary to demonstrate substantial equivalence.
10. Conclusion
The subject device, Distal Access Catheter, has similar technological characteristics and the same intended use as the predicate device, AXS Catalyst Distal Access Catheter (K151667). The differences in technological characteristics do not raise new or different questions of safety or effectiveness. The successful completion of bench performance, biocompatibility, and sterility testing demonstrates that the subject device performs as intended and is substantially equivalent to the predicate.