Lantern Delivery Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.

Device Description

Lantern Delivery Microcatheter is a single lumen intravascular catheter designed to aid physician in accessing distal vasculature. When used in conjunction with a guide catheter and guide wire, Lantern provides access to the target site. Once in place it provides a reinforcing conduit for other intravascular devices.

AI/ML Overview

This document describes the Lantern™ Delivery Microcatheter and its substantial equivalence to a predicate device. The information provided focuses on the non-clinical data, specifically biocompatibility and bench-top testing, to demonstrate its safety and effectiveness.

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

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

Test	Acceptance Criteria	Reported Device Performance/Results
In vitro Cytotoxicity (MEM Elution)	Sample extracts must yield cell lysis grade $\le$ 2	Grade: 1 (slight) - Met
Sensitization (Magnusson-Kligman Method)	Test Group shall yield Grade < 1 score on Magnusson and Kligman scale (provided Control Grade < 1)	Non-sensitizing - Met
Irritation (Intracutaneous Reactivity)	The difference in the mean test article and mean control score must be grade 1.0 or lower	Non-irritant - Met
Systemic Toxicity (Acute) (Acute Systemic Injection)	Sample extracts must not cause significant biological reaction greater than control. That is: Death in 2 or more animals Toxic signs (i.e. convulsions, prostration) Weight loss > 10% in 3 or more animals	Non-toxic - Met
Material Mediated Rabbit Pyrogen	Sample extracts must not cause a total rise in body temperature of $\ge$ 0.5° C	Non-pyrogenic - Met
Hemolysis – Indirect Contact	Sample extracts must be nonhemolytic ($\le$ 2% hemolytic index)	Non-hemolytic - Met
Complement Activation	The concentrations of C3a and SC5b-9 in the test samples are statistically similar to the predicate control and statistically lower than the positive control for all exposure times	No greater biological response than corresponding control - Met
Thrombosis (Dog Thrombogenicity)	Device must be non-thrombogenic after 4 hours in vivo when compared to control device	Non-thrombogenic - Met
Bench-top Testing (various tests)	All predetermined requirements (specific criteria not detailed for each individual test in the document)	All established acceptance criteria were met. All testing met specification. - Met
Pyrogenicity (LAL validation)	< 2.15 EU/device	< 2.15 EU/device - Met

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

The document primarily references biocompatibility testing performed on the predicate device to substantiate the biocompatibility of the Lantern™ Delivery Microcatheter. For bench-top testing, devices "assembled and packaged in the controlled production environment and sterilized twice using an ethylene oxide sterilization cycle" were used.

Sample Size: Not explicitly stated for each test beyond "devices" or "three lots of the longest effective length modified predicate" for LAL validation.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted "pursuant to 21 CFR, Part 58, Good Laboratory Practices."

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)

This device is a physical invasive medical device (microcatheter) and the testing described is primarily non-clinical (biocompatibility and bench-top engineering tests). There is no indication that "experts" were used to establish ground truth in the context of interpreting medical images or clinical outcomes for a test set, as this is not a diagnostic AI device. The "ground truth" for these tests comes from established laboratory standards and measurement techniques.

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

Not applicable. This is not a study requiring reader adjudication for ground truth.

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 is not an AI/diagnostic device, and no MRMC comparative effectiveness study involving human readers or AI assistance is mentioned.

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

Not applicable. This is not an AI/diagnostic device.

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

The ground truth for the non-clinical tests (biocompatibility, bench-top mechanical testing, sterilization, shelf life) is based on:

Established scientific and regulatory standards: e.g., EN ISO 10993-1 guidelines for biocompatibility, 21 CFR, Part 58 Good Laboratory Practices, EN ISO 10555-1:2013 for intravascular catheters, EN ISO 11135-1:2014 for sterilization.
Direct measurements and observations: In-vitro and in-vivo test results against predefined thresholds.
Comparison to a predicate device: For many tests, the new device needed to perform equivalently or better than the predicate.

8. The sample size for the training set

Not applicable. There is no AI component or "training set" in the context of this device. The development of the device would involve engineering design and iterative testing, but not a "training set" in the machine learning sense.

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

Not applicable, as there is no training set mentioned for this device.

Summary

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

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" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other.

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

December 2, 2015

Penumbra, Inc. Mr. Charles DeNault Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502

Re: K152840

Trade/Device Name: Lantern™ Delivery Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 30, 2015 Received: November 2, 2015

Dear Mr. DeNault:

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.

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

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,

Carlos L. Pena -SD/Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K152840

Device Name Lantern™ Delivery Microcatheter

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)

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."

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

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 Lantern™ Delivery Microcatheter.

1.1 Sponsor/Applicant Name and Address

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

Sponsor Contact Information 1.2

Charles DeNault Regulatory Affairs Specialist III Phone: (510) 748-3302 Fax: (510) 217-6414 Email: cdenault@penumbrainc.com

1.3 Date of Preparation of 510(k) Summary

October 30, 2015

Device Trade or Proprietary Name 1.4

Lantern™ Delivery Microcatheter

Device Classification 1.5

Regulatory Class:	II
Classification Panel:	Cardiovascular
Classification Name:	Catheter, percutaneous
Regulation Number:	21 CFR 870.1250
Product Code:	DQY

1.6 Predicate Device

510(k) Number	Clearance Date	Name of Predicate Device	Name ofManufacturer
K100826	January 13, 2010	PX 400 Delivery Microcatheter	Penumbra, Inc.

