Who is the manufacturer of Solitaire Platinum Revascularization Device?

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular filed the 510(k) submission for Solitaire Platinum Revascularization Device (K161879).

What is the FDA product code for Solitaire Platinum Revascularization Device?

NRY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Solitaire Platinum Revascularization Device?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Solitaire Platinum Revascularization Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Solitaire Platinum Revascularization Device

K161879 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · NRY · Sep 21, 2016 · Cardiovascular

Device Facts

Record ID	K161879
Device Name	Solitaire Platinum Revascularization Device
Applicant	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product Code	NRY · Cardiovascular
Decision Date	Sep 21, 2016
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke 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.

Device Story

The Solitaire™ Platinum Revascularization Device is a catheter-based thrombus retriever used by physicians in clinical settings to treat ischemic stroke. The device is navigated through the neurovasculature to the site of a large intracranial vessel occlusion. Once positioned, the device is deployed to engage and remove the thrombus, thereby restoring blood flow. The device features radiopaque markers for fluoroscopic visualization during the procedure. It is designed for use in patients who are ineligible for or have failed IV t-PA therapy. The device is supplied sterile and is intended for single use. By mechanically removing the clot, the device aims to improve clinical outcomes for stroke patients.

Clinical Evidence

No clinical data was performed. Substantial equivalence is supported by non-clinical bench testing, including delivery force, re-sheathing force, multiple re-sheathing durability, body marker tensile strength, radiopacity, and radial force measurements, alongside leveraged biocompatibility data from the predicate device.

Technological Characteristics

The device consists of a Nitinol revascularization stent/retriever and push-wire. Materials include Nitinol, 90% Platinum/10% Iridium markers, PTFE shrink tubing, and Dymax 1128A-M-T adhesive. It is a catheter-based system for neurovascular use. Sterilization is via Ethylene Oxide. The device is designed for manual operation under fluoroscopic guidance.

Indications for Use

Indicated for patients experiencing ischemic stroke within 8 hours of symptom onset, specifically those ineligible for or failing IV t-PA therapy, requiring thrombus removal from large intracranial vessels (e.g., internal carotid, middle cerebral, basilar, or vertebral arteries).

Regulatory Classification

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.

Predicate Devices

Solitaire™ Platinum Revascularization Device (K153071)

