The LifePearl Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The LifePearl Microspheres are offered in a variety of diameters ranging from 100-400 um and are provided in a polycarbonate syringe pre-filled with microspheres in phosphate buffered saline. The microspheres are dyed green to aid in visualization in the delivery syringe. The pre-filled syringe is packaged for single use and sterile in a sealed dispenser tray. The LifePearl Microspheres are delivered to the treatment site through a delivery catheter of internal diameter of ≥ 0.017 inch. At time of use, LifePearl is mixed with non-ionic contrast agent for visualization under fluoroscopy.

AI/ML Overview

The provided document is a 510(k) summary for the LifePearl Microspheres, describing its design, indications for use, and pre-clinical testing for substantial equivalence to a predicate device. It is not a study report for an AI/ML device, and therefore the requested information regarding AI device acceptance criteria, performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

The document focuses on the device itself (LifePearl Microspheres, a physical vascular embolization device), and not on a digital health or AI/ML product. As such, the concept of "acceptance criteria" is tied to the physical and biological performance of the microspheres, and the "study" refers to various pre-clinical tests demonstrating these performances.

Here's a breakdown of the information that can be extracted, organized as requested, with explicit notes for what is not applicable to this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For a physical medical device like LifePearl Microspheres, "acceptance criteria" are typically defined by engineering specifications, material standards, and biological compatibility requirements. The "reported device performance" reflects whether these criteria were met during testing.

Acceptance Criteria Category/Test	Specific Acceptance Criteria (Inferred from "Description")	Reported Device Performance ("Result")
Mechanical Testing	Microspheres are capable of: • Temporary deformation with smooth passage through catheter• Syringe to syringe transfer• Delivery through catheter within force specification• Maintains diameter (after compression, implied)• Suspension (for reference, criteria not explicitly stated)• Meets criteria for residuals (mechanical residuals, e.g., particulate matter, implied)	Meets mechanical specifications
Chemical Testing	Microspheres/solution:• Meets criteria for residuals (chemical residuals)• Maintains pH• Syringe does not leach into microsphere/PBS	Meets chemical specification
Magnetic Resonance Compatibility	Tested to be MR Safe	Pass
Catheter Compatibility	Microspheres can be delivered through a catheter of ID ≥ 0.017"	Pass
Compatibility with Contrast Agents	Microspheres are compatible with contrast agent per IFU	Pass
Shelf Life (product/packaging)	After aging conditioning, the microspheres/packaging meet specifications (specifics of specifications not detailed, but imply maintenance of performance and integrity)	Pass
Animal Testing (Swine)	To assess embolization effectiveness and histopathological evaluation (necrosis, inflammation, and off-target embolization) with results comparable to predicate device.	Results were comparable to predicate device (for embolization effectiveness, necrosis, inflammation, and off-target embolization over 7 and 30 days)
Biocompatibility Testing	Subjected to full battery of biocompatibility testing per ISO 10993-1, -3, -4, -5, -6, -10, -11 criteria (e.g., passing MEM elution assay for cytotoxicity, absence of sensitization/irritation, acceptable hemolysis, systemic toxicity, pyrogenicity, acceptable implantation response, and genotoxicity tests like Ames and chromosomal aberration).	Met all biocompatibility criteria
Packaging Validation	Packaging tested for adequacy under ISTA conditions.	Pass
Sterilization Validation	Meets criteria for ISO 17665-1 (for moist heat sterilization).	Pass

Regarding the specific questions about AI/ML device studies:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable (N/A). This document describes a physical medical device, not an AI/ML device. The "test set" here refers to physical samples of the microspheres and animal subjects for preclinical evaluation.
- For animal testing, swine were used, but the exact number of animals is not specified, nor is their "country of origin" in the context of data provenance. The study was prospective in the sense of being planned preclinical testing.
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):
- N/A. Ground truth as defined for AI/ML performance against human expert labels is not relevant here. For animal studies, histopathological evaluations would typically be performed by veterinary pathologists, but the number and qualifications of such experts are not stated in this summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically for resolving discrepancies in human expert labeling in AI/ML performance studies. This is a preclinical evaluation of a physical device.
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:
- N/A. This refers to studies evaluating AI assistance for human interpretation (e.g., reading medical images). This document is about a physical embolization device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This question pertains to the performance of an AI algorithm in isolation. The document describes a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal testing, histopathology (assessment of necrosis, inflammation, off-target embolization) and potentially imaging confirmation (effectiveness of embolization) served as the basis for evaluating device performance. Other tests rely on physical property measurements (e.g., dimensions, force), chemical analyses (e.g., pH, residuals), and standardized biological assays (e.g., cytotoxicity, hemocompatibility).
The sample size for the training set:
- N/A. This concept applies to AI/ML models. For a physical device, there isn't a "training set" in the same sense. There would be a product development and testing phase where designs are refined based on iterative testing, but not a dataset for training an algorithm.
How the ground truth for the training set was established:
- N/A. As there is no AI/ML training set, this question is not applicable.

