(146 days)
No
The device description and performance studies focus on the physical and mechanical properties of the embolization coils and delivery system, with no mention of AI or ML algorithms for image analysis, decision support, or any other function.
Yes
The device is described as an "implantable medical device intended to exclude the treatment area from blood flow, thus creating stasis and allowing thrombosis to occur" for various vascular abnormalities, which are clear therapeutic actions.
No
The device description and intended use clearly state that these devices are designed for embolization to treat aneurysms and other vascular abnormalities by excluding the treatment area from blood flow, thus creating stasis and allowing thrombosis to occur. This is a therapeutic action, not a diagnostic one.
No
The device description explicitly lists physical components such as coils, delivery pushers, introducer sheaths, and detachment handles, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described devices (Penumbra Coil System and POD System) are implantable medical devices used for embolization. They are physically inserted into the body's vasculature to block blood flow and induce thrombosis.
- Intended Use: The intended uses clearly state treatment of conditions like aneurysms, AVMs, and fistulae by physically occluding blood vessels. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
- Device Description: The description focuses on the physical components (coil, pusher, sheath, handle) and their function in the embolization process within the body.
Therefore, the Penumbra Coil System and POD System are therapeutic medical devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Penumbra Coil 400
The Penumbra Coil 400 is indicated for the embolization of:
- · Intracranial aneurysms.
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
- · Arterial and venous embolizations in the peripheral vasculature.
Ruby Coil System
Ruby Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
POD System (For POD Coils with nominal sizes ≤ 6 mm)
The POD System is indicated for the embolization of:
- · Intracranial aneurysms.
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
- · Arterial and venous embolizations in the peripheral vasculature.
POD System (For POD Coils with nominal sizes > 6 mm)
The POD System is indicated for arterial and venous embolizations in the peripheral vasculature.
Product codes
HCG, KRD
Device Description
The subject devices (Penumbra Coil System and POD System) are designed for embolization in the neuro and/or peripheral vasculature. This is achieved by using coils to exclude the intended treatment area from blood flow, thus creating stasis and allowing thrombosis to occur. The subject devices consist of a bare platinum embolization coil for the treatment of aneurysms or other vascular abnormalities. The devices should only be used by physicians who have received appropriate training in interventional techniques.
The subject devices consist of the following components:
- . Coil: The Coil is attached to a Delivery Pusher both contained within an Introducer Sheath. The Coil is an implantable medical device intended to exclude the treatment area from blood flow, thus creating stasis and allowing thrombosis to occur.
- . Delivery Pusher: The Delivery Pusher is composed of a shaft with a radiopaque positioning marker, a Distal Detachment Tip (DDT) and a pull wire. The Delivery Pusher may also be referred to as the Detachment Pusher.
- . Introducer Sheath: The Introducer Sheath is intended to cover the entire length of the Coil and the distal flexible segment of the Delivery Pusher. The Introducer Sheath is secured onto the Delivery Pusher with a friction lock to prevent unsheathing until use.
- Detachment Handle: The Detachment Handle is packaged separately. It is intended for ● use in multiple coil detachments performed during a single procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, peripheral vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians who have received appropriate training in interventional techniques.
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)
Design Verification (Bench-Top Testing and MR Characterization Testing) was performed on the subject devices as a part of the design control activities. The subject devices met all established requirements.
