The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Device Description

The Penumbra System ACE 64 and ACE 68 Reperfusion Catheters are components to the currently available Penumbra System. The Penumbra System ACE AC 64 and ACE 68 Reperfusion Catheters are used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

The provided text describes the Penumbra System ACE 64 and ACE 68 Reperfusion Catheters, which are medical devices intended for revascularization in patients with acute ischemic stroke. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device.

The document does not contain details about acceptance criteria, reported device performance in terms of clinical outcomes, sample sizes for test or training sets in the context of device performance metrics (like sensitivity/specificity), or the involvement of experts for ground truth establishment for such metrics.

Instead, the "study" described is primarily focused on safety verification through animal testing and a reliance on leveraging non-clinical data from the predicate device due to identical designs.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document describes acceptability in terms of meeting "established requirements" for the device, primarily related to safety in a vascular model. It does not provide quantitative performance metrics typical for diagnostic or AI-driven devices (e.g., sensitivity, specificity, accuracy).

Acceptance Criteria (Implicit)	Reported Device Performance
No significant vessel response on contrast angiograms	No significant vessel response was noted.
No significant pathological findings during gross/histological evaluation	No significant pathological findings were identified.
Meeting all established requirements (Design Validation)	The subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters met all established requirements.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample size: Not explicitly stated for any "test set" in terms of patient numbers or specific metrics. The study refers to an "accepted porcine vascular model," implying animal subjects. The number of animals used is not specified.
Data provenance: Porcine vascular model (animal study).
Retrospective/Prospective: The animal study described is prospective, as it involved evaluating the device in a controlled setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Number of experts: One expert is explicitly mentioned: "Sponsor Pathologist."
Qualifications: "Sponsor Pathologist." Further specific qualifications (e.g., years of experience, board certification) are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The evaluation was performed by a single "Sponsor Pathologist." There is no mention of a multi-reader adjudication process.

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 device (catheter) for mechanical thrombectomy, not an AI or diagnostic software. There is no mention of human readers, AI assistance, or MRMC studies.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the animal study (safety and vascular response) was established by:

Contrast angiography findings.
Gross necropsy and histopathology performed by the Sponsor Pathologist.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."

Summary of what the document does provide:

The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K142458). The key elements for this claim are:

Identical design, materials, manufacturing, packaging, and sterilization methods to the predicate.
Design validation through GLP Animal Testing to assess safety and performance in a "wedged" position using maximum aspiration. The animal study concluded no significant vessel response on angiography and no significant pathological findings.
Leveraging non-clinical data (biocompatibility, bench-top, sterilization, stability) from the predicate device because the new devices are identical.

The FDA 510(k) clearance process often relies heavily on demonstrating substantial equivalence to a predicate device, which can involve a combination of non-clinical testing and leveraging existing data, rather than requiring extensive new clinical trials or complex performance metrics for novel AI/diagnostic devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

January 13, 2016

Penumbra, Inc. Ms. Michaela Mahl, MSBE Senior Manager Regulatory Affairs One Penumbra Place Alameda, California 94502

Re: K152541

Trade/Device Name: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: December 11, 2015 Received: December 14, 2015

Dear Ms. Michaela 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. 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 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.

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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 yours,

Michael J. Hoffmann -A

for 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) K152541

Device Name

Penumbra System® ACE 64 and ACE 68 Reperfusion Catheters

Indications for Use (Describe)

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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1 510(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 Penumbra System ACE 64 and ACE 68 Reperfusion Catheters .

1.1 Sponsor/Applicant Name and Address

Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA

1.2 Sponsor Contact Information

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

Date of Preparation of 510(k) Summary 1.3

December 11, 2015

1.4 Device Trade or Proprietary Name

Penumbra System® ACE 64 and ACE 68 Reperfusion Catheters

Device Classification 1.5

Regulatory Class:	II
Classification Panel:	Neurology
Classification Name:	Percutaneous Catheter
Regulation Number:	21 CFR §870.1250
Product Code:	NRY (Catheter, Thrombus Removal)

1.6 Predicate Devices

510(k) Number / ClearanceDate	Name of Predicate Device	Name of Manufacturer
K142458 / 22May2015	Penumbra System® ACE 64 andACE 68 Reperfusion Catheters	Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA

