(64 days)
Not Found
No
The summary describes a physical medical device (microcatheter) used for delivery, with no mention of software, algorithms, or AI/ML capabilities.
No
The device, Lantern Delivery Microcatheter, is explicitly stated to assist in the delivery of diagnostic agents and therapeutic devices, not to be a therapeutic device itself. Its description defines it as an intravascular catheter providing access and a 'reinforcing conduit for other intravascular devices'.
No
The device is intended to assist in the delivery of diagnostic agents, not to diagnose. Its function is to provide access to the target site and act as a conduit for other devices.
No
The device description clearly states it is a "single lumen intravascular catheter," which is a physical hardware component.
Based on the provided information, the Lantern Delivery Microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the delivery of diagnostic agents and therapeutic devices within the peripheral and neuro vasculature. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically in a lab) diagnostic test.
- Device Description: The description clearly states it's an intravascular catheter designed for accessing distal vasculature and providing a conduit for other intravascular devices. This is a medical device used for intervention and delivery within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests outside of the body, which are hallmarks of IVD devices.
Therefore, the Lantern Delivery Microcatheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Summary of Non-Clinical Data:
- Biocompatibility: Tested in accordance with EN ISO 10993-1. Included In vitro Cytotoxicity (MEM Elution), Sensitization (Magnusson-Kligman Method), Irritation (Intracutaneous Reactivity), Systemic Toxicity (Acute Systemic Injection), Material Mediated Rabbit Pyrogen, Hemocompatibility (Hemolysis – Indirect Contact, Complement Activation), and Thrombosis (Dog Thrombogenicity). All tests met acceptance criteria.
- Design Verification (Bench-Top Testing): Based on design specifications, risk analysis, and guidance documents (Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (FDA - 1995), EN ISO 10555-1:2013). Tests performed included 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, and Tensile / elongation. All testing met specification, showing acceptable physical and mechanical properties.
- Sterilization: Validated EO sterilization process in accordance with EN ISO 11135-1:2014.
- Shelf Life: Established at 36 months based on prior testing with the modified predicate device.
- Pyrogenicity: Established as non-pyrogenic based on prior material mediated rabbit pyrogen biocompatibility testing on the predicate and LAL validation testing on the modified predicate, with production lots routinely monitored to ensure
§ 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).
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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" 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
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Indications for Use
510(k) Number (if known) K152840
Device Name Lantern™ Delivery Microcatheter
Indications for Use (Describe)
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.
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 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 of
Manufacturer |
|---------------|------------------|-------------------------------|-------------------------|
| 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 |
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| 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 of | |
| diagnostic agents, such as contrast | ||
| media, and therapeutic devices, such as | ||
| occlusion coils, to the peripheral and | ||
| neuro 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, and | |
| box | Individual catheter in tray, or hoop | |
| attached to packaging card, pouch, and | ||
| box | ||
| Sterilization | EO | Same |
| Shelf life | 36 months | Same |
1.8 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.
1.9 Indications for Use/Intended Use
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.
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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 (MEM | ||
| Elution) | Sample extracts must yield cell lysis | |
| grade $\le$ 2 | Grade: 1 (slight) | |
| Sensitization (Magnusson- | ||
| Kligman Method) | Test Group shall yield Grade $ 10% in 3 or more | |
| animals | Non-toxic | |
| Material Mediated Rabbit | ||
| Pyrogen | Sample extracts must not cause a total | |
| rise 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-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 |
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| Test | Acceptance Criteria | Results |
|---|---|---|
| Thrombosis (Dog | ||
| Thrombogenicity) | Device must be non-thrombogenic after | |
| 4 hours in vivo when compared to | ||
| control 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.
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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