(262 days)
No
The summary describes a mechanical thrombectomy device and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the revascularization of patients with acute ischemic stroke, which is a therapeutic intervention.
No
The document states that the device is "intended for use in the revascularization of patients," which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the Penumbra System ACE components are physical devices (catheters) intended for use in revascularization, provided sterile, non-pyrogenic, and intended for single use. This indicates a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Penumbra System is for the "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease." This describes a therapeutic intervention performed in vivo (within the body) to restore blood flow.
- Device Description: The device description details components that "provide a larger lumen to assist in the removal of thrombus from the neurovasculature." This further reinforces its role as a device used directly within the patient's circulatory system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens outside the body.
Therefore, the Penumbra System, as described, is a medical device used for a therapeutic procedure within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.
Product codes (comma separated list FDA assigned to the subject device)
NRY
Device Description
The Penumbra System ACE components are additional components to the currently available Penumbra System / Penumbra System MAX. The Penumbra System ACE components provide a larger lumen to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries). Internal Carotid Artery (ICA).
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)
Biocompatibility Testing: Biocompatibility tests were conducted on the materials of the Penumbra System ACE devices in accordance with EN ISO 10993 - 1 guidelines (Biological Evaluation of Medical Devices) for limited duration (
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, with flowing lines beneath them, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2015
Penumbra, Inc. Ms. Michaela Mahl Senior Manager Regulatory Affairs 1351 Harbor Bav Parkway Alameda, California 94502
Re: K142458
Trade/Device Name: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 10, 2015 Received: April 13, 2015
Dear Ms. Michaela Mahl,
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
1
the quality systems (OS) 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" (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 -S
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) K142458
Device Name
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
Indications for Use (Describe)
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.
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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3
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 Penumbra System ACE 64 and ACE 68 Reperfusion Catheters.
1 Sponsor/Applicant Name and Address
Penumbra. Inc. 1351 Harbor Bay Parkway Alameda, CA 94502 USA
2 Sponsor Contact Information
Michaela Mahl Senior Manager, Regulatory Affairs Phone: (510) 748-3288 FAX: (510) 217-6414 Email: michaela.mahl@penumbrainc.com
3 Date of Preparation of 510(k) Summarv
May 07, 2015
4 Device Trade or Proprietary Name
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
5 Device Classification
Regulatory Class: II Classification Panel: Neurology Percutaneous Catheter Classification Name: Regulation Number: 21 CFR §870.1250 Product Code: NRY (Catheter, Thrombus Removal)
6 Predicate Devices
| 510(k) Number / Clearance
| Date | Name of Predicate Device | Name of Manufacturer |
|---|---|---|
| K072718 [28Dec2007], | ||
| K090752 [21Sep2009], | ||
| K100769 [21May2010], | ||
| K113163 [28NOV2011], | ||
| K133317 [13MAY2014] | Penumbra System / ® | |
| Penumbra System MAX | Penumbra, Inc. | |
| 1351 Harbor Bay Parkway | ||
| Alameda, CA 94502 USA |
4
7 Predicate Comparison
