(119 days)
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
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
The Penumbra, Inc. POD Packing Coil is a Class II neurovascular embolization device. The testing described for this device is primarily "bench-top testing" and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device, the POD System (K141134). No clinical studies or AI/ML components are mentioned in the provided text.
Here's an analysis based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily shows specifications for various physical and mechanical properties, and the results confirm that these specifications were met (100% Pass).
| Attribute | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Dimensional/Visual Inspection | Confirm the dimensions of the units meet all product specifications. | 100% Pass |
| Fatigue Resistance | The Coil retains its secondary shape after being cycled into / out of the 0.025 in. ID microcatheter. | 100% Pass |
| Torsional Resistance | Minimum value per specification | 100% Pass |
| Friction through a 0.025 in. ID microcatheter – Pull & Push | Maximum value per specification | 100% Pass |
| Simulated Use Flow Model Testing | Simulated use testing of POD Packing Coil 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. | 100% Pass |
| Distal System Tensile Test | Minimum per specification | 100% Pass |
In addition, biocompatibility tests were performed on the predicate and reference devices, with the following results:
| Test | Acceptance Criteria (Method) | Reported Device Performance (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 |
| Acute Systemic Toxicity | ISO Acute Systemic Injection Test | Non-Toxic |
| Material Mediated Pyrogen | USP Material-Mediated Rabbit Pyrogen Test | Non-pyrogenic |
| Sub-Chronic/Sub-Acute Toxicity | 14 day / 14 dose Repeat Dose study | Non-Toxic |
| In Vitro Hemolysis | ASTM Method (Extraction & Direct Contact) | Non-Hemolytic |
| Dog Thrombogenicity | Thrombogenicity Study in Dogs - ISO | Non-Thrombogenic |
| Coagulation | PT and PTT Test | Non-Thrombogenic |
| Complement Activation | C3a and SC5b-9 through Enzyme Assay | No greater biological response than corresponding control |
| 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 |
2. Sample size used for the test set and the data provenance:
- Bench-top testing: The sample size for the bench-top tests is not explicitly stated as a number. For "Dimensional/Visual Inspection," "Fatigue Resistance," "Torsional Resistance," "Friction," and "Distal System Tensile Test," the result is "100% Pass," which implies all units tested passed, but the number of units is not given. For "Simulated Use Flow Model Testing," the result is also "100% Pass," but again, the number of simulations/devices tested is not specified.
- Biocompatibility testing: The biocompatibility testing was performed on the predicate and reference devices. The sample sizes for these tests are not provided in this summary.
- Data provenance: Not explicitly stated, but bench-top testing is typically conducted in a laboratory setting, and biocompatibility studies adhere to GLP (Good Laboratory Practices), implying controlled experimental conditions rather than patient-derived data directly.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical medical device, and its performance evaluation relies on objective measurements and established engineering and biocompatibility standards, not expert-derived ground truth from interpreting medical images or clinical outcomes in the context of an AI/ML study.
4. Adjudication method for the test set:
- Not applicable. As noted above, this involves objective measurements and standard test protocols for a physical device, not subjective interpretation requiring adjudication among experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No. The document describes bench-top and biocompatibility testing for a physical device. There is no mention of an AI component or a comparative effectiveness study involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm or AI model.
7. The type of ground truth used:
- Bench-top testing: The "ground truth" here is defined by established engineering specifications and performance standards for medical devices (e.g., dimensional tolerances, mechanical strength, resistance to fatigue).
- Biocompatibility testing: The "ground truth" is determined by well-established international standards and guidelines for biological evaluation of medical devices (EN ISO 10993-1) and specific test methodologies (e.g., ISO Elution Test, Magnusson-Kligman Method, ASTM methods, USP tests) that define what constitutes "non-toxic," "non-irritant," etc. These are objective scientific measurements and observations.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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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
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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
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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) |
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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
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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 ●
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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 theendovascularembolization of:• Intracranialaneurysms• Other neurovascularabnormalities suchas arteriovenousmalformations andarteriovenousfistulae• Arterial and venousembolizations in theperipheralvasculature | SAME | SAME |
| Materials/Construction | |||
| Coil | Platinum/Tungsten(92% Pt, 8% W),Nitinol (55% Ni, 45%Ti), Adhesive,Gold/Tin (80% Au,20% Sn), PolyethyleneTerephthalate (PET),Titanium | Platinum/Tungsten(92% Pt, 8% W),Polymer, Adhesive,PolyethyleneTerephthalate (PET),Titanium | SAME as Reference |
| Introducer Sheath | Polypropylene, PET | High DensityPolyethylene, PET | SAME as Reference |
| Dimensions/Shape | |||
| Coil Shape | Complex | Complex, Helical | Wave (two dimensionalshape) |
| 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 inK141134 | SAME | SAME |
| Sterilization | Ethylene Oxide (EO) | SAME | SAME |
| Pyrogenicity(Coil/Pusher) | < 2.15 EU/device | SAME | SAME |
| Pyrogenicity(Detachment Handle) | < 20 EU/device | SAME | SAME |
| Shelf-Life (Coil/Pusherassembly) | 8 years | 5 years | SAME as Reference |
| Shelf-Life (DetachmentHandle) | 3 years | 5 years | SAME as Predicate |
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1.11 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 POD Packing Coil. Design Verification (Bench-Top Testing) was performed on the subject device as a part of the design control activities. The subject POD Packing Coil met all established requirements.
