The Penumbra Embolectomy Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.

Device Description

The Penumbra Embolectomy Aspiration System's fundamental mechanism of action is aspiration. Aspiration draws the embolus or thrombus into the Aspiration Catheter to remove the embolus or thrombus from the body. All Separators function to break up the clot inside of the catheter to make it more amenable to removal from the body via aspiration. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

The provided document describes the Penumbra Embolectomy Aspiration System and its premarket notification for FDA clearance. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, including biocompatibility, bench-top testing, and animal studies. However, it does not include information about AI/algorithm performance, human reader studies, or explicit acceptance criteria for a device with AI components. The information requested in the prompt, such as acceptance criteria for an AI device, sample sizes for test sets (in the context of AI), ground truth establishment for AI models, and MRMC studies, are not present in this document because the device described is a physical medical device (embolectomy system), not an AI/software as a medical device (SaMD).

Therefore, I will provide the information based on the content available, noting where the requested details are not applicable or not provided.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests with acceptance criteria being "All established requirements and acceptance criteria were met." and "All established acceptance criteria were met." or specific pass/fail results for biocompatibility.

2. Sample size used for the test set and the data provenance

This document describes physical device testing, not an AI/algorithm-based device with a "test set" in the computational sense.

Biocompatibility: Tests were conducted on device materials. The specific number of samples for each test (e.g., number of animals for in vivo tests, number of cell cultures) is not provided.
Bench-top Testing: Devices were assembled, packaged, and sterilized for mechanical testing. The specific number of devices tested for each parameter is not provided.
Animal Study: Animal studies were conducted. The specific number of animals used is not provided.
Data Provenance: The studies were conducted by Penumbra, Inc. (USA) and were part of their 510(k) submission to the FDA. They are considered prospective in the sense that they were designed and executed to fulfill regulatory requirements for the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the studies do not involve expert interpretation of data for AI ground truth. The "ground truth" for the device's performance is established by objective laboratory measurements and observations in animal models. For example:

Biocompatibility: Standardized laboratory tests (e.g., L929 MEM Elution Test, Kligman Maximization) with clear pass/fail criteria.
Animal Study: Observations by veterinary professionals and pathologists (e.g., "No abnormal gross or histology findings were noted") whose qualifications are implicit in their role in GLP-compliant studies but not explicitly detailed beyond their observational findings.

4. Adjudication method for the test set

Not applicable. There's no interpretive test set requiring adjudication in the context of an AI algorithm. The tests conducted are objective physical and biological assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, 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 instrument, not an AI system or an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical embolectomy system, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on:

Regulatory Standards: Compliance with EN ISO 10993 -1 guidelines for biocompatibility and EN ISO 10555-1 for intravascular catheters, as well as FDA guidance documents.
Objective Measurements: Results from standardized laboratory tests for physical properties (e.g., tensile strength, flow rate) and biological responses (e.g., cytotoxicity, hemolysis).
In Vivo Observations: Direct observations and histological analysis in animal models (e.g., absence of vessel injury, absence of abnormal gross or histology findings).

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, not an AI system. There is no concept of a "training set" in the context of this device's evaluation.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI algorithm, there is no corresponding ground truth establishment process in this context.

Summary

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9 510(K) SUMMARY

(as required by 21 CFR 807.92)

SEP
19 2012

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 Embolectomy Aspiration System.

Sponsor/Applicant Name and Address 9.1

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

9.2 Sponsor Contact Information

Michaela Mahl Regulatory Affairs Program Manager Phone: (510) 748-3288 FAX: (510) 217-6414 Email: michaela.mahl@penumbrainc.com

9.3 Date of Preparation of 510(k) Summary

September 14, 2012

9.4 Device Trade or Proprietary Name

Penumbra Embolectomy Aspiration System

તે તે રે Common/Usual Name

Penumbra Embolectomy Aspiration System

9.6 Device Classification

Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Embolectomy catheter Regulation Number: 21 CFR § 870.5150 Product Code: DXE

9.7 Predicate Devices

510(k) Number /Clearance Date	Name of Predicate Device	Name ofManufacturer
K100569 / 11Mar2011	Merit Embolectomy Catheter	Merit MedicalSystems, Inc.
K072718 / 28Dec2007	Penumbra System	Penumbra, Inc.
K090752 / 21Sep2009	Penumbra System 054	Penumbra, Inc.
K100769 / 21May2010	Penumbra System Separator Flex [026, 032,041, 054]	Penumbra, Inc.
K113163 / 23Nov2011	Penumbra System MAX	Penumbra, Inc.

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Device Description 9.8

و. و Intended Use

9.10 Summary of Non-Clinical Data

As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990. a summary of any information regarding safety and effectiveness of the device follows.

Included in this section are descriptions of the testing, which substantiates the safe and effective performance of the Penumbra Embolectomy Aspiration System as well as its substantial equivalence to the predicate devices:

. Biocompatibility / Pyrogenicity
. Design Verification (Bench-Top Testing)
. Animal Study

For the subject Penumbra Embolectomy Aspiration System all established requirements and acceptance criteria were met.

