Intracranial aneurysms
Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Arterial and venous embolizations in the peripheral vasculature

Device Description

The Penumbra Coil System consists of the following components, which are sold separately:

Standard Complex Coils attached to detachment pusher
Soft Complex Coils attached to detachment pusher
Soft Coils attached to detachment pusher
Curve Extra Soft Coils attached to detachment pusher
Curve Complex Extra Soft Coils attached to detachment pusher
Detachment Handle

The coils are primarily manufactured from platinum wire and Nitinol wire. The coils are attached to a stainless steel / polymer detachment pusher. The coils are available in varying secondary diameters and shapes based on coil type.

The Penumbra Coils are sterile, non-pyrogenic and intended for single use only. The Penumbra Detachment Handle is sterile, non-pyrogenic and may be used to detach multiple coils within a single patient procedure.

AI/ML Overview

The provided text is a 510(k) Summary for the Penumbra Coil System/Penumbra Coil 400. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific clinical acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in the prompt regarding a study that proves the device meets acceptance criteria, an effects size for MRMC studies, or detailed information about ground truth establishment for a test set. This type of information is typically found in clinical trial reports or performance study reports, which are not part of a 510(k) summary focused on substantial equivalence.

However, based on the non-clinical data presented, I can extract and present the acceptance criteria for those tests and their reported performance.

Non-Clinical Acceptance Criteria and Reported Device Performance

For the non-clinical tests, the "acceptance criteria" are implied by the expected outcome for a safe and effective medical device, and the "reported device performance" are the results obtained.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Cytotoxicity	Non-Toxic	Non-Toxic
Sensitization	Non-Sensitizing	Non-Sensitizing
Intracutaneous Reactivity (Irritation)	Non-Irritant	Non-Irritant
Systemic Toxicity (Acute)	Non-Toxic	Non-Toxic
Subacute / Subchronic Toxicity	Non-Toxic	Non-Toxic
Genotoxicity	Non-Mutagenic	Non-Mutagenic
Implantation	Non-Irritant	Non-Irritant
Haemocompatibility (Complement Activation)	No greater biological response than corresponding control	No greater biological response than corresponding control
Haemocompatibility (Hemolysis)	Non-Hemolytic	Non-Hemolytic
Haemocompatibility (Thrombogenicity)	Non-Thrombogenic	Non-Thrombogenic
Pyrogenicity	Non-Pyrogenic	Non-Pyrogenic
Design Verification Tests (General)	All tests passed successfully	All tests passed successfully
Dimensional / Visual Inspection	Met finished goods release requirements	Passed
Joint Tensile Strength	Met finished goods release requirements	Passed
Fatigue	Met finished goods release requirements	Passed
Friction	Met finished goods release requirements	Passed
Torsion	Met finished goods release requirements	Passed
Stiffness	Met finished goods release requirements	Passed
Corrosion	Met finished goods release requirements	Passed
Handle Function	Met finished goods release requirements	Passed
MRI Compatibility	Met finished goods release requirements	Passed
GLP Simulated Use	Met finished goods release requirements	Passed

Information Not Available in the Provided Text:

Sample size used for the test set and the data provenance: The document is a 510(k) summary demonstrating substantial equivalence for a labeling change. It does not contain information about a test set for clinical performance. The non-clinical tests were conducted using statistical sampling methods as required by Penumbra Design Control procedures, but specific sample sizes are not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set for performance is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the biocompatibility and design verification tests, the "ground truth" is established by the validated methods themselves and the specified acceptance criteria for each test (e.g., "non-toxic," "non-irritant," "passed successfully").
The sample size for the training set: Not applicable as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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K (20330

APR - 2 2012

1 510(k) Summary of Safety & Effectiveness

(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 Penumbra Coil System/Penumbra Coil 400TM

1.1 Sponsor/Applicant Name and Address

Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502

Sponsor Contact Information 1.2

Emilly Tojima Nurthen Penumbra, Inc. Regulatory Affairs Program Manager TEL: 510-748-3314 FAX: 510-217-6414

E-MAIL: emilly.nurthen@penumbrainc.com

1.3 Date of Preparation of 510(k) Summary

March 20, 2012

1.4 Device Trade or Proprietary Name

Penumbra Coil System/Penumbra Coil 400™

Device Classification 1.5

Device, Vascular and Neurovascular Embolization (Product Code: HCG& KRD)

1.6 Predicate Devices

Name of Predicate Device	510(k)Number
Penumbra Coil System/Penumbra Coil 400	K103305

Predicate Device Comparison 1.7

The Penumbra Coil System/Penumbra Coil 400, subject of this 510(k), has the same technological characteristics as the predicate device, and the change is limited to revised product labeling.

