(28 days)
The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.
The APRO 70 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Catheter targets aspiration from the suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Catheter is available in lengths of 125 cm, and 135 cm and is provided with an introducer sheath.
The Alembic Aspiration Tubing connects the APRO 70 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
The provided text is a 510(k) summary for the APRO 70 Catheter and Alembic Aspiration Tubing. This type of submission is for medical devices, not AI/ML-based software as a medical device (SaMD). Therefore, the questions regarding acceptance criteria and study data typical for AI/ML performance (e.g., ground truth establishment, expert adjudication, MRMC studies, training set details) are not applicable to this document.
The document describes the device, its intended use, and demonstrates substantial equivalence to a predicate device through non-clinical bench testing. The performance data is focused on the physical characteristics and functional integrity of the catheter and tubing.
Here's an analysis based on the information provided for this medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications. Introducer Sheath meets the visual and dimensional specifications. Aspiration Tubing meets the visual and dimensional specifications. | The APRO 70 Catheter met the acceptance criteria. The Introducer Sheath met the acceptance criteria. The Alembic Aspiration Tubing met the acceptance criteria. |
| Particulate | Catheter meets the acceptance criteria. Subject device was evaluated with a predicate device under the same test conditions. | The APRO 70 Catheter met the acceptance criteria. |
| Vacuum Integrity | Catheter with Aspiration Tubing is free from collapse and loss of vacuum between aspiration source and catheter tip. | The APRO 70 Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
| Kink Resistance | Catheter distal shaft shall not kink. | The APRO 70 Catheter met the acceptance criteria. |
| Catheter Hub Leakage | Catheter does not leak into hub assembly during aspiration, with methods specified in ISO 10555-1, Annex D. | The APRO 70 Catheter met the acceptance criteria. |
| Catheter Torque Strength | Catheter must withstand the minimum required number of rotations without breakage. | The APRO 70 Catheter met the acceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO 70 Catheter met the acceptance criteria. |
| Fluid Leakage | Catheter must withstand pressure with methods specified in ISO 10555-1, Annex C. | The APRO 70 Catheter met the acceptance criteria. |
| Static Burst | Catheter must withstand pressures anticipated for clinical use. | The APRO 70 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Hub and Shaft | Catheter hub and shaft must meet tensile strength specification. | The APRO 70 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Tip | Catheter tip must meet tip tensile strength specification. | The APRO 70 Catheter met the acceptance criteria. |
| Delivery and Retrieval Force | Catheter delivery and retrieval force must be acceptable. Forces were compared to a predicate. | The APRO 70 Catheter met the acceptance criteria. |
| Tip Buckling Force | Catheter tip buckling force must be acceptable. Forces were compared to a predicate. | The APRO 70 Catheter met the acceptance criteria. |
| Simulated Use | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model, the Catheter and Aspiration Tubing must meet functionality specifications. | The APRO 70 Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for each non-clinical bench test. It states "Alembic performed non-clinical bench testing in accordance with design controls, protocol, and test methods". The data provenance is non-clinical bench testing; it's not patient-derived data, so country of origin or retrospective/prospective distinctions are not applicable in the typical sense for clinical studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth as understood in AI/ML is not relevant for this type of medical device bench testing. The "ground truth" for these tests is defined by established engineering and material science specifications, and ISO standards (e.g., ISO 10555-1), not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication process described for these bench tests. The results are based on quantitative measurements and observations against pre-defined engineering acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device, not an AI/ML-based software. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable. The study presented here is focused on demonstrating the physical and functional performance of the catheter and tubing, and its substantial equivalence to a predicate device through non-clinical bench testing.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML algorithm. The performance documented is that of the physical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this medical device is based on:
- Pre-defined engineering and material specifications.
- Compliance with recognized standards (e.g., ISO 10555-1).
- Functional performance criteria observed during bench testing (e.g., freedom from kinking, maintaining vacuum).
- Comparison to the performance of a legally marketed predicate device in some tests (e.g., Particulate, Delivery and Retrieval Force, Tip Buckling Force sections mention comparison to a predicate).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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April 10, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alembic, LLC Lisa Yen Director of Regulatory and Quality 627 National Avenue Mountain View, California 94043
Re: K230695
Trade/Device Name: APRO 70 Catheter and Alembic Aspiration Tubing Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 10, 2023 Received: March 13, 2023
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 (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.
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
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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 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
Enclosure
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Indications for Use
510(k) Number (if known) K230695
Device Name
APRO 70 Catheter and Alembic Aspiration Tubing
Indications for Use (Describe)
The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.