9.10.1 Biocompatibility Testing

Biocompatibility is established for the Penumbra Embolectomy Aspiration System devices based on tests selected in accordance with EN ISO 10993 -1 guidelines (Biological Evaluation of Medical Devices) for limited duration (<24 hours), external communicating devices, contacting circulating blood. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. In summary, non-clinical testing found the Penumbra Embolectomy Aspiration

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System devices to be biocompatible according to the requirements of EN ISO 10993 requirements. In summary the following tests were performed:

Test	Method	Result
Cytotoxicity	L929 MEM ElutionTest	Non-Toxic
Sensitization	Kligman Maximization	Non-Sensitizing
IntracutaneousReactivity (Irritation)	Intracutaneous InjectionTest	Non-Irritant
Systemic Toxicity(Acute)	ISO Acute SystemicInjection Test	Non-Toxic
Haemocompatibility	Complement Activation	No greater biologicalresponse thancorresponding control
	Hemolysis	Non-Hemolytic
	Coagulation - PT	No Statistical Differencefrom control
	Coagulation - PTT	No Statistical Differencefrom control
	In vivo thrombogenicity	Non-Thrombogenic
Pyrogenicity	USP Material MediatedRabbit Pyrogen Test	Non-Pyrogenic

9.10.2 Bench-top Testing

Testing was based on the design specifications, risk analysis and available guidance documents. These guidance documents include:

. Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (FDA - 1995)
EN ISO 10555-1:2009 Sterile, single-use intravascular catheters Part 1: . ● General Requirements

Devices used for mechanical testing were assembled and packaged in the controlled production environment and sterilized twice using an ethylene oxide sterilization cycle.

The physical and mechanical properties of the Penumbra Embolectomy Aspiration System devices were assessed using standard test methods and predetermined acceptance criteria. All established acceptance criteria were met. The following tests were performed:

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•	Visual & Dimensional
---	----------------------

Pouch Seal Strength .

Tensile Strength .
Bond Strenght .
. Hub Air Aspiration
. Burst Test
.
Friction Test .
Flow Rate Test .
Elongation Test .
Corrosion Test .
. Torsion Test
Simulated Use .
Particulate Test
Flexibility ●

The results of the tests appropriately address the physical and mechanical performance expectations of the device. This is further supported by the surgical handling and performance results reported in the in vivo study. Based on these overall results, the physical and mechanical properties of the Penumbra Embolectomy Aspiration System devices are acceptable for the intended use and substantially equivalent to the predicate devices.

9.10.3 Animal Study

Animal studies were conducted to evaluate the safe use of the Penumbra Embolectomy Aspiration System devices. The studies concluded that:

No vessel injury was noted on the final angiograms following the vessel ● response procedure.
No abnormal gross or histology findings were noted in test vessel segments. .
The use of the devices resulted in no significant vascular response in these . experimental conditions.

9.10.4 Summary of Substantial Equivalence

The Penumbra Embolectomy Aspiration System is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

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

SEP 19 2012

Penumbra, Inc. c/o Michaela Mahl Regulatory Affairs Program Manager 1351 Harbor Bay Parkway Alameda, CA 94502

Re: K121917

Trade/Device Name: Penumbra Embolectomy Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 29, 2012 Received: July 2, 2012

Dear Ms. Mahl:

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. However, we remind you 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

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Page 2 - Ms. Michaela Mahl

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 devicerelated 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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10 Statement of Indication for Use

Indications for Use

510(k) Number (if known): K121917

Device Name: _ Penumbra Embolectomy Aspiration System

Indications for Use:

The Penumbra Embolectorny Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.

AND/OR Over The Counter Use Prescription Use_ X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number KIZL 9/7

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).

Test Category	Specific Test / Parameter	Acceptance Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity	Non-Toxic	Non-Toxic
	Sensitization	Non-Sensitizing	Non-Sensitizing
	Intracutaneous Reactivity (Irritation)	Non-Irritant	Non-Irritant
	Systemic Toxicity (Acute)	Non-Toxic	Non-Toxic
	Haemocompatibility (Complement Act.)	No greater biological response than corresponding control	No greater biological response than corresponding control
	Haemocompatibility (Hemolysis)	Non-Hemolytic	Non-Hemolytic
	Haemocompatibility (Coagulation - PT)	No Statistical Difference from control	No Statistical Difference from control
	Haemocompatibility (Coagulation - PTT)	No Statistical Difference from control	No Statistical Difference from control
	Haemocompatibility (In vivo thrombog.)	Non-Thrombogenic	Non-Thrombogenic
	Pyrogenicity	Non-Pyrogenic	Non-Pyrogenic
Bench-top Testing	Visual & Dimensional	All established acceptance criteria were met (based on design specifications, risk analysis, and guidance docs).	All established acceptance criteria were met.
	Pouch Seal Strength	All established acceptance criteria were met	All established acceptance criteria were met.
	Tensile Strength	All established acceptance criteria were met	All established acceptance criteria were met.
	Bond Strength	All established acceptance criteria were met	All established acceptance criteria were met.
	Hub Air Aspiration	All established acceptance criteria were met	All established acceptance criteria were met.
	Burst Test	All established acceptance criteria were met	All established acceptance criteria were met.
	Friction Test	All established acceptance criteria were met	All established acceptance criteria were met.
	Flow Rate Test	All established acceptance criteria were met	All established acceptance criteria were met.
	Elongation Test	All established acceptance criteria were met	All established acceptance criteria were met.
	Corrosion Test	All established acceptance criteria were met	All established acceptance criteria were met.
	Torsion Test	All established acceptance criteria were met	All established acceptance criteria were met.
	Simulated Use	All established acceptance criteria were met	All established acceptance criteria were met.
	Particulate Test	All established acceptance criteria were met	All established acceptance criteria were met.
	Flexibility	All established acceptance criteria were met	All established acceptance criteria were met.
Animal Study	Vessel Injury (final angiograms)	No vessel injury	No vessel injury was noted.
	Gross/Histology Findings (test vessels)	No abnormal findings	No abnormal gross or histology findings were noted.
	Vascular Response	No significant vascular response	The use of the devices resulted in no significant vascular response.