Bench-Top Testing:
- Dimensional/Visual Inspection: Confirm the dimensions of the units meet all product specifications. Results: Pass
- Fatigue Resistance: The Coil retains its secondary shape after being cycled into/out of the 0.025 inch inner diameter (ID) microcatheter. Results: Pass
- Torsional Resistance: Minimum value per specification. Results: Pass
- Friction through a 0.025 in. ID microcatheter – Pull & Push: Maximum value per specification. Results: Pass
- Simulated Use Flow Model Testing: Simulated use testing with accessory devices in an anatomical model which simulated the tortuosity of the neurovasculature. Devices were delivered through the model to evaluate the effectiveness of the devices to embolize targeted vasculature. Results: Pass
- Distal System Tensile Test: Minimum per specification. Results: Pass
- Stiffness Testing: Maximum value per specification. Results: Pass
Biocompatibility Testing (on predicate and reference devices):
- In Vitro Cytotoxicity (ISO Elution Test (MEM Extract)): Non-Toxic
- Sensitization (Magnusson-Kligman Method): Non-Sensitizing
- Irritation (Intracutaneous Reactivity) (ISO Intracutaneous (Intradermal) Injection Test): Non-Irritant
- Implant study (Intramuscular Implant Test): Non-Irritant
- Systemic Toxicity (Acute) (ISO Acute Systemic Injection Test): Non-Toxic
- Material Mediated Pyrogen (USP Material-Mediated Rabbit Pyrogen Test): Non-pyrogenic
- Sub-Chronic Toxicity (Sub-Acute Toxicity) (14 day / 14 dose Repeat Dose study): Non-Toxic
- Hemo-compatibility:
- In Vitro Hemolysis (ASTM Method (Extraction & Direct Contact)): Non-Hemolytic
- Dog Thrombogenicity Coagulation (Thrombogenicity Study in Dogs - ISO PT and PTT Test): Non-Thrombogenic
- Complement Activation (C3a and SC5b-9 through Enzyme Assay): No greater biological response than corresponding control
- Genotoxicity:
- Mouse Lymphoma (ISO In Vitro Mouse Lymphoma): Non-Mutagenic
- Ames Mutagenicity (Salmonella typhimurium Reverse Mutation Assay (Ames Test)): Non-Mutagenic
- In Vivo Mouse Micronucleus (ISO In Vivo Mouse Micronucleus Assay): Non-Mutagenic
MR Compatibility Testing:
Testing in 1.5T & 3T MR environment was performed to advise the MR conditional statement in the Instructions for Use (IFU). Testing was done in accordance to standards ASTM F2182-11, ASTM F2052-15, ASTM F2213-06 (R-11), and ASTM F2119-07 (R-13).
MRA Testing:
MRA artifact associated with a Penumbra coil array in the form of an 8 mm diameter sphere was assessed per ASTM F2119-07 (R-13) using a clinical MRA sequence. The maximum artifact distance beyond the implant was 2 mm using this sequence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 17, 2018
Penumbra, Inc. Aditi Kolla Regulatory Specialist III One Penumbra Place Alameda, California 94502
Re: K173614
Trade/Device Name: Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System); POD System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: March 10, 2018 Received: March 13, 2018
Dear Aditi Kolla:
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 mav, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/6 description: The image shows the text "Carlos L. Pena -S-D". The text is written in a simple, sans-serif font. The letters are black, and the background is white. The letters "FDA" are in the background in a light blue color.
Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173614
Device Name
Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System) POD System
Indications for Use (Describe)
Penumbra Coil 400
The Penumbra Coil 400 is indicated for the embolization of:
- · Intracranial aneurysms.
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
- · Arterial and venous embolizations in the peripheral vasculature.
Ruby Coil System
Ruby Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
POD System (For POD Coils with nominal sizes ≤ 6 mm)
The POD System is indicated for the embolization of:
- · Intracranial aneurysms.
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
- · Arterial and venous embolizations in the peripheral vasculature.
POD System (For POD Coils with nominal sizes > 6 mm)
The POD System is indicated for arterial and venous embolizations in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☒ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(k) Summary
K173614
(as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra Inc. is providing the summary of Substantial Equivalence for the subject Penumbra Coil System and POD System.
1. Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
2. Sponsor Contact Information
Aditi Kolla Regulatory Affairs Specialist III Phone: (510) 995-2010 Fax: (510) 217-6414 Email: akolla@penumbrainc.com
3. Date of Preparation of 510(k) Summary
March 10, 2018
4. Device Trade or Proprietary Name
Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System) POD System
5. Primary Device Classification
II Regulatory Class: Classification Panel: Neurology Classification Name: Neurovascular Embolization Device Regulation Number: 21 CFR 882.5950 Product Code: HCG
6. Secondary Device Classification
Regulatory Class: Classification Panel: Classification Name: Regulation Number: Product Code:
II Cardiovascular Vascular Embolization Device 21 CFR 870.3300 KRD
7. Predicate and Reference Devices
4
| 510(k)
Number | Clearance Date | of Predicate Device | Name of
Manufacturer |
|------------------|----------------|----------------------|-------------------------|
| Predicate Device | | | |
| K120330 | April 02, 2012 | Penumbra Coil System | Penumbra, Inc. |
| Reference Device | | | |
| K170852 | July 19, 2017 | POD Packing Coil | Penumbra, Inc. |
8. Predicate Device Comparison
| Attribute | Penumbra Coil
System
(Predicate Device) | POD Packing Coil
(Reference Device) | Penumbra Coil
System and POD
System (Subject
Device) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| General | | | |
| 510(k) No. | K120330 | K170852 | K173614 |
| Classification | Class II (HCG, KRD) | SAME | SAME |
| Intended Use | Indicated for the
embolization of:
-Intracranial aneurysms
-Other neurovascular
abnormalities such as
arteriovenous
malformations and
arteriovenous fistulae.