| System Name | Penumbra System
Reperfusion Catheter | | Penumbra System ACE
Reperfusion Catheter |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Device Name | 5MAX ACE | ACE 64 | ACE 68 |
| 510(k) No. | K090752 | K142458 | SAME |
| Classification | Class II, NRY | SAME | |
| Indication | The Penumbra System is
intended for use in the
revascularization of patients
with acute ischemic stroke
secondary to intracranial large
vessel occlusive disease (within
the internal carotid, middle
cerebral - M1 and M2
segments, basilar, and vertebral
arteries) within 8 hours of
symptom onset. | The Penumbra System is intended for
use in the revascularization of patients
with acute ischemic stroke secondary
to intracranial large vessel occlusive
disease (within the internal carotid,
middle cerebral – M1 and M2
segments, basilar, and vertebral
arteries) within 8 hours of symptom
onset. The Reperfusion Catheters ACE
64 and ACE 68 are intended for use in
revascularization within the Internal
Carotid Artery (ICA) within 8 hours of
symptom onset. | |
| Materials | | | |
| Proximal hub | Grilamid (TR55-LX) | SAME | |
| Strain Relief [Hub Sleeve] | Grilamid (TR55) | SAME | |
| Strain Relief | Stainless Steel, 304 | SAME | |
| ID Band | Polyolefin, PET yellow [black
ink] | SAME | |
| Catheter Shaft | | | |
| Distal Extrusions | Tecoflex 80A, Pellethane 80A,
Pebas 35D, Pebax 35D/40D
Blend, Pebax 40D, Pebax 55D,
Pebax 63D | Pellethane 80A, Tecoflex 80A,
Tecoflex 80A/Pebax 35D, Pebax 35D,
Pebax 35D/40D Blend, Pebax 40D,
Pebax 40D/55D Blend, Pebax 55D,
Pebax 63D | |
| Proximal Extrusions | Pebax 55D, Pebax 72D,
Vestamid | Pebax 55D, Pebax
72D, Vestamid | Pebax 55D/72D
Blend, Pebax
72D, Vestamid |
| Proximal Coil
Reinformcement | SS flat (0.002 in x 0.007 in) | SS flat (0.0015 in x
0.006 in) and SS
round (0.0025 in) | SS flat (0.0015
in x 0.006 in)
and NiTi round
(0.0025 in) |
| Extrusion Colorants | Clear/ Natural or Purple | SAME | |
| Tip Shape | Straight | SAME | |
| Markerband | C-cut Pt/Ir band | SAME | |
| Coating | SRDX Harmony (proprietary) | SAME | |
| Dimensions | | | |
| Proximal OD | 0.083 in Max | 0.084 in Max | 0.084 in Max |
| Proximal ID | 0.068 in Min | 0.068 in Min | 0.068 in Min |
| Distal OD | 0.074 in Max | 0.080 in Max | 0.084 in Max |
| System Name | Penumbra System
Reperfusion Catheter | Penumbra System ACE
Reperfusion Catheter | |
| Device Name | 5MAX ACE | ACE 64 | ACE 68 |
| Distal ID | 0.060 in Min | 0.064 in Min | 0.068 in Min |
| Effective Length | 125, 127, 132 cm | 115, 120, 125, 127, 132 cm | |
| Coating Length | 30 cm | SAME | |
| Accessories | | | |
| Peelable Sheath | PTFE | SAME | |
| Rotating Hemostasis Valve | Polycarbonate, silicone o-ring | SAME | |
| Shaping Mandrel | 0.038in OD | SAME | |
| Packaging Materials | | | |
| Pouch | Polyester/Polyethylene/
Tyvek® | SAME | |
| Packaging Hoop | Polyethylene | SAME | |
| Packaging Card | Polyethylene | SAME | |
| Display Carton | SBS Paperboard | SAME | |
| Packaging Configuration | Individual | SAME | |
| Sterilization | EO | SAME | |
| Shelf-Life | 36 Months | SAME | |
5
Device Description 8
The Penumbra System ACE components are additional components to the currently available Penumbra System / Penumbra System MAX. The Penumbra System ACE components provide a larger lumen to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
9 Indications for Use
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.
6
10 Summary of Non-Clinical Data
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding substantial equivalence of the device follows.
Included in this section are summary descriptions of the testing, which substantiates the performance of the subject Penumbra System ACE 64 and ACE 68 as well as its substantial equivalence to the predicate devices:
- . Biocompatibility
- Design Verification (Bench-Top Testing) •
- Design Validation (GLP Animal Testing) .
The subject Penumbra System ACE 64 and ACE 68 devices met all established requirements.