Related Devices

K183022 — Solitaire 4 Revascularization Device · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jan 29, 2019
K153071 — Solitaire Platinum Revascularization Device · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Dec 23, 2015
K203358 — Solitaire X Revascularization Device · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Mar 1, 2021
K113455 — SOLITAIRE FR REVASCULARIZATION DEVICE · Micro Therapeutics Dba Ev3 Neurovascular · Mar 2, 2012
K222848 — pRESET Thrombectomy Device · Phenox Limited · Jan 20, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 21, 2016 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Mr. Ryan Kenney Product Specialist, Regulatory Affairs 9775 Toledo Way Irvine, California 92618 Re: K161879 Trade/Device Name: Solitaire™ Platinum Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: August 19, 2016 Received: August 22, 2016 Dear Mr. Kenney: 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. 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 801 ); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. # Michael J.Hoffmann -A for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161879 #### Device Name Solitaire™ Platinum Revascularization Device #### Indications for Use (Describe) The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke 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. 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### K161879 510(k) Summary | 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 Establishment Registration No. 2029214 | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ryan Kenney Product Specialist, Regulatory Affairs Telephone: (949) 297-5489 E-mail: ryan.j.kenney@medtronic.com | | Date Summary Prepared: | September 08, 2016 | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name of Device: | Solitaire™ Platinum Revascularization Device | | Common Name of Device: | Catheter, Thrombus Retriever | | Classification of Device: | 21 CFR 870.1250 – Class II | | Product Code: | NRY | | Predicate Device: | Solitaire™ Platinum Revascularization Device 510(k)#: K153071 | | Performance Data: | The following performance testing was performed to support the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices: Delivery Force Testing Re-Sheathing Force Testing Multiple Re-Sheathing Durability Body Marker Tensile Body Marker Radiopacity (in-process) Proximal Marker Band to Distal Marker Band (in-process) Af Temperature (in-process) Radial Force (in-process) The following performance testing was leveraged from the predicate device: Total System Length Kink Resistance Distal Finger Marker Coil and Push-wire Tensile Clot Retrieval and Device Recovery Durability Torque Response Torque Strength Radiopacity (Fluoroscopic Visualization Distal Finger Marker Coil) Fluorosafe Marker Location | | | Biocompatibility Particulate | | | The materials of construction, design, and packaging process for this portfolio expansion of the subject 4-20-05 and 6-24-06 SolitaireTM Platinum Revascularization Devices (K161879) are equivalent to the predicate SolitaireTM Platinum Revascularization Device (K153071). | | | In addition, the manufacturing process of the subject 4-20-05 and 6- 24-06 SolitaireTM Platinum Revascularization Devices (K161879) is equivalent to the predicate SolitaireTM Platinum Revascularization Device (K153071). Therefore; no additional biocompatibility, sterilization, packaging, or shelf life validations are required. | | | Non-clinical bench testing confirmed that the portfolio expansion of the subject 4-20-05 and 6-24-06 SolitaireTM Platinum Revascularization Devices do not introduce new risks or increase existing risks. | | Conclusion: | The subject 4-20-05 and 6-24-06 SolitaireTM Platinum Revascularization Devices (K161879) are substantially equivalent to the predicate SolitaireTM Platinum Revascularization Device (K153071) based on non-clinical bench testing, similarities in design, principles of operation, and indications for use. | {4}------------------------------------------------ ## Device Description: The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The device is designed for use in the neurovasculature such as the internal carotid artery. M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. ## Indications for Use: The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke 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. #### Device Comparison: The following table provides a comparative of the technological characteristics associated with the portfolio expansion of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices (K161879) and the predicate Solitaire™ Platinum Revascularization Device (K153071). {5}------------------------------------------------ | | Predicate Device | Subject Devices | Rationale for Difference (if applicable) | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Solitaire™ Platinum Revascularization Device (K153071) | 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices (K161879) | | | Indication for Use | The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke 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. | Same as K153071. | N/A. | | Method of Supply | Stored within dispenser coil, Tyvek pouch, and shipping carton. | Same as K153071. | N/A. | | Sterilization Method | Ethylene Oxide | Same as K153071. | N/A. | | Device Size(s) | 4-20-10 4-40-10 6-20-10 | 4-20-05 6-24-06 | The subject devices share identical technological characteristics to the predicate device. Non- clinical bench testing has demonstrated that the devices do not raise questions about the safety and effectiveness. | | Materials | | | | | | Predicate Device Solitaire™ Platinum Revascularization Device (K153071) | Subject Devices 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices (K161879) | Rationale for Difference (if applicable) | | Solitaire™ Platinum Non- Detachable EP | Nitinol | Same as K153071. | N/A | | Push-wire | Nitinol | Same as K153071. | N/A | | Proximal Coil | 90% Platinum/ 10% Iridium | Same as K153071. | N/A | | Body Marker | N/A | 90% Platinum/ 10% Iridium. | Same material as the Body Finger Marker Coil. | | Body Finger Marker Coil | 90% Platinum/ 10% Iridium | N/A | Not a design feature of the subject devices. | | Distal Finger Marker Coil | 90% Platinum/ 10% Iridium | Same as K153071. | N/A | | Push-wire Shrink Tubing | PTFE | Same as K153071. | N/A | | Dymax Glue | Dymax 1128A-M-T | Same as K153071. | N/A | | Guidewire Clip | UV Curing Adhesive | Same as K153071. | N/A | | Dispenser Coil | HDPE, ID Coated with Hydro-Sil 2000 | Same as K153071. | N/A | | Stent Introducer Sheath | PTFE/Grilamid | Same as K153071. | N/A | {6}------------------------------------------------ ## Sterilization and Shelf Life: The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are sterilized using the identical validated, Ethylene Oxide (EO) sterilization cycle as the predicate Solitaire™ Platinum Revascularization Device. The materials of construction, design, manufacturing process, sterilization load configuration and packaging process for this portfolio expansion of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are equivalent to the predicate Solitaire™ Platinum Revascularization Device. The packaging of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices remains functional and maintain sterility for up to two (2) years. Therefore, no additional sterilization or shelf life validation testing is required for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. ## Biocompatibility: The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not introduce any new