-Arterial and venous
embolizations in the
peripheral vasculature. | SAME | SAME |
| Materials/
Construction | | | |
| Coil | Platinum/Tungsten
(92% Pt, 8% W),
Nitinol (55% Ni, 45%
Ti), Adhesive,
Gold/Tin (80% Au,
20% Sn), Polyethylene
Terephthalate (PET),
Titanium | Platinum/Tungsten
(92% Pt, 8% W),
Polymer, Adhesive,
Polyethylene
Terephthalate (PET),
Titanium | SAME as
Reference |
| Dimensions/Shape | | | |
| Coil Shape | Complex, Helical, J | Wave | SAME as Predicate |
| Coil Length | 1 - 60 cm | 2 - 60 cm | SAME as Predicate |
| Coil
Secondary | 2-32 mm | Not Present | 2-40 mm |
| Attribute | Penumbra Coil
System
(Predicate
Device) | POD Packing Coil
(Reference Device) | Penumbra Coil
System and POD
System (Subject
Device) |
| Diameter
Coil Primary Diameter | 0.022 in. max | SAME | SAME |
| Device Packaging | specified in K120330 | SAME | SAME |
| Sterilization | Ethylene Oxide (EO) | SAME | SAME |
| Shelf-Life
(Coil/Pusher
assembly) | 8 years | 8 years | Penumbra Coil System: 8 years
POD System: 5 years |
5
9. Device Description
The subject devices (Penumbra Coil System and POD System) are designed for embolization in the neuro and/or peripheral vasculature. This is achieved by using coils to exclude the intended treatment area from blood flow, thus creating stasis and allowing thrombosis to occur. The subject devices consist of a bare platinum embolization coil for the treatment of aneurysms or other vascular abnormalities. The devices should only be used by physicians who have received appropriate training in interventional techniques.
The subject devices consist of the following components:
- . Coil: The Coil is attached to a Delivery Pusher both contained within an Introducer Sheath. The Coil is an implantable medical device intended to exclude the treatment area from blood flow, thus creating stasis and allowing thrombosis to occur.
- . Delivery Pusher: The Delivery Pusher is composed of a shaft with a radiopaque positioning marker, a Distal Detachment Tip (DDT) and a pull wire. The Delivery Pusher may also be referred to as the Detachment Pusher.
- . Introducer Sheath: The Introducer Sheath is intended to cover the entire length of the Coil and the distal flexible segment of the Delivery Pusher. The Introducer Sheath is secured onto the Delivery Pusher with a friction lock to prevent unsheathing until use.
- Detachment Handle: The Detachment Handle is packaged separately. It is intended for ● use in multiple coil detachments performed during a single procedure.
10. Indications for Use
Penumbra Coil 400
The Penumbra Coil 400 is indicated for the embolization of:
- Intracranial aneurysms. ●
- Other neurovascular abnormalities such as arteriovenous malformations and ● arteriovenous fistulae.
- Arterial and venous embolizations in the peripheral vasculature. ●
6
Ruby Coil System
Ruby Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
POD System (For POD Coils with nominal sizes ≤ 6 mm)
The POD System is indicated for the embolization of:
- Intracranial aneurysms.
- Other neurovascular abnormalities such as arteriovenous malformations and ● arteriovenous fistulae.
- Arterial and venous embolizations in the peripheral vasculature. ●
POD System (For POD Coils with nominal sizes > 6 mm)
The POD System is indicated for arterial and venous embolizations in the peripheral vasculature.
11. Summary of Non-Clinical Data
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of information regarding Substantial Equivalence of the device is as follows.
Included in this section are descriptions of the design control testing performed on the subject Penumbra Coil System and POD System. Design Verification (Bench-Top Testing and MR Characterization Testing) was performed on the subject devices as a part of the design control activities. The subject devices met all established requirements.