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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510(k) Summary
510(k) Number:
This 510(k) Summary is provided in accordance with the requirements of 21 CFR §807.92.
1) Submitter information
| Submitter: | Alembic, LLC627 National Ave.Mountain View, CA 94043 |
|---|---|
| Contact: | Lisa YenDirector of Regulatory and QualityTelephone Number: (650) 388-5087Fax: (650) 390-0107Email: lyen@alembicllc.com |
Date Prepared: April 7, 2023
2) Device Name and Classification
| Trade/Proprietary Name: | APRO™ 70 Catheter and Alembic Aspiration Tubing |
|---|---|
| Common Name: | Catheter, Thrombus Retriever |
| Classification Name: | Percutaneous Catheter, 21 CFR 870.1250 |
| Regulatory Class: | Class II |
| Product Code: | NRY |
| Review Panel: | Neurology |
3) Legally Marketed Predicate Device
| Predicate Device: | K223545 APRO 70 Catheter and Alembic Aspiration |
|---|---|
| ------------------- | ------------------------------------------------- |
4) Device Description
The APRO 70 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Catheter targets aspiration from the suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under
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fluoroscopy. For the aspiration source, the APRO 70 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Catheter is available in lengths of 125 cm, and 135 cm and is provided with an introducer sheath.
The Alembic Aspiration Tubing connects the APRO 70 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
5) Indications for Use
The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.
6) Technological Characteristics Comparison
Alembic has demonstrated the subject APRO 70 Catheter and Alembic Aspiration Tubing are substantially equivalent to the predicate based on the same materials, same design concept, and the same fundamental operating principles. A comparison of the APRO 70 Catheter with the predicate device is summarized in Table 1 below. There are no changes to the Alembic Aspiration Tubing compared to K223545.
| Category | Subject DeviceAPRO 70 Catheter | Predicate DeviceAPRO 70 Catheter |
|---|---|---|
| 510(k) Number | K230695 | K223545 |
| Regulatory Class | Identical to predicate | Class II, 21 CFR 870.1250, NRY |
| Indications forUse | Identical to predicate | The APRO 70 Catheter with an aspiration pump and theAlembic Aspiration Tubing is intended for use in therevascularization of patients with acute ischemic strokesecondary to intracranial large vessel occlusive disease(within the internal carotid, middle cerebral – M1 and M2segments, basilar, and vertebral arteries) within 8 hours ofsymptom onset. Patients who are ineligible for intravenoustissue plasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates for treatment.The Alembic Aspiration Tubing is intended to connect theAPRO 70 Catheter to the aspiration pump. |
| Principles ofOperation | Identical to predicate | Using conventional catheterization techniques underfluoroscopic guidance, advance the catheter into the targetvessel over an appropriate neurovascular guidewire. Positionthe catheter proximal to the thrombus to aspirate. |
Table 1 - Subject APRO 70 Catheter Comparison with the Predicate Device
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| Category | Subject DeviceAPRO 70 Catheter | Predicate DeviceAPRO 70 Catheter |
|---|---|---|
| Accessory DevicesProvided | Identical to predicate | Introducer sheath |
| Materials | ||
| Hub | Identical to predicate | Polycarbonate |
| Strain Relief | Identical to predicate | Santoprene (thermoplastic elastomer) |
| Liner | Identical to predicate | Polytetrafluoroethylene/Tecoflex composite |
| Shaft Coil andBraid | Identical to predicate | 304V stainless steel braid304V stainless steel coil |
| Extrusions | Identical to predicate | Thermoplastic polyurethanes, thermoplastic elastomer |
| Marker Band | Identical to predicate | Platinum/ iridium |
| Coating | Identical to predicate | Hydrophilic Coating |
| Dimensions | ||
| Proximal OuterDiameter (OD) | Identical to predicate | 0.083 inch |
| Proximal InnerDiameter (ID) | Identical to predicate | 0.070 inch |
| Distal OD | Identical to predicate | 0.083 inch |
| Distal ID | Identical to predicate | 0.070 inch |
| Effective Lengths | Identical to predicate | 125, 132, 135 cm |
| Coated Length | Identical to predicate | 90, 97, 100 cm |
| Tip Shape | Identical to predicate | Straight |
| Accessories | ||
| Introducer Sheath | Identical to predicate | Pebax |
| Packaging Materials | ||
| Pouch | Identical to predicate | Nylon/polyethylene/Tyvek |
| Packaging Tube | Identical to predicate | High density polyethylene |
| Packaging Card | Identical to predicate | High density polyethylene |
| Shelf Carton | Identical to predicate | Solid bleached sulfate paperboard |
| Other | ||
| Sterilization | Identical to predicate | Ethylene oxide |
| Use Conditions | Identical to predicate | Sterile, single use, disposable |
| Shelf life | 1 year | 6 months |
7) Performance Data
Alembic performed non-clinical bench testing in accordance with design controls, protocol, and test methods that were previously reviewed in a relevant prior pre-market submission. Included in Table 2 is the description of each performance test that was conducted to support substantial equivalence determination. The results demonstrate substantial equivalence of the subject APRO 70 Catheter and Alembic Aspiration Tubing to the legally marketed predicate device.
