(138 days)
No
The device description and performance studies focus on mechanical aspiration and do not mention any AI or ML components or capabilities.
Yes.
The device is indicated for the "removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism." This directly treats a medical condition.
No
This device is used for the removal of emboli and thrombi (treatment), not for diagnosing their presence or characteristics.
No
The device description clearly outlines multiple hardware components including catheters, a pump, tubing, and a canister. There is no mention of software being the primary or sole component of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The INDIGO Aspiration System is a medical device designed to physically remove thrombus (blood clots) from blood vessels within the body using mechanical aspiration. It is an interventional device used directly on the patient.
- Intended Use: The intended use clearly states the removal of emboli and thrombi from vessels and treatment of pulmonary embolism, which are procedures performed in vivo (within the living body).
- Device Description: The description details a system of catheters, pumps, and tubing used to physically interact with and remove material from the patient's vasculature.
- Lack of Diagnostic Testing: There is no mention of analyzing samples from the patient for diagnostic purposes. The system's function is therapeutic (removing blockages), not diagnostic (identifying a condition through sample analysis).
Therefore, the INDIGO Aspiration System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, and for the treatment of pulmonary embolism.
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 Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
Product codes (comma separated list FDA assigned to the subject device)
QEW
Device Description
The INDIGO® Aspiration System is comprised of the several devices:
- INDIGO Aspiration Catheter
- Penumbra Aspiration Pump
- INDIGO Aspiration Pump Canister
- INDIGO Aspiration Tubing
- INDIGO Separator
The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
Lightning Aspiration Tubing
The Lightning Aspiration Tubing is a component to the currently available Indigo Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the peripheral arterial and venous systems, pulmonary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians who have received appropriate training in surgical procedures and/or interventional techniques.
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)
Non-Clinical Data/ Performance Data:
- Biocompatibility testing: Performed on Lightning Flash Aspiration Tubing, Flash Aspiration Catheter, RHV, Reducer, Connector Cap (Accessories). Tests included Cytotoxicity, Sensitization, Irritation, Systemic Toxicity (Acute Systemic Injection, Material Mediated Pyrogen), and Hemocompatibility (Thrombogenicity, Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Complement Activation, Direct/Indirect hemolysis). Results showed the devices to be biocompatible.
- Design Verification (Bench-Top) Testing: Performed on Lightning Flash Aspiration Tubing and Flash Aspiration Catheter and Select Catheter. Tests included Dimensional/Visual Inspection, Performance/Simulated Use Testing, Tensile Testing, Friction Testing, Simulated Use and Torsion Testing, Vacuum Test, Indigo Aspiration System Compatibility, Valve Sense Testing, Coating Integrity Testing, Particulate Testing, Hub Air Aspiration, Catheter Pressure, Hub / Shaft Tensile Strength, Catheter Shaft Tensile, Elongation to Failure, and Corrosion. The in vitro bench-top tests demonstrated that the subject Lightning Flash met all acceptance criteria and performed similarly to the predicate devices and function as intended without raising new questions of safety and effectiveness.
- Clinical Performance Data: No clinical study was conducted as bench and previously performed animal testing was determined sufficient. A literature review of published clinical study articles featuring the predicate device and other devices with similar dimensions used for direct aspiration was used to support substantial equivalence.
- Electrical Safety/EMC Testing: Conducted on the Lightning Flash Aspiration Tubing. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and ISO 10079-1.
- Software: Software verification and validation testing and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005). Software considered a Minor Level of Concern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.5150 Embolectomy catheter.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger font and is placed inside a blue square.
January 30, 2023
Penumbra, Inc. Deanna Kimlinger Senior Regulatory Specialist One Penumbra Place Alameda, California 95132
Re: K222358
Trade/Device Name: Indigo® Aspiration System - Lightning® Flash Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW
Dear Deanna Kimlinger:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 20, 2022. Specifically, FDA is updating this SE Letter to correct a typo in the device trade name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, by phone (301-796-6075), or email (gregory.oconnell(@fda.hhs.gov).
Sincerely,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.01.30
12:06:11 -05'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2022
Penumbra, Inc. Deanna Kimlinger Senior Regulatory Specialist One Penumbra Place Alameda, California 95132
Re: K222358
Trade/Device Name: Indigo® Aspiration System - Lighting® Flash Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: November 17, 2022 Received: November 18, 2022
Dear Deanna Kimlinger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
2
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/6 description: The image shows a digital signature. The signature is for Gregory W. O'connell. The date of the signature is 2022.12.20, and the time is 15:45:58 -05'00'.
