INDIGO Aspiration System
Device Facts
| Record ID | K161523 |
|---|---|
| Device Name | INDIGO Aspiration System |
| Applicant | Penumbra, Inc. |
| Product Code | QEW · Cardiovascular |
| Decision Date | Jul 1, 2016 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
INDIGO Aspiration Catheters and Separators: As part of the INDIGO™ Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. INDIGO Aspiration Tubing: As part of the INDIGO™ Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX. Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for the Penumbra Aspiration Systems.
Device Story
INDIGO Aspiration System consists of aspiration catheter, separator, tubing, and vacuum pump. Catheter introduced via guide catheter/sheath over guidewire to occlusion site. Separator deployed through catheter; advanced/retracted at proximal margin of occlusion to mechanically separate/debulk thrombus. Aspiration pump provides vacuum to aspirate clot through catheter. Used in peripheral vasculature; operated by clinicians under fluoroscopic guidance. System reduces/eliminates endovascular clot burden. Benefits include effective thrombus removal and restoration of vessel patency.
Clinical Evidence
Bench testing only. No clinical data presented. Testing included dimensional/visual inspection, simulated use in anatomical vascular flow models, separator shape verification, break force testing, PTFE coating integrity, and particulate testing. All tests met predetermined acceptance criteria.
Technological Characteristics
Separator 8 features Nitinol core wire, PTFE coating, Platinum alloy (92%Pt/8%W) distal/tip coils, and Pebax 63D proximal coil. Separator cone tip uses Pebax 40D or 35D with Tungsten/Titanium Oxide. Diamond-shaped cone. Sterilized via Ethylene Oxide (EO) per EN ISO 11135:2014. Compatible with Penumbra Aspiration Pump. Dimensions: 90cm or 150cm length, 0.072" distal cone OD.
Indications for Use
Indicated for removal of fresh, soft emboli and thrombi from peripheral arterial and venous vessels.
Regulatory Classification
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Predicate Devices
- Separator 8 (K160533)
Reference Devices
Submission Summary (Full Text)
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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 abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2016
Penumbra, Inc. Ms. Aditi Kolla Regulatory Affairs Manager One Penumbra Place Alameda. CA 94502
Re: K161523
Trade/Device Name: INDIGO™ Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 1, 2016 Received: June 2, 2016
Dear Ms. Kolla:
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 yours,
# Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K161523
Device Name INDIGO™ Aspiration System
### Indications for Use (Describe)
INDIGO Aspiration Catheters and Separators:
As part of the INDIGO™ Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
INDIGO Aspiration Tubing:
As part of the INDIGO™ Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for the 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 subject Separator 8.
#### 1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
#### 1.2 Sponsor Contact Information
Aditi Kolla Regulatory Affairs Specialist Phone: (510) 995-2010 Fax: (510) 217-6414 Email: akolla@penumbrainc.com
#### 1.3 Date of Preparation of 510(k) Summary
June 24, 2016
#### Device Trade or Proprietary Name 1.4
INDIGO™ Aspiration System
#### Device Classification 1.5
Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Catheter, Embolectomy Regulation Number: 21 CFR 870.5150 Product Code: DXE
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#### Predicate and Reference Devices 1.6
| Predicate Device | | | |
|-------------------|-----------------|---------------------------------------------|-------------------------|
| 510(k) Number | Clearance Date | Name of Predicate Device | Name of<br>Manufacturer |
| K160533 | May 24, 2016 | Separator 8 | Penumbra, Inc. |
| Reference Devices | | | |
| 510(k) Number | Clearance Date | Name of Predicate Device | Name of<br>Manufacturer |
| K100826 | 13 July 2010 | PX 400 Microcatheter | Penumbra, Inc. |
| K082290 | 31 October 2008 | Neuron 6F Delivery<br>Catheters 053 and 070 | Penumbra, Inc. |
#### 1.7 Predicate Comparison
| Common Device Name | Penumbra Embolectomy Aspiration System | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Trade Name | INDIGO™ Aspiration System | |
| 510(k) No. | K160533 | K161523 |
| Classification | Class II, DXE | Class II, DXE |
| Intended Use | INDIGO Aspiration Catheters<br>and Separators<br>As part of the Penumbra<br>Embolectomy Aspiration System<br>(INDIGO™ Aspiration System),<br>the INDIGO Aspiration Catheters<br>and Separators are indicated for<br>the removal of fresh, soft emboli<br>and thrombi from vessels of the<br>peripheral arterial and venous<br>systems.<br><br>INDIGO Aspiration Tubing<br>As part of the Penumbra<br>Embolectomy Aspiration System<br>(INDIGO™ Aspiration System),<br>the INDIGO Sterile Aspiration<br>Tubing is indicated to connect the<br>INDIGO Aspiration Catheters to<br>the Penumbra Pump MAX.<br><br>Penumbra Pump MAX<br>The Penumbra Pump MAX is<br>indicated as a vacuum source for<br>the Penumbra Aspiration<br>Systems. | Same |
| Separator<br>Materials | Separator 8 | Subject Separator 8 (90 cm, 150 cm) |
| Core Wire | Nitinol | Same |
| Coating | PTFE | Same |
| Distal External Coil | Platinum Alloy (92%Pt/8%W) | Same |
| Tip External Coil | Platinum Alloy (92%Pt/8%W) | Same |
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Image /page/5/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 the main focus of the image. The red circle with the white "P" is located to the right of the word "Penumbra" and serves as a logo for the company.
