(29 days)
No
The device description, intended use, and performance studies do not mention any AI, machine learning, or deep learning components. The device is a physical catheter used for guidance and retrieval, without any indication of integrated computational intelligence.
No
This device is an intermediate catheter used for guiding and inserting other interventional devices, facilitating procedures, and acting as a conduit for retrieval devices. It does not directly treat a condition.
No
The APRO 55 Intermediate Catheter is used to facilitate the insertion and guidance of other interventional devices and for retrieval of devices, rather than for diagnosing a condition or disease.
No
The device is a physical medical device (catheter) used for interventional procedures, clearly involving hardware components and not primarily operating as software.
No.
The device is an intermediate catheter used to facilitate the insertion and guidance of interventional devices into blood vessels, and for retrieval of devices. It is an invasive surgical device used for direct intervention on the human body, not for in vitro analysis of specimens.
N/A
Intended Use / Indications for Use
The APRO 55 Intermediate 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 APRO 55 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
Product codes
DQY, QJP
Device Description
The APRO 55 Intermediate Catheter is a single-lumen, braid and coil reinforced catheter. The catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 55 Intermediate Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The catheter is provided with an Introducer Sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic guidance
Anatomical Site
peripheral and neurovascular systems / selected blood vessel in the peripheral and neurovascular systems
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)
Bench Testing: Performance bench testing was not conducted as sterility and shelf-life testing was sufficient for verification and validation of the change in packaging configuration.
Sterility and Shelf-Life: The APRO 55 Intermediate Catheter is sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 10⁻⁶ in accordance with ISO 11135. Aging studies established that the packaging remains functional for the labeled expiration date. Both t=0 and aging studies for packaging integrity and seal strength were performed and met the acceptance criteria.
Biocompatibility: The design and manufacturing of the subject device utilize the same materials, processing methods, and sterilization as the predicate device (K234115) and the reference device (K243297), for which Alembic has already conducted biocompatibility testing in compliance with ISO 10993-1. Therefore, no additional biocompatibility testing is required.
Animal Study: An animal study was deemed not necessary to support the substantial equivalence of the subject device.
Clinical Testing: Human clinical data were not deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K234115 APRO 55 Catheter
Reference Device(s)
K243297 APRO 70 Swift Catheter
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).
FDA 510(k) Clearance Letter - APRO 55 Intermediate Catheter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 29, 2025
Alembic, LLC
Lisa Yen
Vice President of Regulatory and Quality
627 National Avenue
Mountain View, California 94043
Re: K250962
Trade/Device Name: APRO 55 Intermediate Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: DQY, QJP
Dated: March 28, 2025
Received: March 31, 2025
Dear Lisa Yen:
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
K250962 - Lisa Yen 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
K250962 - Lisa Yen 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,
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
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
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): K250962
Device Name: APRO 55 Intermediate Catheter
Indications for Use (Describe)
The APRO 55 Intermediate 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 APRO 55 Intermediate 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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Page 5
510(k) Summary K250962
Date Prepared: April 24, 2025
| Applicant Name | Alembic, LLC |
|---|---|
| Applicant Address | 627 National Avenue, Mountain View, CA 94043 United States |
| Applicant Contact Telephone | 650-388-5087 |
| Applicant Contact | Lisa Yen |
| Applicant Contact Email | lyen@alembicllc.com |
| Device Trade Name | APRO® 55 Intermediate Catheter |
| Common Name | Percutaneous catheter |
| Classification Name | Percutaneous Catheter (DQY) Catheter, Percutaneous, Neurovasculature (QJP) |
| Regulation Number | 21 CFR 870.1250 |
| Product Codes | DQY, QJP |
| Predicate Device | K234115 APRO® 55 Catheter |
| Reference Device | K243297 APRO® 70 Swift Catheter |
Device Description
The APRO 55 Intermediate Catheter is a single-lumen, braid and coil reinforced catheter. The catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 55 Intermediate Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The catheter is provided with an Introducer Sheath.
Indications for Use
The APRO 55 Intermediate 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 APRO 55 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
Technological Characteristics Comparison
The subject device has the same intended use and is identical to the predicate device, APRO 55 Catheter (K234115), in terms of technology, principle of operation, materials, sterilization method, and performance. The only difference lies in the packaging configuration. A comparison of the subject, predicate, and reference devices is provided in Table 1 below.
