(134 days)
No
The summary describes a mechanical embolization coil and its delivery system, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The "Intended Use / Indications for Use" states that the device is indicated for "arterial and venous embolization," which is a procedure used to treat a condition or disease (e.g., stopping blood flow to a tumor or an aneurysm). This direct therapeutic action classifies it as a therapeutic device.
No
The device is an embolization coil used for therapeutic purposes (arterial and venous embolization), not for diagnosing medical conditions.
No
The device description clearly states it is an embolization coil, a physical medical device, and includes components like a delivery pusher and a hand-held detacher.
Based on the provided information, the Concerto Versa™ Detachable Coil is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arterial and venous embolization in the peripheral vasculature." This describes a medical device used within the body for a therapeutic purpose (blocking blood vessels).
- Device Description: The description details a physical coil and delivery system used for this embolization procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The Concerto Versa™ does not perform this function.
Therefore, the Concerto Versa™ Detachable Coil is a medical device used for an interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
The Concerto Versa™ Detachable Coil is an embolization coil that consists of a platinum embolization coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately and was most recently cleared in K162704. The Concerto Versa™ Detachable Coil is supplied sterile and is intended for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench testing was performed and leveraged to evaluate the performance of the Concerto Versa ™ Detachable Coil. A subset of design verification testing was conducted based on the FDA Guidance for Vascular and Neurovascular Embolization Devices to evaluate the physical and mechanical properties of the subject device and demonstrate substantial equivalence to the predicate. The following tests were performed shown in the table below, and all passed. Verification and validation testing was performed using a clinically relevant tortuosity model of the splenic and gastroduodenal arteries. All other bench testing was leveraged, as based on the similarities with the predicate device. GLP acute animal data was also leveraged from the predicate device.
Additionally, the following clinically relevant endpoints were addressed as follows:
- Device migration, occlusion effectiveness and recanalization were evaluated through • design verification testing with passing results, which are similar to the predicate device.
- Acute complications were addressed based upon the materials, delivery of the device to the target location and clinical applications which are similar to that of the predicate device.
- Local foreign-body reaction was addressed through the product specifications requiring the device to be biocompatible per ISO10993-1 and to be provided sterile.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Concerto Detachable Coil System K090046
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
February 9, 2021
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Rita De Rama Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K202850
Trade/Device Name: Concerto Versa™ Detachable Coil Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD, Dated: September 25, 2020 Received: September 28, 2020
Dear Rita De Rama:
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
1
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,
Finn Donaldson Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202850
Device Name Concerto Versa™ Detachable Coil
Indications for Use (Describe)
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
X 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 K202850
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration: 2029214 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person(s): | Rita De Rama
Sr. Specialist, Regulatory Affairs
Telephone: (949) 383-7061
Email: rita.r.derama@medtronic.com |
| Date Summary
| Prepared: | February 4, 2021 |
|---|---|
| Trade Name of | |
| Device: | Concerto VersaTM Detachable Coil |
| Device Classification | |
| Name: | Vascular Device for Promoting Embolization |
| FDA Review Panel: | Cardiovascular |
| Classification Product | |
| Code: | KRD |
| Regulation Number: | 870.3300 |
| Regulation | |
| Description: | Vascular embolization device |
| Device Classification: | Class II |
| Predicate Device: | Concerto Detachable Coil System |
| K090046 |
Device Description
The Concerto Versa™ Detachable Coil is an embolization coil that consists of a platinum embolization coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately and was most recently cleared in K162704. The Concerto Versa™ Detachable Coil is supplied sterile and is intended for single-use only.
Indication for Use Statement
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.
Device Comparison
The Concerto Versa™ Detachable Coil is a design modification adding larger sizes, with coil loop diameters of 3-32mm and lengths of 5-65cm. The intention is to expand the Concerto Detachable Coil System family by adding thirty-two new model numbers to the currently cleared Concerto product portfolio (predicate device). These new model numbers are a line extension of the predicate device and come in a 3D platinum configuration enlaced with Nylon fibers. The first
4
loop of the 3mm - 14mm models are oversized to perform vessel embolization, while the first loop of 16mm - 32mm models are undersized to perform saccular embolization. The subject Concerto Versa™ Detachable Coil and the predicate Concerto™ Detachable Coil System have many of the same technological characteristics. A comparison of the subject device and the predicate is provided below.