10.1 Biocompatibility Testing
Biocompatibility tests conducted on the materials of the Penumbra System ACE devices were selected in accordance with EN ISO 10993 - 1 guidelines (Biological Evaluation of Medical Devices) for limited duration (In Vitro Cytotoxicity | Sample extracts must yield cell
lysis grade 2 or lower | Grade 1: Slight | Pass |
| Sensitization | Test Group shall yield Grade 10% weight loss in 3 or
more test animals
• Mortality of 2 or more test
animals
• Abnormal behavior in 2 or
more test animals | No evidence of systemic
toxicity from sample
extracts
• No weight loss (all gained
weight)
• No death
• All test animals appeared
normal | Pass |
7
| Test | Acceptance Criteria | Results | Pass / Fail |
|---|---|---|---|
| Rabbit Pyrogen Study | Sample Extracts must not | ||
| cause a total rise in body | |||
| temperature of $≥0.5°C$ | Non-pyrogenic: No | ||
| evidence of material- | |||
| mediated pyrogenicity; no | |||
| single animal had a total | |||
| body temperature rise of | |||
| $≥0.5°C$ | Pass | ||
| Hemocompatibility | |||
| In Vitro Hemolysis | Sample extracts must be non- | ||
| hemolytic ( $≤$ 2% hemolytic | |||
| index) | Non-hemolytic: | ||
| Hemolytic Index = 0.70% | |||
| Corrected Hemolytic index | |||
| = 0.00% | Pass | ||
| Complement Activation | The concentrations of C3a and | ||
| SC5b-9 in the test samples are | |||
| statistically similar to the | |||
| predicate (Exposure Control & | |||
| Ref Material) control and | |||
| statistically lower than the | |||
| positive control for all | |||
| exposure times | The test sample | ||
| concentrations of C3a and | |||
| SC5b-9 were statistically | |||
| similar or lower than the | |||
| predicate control sample | |||
| concentrations, and | |||
| statistically lower than the | |||
| positive control sample | |||
| concentrations at all three | |||
| exposure times | Pass | ||
| Dog Thrombogenicity | The device must be non- | ||
| thrombogenic after 4 hours in | |||
| vivo when compared to a | |||
| control device (Boston | |||
| Scientific Excelsior SL-10 | |||
| microcatheter) | No significant thrombosis | ||
| with a Grade of 0 was | |||
| observed in 2 out 2 test site | |||
| and 2 out of 2 control sites. | |||
| Based on the evaluation | |||
| criteria, the amount of | |||
| thrombosis was not | |||
| considered significant | Pass |
In summary non-clinical testing substantiates that the Penumbra System ACE devices are non-cytotoxic, non-sensitizing, non-irritating, non-toxic, nonpyrogenic, non-hemolytic, and non-thrombogenic.
10.2 Bench-top Testing
The physical and mechanical properties of the Penumbra System ACE devices were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
| Attribute | Specification | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensional/ | |||
| Visual Inspection | These evaluations confirm that the units used in this | ||
| Design Verification testing meet all inspection | |||
| criteria for release of finished goods (clinically | |||
| acceptable) product. | Pass | ||
| Attribute | Specification | Acceptance | |
| Criteria | Results | ||
| Simulated Use | |||
| (Intracranial | |||
| Access, Vessel | |||
| Access Entry | |||
| Performance & | |||
| Clot Removal) | Simulated use testing of the Reperfusion Catheter | ||
| and Separator was performed with accessory | |||
| devices in an anatomical model which simulated the | |||
| tortuosity of the neurovasculature. Devices were | |||
| delivered through the tortuous anatomical model to | |||
| evaluate the effectiveness of the devices to remove | |||
| clots and that the Reperfusion Catheter does not | |||
| collapse under vacuum. | 100% Pass | ||
| Torsion | |||
| (Reperfusion | |||
| Catheter) | Number of turns will be | ||
| recorded | Data was recorded for informational | ||
| purposes only | |||
| Injection Flow | |||
| Rate | Injection flow rate will be | ||
| recorded for various pressure | |||
| settings | Data was recorded for informational | ||
| purposes only | |||
| Flow Rate | Flow rate (cc/min) with and | ||
| without Separator in test article | |||
| lumen will be reported | Data was recorded for informational | ||