1.7 Predicate Comparison

Attribute	Predicate Device	Subject Device
Device name	PX 400 Delivery Microcatheter	Lantern Delivery Microcatheter

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

Attribute	Predicate Device	Subject Device
Device name	PX 400 Delivery Microcatheter	Lantern Delivery Microcatheter
Classification	Class II, DQY	Same
Indications for Use	Intended to assist in the delivery ofdiagnostic agents, such as contrastmedia, and therapeutic devices, such asocclusion coils, to the peripheral andneuro vasculature.	Same
Shaft materials	Nylon, Polyether block amide	Same
Hub materials	Nylon	Same
ID Band	Polyolefin, PET	Same
Strain Relief	Stainless Steel	Same
Marker band materials	Pt/Ir	Same
Coating	Hydrophilic	Same
Effective length	150 cm	80, 110, 115, 130,135, 150, 160 cm
Proximal outer diameter	0.045 in. max	0.040 in. max
Distal outer diameter	0.040 in. max	0.037 in. max
Inner diameter	0.025 in. min	Same
Packaging materials	Polyethylene, PET, Polyester, Tyvek	Same
Packaging configuration	Individual catheter in tray, pouch, andbox	Individual catheter in tray, or hoopattached to packaging card, pouch, andbox
Sterilization	EO	Same
Shelf life	36 months	Same

1.8 Device Description

1.9 Indications for Use/Intended Use

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

1.10 Summary of Non-Clinical Data

Included in this section is a description of the testing, which substantiates the safe and effective performance of the Lantern Delivery Microcatheter as well as its substantial equivalence to the predicate device:

. Biocompatibility
Design Verification (Bench-Top Testing) .
Sterilization ●
. Shelf life

The subject Lantern Delivery Microcatheter met all predetermined requirements.

1.10.1 Biocompatibility Testing

Biocompatibility testing previously performed on the predicate device substantiates the biocompatibility of Lantern. 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 Laboratory Practices. The following tests were performed:

Test	Acceptance Criteria	Results
In vitro Cytotoxicity (MEMElution)	Sample extracts must yield cell lysisgrade $\le$ 2	Grade: 1 (slight)
Sensitization (Magnusson-Kligman Method)	Test Group shall yield Grade $<$ 1 scoreon Magnusson and Kligman scale(provided Control Grade $<$ 1)	Non-sensitizing
Irritation (IntracutaneousReactivity)	The difference in the mean test articleand mean control score must be grade1.0 or lower	Non-irritant
Systemic Toxicity (Acute)
Acute Systemic Injection	Sample extracts must not causesignificant biological reaction greaterthan control. That is:Death in 2 or more animals Toxic signs (i.e. convulsions,prostration) Weight loss > 10% in 3 or moreanimals	Non-toxic
Material Mediated RabbitPyrogen	Sample extracts must not cause a totalrise in body temperature of $\ge$ 0.5° C	Non-pyrogenic
Hemocompatibility
Hemolysis – Indirect Contact	Sample extracts must be nonhemolytic( $\le$ 2% hemolytic index)	Non-hemolytic
Complement Activation	The concentrations of C3a and SC5b-9in the test samples are statisticallysimilar to the predicate control andstatistically lower than the positivecontrol for all exposure times	No greater biologicalresponse than correspondingcontrol

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

Test	Acceptance Criteria	Results
Thrombosis (DogThrombogenicity)	Device must be non-thrombogenic after4 hours in vivo when compared tocontrol device	Non-thrombogenic

1.10.2 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 10555-1:2013,Sterile, single-use intravascular catheters – Part 1: General Requirements.

The physical and mechanical properties of Lantern Delivery Microcatheter were assessed using standard test methods and pre-determined acceptance criteria. Devices used for mechanical testing were assembled and packaged in the controlled production environment and sterilized twice using an ethylene oxide sterilization cycle. All established acceptance criteria were met. The following tests were performed:

Packaging inspection ●
Dimensional/visual inspection ●
Inspection of design features
Hub/ air aspiration ●
Steam shaping
Kink resistance ●
Simulated use ●
Torsion ●
Corrosion ●
Particulate ●
Friction ●
Static burst pressure ●
Tensile / elongation ●

All testing met specification. The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the Lantern Delivery Microcatheter are acceptable for the intended use and substantially equivalent to the predicate device.

1.11 Sterilization

The Lantern Delivery Microcatheter is sterilized using a validated EO sterilization process in accordance with EN ISO 11135-1:2014. Sterilization of Health Care Products – Ethvlene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. Sterilization validation is based on prior testing performed with the modified predicate device.

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

1.12 Pyrogenicity

The Lantern Delivery Microcatheter has established to be non-pyrogenic based on the prior material mediated rabbit pyrogen biocompatibility testing performed on the predicate, and LAL validation testing performed on the modified predicate. In the LAL validation, three lots of the longest effective length modified predicate were tested for inhibition via the kinetic turbidimetric test method. All three lots met the acceptance criteria of < 2.15 EU/ device. Therefore, production lots of both the predicate device and Lantern are routinely monitored to ensure < 2.15 EU/ device with existing LAL validation.

1.13 Shelf life

The Lantern Delivery Microcatheter has established a shelf life of 36 months based on prior testing performed with the modified predicate device.

1.14 Summary of Substantial Equivalence

The Lantern Delivery Microcatheter is substantially equivalent to the predicate devices 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).