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A. Design Verification Testing – Non-Clinical Bench
| Table 2 – Summary of Non-Clinical Bench Test Results | ||
|---|---|---|
| Test | Acceptance Criteria | Conclusion |
| Visual and DimensionalCharacteristics | Catheter meets the visual anddimensional specifications.Introducer Sheath meets the visual anddimensional specifications.Aspiration Tubing meets the visual anddimensional specifications. | The APRO 70 Catheter met theacceptance criteria.The Introducer Sheath met theacceptance criteria.The Alembic Aspiration Tubingmet the acceptance criteria. |
| Particulate | Catheter meets the acceptance criteria.Subject device was evaluated with apredicate device under the same testconditions. | The APRO 70 Catheter met theacceptance criteria. |
| Vacuum Integrity | Catheter with Aspiration Tubing is freefrom collapse and loss of vacuum betweenaspiration source and catheter tip. | The APRO 70 Catheter andAlembic Aspiration Tubing metthe acceptance criteria. |
| Kink Resistance | Catheter distal shaft shall not kink. | The APRO 70 Catheter met theacceptance criteria. |
| Catheter Hub Leakage | Catheter does not leak into hub assemblyduring aspiration, with methods specifiedin ISO 10555-1, Annex D. | The APRO 70 Catheter met theacceptance criteria. |
| Catheter Torque Strength | Catheter must withstand the minimumrequired number of rotations withoutbreakage. | The APRO 70 Catheter met theacceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamicpressure. | The APRO 70 Catheter met theacceptance criteria. |
| Fluid Leakage | Catheter must withstand pressurewith methods specified in ISO 10555-1, Annex C. | The APRO 70 Catheter met theacceptance criteria. |
| Static Burst | Catheter must withstand pressuresanticipated for clinical use. | The APRO 70 Catheter met theacceptance criteria. |
| Tensile Strength ofCatheter Hub and Shaft | Catheter hub and shaft must meet tensilestrength specification. | The APRO 70 Catheter met theacceptance criteria. |
| Tensile Strength ofCatheter Tip | Catheter tip must meet tip tensile strengthspecification. | The APRO 70 Catheter met theacceptance criteria. |
| Delivery and RetrievalForce | Catheter delivery and retrieval force mustbe acceptable. Forces were compared to apredicate. | The APRO 70 Catheter met theacceptance criteria. |
| Tip Buckling Force | Catheter tip buckling force must beacceptable. Forces were compared to apredicate. | The APRO 70 Catheter met theacceptance criteria. |
| Simulated Use | When used per the Instructions for Usewith accessory devices in an anatomicalneurovascular model, the Catheter andAspiration Tubing must meetfunctionality specifications. | The APRO 70 Catheter andAlembic Aspiration Tubing metthe acceptance criteria. |
Table 2 – Summary of Non-Clinical Bench Test Results
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B. Design Verification Testing - Animal
Substantial equivalence was established based on non-clinical bench performance data. Animal testing data were not deemed necessary.
C. Sterilization and Shelf-Life
Sterilization studies for the subject APRO 70 Catheter have established that the subject device remains sterile for the labeled expiration date. Additional sterilization data were not deemed necessary.
Aging studies for the subject APRO 70 Catheter have established that the subject device and packaging remains functional for the labeled expiration date. Aging studies for the subject device functionality were performed and met the acceptance criteria.
D. Biocompatibility
Biocompatibility studies for the predicate APRO 70 Catheter and Alembic Aspiration Tubing (K223545) have previously established that the subject device is biocompatible. Additional biocompatibility data were not deemed necessary because there are no changes to the design, material, or manufacturing of the APRO 70 Catheter and Alembic Aspiration Tubing compared to the predicate (K223545).
E. Clinical Testing
Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary.
8) Conclusion
Based on the comparison of the technological characteristics and the non-clinical testing, the subject device is found to be substantially equivalent to the predicate device. The revised Instructions for Use and the extended shelf-life do not raise new questions of safety and effectiveness. Testing was conducted to demonstrate that the subject device meets the specifications and performs as intended.
§ 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).