| Common Device Name | Penumbra Embolectomy Aspiration System | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Trade Name | INDIGO™ Aspiration System | |
| 510(k) No. | K160533 | K161523 |
| Proximal Coil | Stainless Steel 304 | Pebax 63D - colorant (green for 90 cm<br>length/orange for 150 cm length) |
| Solder Joint | Gold Solder [Au/Sn] & Silver<br>Solder [SN/Ag] | Same |
| Separator Cone Tip | Pebax 40D, Transparent Blue<br>(or)<br>Pebax 35D with 40% Alldyne<br>Tungsten and 5% Titanium Oxide<br>(TiO2) | Same |
| Dimensions | | |
| Total Length | 150 cm | 90 cm, 150 cm |
| Working Length | 96cm | 50cm, 96cm |
| Flex Length | 30 cm | 20 cm |
| Cone Shape | teardrop | diamond |
| Distal Cone OD | 0.068" (1.73mm) | 0.072" (1.83mm) |
| Center Section OD | 0.021" (0.533mm) | Same |
| Cone Length | 5mm | 7mm |
| Accessories | Torque Device & Introducer<br>Sheath | Same |
| Packaging Materials<br>& Configuration | Commonly utilized for<br>interventional devices | Same |
| Aspiration Source | Aspiration Pump | Same |
| Sterilization | EO | Same |
| Shelf-Life | 36 Months | Same |
#### Device Description 1.8
The INDIGO Aspiration System is comprised of several devices:
- INDIGO Aspiration Catheter
- INDIGO SeparatorTM
- INDIGO Aspiration Tubing ●
- INDIGO Pump/Canister Tubing .
- Penumbra Aspiration Pump
The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used in parallel with the INDIGO Separator and an aspiration source to separate the embolus or thrombus and aspirate it from the occluded vessel. The INDIGO Separator is deployed from the INDIGO Aspiration Catheter. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion. This facilitates aspiration and debulking of the thrombus and reduces or eliminates the endovascular clot burden. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the INDIGO
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Aspiration Tubing and the INDIGO Pump/Canister Tubing. The INDIGO Separator is provided with an introducer and torque device. The INDIGO Aspiration Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The devices are visible under fluoroscopy.
# 1.9 Intended Use
## INDIGO Aspiration Catheters and Separators
As part of the INDIGO™ Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
### INDIGO Aspiration Tubing
As part of the INDIGO™ Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX.
### Penumbra Pump MAX
The Penumbra Pump MAX is indicated as a vacuum source for the Penumbra Aspiration Systems.
### 1.10 Summary of Non-Clinical Data
Included in this section is a description of the testing, which substantiates the substantial equivalence of subject Separator 8 to the predicate device:
- Design Verification (Bench-Top Testing) .
- Shelf-life .
The subject Separator 8 met all predetermined requirements.
### 1.10.1 Biocompatibility Testing
Biocompatibility testing previously performed on the predicate and reference devices listed in Section 1.6 substantiate the biocompatibility of the subject Separator 8. 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.
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# 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 subject Separator 8 devices 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 summary of the testing performed on subject Separator 8 is listed below:
| Attribute | Specification | Acceptance<br>Criteria | Results |
|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------|
| Dimensional/<br>Visual Inspection | These evaluations confirm that the units<br>used in this Design Verification testing<br>meet all inspection criteria for release of<br>finished goods (clinically acceptable)<br>product. | | 100% Pass |
| Simulated Use<br>(Peripheral Access,<br>Vessel Access Entry<br>Performance & Clot<br>Removal) | Simulated use testing of the Aspiration<br>Catheter and Separator was performed with<br>accessory devices in an anatomical<br>Vascular Flow model which simulated the<br>tortuosity of the peripheral vasculature.<br>Devices were delivered through the tortuous<br>anatomical model to evaluate the<br>effectiveness of the devices to remove clots<br>and that the Aspiration Catheter does not<br>collapse under vacuum. | | 100% Pass |
| Separator Shape | Must be diamond<br>shaped | 100% Must<br>meet<br>Specification | 100% Pass |
| Advanced Separator<br>8 and Wire Joint<br>Break Force | $\ge$ 0.67 lb | 100% Must<br>meet<br>Specification | 100% Pass |
| Core Wire PTFE<br>Coating Integrity | Coating has not<br>delaminated,<br>peeled, or flaked | 100% Must<br>meet<br>Specification | 100% Pass |
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| Attribute | Specification | Acceptance<br>Criteria | Results |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------|
| | after simulated use | | |
| Particulate Testing<br>with Heparinized<br>Saline (Separator) | The maximum<br>number of particles:<br>$\geq$ 10 μm will be $\leq$<br>6000 particles<br>$\geq$ 25 μm will be $\leq$<br>600 particles. | 100% Must meet<br>Specification | 10μm<br>100% Pass<br><br>25μm<br>100% Pass |
| | $\geq$ 75 μm & $\geq$ 125<br>μm will be recorded | Data was recorded for informational<br>purposes only | |
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 subject Separator 8 devices are acceptable for the intended use and substantially equivalent to the predicate device.
### 1.11 Sterilization
The sterilization data from previous pre-market notification listed in Section 1.6 are directly applicable to the subject devices and no additional testing was required or performed. The subject devices were adopted into the existing validated Ethylene Oxide (EO) sterilization cycle as per TIR28, Annex A. Therefore, the subject Separator 8 has proved to be sterile in accordance with EN ISO 11135:2014.
### 1.12 Shelf-life
The subject Separator 8 has proved to have a 36 month shelf-life.
### 1.13 Summary of Substantial Equivalence
The subject Separator 8 device is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
