(28 days)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX
The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
The Penumbra System ACE 68 Reperfusion Catheter is a component to the currently available Penumbra System. The ACE 68 Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. ACE 68 is provided sterile, non-pyrogenic, and intended for single use only.
The document describes the Penumbra System ACE 68 Reperfusion Catheter and its substantial equivalence to a predicate device. Below is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Packaging Inspection | Confirm the packaging and dimensions of the units meet all product specifications. | Pass |
| Dimensional/Visual | Meet product specifications. | Pass |
| Kink Resistance | No kinking when formed in a defined radius. | Pass |
| Markerband Visibility | The markerband is fluoroscopically visible. | Pass |
| Simulated Use (Intracranial Access, Vessel Access Entry Performance & Clot Removal) | Reperfusion Catheter does not collapse under vacuum; devices effectively remove clots in an anatomical model which simulated the tortuosity of the neurovasculature. | Pass |
| Particulate testing (≥ 10 µm) | ≤ 6000 particles | Pass |
| Particulate testing (≥ 25 µm) | ≤ 600 particles | Pass |
| Particulate testing (≥ 75 µm) | Measured for informational purposes only (FIPO) | FIPO |
| Particulate testing (≥ 125 µm) | Measured for informational purposes only (FIPO) | FIPO |
| Coating Integrity | Coating has not delaminated, peeled, or flaked prior to or after simulated use particulate testing. | Pass |
| Hub Air Aspiration | No leaks detected when vacuum is pulled on the injection lumen. | Pass |
| Static Burst Pressure Test | 45 psi for 30 sec minimum. | Pass |
| ACE 68 / Sheath or 8F Guide Catheter Friction Force | Minimum value per specification. | Pass |
| ACE 68 / 0.014 in. Guidewire Friction Force | Minimum value per specification. | Pass |
| Joint sections bond strength | Minimum value per specification. | Pass |
| Hub to shaft tensile strength | Minimum value per specification. | Pass |
| Hub to hypotube tensile strength | Minimum value per specification. | Pass |
| Elongation to failure | Elongation ≥ 5% | Pass |
| Torsion | Number of turns will be recorded for informational purposes only. | FIPO |
| Corrosion | No visible corrosion on Reperfusion Catheter immediately after corrosion testing procedure. | Pass |
| Shelf Life | Devices underwent transportation conditioning per ASTM D4169 and accelerated aging equal to 8 months; successful testing verifies 8-month shelf life. | Verified 8 months shelf life |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size for individual tests conducted as part of design verification or shelf-life testing. It merely states that "The physical and mechanical properties of the ACE 68 Reperfusion Catheter were assessed using standard test methods and pre-determined acceptance criteria." and "all tests passed successfully."
The data provenance is from bench-top testing conducted by the manufacturer, Penumbra, Inc. This is prospective data generated specifically for the device submission. The country of origin of the data is not specified beyond being generated by Penumbra, Inc. in Alameda, California, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
No information is provided regarding the number of experts or their qualifications for establishing ground truth for the test set. The tests described are primarily physical and mechanical properties and simulated use, not diagnostic interpretations requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective physical and mechanical tests rather than subjective evaluations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for this device. The study focused on the physical and mechanical performance of the device and its substantial equivalence to a predicate, not on a human-in-the-loop performance with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, this device is a medical catheter system, not an AI algorithm. Therefore, an algorithm-only standalone performance study is not applicable.
7. The Type of Ground Truth Used
The ground truth used for these tests are engineering specifications, physical measurements, and observable outcomes (e.g., no kinking, fluoroscopic visibility, no leaks, effective clot removal in a simulated environment, no corrosion, specific pressure resistance values). For "Simulated Use," the ground truth is whether the device performed as expected in the anatomical model (e.g., did not collapse, removed clots).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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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 two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The abstract symbol is a stylized representation of a human figure, composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2016
Penumbra, Inc. Mr. Charles DeNault Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502
Re: K161640
Trade/Device Name: Penumbra System ACE 68 Reperfusion Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: June 13, 2016 Received: June 14, 2016
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.