| purposes only | |||
| Reperfusion | |||
| Catheter Tip | |||
| Pressure | Aspiration (Suction) Pressure | ||
| and Pump MAX vacuum | |||
| pressure will be reported | Data was recorded for informational | ||
| purposes only | |||
| Coating Integrity | Coating has not delaminated. | ||
| peeled, or flaked after simulated | |||
| use | 100% Must | ||
| meet | |||
| Specification | 100% Pass | ||
| Particulate | |||
| Testing | |||
| (Reperfusion | |||
| Catheter | |||
| Hydrophilic | |||
| Coating) | The maximum number of | ||
| particles: | |||
| ≥ 10 um will be ≤ 6000 particles | |||
| ≥ 25 um will be ≤ 600 particles. | 100% Must | ||
| meet | |||
| Specification | 10um | ||
| 100% Pass | |||
| 25 um | |||
| 100% Pass | |||
| ≥ 75 µm & ≥ 125 µm will be | |||
| recorded | Data was recorded for informational | ||
| purposes only | |||
| Particulate | |||
| Testing | |||
| (Reperfusion | |||
| Catheter | |||
| /Separator) | The maximum number of | ||
| particles: | |||
| ≥ 10 um will be ≤ 6000 particles | |||
| ≥ 25 um will be ≤ 600 particles. | 100% Must | ||
| meet | |||
| Specification | 10μm | ||
| 100% Pass | |||
| 25 um | |||
| 100% Pass | |||
| ≥ 75 um & ≥ 125 um will be | |||
| recorded | Data was recorded for informational | ||
| purposes only | |||
| Coating Integrity | Coating is not grossly damaged | ||
| after undergoing particulate | |||
| testing | 100% Must | ||
| meet | |||
| Specification | 100% Pass | ||
| Hub/Catheter Air | |||
| Aspiration | When negative pressure is | ||
| pulled, no air may leak into hub | 100% Must | ||
| meet | |||
| Specification | 100% Pass | ||
| Pressure Test | 45 psi for 30 sec MIN | 100% Must | |
| meet | |||
| Specification | 100% Pass | ||
| Attribute | Specification | Acceptance | |
| Criteria | Results | ||
| Reperfusion | |||
| Catheter/Sheath | |||
| or 8F Guide & | |||
| 0.014" | |||
| Guidewire | |||
| compatibility | |||
| (Friction Force) | Maximum value per | ||
| specification | 100% Must | ||
| meet | |||
| Specification | 100% Pass | ||
| Markerband | |||
| Section Bond | |||
| Strength | Minimum value per specification | 100% Must | |
| meet | |||
| Specification | 100% Pass | ||
| Joint Sections | |||
| Bond Strength | Minimum value per specification | 100% Must | |
| meet | |||
| Specification | 100% Pass | ||
| Hub to Shaft & | |||
| Hub to Hypotube | |||
| Bond Strength | Minimum value per specification | 100% Must | |
| meet | |||
| Specification | 100% Pass | ||
| Steam-Shaped | |||
| Distal Tip | |||
| Tensile | Minimum value per specification | 100% Must | |
| meet | |||
| Specification | 100% Pass | ||
| Elongation to | |||
| Failure - | |||
| Reperfusion | |||
| Catheter | % Elongation ≥ 5% | 100% Must | |
| meet | |||
| Specification | 100% Pass | ||
| Kink Resistance | No kinking when formed in a | ||
| defined radius | 100% Must | ||
| meet | |||
| Specification | 100% Pass | ||
| Corrosion | No visible corrosion on | ||
| Reperfusion Catheter | |||
| immediately after Corrosion | |||
| Testing procedure | 100% Must | ||
| meet | |||
| Specification | 100% Pass |
8
9
The results of the tests appropriately address the physical and mechanical performance expectations of the device. This is further supported by the surgical handling and performance results reported in the in vivo study. Based on these overall results, the physical and mechanical properties of the subject Penumbra System ACE devices are acceptable for the intended use and substantially equivalent to the predicate device.
10.3 Animal Study
An animal study was conducted to evaluate the safe use of the Penumbra System ACE devices in a swine model. The study concluded that:
- No vessel injury was noted on the final angiograms following the vessel . response procedure.
- No abnormal gross or histology findings were noted in test vessel . segments.
10
- The use of the Penumbra System ACE devices resulted in no significant • vascular response in these experimental conditions.
10.4 Summary of Substantial Equivalence
The subject Penumbra System ACE devices are substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.