The Ruby XL System is comprised of a platinum embolization coil attached to a composite delivery pusher, and the Penumbra Detachment Handle. The coil/delivery pusher is packaged separately from the Penumbra Detachment Handle.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the Ruby XL System, a vascular embolization device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on a clinical or performance study in the way an AI/ML device would.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size, data provenance, expert ground truth, MRMC study, standalone performance) is not applicable to this document.

This submission focuses on bench-top performance testing, biocompatibility, and shelf-life, establishing substantial equivalence based on the device's physical characteristics, materials, and mechanical performance compared to a predicate embolization coil system. No AI/ML components are mentioned or evaluated in this regulatory filing.

Here's a breakdown of what is provided and why the AI/ML-specific questions are not applicable:

1. A table of acceptance criteria and the reported device performance

This document does not present acceptance criteria in the typical sense of numerical thresholds for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various bench-top performance tests (Dimensional/Visual, Packaging, Radiopacity, Friction, Fatigue Resistance, Torsional Resistance, Stiffness, Simulated Use, Corrosion, Tensile, MRI Compatibility) and states that these tests were "used in support of the subject device to determine substantial equivalence."
No specific reported numerical performance values are given for these tests beyond the general statement that they substantiate the device's performance.

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

Not applicable as no AI/ML test set was used. The "test set" here would refer to the physical devices undergoing bench-top testing. Data provenance is not relevant for physical device testing in this context.

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)

Not applicable. Ground truth, in the AI/ML context, refers to expert labeling or an objective standard against which an algorithm's output is compared. For this device, "ground truth" would be the established physical and mechanical properties and material standards. No human experts are described as defining a "ground truth" for a test set of images or data to evaluate an algorithm.

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

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/ML ground truth, which is not part of this submission.

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

No. This is a physical medical device (embolization coil system), not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant.

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

No. This is a physical medical device.

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

Not applicable for an AI/ML context. The "ground truth" for this device's performance is established engineering and material science standards and physical measurements.

8. The sample size for the training set

Not applicable as no AI/ML algorithm was trained.

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

Not applicable as no AI/ML algorithm was trained.

Summary based on the provided document:

The Ruby XL System is a medical device (vascular embolization device), not a software/AI/ML product. The 510(k) submission demonstrates substantial equivalence to a predicate device (Penumbra Coil System and POD System) based on:

Indications for Use: The subject device is indicated for arterial and venous embolizations in the peripheral vasculature, which is a subset of the predicate's indications.
Design and Materials: The document states "SAME" for various material and construction attributes, coil dimensions, detachment mechanism, sterilization method, and method of supply, indicating identical or highly similar characteristics to the predicate.
Non-Clinical Safety and Performance Data: Bench-top testing (e.g., Dimensional, Packaging, Radiopacity, Friction, Fatigue, Stiffness, Simulated Use, Corrosion, Tensile, MRI Compatibility) and Biocompatibility testing were performed. These tests are the "study" that substantiates the device's performance and safety, leading to the determination of substantial equivalence. The document explicitly states "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."

Therefore, the requested AI/ML specific criteria and study details are not relevant to this 510(k) submission for a physical medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 14, 2025

Penumbra, Inc. Samyukta Rangachari Regulatory Affairs Specialist One Penumbra Place Alameda, California 94502

Re: K250079

Trade/Device Name: Ruby XL System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: January 10, 2025 Received: January 13, 2025

Dear Samyukta Rangachari:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new

{1}------------------------------------------------

premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

{2}------------------------------------------------

803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Finn E. Finn E. Donaldson -S Donaldson -S Pate: 2025.03.14 09:04:35 -04'00'

Finn Donaldson Acting Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K250079

Device Name Ruby XL System

Indications for Use (Describe)

The Ruby XL System is indicated for arterial and venous embolizations in the peripheral vasculature.

Type of Use (Select one or both, as applicable)

X 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."

{4}------------------------------------------------

510(k) Summary

1. Submitter

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

Contact Person: Samyukta Rangachari Regulatory Affairs Specialist III Phone: (763) 742-9306 Email: srangachari@penumbrainc.com

Date of Preparation: January 10, 2025

2. Subject Device

Ruby XL System

Regulatory Class: ll Classification Panel: Cardiovascular Classification Name: Vascular embolization device Regulation Number: 21 CFR §870.3300 Product Code: KRD

3. Predicate/Reference Devices

510(k) Number	Name of Device
Predicate
K173614	Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System) and POD System

{5}------------------------------------------------

4. Predicate Comparison

Table 1: Predicate Comparison

Attributes	Predicate Device	Subject Device
General
Trade Name	Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System);POD System	Ruby XL System
510(k) No.	K173614	K250079
Indications for use	Indicated for the embolization of:• Intracranial aneurysms• Other neurovascular abnormalities such as arteriovenousmalformations and arteriovenous fistulae• Arterial and venous embolizations in the peripheral vasculature	Indicated for arterial andvenous embolizations in theperipheral vasculature.
Classification	Class II, HCG & KRD	Class II, KRD
Materials/Construction
Coil Implant	Platinum/Tungsten, Adhesive, Titanium, Polymer	SAME
Introducer Sheath	Polymer	SAME
Dimensions/Shape
Coil Secondary Shape	Complex, Finish	SAME
Coil Length	Appropriately Sized For Target Vasculature	SAME
Coil Primary Diameter
Coil Secondary Diameter
Detachment Pusher Length
Detachment Mechanism	Mechanical	SAME
Other
Sterilization Method, SAL	Ethylene Oxide, >10-6	SAME
Method of Supply	Sterile, single use only	SAME
Device Packaging Materials andDimensions	As specified in K173614	SAME

{6}------------------------------------------------

5. Device Description

6. Indications for Use

The Ruby XL System is indicated for arterial and venous embolizations in the peripheral vasculature.

7. Summary of Non-Clinical Data/Performance Data

Included in this section are summary descriptions of the testing which substantiates the performance of the subject Ruby XL System.

7.1 Summary of Performance Testing – (Bench-Top) Testing

The following bench-top performance (design verification) tests were used in support of the subject device to determine substantial equivalence:

Dimensional/Visual
Packaging Inspection, Leak and Seal Strength Testing
Radiopacity Testing
Friction Testing
Fatigue Resistance Testing ●
Torsional Resistance Testing
Stiffness Testing
Simulated Use and Compatibility Testing
Corrosion Testing
Tensile Testing
MRI Compatibility Testing

7.2 Summary of Biocompatibility

Biocompatibility was evaluated for the subject device in accordance with ISO 10993-1 and the FDA Guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

The following endpoints were evaluated in support of the subject device to determine substantial equivalence:

{7}------------------------------------------------

Cytotoxicity Testing ●
. Sensitization Testing
Irritation Testing
Systemic Toxicity: Acute Systemic Injection Testing & Material Mediated Pyrogenicity ● Testing
Subacute/Subchronic Toxicity Testing ●
. Genotoxicity Testing
Implantation Testing ●
Hemocompatibility Testing ●
Chronic Toxicity Testing ●
Carcinogenicity Assessment

7.3 Summary of Shelf-Life

The shelf-life of the subject device is established for 12 months based on accelerated aging data.

8. Summary of Performance Data – Animal, Clinical

No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.

9. Summary of Substantial Equivalence

The subject Ruby XL System is substantially equivalent to the predicate device with regards to intended use, operating principle, design concept, fundamental technology, and device performance.

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).