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Device Description 1.8

The Penumbra Coil System consists of the following components, which are sold separately:

. Standard Complex Coils attached to detachment pusher
. Soft Complex Coils attached to detachment pusher
J Soft Coils attached to detachment pusher �
Curve Extra Soft Coils attached to detachment pusher .
Curve Complex Extra Soft Coils attached to detachment pusher .
Detachment Handle .

1.9 Intended Use

The Penumbra Coil System is intended for the 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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	Penumbra Embolization Coil	PenumbraEmbolization Coil
510(k) No.	K103305	To be K120330
Classification	Class II, HCG, KRD	Class II, HCG, KRD
Indication	Intended for the embolization of:• Intracranial aneurysms• Other neurovascular abnormalities suchas arteriovenous malformations andarteriovenous fistulae• Arterial and venous embolizations in theperipheral vasculature	Same
Materials	Coil: Platinum/tungsten, NitinolPusher: stainless steel, polymer	Same
Sterilization	EtO	Same
Shelf-Life	36-Months	Same

1.10 Comparison to predicate Device

1.11 Summary of Non-clinical Data:

Biocompatibility 1.11.1

Biocompatibility tests conducted with Penumbra Coil System were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for a blood contacting permanent implant device. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.

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Test	Method	Result
Cytotoxicity	L929 MEM Elution Test	Non-Toxic
Sensitization	Kligman Maximization	Non-Sensitizing
IntracutaneousReactivity (Irritation)	Intracutaneous InjectionTest	Non-Irritant
Systemic Toxicity*(Acute)	ISO Acute SystemicInjection Test	Non-Toxic
Subacute / SubchronicToxicity	In vivo Subacute Toxicity	Non-Toxic
Genotoxicity	Ames testMouse Lymphoma	Non-Mutagenic
Implantation	In vivo Implantation	Non-Irritant
Haemocompatibility	Complement Activation	No greater biologicalresponse thancorresponding control
	HemolysisIn vivo thrombogenicity	Non-HemolyticNon-Thrombogenic
Pyrogenicity	USP Material MediatedRabbit Pyrogen Test	Non-Pyrogenic

ISO-10993 GLP Testing Summary for the Penumbra Coil System

In summary, non-clinical testing found the Penumbra Coil System to be biocompatible according to the requirements of ISO 10993-1. Additionally, the product was found to be non-pyrogenic.

1.11.2 Design Verification (Bench-Top Testing)

Design Verification testing was conducted to evaluate the physical and mechanical properties of the Penumbra Coil System. All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements. The tests performed on the Penumbra Coil System included:

Dimensional / Visual Inspection (all sizes) .
Joint Tensile Strength ●
Fatigue .
Friction .

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Torsion .
Stiffness .
Corrosion .
Handle Function .
MRI Compatibility .
GLP Simulated Use .

All tests performed passed successfully.

The physical, mechanical and performance testing of the subject Penumbra Coil System demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Penumbra, Inc. c/o Mr. Seth Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502

Re: K120330

Trade/Device Name: Penumbra Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: February 1, 2012 Received: February 2, 2012

Dear Mr. Schulman:

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.

APR - 2 2012

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Page 2 - Mr. Seth Schulman

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.

Qurle. A. Rimmer mo for

Malvina B. Evdelman, MD. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K120330

Device Name: Penumbra Coil System

Indications For Use:

The Penumbra Coil 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

Prescription Use . X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

. ( Page 1 of

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices .

KI20330 510(k) Number.

Regulation Number and Section

§ 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).