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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,
Carlos L. Pena -S/A
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) K161640
Device Name
Penumbra System ACE 68 Reperfusion Catheter
Indications for Use (Describe)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
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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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 Penumbra System® ACE™ 68 Reperfusion Catheter.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Charles DeNault Regulatory Affairs Specialist III Phone: (510) 748-3302 FAX: (510) 217-6414 Email: cdenault(@penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
June 13, 2016
Device Trade or Proprietary Name 1.4
Penumbra System® ACE™ 68 Reperfusion Catheter
1.5 Device Classification
Regulatory Class: II Classification Panel: Neurology Classification Name: Percutaneous Catheter Regulation Number: 21 CFR §870.1250 Product Code: NRY (Catheter, Thrombus Removal)
1.6 Predicate Devices
| 510(k)Number | Clearance Date | Name of Predicate Device | Name of Manufacturer |
|---|---|---|---|
| K160449 | May 25, 2016 | Penumbra System and PenumbraAspiration Pump | Penumbra. Inc.One Penumbra PlaceAlameda, CA 94502 USA |
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1.7 Predicate Comparison
Design modifications were made to the subject device. Changes include a reduction of the device markerband length as well as dimensional changes to the device PTFE liner, coil reinforcement filaments, and extrusions.
| Predicate | Subject | |
|---|---|---|
| General | ||
| 510(k) No. | K160449 | K161640 |
| Classification | Class II, NRY | SAME |
| Indication | Penumbra Reperfusion Catheters andSeparatorsAs part of the Penumbra System, theReperfusion Catheters and Separators areindicated for use in the revascularization ofpatients with acute ischemic stroke secondary tointracranial large vessel occlusive disease(within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebralarteries) within 8 hours of symptom onset.Penumbra Aspiration TubingAs part of the Penumbra System, the PenumbraSterile Aspiration Tubing is indicated toconnect the Penumbra Reperfusion Catheters tothe Penumbra Pump MAX.Penumbra Pump MAXThe Penumbra Pump MAX is indicated as avacuum source for Penumbra Aspiration | SAME |
| Materials | Systems. | |
| Proximal hub | Grilamid (TR55-LX) | SAME |
| Strain Relief [HubSleeve] | Grilamid (TR55) | SAME |
| Strain Relief | 304 Stainless Steel (SS) | SAME |
| ID Band | Polyolefin, PET yellow [black ink] | SAME |
| Liner | PTFE | SAME |
| Coil Reinforcement | 304V SS, Nitinol (55% Ni, 45% Ti) | SAME |
| Proximal Extrusions | Vestamid, Pebax 72D, Pebax 55D/72Dblend | SAME |
| Distal Extrusions | Pebax 63D, Pebax 55D, Pebax 40D/55DBlend, Pebax 40D, Pebax 35D/40D Blend,Pebax 35D, Tecoflex 80A/Pebax 35D,Tecoflex 80A, Pellethane 80A | SAME |
| Extrusion Colorants | Clear/Natural or Purple | SAME |
| Markerband | Platinum/Iridium (90% Pt, 10% Ir) | SAME |
| Predicate | Subject | |
| Coating | SRDX Harmony (proprietary) | SAME |
| Dimensions | ||
| Proximal OD | 0.084 in. max | SAME |
| Proximal ID | 0.068 in. min | SAME |
| Distal OD | 0.084 in. max | SAME |
| Distal ID | 0.068 in. min | SAME |
| Effective Lengths | 115, 120, 125, 127, 132 cm | SAME |
| Distal Flex Length | 30 cm | SAME |
| Coating Length | 30 cm | SAME |
| Tip Shape | Straight | SAME |
| Accessories | ||
| Peelable Sheath | PTFE | SAME |
| Rotating HemostasisValve | Polycarbonate, silicone o-ring | SAME |
| Shaping Mandrel | 0.038 in. OD stainless steel | SAME |
| Packaging Materials | ||
| Pouch | Polyester/Polyethylene/Tyvek | SAME |
| Packaging Hoop | Polyethylene | SAME |
| Packaging Tray(Kit configuration) | Polyethylene terephthalate, Polystyrene | SAME |
| Packaging Card | Polyethylene | SAME |
| Display Carton | SBS Paperboard | SAME |
| Other | ||
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | 8 Months |
| Use | Single use, disposable | SAME |
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Image /page/5/Picture/0 description: The image shows the word "Penumbra" in red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern. The font is sans-serif.