| Technological Characteristics Comparison Table | ||
|---|---|---|
| Design Feature | Predicate Device: | |
| Concerto Detachable Coil | ||
| System (K090046) | Subject Device: | |
| Concerto Versa™ | ||
| Detachable Coil | ||
| Indication for Use (IFU) | ||
| Statement | The Concerto Detachable Coil | |
| System is indicated for arterial and | ||
| venous embolizations in the | ||
| peripheral vasculature. | The Concerto Versa™ | |
| Detachable Coil is indicated for | ||
| arterial and venous | ||
| embolization in the peripheral | ||
| vasculature. | ||
| Dimensions | ||
| Device Size Range | Concerto Nylon Helix: | |
| 2-10mm – Loop OD | ||
| 1-30cm - Length | ||
| Concerto PGLA Helix: | ||
| 2 -20mm Loop OD | ||
| 1-50cm - Length | ||
| Concerto PGLA 3D: | ||
| 2-18mm Loop OD | ||
| 2-40cm - Length | 3-32mm Loop OD | |
| 5-65cm Length | ||
| Coil Shape | Helical & 3D | 3D |
| Coil Wire OD (inches) | 2-3mm: 0.0015'' | |
| 4-6mm: 0.0020'' | ||
| 7-10mm: 0.00225'' | ||
| 12-20mm: 0.00275'' | 3-6mm: 0.0025'' | |
| 7-9mm: 0.00275'' | ||
| 10-32mm: 0.0035'' | ||
| Fiber OD/Length | 0.001''/2.0mm | 0.0015''/3.5mm |
| Distance between two fibers | 2mm | Models CV-3-5 and CV-4-5: |
| ≥3mm | ||
| Other Models: ≥4mm | ||
| Delivery System (Pusher) | ||
| Delivery System | Pusher: Composite Hypotube | |
| Stainless Steel with PTFE outer | ||
| jacket and liner & PET & Pt/W | ||
| alignment marker | Same | |
| Delivery Wire/Pusher Length | 188cm | Same |
| Technological Characteristics Comparison Table | ||
| Design Feature | Predicate Device: | |
| Concerto Detachable Coil | ||
| System (K090046) | Subject Device: | |
| Concerto Versa™ | ||
| Detachable Coil | ||
| Delivery Wire/Pusher Distal | ||
| OD | 0.0142" | Same |
| Delivery Wire/Pusher | ||
| Proximal OD | 0.0140" | 0.0200" |
| Introducer Sheath | ||
| ID/OD/Length | ID: 0.047cm | |
| OD: 0.077cm | ||
| Length: 120cm | ID: 0.071cm | |
| OD: 0.107cm | ||
| Length: 130cm | ||
| Materials - Permanent Patient Contacting (Implant) | ||
| Implant Coil Wire | Pt (92%)/ W (8%) | Same |
| Coil Shell/Cap Shell | Pt (92%)/ W (8%) | Stainless Steel 316L |
| Stretch Resistant Member | Polypropylene | Same |
| Fiber | PGLA or Nylon 6 | Nylon 6 |
| Detach Subassembly | Stainless Steel 316L | Same |
| Accessories/Product Compatibility | ||
| Catheter Compatibility | Nylon: | |
| 2mm to 4mm, minimum micro | ||
| catheter inside diameter is 0.0165" | ||
| 5mm to 10mm, minimum micro | ||
| catheter inside diameter is 0.021" | ||
| PGLA: | ||
| 12mm and above, minimum micro | ||
| catheter inside diameter is 0.021" | The Concerto Versa™ | |
| Detachable Coil should only be | ||
| delivered through a delivery | ||
| catheter (either micro catheter | ||
| or diagnostic catheter) with a | ||
| minimum inner diameter of | ||
| 0.027" and a maximum inner | ||
| diameter of 0.041". | ||
| Method of Coil Detachment | Instant Detacher - Retraction of | |
| release cord from distal orifice of | ||
| implant delivery pusher | Same | |
| Sterilization | ||
| Method | Ethylene Oxide (EO) | Same |
| Stability | ||
| Shelf life | 3 years | Same |
| Magnetic Resonance Imaging | ||
| Compatibility | MR Conditional | Same |
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K202850 Page 3 of 6
6
Biocompatibility
Based on minor changes in the subject device, cytotoxicity testing was conducted on the Concerto Versa ™ Detachable Coil per ISO 10993-5: 2009 and passed. All other biocompatibility testing per ISO 10993-1:2009 was leveraged for the Concerto Versa ™ Detachable Coil, as based on the predicate device described below:
| Test | Test Method | Results |
|---|---|---|
| Biocompatibility | ||
| Sensitization | ISO Guinea Pig Maximization Sensitization | |
| Test | Pass | |
| Irritation | ISO Intracutaneous Reactivity Test | Pass |
| Acute Systemic Toxicity | ISO Acute Systemic Injection Test | Pass |
| Pyrogenicity | Materials Mediated Pyrogen | Pass |
| Sub-Chronic/ Sub-Acute Toxicity | Sub-Acute /Sub-Chronic Toxicity | Pass |
| Genotoxicity | Bacterial Reverse Mutation (Ames Assay) | Pass |
| In Vitro Mouse Lymphoma | Pass | |
| Implantation | Intramuscular Implantation (13 wk) | Pass |
| Intramuscular Implantation (1 wk) | Pass | |
| Intramuscular | ||
| Implantation (4 wk) | Pass | |
| Hemocompatibility | ||
| Complement Activation (SC5b-9) | Pass | |
| In-Vivo Thrombogenicity Assay (Porcine, 4- | ||
| hr) | Pass | |
| Partial Thromboplastin Time (PTT) | Pass | |
| Platelet & Leukocyte Count (P&L) | Pass | |
| Hemolysis Assay (Direct Contact and Extract | ||
| Method) | Pass |
Performance Data
Non-clinical bench testing was performed and leveraged to evaluate the performance of the Concerto Versa ™ Detachable Coil. A subset of design verification testing was conducted based on the FDA Guidance for Vascular and Neurovascular Embolization Devices to evaluate the physical and mechanical properties of the subject device and demonstrate substantial equivalence to the predicate. The following tests were performed shown in the table below, and all passed. Verification and validation testing was performed using a clinically relevant tortuosity model of the splenic and gastroduodenal arteries. All other bench testing was leveraged, as based on the similarities with the predicate device. GLP acute animal data was also leveraged from the predicate device.