Summary

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

September 17, 2015

MicroVention, Inc. Ms. Naomi Gong, RAC Senior Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA, 92780

Re: K150958

Trade/Device Name: LifePearl Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: July 31, 2015 Received: August 03, 2015

Dear Ms. Naomi Gong:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (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 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.

M.A. Hillebrand

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

Enclosure

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Indications for Use

510(k) Number (if known) K150958

Device Name LifePearl Microspheres

Indications for Use (Describe) LIFEPEARL™ Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations (AVM's).

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)

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510(k) Summary - K150958

Trade Name:	LifePearl™ Microspheres
Generic Name:	Vascular embolization device
Classification:	Class II, 21 CFR 870.3300 (KRD)
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, California U.S.A.714-247-8000
Contact:	Naomi Gong
Date:	April 8, 2015

Predicate Devices:

Number	Description	Clearance Date
K083091	Biocompatibles U.K. LC Bead/Bead BlockMicrospheres	December 24, 2008

Device Description:

Indications For Use:

The LifePearl Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors.

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Verification and Test Summary:

Pre-clinical Testing	Description	Result
Mechanical• Compression• Robustness• Delivery force• Dimensional• Resilience• Time to suspension/time in suspension	Microspheres are capable of:• Temporary deformation with smooth passage through catheter• Syringe to syringe transfer• Delivery through catheter within force specification• Maintains diameter• Suspension (for reference)• Meets criteria for residuals• Maintains pH• Syringe does not leach into microsphere/PBS	Meets mechanicalspecifications
Chemical• Residual testing• pH test of solution• Syringe leachables testing		Meets chemicalspecification
Magnetic resonance compatibility	Tested to be MR Safe	Pass
Catheter compatibility	Microspheres can be deliveredthrough a catheter of ID ≥ $0.017$ "	Pass
Compatibility with contrast agents (Omnipaque)	Microspheres are compatible withcontrast agent per IFU	Pass
Shelf Life (product/packaging)	After aging conditioning, themicrospheres/packaging meetspecifications	Pass
Animal testing (swine) - device compared to predicatedevice (7 day and 30 day)	To assess embolization effectivenessand histopathological evaluation(necrosis, inflammation, and off-target embolization)	Results werecomparable topredicate device
Bicompatibility testing (ISO 10993-1)• Cytotoxicity (ISO 10993-5)➤ MEM elution assay➤ Agar diffusion assay• Sensitization/Irritation (ISO 10993-10)➤ Guinea pig maximization sensitization➤ Intracutaneous reactivity• Hemocompatibility (ISO 10993-4)➤ Hemolysis (Direct and Indirect)➤ UPTT• Systemic toxicity (ISO 10993-11)➤ Systemic toxicity➤ Rabbit pyrogen test• Implantation (ISO 10993-6)➤ 2 and 13wk implantation• Genotoxicity (ISO 10993-3)➤ Ames Test➤ Chromosomal aberration➤ Rodent Bone Marrow Micronucleus	Subjected to full battery ofbiocompatibility testing	Met allbiocompatibilitycriteria
Packaging validation	Subjected to ISTA conditions –Packaging tested for adequacy.	Pass
Sterilization validation	Meets criteria for ISO 17665-1	Pass

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Technological Comparison:

	Biocompatibles UKLC Bead/Bead Block(K083091)	LifePearl Microspheres
Indications for Use	Intended for embolization of arteriovenousmalformations and hypervascular tumors.	Same
Microsphere material	Macromer derived from polyvinyl alcohol(PVA)	Copolymer of Polyethylene glycoldiacrylamide
Microsphere diameter	100-1200 μm	100-400 μm
Microsphere container	LC Beads: packaged in sealed glass vialBead Block: packaged in polycarbonate syringe	Same as Bead Block
Microsphere volume per syringe	1.0 or 2.0 mLStorage media: phosphate buffered saline	2.0 mLStorage media: phosphate buffered saline
Delivery method	Delivered to treatment site by catheter underfluoroscopic visualization	Same
Radiopacity method	Mixed with contrast media prior to injection	Same
Method of supply	Sterile and single use	Same
Sterilization Method	Steam	Same

Summary of Applicable Standards:

FDA Guidance on Vascular and Neurovascular Embolization Devices (2004) ISO 17665-1, Sterilization of healthcare products (Medical Device) - Moist Heat ISO 10993-1, Biological evaluation of medical devices

Summary of Substantial Equivalence:

The data presented in this submission demonstrates the technological similarity and equivalency of the LifePearl Microspheres when compared with the predicate device, Biocompatibles LC Bead/Bead Block Microspheres.

The devices,

Have the same intended use,
I Use the same operating principle,
l Incorporate similar basic design and construction,
트 Are sterilized using same methods and processes.

In summary, the LifePearl Microspheres described in this substantially equivalent to the predicate device.

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).