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1.7 Predicate Comparison

System Name	PredicateReperfusion Catheters		SubjectReperfusion Catheters
	ACE 64	ACE 68	ACE 64	ACE 68
Device Name	ACE 64		ACE 68
510(k) No.	K142458		SAME
Classification	Class II, NRY		SAME
Indication	The Penumbra System is intended foruse in the revascularization of patientswith acute ischemic stroke secondaryto intracranial large vessel occlusivedisease (within the internal carotid,middle cerebral - M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset. The Reperfusion Catheters ACE64 and ACE 68 are intended for use inrevascularization within the InternalCarotid Artery (ICA) within 8 hours ofsymptom onset.		The Penumbra System is intended foruse in the revascularization of patientswith acute ischemic stroke secondaryto intracranial large vessel occlusivedisease (within the internal carotid,middle cerebral – M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset.
Materials
Proximal hub	Grilamid (TR55-LX)	SAME	SAME	SAME
Strain Relief [Hub Sleeve]	Grilamid (TR55)	SAME	SAME
Strain Relief	Stainless Steel, 304	SAME	SAME
ID Band	Polyolefin, PET yellow [black ink]	SAME	SAME
Catheter Shaft
Distal Extrusions	Pellethane 80A, Tecoflex 80A,Tecoflex 80A/Pebax 35D, Pebax 35D,Pebax 35D/40D Blend, Pebax 40D,Pebax 40D/55D Blend, Pebax 55D,Pebax 63D		SAME
Proximal Extrusions	Pebax 55D, Pebax72D, Vestamid	Pebax 55D/72DBlend, Pebax72D, Vestamid	SAME	SAME
Proximal CoilReinforcement	SS flat (0.0015 in x0.006 in) and SSround (0.0025 in)	SS flat (0.0015in x 0.006 in)and NiTi round(0.0025 in)	SAME	SAME
Extrusion Colorants	Clear/ Natural or Purple	SAME	SAME
Tip Shape	Straight		SAME
Markerband	C-cut Pt/Ir band		SAME
Coating	SRDX Harmony (proprietary)		SAME
Dimensions
Proximal OD	0.084 in Max	0.084 in Max	SAME	SAME
Proximal ID	0.068 in Min	0.068 in Min	SAME	SAME
Distal OD	0.080 in Max	0.084 in Max	SAME	SAME
Distal ID	0.064 in Min	0.068 in Min	SAME	SAME
Effective Length	115, 120, 125, 127, 132 cm		SAME
Coating Length	30 cm		SAME
Accessories
System Name	PredicateReperfusion Catheters		SubjectReperfusion Catheters
Device Name	ACE 64	ACE 68	ACE 64	ACE 68
Rotating Hemostasis Valve	Polycarbonate, silicone o-ring		SAME
Shaping Mandrel	0.038in OD		SAME
Packaging Materials
Pouch	Polyester/Polyethylene/Tyvek®		SAME
Packaging Hoop	Polyethylene		SAME
Packaging Card	Polyethylene		SAME
Display Carton	SBS Paperboard		SAME
Packaging Configuration	Individual		SAME
Sterilization	EO		SAME
Shelf-Life	36 Months		SAME

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Device Description 1.8

1.9 Indications for Use

1.10 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 substantial equivalence of the devices follows.

Included in this section is a summary description of the testing, which substantiates the performance of the subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters as well as its substantial equivalence to the predicate devices:

· Design Validation (GLP Animal Testing)
The subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters met all established requirements.

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1.10.1 Animal Study

The safety and performance of the ACE 64 and ACE 68 Reperfusion Catheters, when "wedged" in a vessel and using maximum aspiration, was evaluated in the accepted porcine vascular model. The purpose of this study was to evaluate the Reperfusion Catheter ACE aspiration vascular response when "wedged" within a swine artery. Safety of the test articles was assessed by consideration of the acute and chronic vascular response. Vascular response was assessed by contrast angiography and by gross necropsy and histopathology of associated vasculature performed by the Sponsor Pathologist.

The study concluded that:

. No significant vessel response was noted on the contrast angiograms following the aspiration treatment with the test article in a wedged position.
No significant pathological findings were identified during the gross or . histopathological evaluation.

1.10.2 Leveraged Non-Clinical Data

The subject and predicate devices are identical. There are no changes in the device design, materials, manufacturing, packaging and sterilization methods, therefore biocompatibility data, bench-top data, sterilization data and stability data from the predicate devices (K142458) are directly applicable and no additional testing is required or was performed.

1.11 Summary of Substantial Equivalence

The subject Penumbra System ACE 64 and ACE 68 Reperfusion Catheters are substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).