materials into the finished device or the manufacturing process. The material of construction for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are identical to the predicate Solitaire™ Platinum {7}------------------------------------------------ Revascularization Device. Biocompatibility was leveraged from the predicate Solitaire™ Platinum Revascularization Device in support of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. A summary of the biocompatibility testing leveraged for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices is summarized in the table below. | Test Category | Test Description | Method | Acceptance Criteria | Conclusion | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cytotoxicity | L929 MTT Cytotoxicity | ISO 10993-5 | Viability is ≥70%. | The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-5 and are substantially equivalent to the predicate device. | | Sensitization | Guinea Pig Maximization Sensitization | ISO 10993-10 | Test article does not elicit a sensitization response. | The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-10 and are substantially equivalent to the predicate device. | | Irritation | Intracutaneous Irritation Test | ISO 10993-10 | Differences in the mean test and control scores of the extract dermal observations are < 1.0. | The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-10 and are substantially equivalent to the predicate device. | | Acute Systemic Toxicity | Acute Systemic Injection Test Materials Mediated Rabbit Pyrogen | ISO 10993-11 | No abnormal clinical signs and weight loss in excess of 10%. Temperature rise ≥0.5°C | The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-11 and are substantially equivalent to the predicate device. | | Test Category | Test Description | Method | Acceptance Criteria | Conclusion | | Hemo- compatibility | Hemolysis | ISO 10993-4 | No significant differences between the test article extract and negative control article results. The test article is considered non-hemolytic | The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-4 and are substantially equivalent to the predicate device. | | | Partial Thromboplastin Time | | Clotting times are similar to the negative control and the reference material (HDPE) indicating the device materials are not an activator of the intrinsic coagulation pathway. | | | | Platelet and Leukocyte Count | | Test article does not adversely affect the platelet and leukocyte components of the blood compared to the reference material. | | | | Complement Activation C3a and SC5b-9 Assay | | Levels of C3a and SC5b-9 are comparable and less than the positive control. | | | | Thrombosis | | Thrombo-resistance properties are acceptable in clinical use. | | | | | | | | | Genotoxicity | Bacterial Mutagenicity Test | ISO 10993-3 | Test article is considered non-mutagenic | The subject 4-20-05 and 6-24-06 devices met the acceptance criteria for ISO 10993-3 and are substantially equivalent to the predicate device. | | | In-vitro Mouse Lymphoma Assay | | Test article is considered non-mutagenic | | | | In-vivo Mouse Micronucleus Assay | | Test article is considered non-mutagenic | | | | | | | | | Test Description | Method | Acceptance Criteria | Conclusion | | | Delivery Force | Peak delivery force was measured through a representative tortuous anatomical model. | Stent must be below delivery force specification. | The subject 4-20-05 and 6-24- 06 devices met the acceptance criteria for delivery force and are substantially equivalent to the predicate device. | | | Re-sheathing Force | Retrieval force was measured through a representative tortuous anatomical model. | Stent must be below re-sheathing force specification. | The subject 4-20-05 and 6-24- 06 devices met the acceptance criteria for re-sheathing force and are substantially equivalent to the predicate device. | | | Multiple Re- sheathing Durability | Samples were evaluated on their ability to withstand delivery and withdrawal forces in a representative tortuous model beyond the recommended number of passes and re- sheathings allowed per the Instructions for Use (IFU). | The subject 4-20- 05 and 6-24-06 devices must reliably deploy and resheath up to four (4) times. | The subject 4-20-05 and 6-24- 06 devices showed no irregularities, breaks, kinks, body marker migration, glue separations, or other observed defects after all deployment and resheathing attempts. The subject 4-20-05 and 6-24- 06 devices met the acceptance criteria for multiple re- sheathing durability and are substantially equivalent to the predicate device. | | | Body Marker Tensile | Body Marker tensile strength testing is performed to verify the strength of the laser weld of the Platinum/Iridium markercoil to the Nitinol distal finger of the device. | Body marker should be greater than or equal to existing tensile strength specification. | The subject 4-20-05 and 6-24- 06 devices met acceptance criteria for body marker tensile and are substantially equivalent to the predicate device. | | | Test Description | Method | Acceptance Criteria | Conclusion | | | Body Marker Radiopacity | Verification analysis of body markers. | The radiopaque body markers must be visible using standard catheter laboratory equipment | The subject 4-20-05 and 6-24- 06 devices met acceptance criteria for body marker radiopacity and are substantially equivalent to the predicate device. | | | Proximal Marker to Distal Marker | The length of the laser cut and electro- polished stents are measured 100% in process. | Length of stent must meet all inspection criteria | The subject 4-20-05 and 6-24- 06 devices met acceptance criteria for proximal marker to distal marker and are substantially equivalent to the predicate device. | | | A f Temperature | In-process 100% tracking of heat set parameters used to set final Af | Temperature should be less than or equal to existing A f temperature specification. | The subject 4-20-05 and 6-24- 06 Solitaire™ Platinum Revascularization Devices met acceptance criteria for Af and are substantially equivalent to the predicate device. | | | Radial Force | The radial force was measured 100% in- process. | Stent must be within existing radial force specification. | Radial force was measured 100% in-process. The subject 4-20-05 and 6-24- 06 devices met acceptance criteria for radial force and are substantially equivalent to the predicate device. | | {8}------------------------------------------------ {9}------------------------------------------------ ## Performance Data – Bench: A summary of the bench testing performed for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices is summarized in the table below. {10}------------------------------------------------ ## Performance Data – Animal: The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not change the indications for use or the fundamental scientific technology of the predicate Solitaire™ Platinum Revascularization Device. Therefore, no additional non-clinical animal testing was performed for the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. #### Performance Testing - Clinical: The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices do not change the indications for use or the fundamental scientific technology of the predicate device. The subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices are substantially equivalent to the predicate Solitaire™ Platinum Revascularization Device and do not raise new questions of the safety and effectiveness of the subject 4-20-05 and 6-24-06 Solitaire™ Platinum Revascularization Devices. Therefore, no additional clinical study was performed.