Device Description 1.8
The Penumbra System ACE 68 Reperfusion Catheter is a component to the currently available Penumbra System. The ACE 68 Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel in the neurovasculature. ACE 68 is provided sterile, non-pyrogenic, and intended for single use only.
Indications for Use 1.9
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to
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Penumbr
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.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX
The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
1.10 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 devices follows.
Included in this section is a summary description of the testing, which substantiates the performance of the subject ACE 68 Reperfusion Catheter as well as its substantial equivalence to the predicate devices:
- . Design Verification (Bench-Top Testing)
- . Shelf Life Testing
The subject ACE 68 Reperfusion Catheters met all established requirements.
1.10.1 Design Verification (Bench-Top Testing)
The physical and mechanical properties of the ACE 68 Reperfusion Catheter were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
| Attribute | Specification | Results |
|---|---|---|
| Packaging Inspection | Confirm the packaging and dimensions of the units meet all product specifications. | Pass |
| Dimensional/Visual | product specifications. | Pass |
| Kink Resistance | No kinking when formed in a defined radius | Pass |
| Markerband Visibility | The markerband is fluoroscopically visible | Pass |
| Simulated Use (IntracranialAccess, Vessel Access EntryPerformance & ClotRemoval) | Simulated use testing of the Reperfusion Catheter and Separatorwas performed with accessory devices in an anatomical modelwhich simulated the tortuosity of the neurovasculature. Deviceswere delivered through the tortuous anatomical model toevaluate the effectiveness of the devices to remove clots and thatthe Reperfusion Catheter does not collapse under vacuum. | Pass |
| Particulate testing | ≥ 10 μm will be ≤ 6000 particles≥ 25 μm will be ≤ 600 particles | Pass |
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Image /page/7/Picture/0 description: The image shows the word "Penumbra" in red font, followed by a red circle with a white "P" inside. The word "Penumbra" is written in a sans-serif font and is slightly bolded. The red circle with the white "P" is located to the right of the word "Penumbra" and is slightly smaller in size.
| Attribute | Specification | Results |
|---|---|---|
| ≥ 75 µm will be measured for informational purposes only(FIPO) | FIPO | |
| ≥ 125 µm will be measured for informational purposes only(FIPO) | FIPO | |
| Coating Integrity | Coating has not delaminated, peeled, or flaked prior to or aftersimulated use particulate testing | Pass |
| Hub Air Aspiration | No leaks detected when vacuum is pulled on the injection lumen | Pass |
| Static Burst Pressure Test | 45 psi for 30 sec minimum | Pass |
| ACE 68 / Sheath or 8FGuide Catheter FrictionForce | Minimum value per specification | Pass |
| ACE 68 / 0.014 in.Guidewire Friction Force | Minimum value per specification | Pass |
| Joint sections bond strength | Minimum value per specification | Pass |
| Hub to shaft tensile strength | Minimum value per specification | Pass |
| Hub to hypotube tensilestrength | Minimum value per specification | Pass |
| Elongation to failure | Elongation ≥ 5% | Pass |
| Torsion | Number of turns will be recorded for informational purposesonly. | FIPO |
| Corrosion | No visible corrosion on Reperfusion Catheter immediately aftercorrosion testing procedure | Pass |
1.10.2 Shelf Life Testing
The device stability and packaging integrity of the ACE 68 Reperfusion Catheter were assessed using standard test methods and pre-determined acceptance criteria. Devices underwent transportation conditioning per ASTM D4169 and accelerated aging equal to 8 months. Results of successful testing verify the ACE 68 Reperfusion Catheter may be labeled with an 8-month shelf life.
1.11 Summary of Substantial Equivalence
The subject Penumbra System ACE 68 Reperfusion Catheter is substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
§ 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).