Additionally, the following clinically relevant endpoints were addressed as follows:
- Device migration, occlusion effectiveness and recanalization were evaluated through ● design verification testing with passing results, which are similar to the predicate device.
- Acute complications were addressed based upon the materials, delivery of the device to the target location and clinical applications which are similar to that of the predicate device.
- Local foreign-body reaction was addressed through the product specifications requiring the device to be biocompatible per ISO10993-1 and to be provided sterile.
7
K202850
Page 5 of 6
| Test | Specification | Results |
|---|---|---|
| Friction in Catheter | Friction force shall meet specification when delivered in a clinically | |
| relevant model with a catheter. | Pass | |
| Coil Force Transfer Ratio | Force transfer of delivery system and implant meet specification | |
| when delivered into a catheter. | Pass | |
| Pusher Length | The delivery system (pusher) length measurement shall meet | |
| specification. | Pass | |
| Coil Visual Inspection | The coil shall have no damage and kinks. | |
| The 1st loop shall be a full loop. | Pass | |
| Friction in Sheath | Friction force shall meet specification when delivered through a | |
| sheath. | Pass | |
| Fatigue | The coil shall be able to be re-sheathed and re-deployed in a | |
| clinically relevant model with a catheter 6 times minimum, without | ||
| breaking or prematurely detaching. | Pass | |
| PP Tensile | Stretch resistance tensile strength must meet specification. | Pass |
| Kink resistance | The distal end of 27cm pusher shall be able to track through a 0.027" | |
| catheter that is wrapped around a 3.8mm pin gage without kinking. | Pass | |
| Detachment | The coil must detach when detachment is attempted. | Pass |
| Tip Buckling | Tip buckling force shall meet minimum and maximum | |
| specifications. | Pass | |
| Tinius Olsen | The distal 25cm of the pusher shall meet specification when | |
| deflected 60° in a Tinius-Olsen with a 1/8" span, at room | ||
| temperature. | Pass | |
| Loop Deformation | The loop deformation force shall meet specifications. | Pass |
| Anchor Flow Rate | Anchor flow rate shall meet specifications based on size vessel | |
| model size and coil size. | Pass | |
| 1st Loop OD | ||
| Measurement | 1st Loop OD must meet specifications based on size. | Pass |
| Flow Occlusion | For each size coil: The reduction flow of specified coil shall meet | |
| specification in the appropriate vessel model. | Pass | |
| Primary Wind OD | ||
| Measurement | Primary wind OD shall meet specification. | Pass |
| Coil Length | Coil length shall meet specification based on coil model. | Pass |
| Pusher Elongation | Elongation force on the pusher to cause release cord actuation must | |
| meet specification. | Pass | |
| Pusher Skive Tensile | Tensile strength of pusher must meet specification. | Pass |
| Test | Specification | Results |
| Primary wind weld | ||
| tensile strength | Primary implant weld tensile strengths must meet specification. | Pass |
| Couple Tube Tensile | Coupler Weld tensile strength must meet specification. | Pass |
| Shield Coil Tensile | Shield Coil weld tensile strength shall meet specification. | Pass |
| Detachment | Detachment times will be less than 5s. | Pass |
| Detachment | The coil should be able to be manually detached by the back-up | |
| method at the secondary detachment break location. | Pass | |
| Fiber Amount Counting | Fiber amount shall meet specification based on coil model. | Pass |
| Fiber Pull Out Force | Fiber pull out force shall meet specification. | Pass |
| Distribution Simulation | Device shall keep integrity with packaging throughout shipping. | Pass |
8
K202850
Page 6 of 6
Conclusion:
The subject Concerto Versa™ Detachable Coil and Instant Detacher is substantially equivalent to the predicate Concerto Detachable Coil System. There is no change to the Indication for Use (IFU) Statement for the subject device in comparison to the predicate device. The subject and the predicate devices differ slightly in regard to minor technological characteristics, while maintaining the same fundamental scientific technology. The information provided in this submission supports a determination of substantial equivalence for the subject Concerto Versa™ Detachable Coil and Instant Detacher.