(28 days)
No
The document describes a mechanical aspiration system for removing blood clots and does not mention any AI/ML components or capabilities.
Yes
The device is used for the revascularization of patients with acute ischemic stroke, which is a therapeutic intervention aimed at restoring blood flow.
No
Explanation: The device description and intended use clearly state that the Penumbra System components (catheters, separators, tubing, pump) are used for the "revascularization of patients with acute ischemic stroke" by aspirating thrombus. This is a therapeutic intervention, not a diagnostic one. The performance studies also focus on mechanical and physical properties relevant to its therapeutic function, not diagnostic accuracy.
No
The device description and performance studies clearly indicate this is a physical medical device (catheter) with associated hardware components (tubing, pump). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the revascularization of patients with acute ischemic stroke by physically removing blood clots from vessels. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a catheter and aspiration system designed to physically interact with and remove thrombus from blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo to treat a medical condition.
N/A
Intended Use / Indications for Use
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.
Product codes
NRY
Device Description
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.
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)
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
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: Packaging Inspection, Dimensional/Visual, Kink Resistance, Markerband Visibility, Simulated Use (Intracranial Access, Vessel Access Entry Performance & Clot Removal), Particulate testing, Coating Integrity, Hub Air Aspiration, Static Burst Pressure Test, ACE 68 / Sheath or 8F Guide Catheter Friction Force, ACE 68 / 0.014 in. Guidewire Friction Force, Joint sections bond strength, Hub to shaft tensile strength, Hub to hypotube tensile strength, Elongation to failure, Torsion, Corrosion.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 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.
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,
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
2
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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3
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 Penumbra | |
| Aspiration Pump | Penumbra. Inc. | ||
| One Penumbra Place | |||
| Alameda, CA 94502 USA |
4
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 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 | SAME | |
| Materials | Systems. | |
| Proximal hub | Grilamid (TR55-LX) | SAME |
| Strain Relief [Hub | ||
| Sleeve] | 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/72D | |
| blend | SAME | |
| Distal Extrusions | Pebax 63D, Pebax 55D, Pebax 40D/55D | |
| Blend, 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 Hemostasis | ||
| Valve | 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
6
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 (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. | 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 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 |
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.