12. Bench-Top Testing
Design verification testing was conducted to evaluate the physical and mechanical properties of the subject devices and demonstrate substantial equivalence to predicate. The following tests were performed and all tests passed:
7
| Attribute | Specification | Results |
|---|---|---|
| Dimensional/Visual | ||
| Inspection | Confirm the dimensions of the units meet all | |
| product specifications. | Pass | |
| Fatigue Resistance | The Coil retains its secondary shape after being | |
| cycled into/out of the 0.025 inch inner diameter | ||
| (ID) microcatheter. | Pass | |
| Torsional Resistance | Minimum value per specification | Pass |
| Friction through a 0.025 in. | ||
| ID microcatheter – Pull & | ||
| Push | Maximum value per specification | Pass |
| Simulated Use Flow Model | ||
| Testing | Simulated use testing with accessory devices in | |
| an anatomical model which simulated the | ||
| tortuosity of the neurovasculature. Devices were | ||
| delivered through the model to evaluate the | ||
| effectiveness of the devices to embolize targeted | ||
| vasculature. | Pass | |
| Distal System Tensile Test | Minimum per specification | Pass |
| Stiffness Testing | Maximum value per specification | Pass |
12.1. Biocompatibility Testing
Biocompatibility testing previously applicable to the predicate device and reference device substantiates the biocompatibility of the subject devices. Studies were selected in accordance with EN ISO 10993-1 guidelines (Biological Evaluation of Medical Devices). All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. The following tests were performed on the predicate and reference devices:
| Test | Method | Results |
|---|---|---|
| In Vitro Cytotoxicity | ISO Elution Test (MEM Extract) | Non-Toxic |
| Sensitization | Magnusson-Kligman Method | Non-Sensitizing |
| Irritation (Intracutaneous | ||
| Reactivity) | ISO Intracutaneous (Intradermal) | |
| Injection Test | Non-Irritant | |
| Implant study | Intramuscular Implant Test | Non-Irritant |
| Systemic Toxicity (Acute) | ||
| Acute Systemic Toxicity | ISO Acute Systemic Injection Test | Non-Toxic |
| Material Mediated Pyrogen | USP Material-Mediated Rabbit | |
| Pyrogen Test | Non-pyrogenic | |
| Sub-Chronic Toxicity (Sub-Acute Toxicity) | ||
| Sub-Chronic/Sub-Acute | ||
| Toxicity | 14 day / 14 dose Repeat Dose study | Non-Toxic |
| Hemo-compatibility | ||
| In Vitro Hemolysis | ASTM Method (Extraction & | |
| Direct Contact) | Non-Hemolytic | |
| Dog Thrombogenicity | ||
| Coagulation | Thrombogenicity Study in Dogs - ISO | |
| PT and PTT Test | Non-Thrombogenic |
8
| Complement Activation | C3a and SC5b-9 through
Enzyme Assay | No greater
biological response
than corresponding
control |
|-------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------|
| Genotoxicity | | |
| Mouse Lymphoma | ISO In Vitro Mouse Lymphoma | Non-Mutagenic |
| Ames Mutagenicity | Salmonella typhimurium
Reverse Mutation Assay (Ames
Test) | Non-Mutagenic |
| In Vivo Mouse
Micronucleus | ISO In Vivo Mouse
Micronucleus Assay | Non-Mutagenic |
The leveraged non-clinical testing substantiates that the subject Penumbra Coil System and POD System is non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic, nonmutagenic, non-genotoxic, non-hemolytic, and non-thrombogenic.
12.2. MR Compatibility Testing
Testing in 1.5T & 3T MR environment was performed to advise the MR conditional statement in the Instructions for Use (IFU). Testing was done in accordance to standards ASTM F2182-11, ASTM F2052-15, ASTM F2213-06 (R-11), and ASTM F2119-07 (R-13).
12.3. MRA Testing
MRA artifact associated with a Penumbra coil array in the form of an 8 mm diameter sphere was assessed per ASTM F2119-07 (R-13) using a clinical MRA sequence. The maximum artifact distance beyond the implant was 2 mm using this sequence.
13. Summary of Substantial Equivalence
The subject Penumbra Coil System (i.e., Penumbra Coil 400 and Ruby Coil System) and POD System are substantially equivalent to the predicate device Penumbra Coil System. The subject devices have identical intended use as the predicate device. The subject and the predicate devices differ slightly in regards to minor technological variations, while maintaining the same fundamental scientific technology. However, these differences do not raise different questions of safety and effectiveness.
The device testing described in the 510(k) Summary demonstrate the subject devices are substantially equivalent to the predicate device in regards to operating principle, fundamental technology and device performance.