1.11.1 Bench-top Testing
Design Verification testing was conducted to evaluate the physical and mechanical properties of the POD Packing Coil and demonstrate substantial equivalence to predicate. The following tests were performed and all tests passed:
| Attribute | Specification | Results |
|---|---|---|
| Dimensional/VisualInspection | Confirm the dimensions of the units meet allproduct specifications. | 100%Pass |
| Fatigue Resistance | The Coil retains its secondary shape after beingcycled into / out of the 0.025 in. ID microcatheter. | 100%Pass |
| Torsional Resistance | Minimum value per specification | 100%Pass |
| Friction through a 0.025in. ID microcatheter –Pull & Push | Maximum value per specification | 100%Pass |
| Simulated Use FlowModel Testing | Simulated use testing of POD Packing Coil withaccessory devices in an anatomical model whichsimulated the tortuosity of the neurovasculature.Devices were delivered through the model toevaluate the effectiveness of the devices toembolize targeted vasculature. | 100%Pass |
| Distal System TensileTest | Minimum per specification | 100%Pass |
1.11.2 Biocompatibility Testing
Biocompatibility testing previously performed on the predicate device and reference device substantiates the biocompatibility of the subject device POD Packing Coil. 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
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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 | ISO Intracutaneous (Intradermal) | Non-Irritant | |
| Reactivity) | Injection Test | ||
| 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 RabbitPyrogen Test | Non-pyrogenic | |
| Sub-Chronic Toxicity | |||
| (Sub-Acute Toxicity) | |||
| Sub-Chronic/Sub-Acute | 14 day / 14 dose Repeat Dose study | Non-Toxic | |
| Toxicity | |||
| Hemo-compatibility | |||
| In Vitro Hemolysis | ASTM Method (Extraction & Direct | Non-Hemolytic | |
| Contact) | |||
| Dog Thrombogenicity | Thrombogenicity Study in Dogs - ISO | Non-Thrombogenic | |
| Coagulation | PT and PTT Test | Non-Thrombogenic | |
| No greater | |||
| Complement Activation | C3a and SC5b-9 through Enzyme | biological response | |
| Assay | than corresponding | ||
| control | |||
| Genotoxicity | |||
| Mouse Lymphoma | ISO In Vitro Mouse Lymphoma | Non-Mutagenic | |
| Ames Mutagenicity | Salmonella typhimurium Reverse | Non-Mutagenic | |
| Mutation Assay (Ames Test) | |||
| In Vivo MouseISO In Vivo Mouse Micronucleus | Non-Mutagenic | ||
| Micronucleus | Assay |
The leveraged non-clinical testing substantiates that the POD Packing Coil is noncytotoxic, non-sensitizing, non-irritating, non-toxic, non-mutagenic, non-mutagenic, nongenotoxic, non-hemolytic, and non-thrombogenic.
1.12 Summary of Substantial Equivalence
The subject device POD Packing Coil device is substantially equivalent to the predicate device POD System. The subject device has identical intended use as the predicate device. The subject device and the predicate devices differ slightly in regards to minor technological variations, while maintaining the same fundamental scientific technology.
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Image /page/8/Picture/0 description: The image shows the logo for Penumbra, a healthcare company. The logo consists of the word "Penumbra" in a red, sans-serif font, followed by a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the top of the letter to the edge of the circle. The logo is simple and modern, and the red color gives it a sense of energy and urgency.
However, these differences do not raise different questions of safety and effectiveness. The device testing described in Section 1.11 demonstrate the subject device is substantially equivalent to the predicate device in regards to operating principle, fundamental technology and device performance.
§ 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).