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K222358
Device Name Indigo® Aspiration System - Lightning® Flash
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, and for the treatment of pulmonary embolism.
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 Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump 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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4
510(k) Summary 1
(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 Indigo "Aspiration System - Lightning" Flash.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Deanna Kimlinger Senior Regulatory Affairs Specialist Phone: (925) 212-9088 FAX: (510) 217-6414 Email: dkimlinger@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
December 20, 2022
1.4 Device Trade or Proprietary Name
Indigo
1.5 Device Classification
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Cardiovascular |
| Classification Name: | Catheter, Embolectomy |
| Regulation Number: | 21 CFR §870.5150 |
| Product Code: | QEW |
1.6 Predicate and Reference Devices - Lightning Flash
| 510(k) Number | Name of Device | |
|---|---|---|
| Lightning Flash Aspiration Tubing | ||
| Predicate | K210323 | Indigo Aspiration System – Lightning Aspiration Tubing |
| Reference | K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
| Flash Aspiration Catheter | ||
| Predicate | K192981 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
| Reference | K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
| Reference | K180466 | FlowTriever Retrieval/Aspiration System |
| Select Catheter (Accessory) | ||
| Predicate | K111380 | Neuron MAX System |
5
1.7 Predicate Comparison
| System Name | Indigo® Aspiration System | |||
|---|---|---|---|---|
| Lightning Aspiration Tubing | ||||
| [Predicate] | CAT12 & SEP12 | |||
| [Predicate] | CAT12 & SEP12 with | |||
| PE Treatment Indication | ||||
| [Reference] | Lightning Flash | |||
| [Subject] | ||||
| Classification | Class II, QEW | Class II, QEW | Class II, QEW | SAME |
| 510(k) no. | K210323 | K192981 | K202821 | K222358 |
| Indication | 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, and for the treatment | ||||
| of pulmonary embolism. |
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 Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump
is indicated as a vacuum source
for the Penumbra Aspiration | 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
Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump
is indicated as a vacuum source
for Penumbra Aspiration
Systems. | 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, and for the treatment
of pulmonary embolism.
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 Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump
is indicated as a vacuum source
for the Penumbra Aspiration
Systems. | SAME AS PREDICATE
K210323 and
REFERENCE K202821 |
| Aspiration Tubing | Lightning Aspiration Tubing
[Predicate] | Lightning Flash Aspiration Tubing
[Subject] | | |
| 510(k) No. | | K210323 | K222358 | |
| Materials | | | | |
| Materials | | Biocompatible, commonly utilized for
interventional devices | SAME | |
| Dimensions | | | | |
| Proximal OD | | Appropriately sized for the Aspiration
Catheter | SAME plus larger diameters | |
| Proximal ID | | | | |
| Distal OD | | | | |
| Distal ID | | | | |
| Effective Length | | | | |
| Aspiration Catheter | | Indigo System – CAT12
[Predicate] | Indigo System – Flash Aspiration
Catheter
[Subject] | |
| 510(k) No. | | K192981 | K222358 | |
| Materials | | | | |
| Materials | | Biocompatible, commonly utilized for
interventional devices | SAME with subset of colorants | |
| Coating | | Hydrophilic | SAME | |
| Dimensions | | | | |
| Proximal OD | | | | |
| Proximal ID | | | SAME plus larger diameters | |
| Distal OD | | Appropriately sized for the target vessel | | |
| Distal ID | | | | |
| Effective Length | | | | |
| Accessories | | | | |
| | | Sheath: Grilamid | SAME | |
| Introducer | | ID Band: Polyolefin | SAME | |
| Rotating
Hemostasis | Materials | Polycarbonate/Silicone/PTFE | Polycarbonate/Silicone/PVC/PTFE/
Polyolefin with foil/Loctite/
Thermoplastic Polymer | |
| Valve
(RHV) | French
Size | 10F | 13F | |
| Select Catheter
(Accessory) | | Neuron MAX - 6F Select Catheter
[Predicate] | Indigo System – Select Catheter
[Subject] | |
| 510(k) No. | | K111380 | K222358 | |
| Materials | | | | |
| Materials | | Biocompatible, commonly utilized for
interventional devices | SAME | |
6
7
| Dimensions | ||
|---|---|---|
| OD [Maximum] | ||
| ID [Minimum] | ||
| Working Length | Appropriately sized for the introduction | |
| of interventional devices into the target | ||
| vessel | SAME plus expanded working | |
| length range | ||
| Accessories | ||
| Torque Device | Polycarbonate/Brass/Polypropylene | SAME |
| Packaging Materials | Commonly used materials for medical | |
| devices | SAME | |
| Aspiration Source | Penumbra Aspiration Pump | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | 12 Months |
| Use | Single use, disposable | SAME |
1.8 Device Description
The INDIGO® Aspiration System is comprised of the several devices:
- INDIGO Aspiration Catheter
- Penumbra Aspiration Pump
- INDIGO Aspiration Pump Canister
- INDIGO Aspiration Tubing
- INDIGO Separator
The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
8
Lightning Aspiration Tubing
The Lightning Aspiration Tubing is a component to the currently available Indigo Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration. Intended users for this device are physicians who have received appropriate training in surgical procedures and/or interventional techniques. The device is provided sterile, non-pyrogenic, and intended for single use only.
1.9 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, and for the treatment of pulmonary embolism.
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 Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
1.10 Summary of Non-Clinical Data/ Performance 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 are summary descriptions of the testing which substantiates the performance of the subject Lightning Flash.
1.10.1 Biocompatibility
Biocompatibility testing was conducted on the subject Lightning Flash. Biocompatibility testing was leveraged for the Introducer (K192981) and Select Catheter (K111380) accessories. The following tests were performed:
9
- Lightning Flash Aspiration Tubing
- O Cytotoxicity
- O Sensitization
- o Irritation
- . Flash Aspiration Catheter
- Cytotoxicity O
- Sensitization O
- O Irritation
- Systemic Toxicity O
- Acute Systemic Injection
- I Material Mediated Pyrogen
- Hemocompatibility O
- . Thrombogenicity
- Prothrombin Time (PT)
- . Partial Thromboplastin Time (PTT)
- . Complement Activation
- . Direct/Indirect hemolysis
- . RHV, Reducer, Connector Cap (Accessories)
- Cytotoxicity O
- Sensitization O
- O Irritation
- Systemic Toxicity O
- . Acute Systemic Injection
- Material Mediated Pyrogen
- Hemocompatibility o
- . Direct/Indirect hemolysis
The results from the testing performed showed the subject devices to be biocompatible.
1.10.2 Design Verification (Bench-Top) Testing
Non-clinical laboratory testing was performed on the subject Lightning Flash devices to determine substantial equivalence. The following tests were performed:
- Lightning Flash Aspiration Tubing
- . Flash Aspiration Catheter and Select Catheter
- Dimensional/Visual Inspection O
- Performance/Simulated Use O Testing
- Tensile Testing O
- Dimensional/Visual Inspection o
- Friction Testing O
- Performance/Simulated Use and Torsion o Testing
- Vacuum Test o
10
- o Indigo Aspiration System Compatibility
- o Valve Sense Testing
- Coating Integrity Testing O
- Particulate Testing O
- O Hub Air Aspiration
- Catheter Pressure O
- Hub / Shaft Tensile Strength O
- Catheter Shaft Tensile O
- Elongation to Failure O
- o Corrosion
The in vitro bench-top tests demonstrated that the subject Lightning Flash met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the Lightning Flash devices function as intended and does not raise any new questions of safety and effectiveness compared to the predicate devices.
1.10.3 Performance Data – Clinical
No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes. A review was conducted considering published clinical study articles that featured the predicate device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the determination of substantial equivalence by leveraging clinical outcomes from devices that are considered technologically equivalent.
1.10.4 Electrical Safety/EMC Testing
Electrical Safety and EMC testing were conducted on the Lightning Flash Aspiration Tubing. The subject device complies with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and ISO 10079-1.
1.10.5 Software
Software verification and validation testing and documentation for the Lightning Flash Aspiration Tubing was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005). The software for this device was considered as a Minor Level of Concern.
1.11 Summary of Substantial Equivalence
The subject Indigo Aspiration System - Lightning Flash is substantially equivalent to the predicate devices, provided in Section 1.6 with regards to intended use, operating principle, design concept, materials, sterilization processes and packaging processes.