(119 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a bare platinum embolization coil and its delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is used for endovascular embolization of aneurysms and other vascular abnormalities, which is a therapeutic intervention aimed at treating medical conditions.
No
Reason: The device is an embolization coil used for therapeutic purposes (occluding blood flow) and is not described as gathering or analyzing information to diagnose a condition.
No
The device description explicitly lists hardware components such as coils, delivery pushers, introducer sheaths, and detachment handles, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The description clearly states that the Penumbra Occlusion Device (POD) is a bare platinum embolization coil intended for the endovascular embolization of intracranial aneurysms and other vascular abnormalities. This is a therapeutic device used to physically block blood flow within the body, not to analyze samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic information derived from such analysis.
Therefore, the POD System is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
POD is indicated for the endovascular embolization of:
- Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arterioyenous fistulae
- · Arterial and venous embolizations in the peripheral vasculature
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
The Penumbra Occlusion Device (POD), including the subject device, is a bare platinum embolization coil for the treatment of aneurysms or other vascular abnormalities. It is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. It is also intended for arterial and venous embolization in the peripheral vasculature. The POD System should only be used by physicians who have received appropriate training in interventional techniques.
The POD System consists 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, Neurovascular, 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)
Bench-top testing (Design Verification) was performed on the subject device. All tests passed. These tests included:
- Dimensional/Visual Inspection
- Fatigue Resistance
- Torsional Resistance
- Friction through a 0.025 in. ID microcatheter – Pull & Push
- Simulated Use Flow Model Testing
- Distal System Tensile Test
Biocompatibility testing was previously performed on the predicate and reference devices, substantiating the biocompatibility of the subject device. Tests performed include:
- In Vitro Cytotoxicity (Non-Toxic)
- Sensitization (Non-Sensitizing)
- Irritation (Intracutaneous Reactivity) (Non-Irritant)
- Implant study (Non-Irritant)
- Systemic Toxicity (Acute) (Non-Toxic)
- Material Mediated Pyrogen (Non-pyrogenic)
- Sub-Chronic/Sub-Acute Toxicity (Non-Toxic)
- Hemo-compatibility: In Vitro Hemolysis (Non-Hemolytic), Dog Thrombogenicity (Non-Thrombogenic), Coagulation (Non-Thrombogenic), Complement Activation (No greater biological response than corresponding control)
- Genotoxicity: Mouse Lymphoma (Non-Mutagenic), Ames Mutagenicity (Non-Mutagenic), In Vivo Mouse Micronucleus (Non-Mutagenic)
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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2017
Penumbra, Inc. Aditi Kolla Regulatory Specialist II One Penumbra Place Alameda, California 94502
Re: K170852
Trade/Device Name: POD Packing Coil Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: May 25, 2017 Received: May 25, 2017
Dear Ms. 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 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 device
1
related 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.
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/ResourcesforYou/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,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS 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) K170852
Device Name POD Packing Coil
Indications for Use (Describe) POD is indicated for the endovascular embolization of:
- Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arterioyenous fistulae
- · 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) |
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
Image /page/3/Picture/0 description: The image features the word "Penumbra" in a bold, red font, followed by a circular logo. The logo is red with a white "P" inside. The overall design is clean and professional.
510(k) Summary
(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 POD Packing Coil.
1.1 Sponsor/Applicant Name and Address
Penumbra. Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Aditi Kolla Regulatory Affairs Specialist II Phone: (510) 995-2010 Fax: (510) 217-6414 Email: akolla@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
July 18, 2017
Device Trade or Proprietary Name 1.4
POD Packing Coil
1.5 Primary Device Classification
II Regulatory Class: Classification Panel: Neurology Neurovascular embolization device Classification Name: Regulation Number: 21 CFR 882.5950 Product Code: HCG
1.6 Secondary Device Classification
Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Vascular embolization device Regulation Number: 21 CFR 870.3300 Product Code: KRD
4
Predicate and Reference Devices 1.7
| 510(k) Number | Clearance Date | Name of Device | Name of Manufacturer |
|---|---|---|---|
| Predicate Device | |||
| K141134 | July 03, 2014 | POD System | Penumbra, Inc. |
| Reference Device | |||
| K160832 | April 20, 2016 | Penumbra Smart Coil | Penumbra, Inc. |
Device Description 1.8
The Penumbra Occlusion Device (POD), including the subject device, is a bare platinum embolization coil for the treatment of aneurysms or other vascular abnormalities. It is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. It is also intended for arterial and venous embolization in the peripheral vasculature. The POD System should only be used by physicians who have received appropriate training in interventional techniques.
The POD System consists 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
1.9 Indications For Use
POD is indicated for the endovascular embolization of:
- Intracranial aneurysms ●
- Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature ●
5
Image /page/5/Picture/0 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern, and the colors are bold and eye-catching.
1.10 Predicate Device Comparison
| Attribute | POD System
(Predicate Device) | Penumbra Smart Coil
(Reference Device) | POD Packing Coil
(Subject Device) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------|
| General | | | |
| 510(k) No. | K141134 | K160832 | K170852 |
| Classification | Class II (HCG, KRD) | SAME | SAME |
| Intended Use | Indicated for the
endovascular
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 |
| Introducer Sheath | Polypropylene, PET | High Density
Polyethylene, PET | SAME as Reference |
| Dimensions/Shape | | | |
| Coil Shape | Complex | Complex, Helical | Wave (two dimensional
shape) |
| Coil Length | 1 - 60 cm | SAME | 2 - 60 cm |
| Coil Primary Diameter | 0.022 in. max | 0.0135 in. max | SAME as Predicate |
| Other | | | |
| Device Packaging | As specified in
K141134 | SAME | SAME |
| Sterilization | Ethylene Oxide (EO) | SAME | SAME |
| Pyrogenicity
(Coil/Pusher) |