Page 6
Table 1. Comparison with the Predicate and Reference Devices
| Category | Subject Device APRO 55 Intermediate Catheter | Predicate Device APRO 55 Catheter | Reference device APRO 70 Swift Catheter |
|---|---|---|---|
| 510(k) Number | K250962 | K234115 | K243297 |
| Regulatory Class, Product Code | Same | Class II, 21 CFR 870.1250, DQY, QJP | Class II, 21 CFR 870.1250, DQY, QJP |
| Indications for Use | The APRO 55 Intermediate 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 APRO 55 Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | The APRO 55 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 APRO 55 Catheter is also indicated for use as a conduit for retrieval devices. | The APRO 70 Swift 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 APRO 70 Swift Catheter is also indicated for use as a conduit for retrieval devices. |
Materials
| Component | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Hub | Same | Nylon | Nylon |
| Adhesive | Same | Cyanoacrylate | Cyanoacrylate |
| Strain Relief | Same | Santoprene (thermoplastic elastomer) | Santoprene (thermoplastic elastomer) |
| Liner | Same | Polytetrafluoroethylene/Tecoflex composite | Polytetrafluoroethylene/Tecoflex composite |
| Shaft Coil or Braid | Same | 304V stainless steel braid 304V stainless steel coil | 304V stainless steel braid 304V stainless steel coil |
| Extrusions | Same | Thermoplastic polyurethanes, thermoplastic elastomer | Thermoplastic polyurethanes, thermoplastic elastomer |
| Marker Band | Same | Platinum/iridium | Platinum/iridium |
| Coating | Same | Hydrophilic coating | Hydrophilic coating |
Dimensions
| Parameter | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Outer Diameter | Same as predicate | 0.066 inch | 0.083 inch |
| Inner Diameter | Same as predicate | 0.055 inch | 0.070 inch |
| Effective Length | Same as predicate | 125, 137 cm | 125, 132, 135 cm |
| Coated Length | Same as predicate | 90, 102 cm | 90, 97, 100 cm |
| Tip Shape | Same | Straight | Straight |
Page 7
Table 1. Comparison with the Predicate and Reference Devices (continued)
| Category | Subject Device APRO 55 Intermediate Catheter | Predicate Device APRO 55 Catheter | Reference device APRO 70 Swift Catheter |
|---|---|---|---|
| 510(k) Number | K250962 | K234115 | K243297 |
Accessories
| Component | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Introducer Sheath | Same | Yes | Yes |
Packaging Materials
| Component | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Pouch | Same | Nylon/polyethylene/Tyvek | Nylon/polyethylene/Tyvek |
| Hoop Coil | Same as reference | Not included | Polyethylene |
| Packaging Tube | Not included | Polyethylene | Not included |
| Packaging Card | Same | Polyethylene | Polyethylene |
| Shelf Carton | Same | Solid bleached sulfate paperboard | Solid bleached sulfate paperboard |
Other
| Parameter | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Sterilization | Same | Ethylene oxide | Ethylene oxide |
| Shelf Life | Same as reference | 6 months | 1 year |
| Method of Supply | Same | Sterile and single use | Sterile and single use |
| Packaging Configuration | Same as reference | The catheter is placed in a polyethylene dispenser tube. The dispenser tube and the introducer sheath are positioned on a polyethylene packaging card, which is then inserted into a Tyvek pouch. The pouch, along with the instructions for use (IFU) is packaged in a bleached sulfate carton box. | The catheter is placed in a coiled polyethylene dispenser tube. The introducer sheath, positioned on a polyethylene packaging card, is attached to the dispenser tube, which is then inserted into a Tyvek pouch. The pouch, along with the IFU is packaged in a bleached sulfate carton box. |
Page 8
Non-Clinical Testing Summary
The following data were provided to evaluate the performance and support the substantial equivalence of the APRO 55 Intermediate Catheter.
Bench Testing
Performance bench testing was not conducted as sterility and shelf-life testing was sufficient for verification and validation of the change in packaging configuration.
Sterility and Shelf-Life
The APRO 55 Intermediate Catheter is sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 10⁻⁶ in accordance with ISO 11135. Aging studies established that the packaging remains functional for the labeled expiration date. Both t=0 and aging studies for packaging integrity and seal strength were performed and met the acceptance criteria.
Biocompatibility
The subject APRO 55 Intermediate Catheter is classified as an externally communicating device with circulating blood contact for a limited duration (≤24 hours) in accordance with ISO 10993-1 and the FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process."
The design and manufacturing of the subject device utilize the same materials, processing methods, and sterilization as the predicate device (K234115) and the reference device (K243297), for which Alembic has already conducted biocompatibility testing in compliance with ISO 10993-1. Therefore, no additional biocompatibility testing is required.
Animal Study
An animal study was deemed not necessary to support the substantial equivalence of the subject device.
Clinical Testing Summary
Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary.
Conclusion
Based on the comparison of the technological characteristics and the non-clinical testing described in this 510(k) Summary, the subject device is found to be substantially equivalent to the predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness.