(161 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the microspheres and their delivery system, with no mention of AI or ML.
Yes
The device, LifePearl Microspheres, is indicated for the embolization of hypervascular tumors and arteriovenous malformations, which are medical treatments designed to alleviate or cure a disease or condition.
No
This device, LifePearl Microspheres, is an embolic agent used for the treatment of hypervascular tumors and arteriovenous malformations (AVMs). It is a therapeutic device designed to block blood flow, not to diagnose a condition.
No
The device description clearly states that the device is a physical embolic agent consisting of biocompatible hydrogel microspheres, provided in a pre-filled syringe. This is a hardware device, not software.
Based on the provided information, the LIFEPEARL™ Microspheres are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). This is a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The device is a physical embolic agent delivered through a catheter. It is designed to physically block blood flow.
- Lack of In Vitro Testing: The description does not mention any testing of samples (like blood, tissue, or urine) outside the body to diagnose a condition or monitor a treatment.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The LIFEPEARL™ Microspheres are a therapeutic device used in vivo (within the body) to treat a condition.
N/A
Intended Use / Indications for Use
LIFEPEARL™ Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations (AVM's).
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical Testing:
- Mechanical: Tests include Compression, Robustness, Delivery force, Dimensional, Resilience, Time to suspension/time in suspension. Results: "Meets mechanical specifications".
- Chemical: Tests include Residual testing, pH test of solution, Syringe leachables testing. Results: "Meets chemical specification".
- Magnetic resonance compatibility: "Tested to be MR Safe". Result: "Pass".
- Catheter compatibility: "Microspheres can be delivered through a catheter of ID ≥ 0.017"". Result: "Pass".
- Compatibility with contrast agents (Omnipaque): "Microspheres are compatible with contrast agent per IFU". Result: "Pass".
- Shelf Life (product/packaging): "After aging conditioning, the microspheres/packaging meet specifications". Result: "Pass".
- Animal testing (swine): (7 day and 30 day) - device compared to predicate device. "To assess embolization effectiveness and histopathological evaluation (necrosis, inflammation, and off-target embolization)". Results: "Results were comparable to predicate device".
- Biocompatibility testing (ISO 10993-1): Includes Cytotoxicity (MEM elution assay, Agar diffusion assay), Sensitization/Irritation (Guinea pig maximization sensitization, Intracutaneous reactivity), Hemocompatibility (Hemolysis (Direct and Indirect), UPTT), Systemic toxicity (Systemic toxicity, Rabbit pyrogen test), Implantation (2 and 13wk implantation), Genotoxicity (Ames Test, Chromosomal aberration, Rodent Bone Marrow Micronucleus). "Subjected to full battery of biocompatibility testing". Results: "Met all biocompatibility criteria".
- Packaging validation: "Subjected to ISTA conditions – Packaging tested for adequacy." Result: "Pass".
- Sterilization validation: "Meets criteria for ISO 17665-1". Result: "Pass".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
510(k) Summary - K150958
| Trade Name: | LifePearl™ Microspheres |
|---|---|
| Generic Name: | Vascular embolization device |
| Classification: | Class II, 21 CFR 870.3300 (KRD) |
| Submitted By: | MicroVention, Inc |
| 1311 Valencia Avenue | |
| Tustin, 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 Block | |
| Microspheres | December 24, 2008 |
Device Description:
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.
Indications For Use:
The LifePearl Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors.
4
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 mechanical | |
| specifications | ||
| Chemical | ||
| • Residual testing | ||
| • pH test of solution | ||
| • Syringe leachables testing | 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 (Omnipaque) | Microspheres are compatible with | |
| contrast agent per IFU | Pass | |
| Shelf Life (product/packaging) | After aging conditioning, the | |
| microspheres/packaging meet | ||
| specifications | Pass | |
| Animal testing (swine) - device compared to predicate | ||
| device (7 day and 30 day) | To assess embolization effectiveness | |
| and histopathological evaluation | ||
| (necrosis, inflammation, and off- | ||
| target embolization) | Results were | |
| comparable to | ||
| predicate 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 of | |
| biocompatibility testing | Met all | |
| biocompatibility | ||
| criteria | ||
| 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 UK
LC Bead/Bead Block
(K083091) | LifePearl Microspheres |
|--------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------|
| Indications for Use | Intended for embolization of arteriovenous
malformations and hypervascular tumors. | Same |
| Microsphere material | Macromer derived from polyvinyl alcohol
(PVA) | Copolymer of Polyethylene glycol
diacrylamide |
| Microsphere diameter | 100-1200 μm | 100-400 μm |
| Microsphere container | LC Beads: packaged in sealed glass vial
Bead Block: packaged in polycarbonate syringe | Same as Bead Block |
| Microsphere volume per syringe | 1.0 or 2.0 mL
Storage media: phosphate buffered saline | 2.0 mL
Storage media: phosphate buffered saline |
| Delivery method | Delivered to treatment site by catheter under
fluoroscopic 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.