(113 days)
No
The device description and performance studies focus on the physical and mechanical properties of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is indicated for introducing other interventional devices, rather than directly providing therapy itself.
No
The device is a medical device for introducing other interventional devices into the vasculature. Its function is to provide access and guidance for other tools, not to diagnose medical conditions.
No
The device description clearly details a physical catheter with specific material properties, dimensions, and accessories. The performance studies also focus on physical and material characteristics, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a catheter designed for insertion into blood vessels, including features like a reinforced shaft, radiopaque marker, hydrophilic coating, and a PTFE-lined lumen. These are characteristics of a device used for accessing and navigating within the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
Therefore, the 091 Long Sheath is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DOY, DTL, GCC
Device Description
The InNeuroCo, Inc. 091 Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless steel double coil. It has a radiopaque Platinum/Iridium marker band on the distal end. The distal 10 cm of the 091 Long Sheath Catheter has a hydrophilic coating. The catheter has a nominal outer diameter of 0.109 inches and a nominal inner diameter of 0.091 inches. It is available in three working lengths: 70 cm, and 90 cm. The 091 Long Sheath has a PTFE-lined lumen. The 091 Long Sheath is inserted at a vascular access point to provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and a Vessel Dilator. The 091 Long Sheath is supplied 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
peripheral, coronary, and neuro vasculature
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-Material Mediated Pyrogen Testing
Test Method: completed per ISO 10993-11
Acceptance Criteria: The test article extracts must not cause a febrile reaction greater than 0.5 degrees C in any individual subject.
Conclusions: Test results for the InNeuroCo Super Distal Access (K161262) and the Zenith Catheter (K171672) were leveraged for the 091 Long Sheath as the materials and manufacturing processes are equivalent.
Biocompatibility- Cytotoxicity MEM Elution
Test Method: completed per ISO 10993-5
Acceptance Criteria: The cultures treated with the test article must not have a reactivity grade greater than 2.
Conclusions: Test articles met the acceptance criteria for Cytotoxicity MEM Elution.
Biocompatibility- Hemolysis ASTM Method, extract human blood
Test Method: completed per ISO 10993-4
Acceptance Criteria: The hemolytic index above the negative control article must be less than 5%.
Conclusions: Test articles met the acceptance criteria for Hemolysis ASTM Method, extract human blood.
Biocompatibility- Hemolysis, ASTM method, direct contact (human blood)
Test Method: completed per ISO 10993-4
Acceptance Criteria: The hemolytic index above the negative control article must be less than 5%.
Conclusions: Test articles met the acceptance criteria for Hemolysis, ASTM method, direct contact (human blood).
Biocompatibility- Unactivated Partial Thromboplastin Time
Test Method: completed per ISO 10993-4
Acceptance Criteria: There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control.
Conclusions: Test article met the acceptance criteria for Unactivated Partial Thromboplastin Time.
Biocompatibility- Complement Activation
Test Method: completed per ISO 10993-4
Acceptance Criteria: There must be no statistical increase between either the C3a or SC5b-9 concentrations in plasma exposed to the test article as compared to the negative and untreated controls.
Conclusions: Test article met the acceptance criteria for Complement Activation.
Biocompatibility-Dog Thrombogenicity
Test Method: completed per ISO 10993-4
Acceptance Criteria: The test articles must receive a thrombus formation score less than or equal to that of the control.
Conclusions: Test article met the acceptance criteria for Dog Thromboresistance.
Biocompatibility- Maximization Sensitization
Test Method: completed per ISO 10993-10
Acceptance Criteria: The test article must elicit a positive response in less than 10% of the test animals.
Conclusions: Test article met the acceptance criteria for Maximization Sensitization.
Biocompatibility- Intracutaneous Toxicity/Reactivity
Test Method: completed per ISO 10993-10
Acceptance Criteria: The test article extracts must not induce a significantly greater biological reaction than the control.
Conclusions: Test article met the acceptance criteria for Intracutaneous Toxicity/Reactivity.
Biocompatibility-Acute Systemic Toxicity Test
Test Method: completed per ISO 10993-11
Acceptance Criteria: The test article extracts must not induce a significantly greater biological reaction than the control.
Conclusions: Not specified, but generally implies meeting acceptance criteria.
Animal Testing- Angiographic Evaluation
Test Method: Product evaluated within a porcine model for clinically significant injury.
Acceptance Criteria: No units tested can cause vessel injury.
Conclusions: Test article met the acceptance criteria for Animal Testing.
Bench Testing - Chemical Compatibility
Test Method: Catheter exposed to chemicals readily available in a clinical setting.
Acceptance Criteria: Chemicals have no negative effect on the catheter or accessories.
Conclusions: Test articles met the acceptance criteria for Chemical Compatibility.
Bench Testing - Visual Inspection
Test Method: completed per ISO 10555-1
Acceptance Criteria: Catheter shall appear free from damage, including a rounded tip and smooth transition points.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Visual Inspection.
Bench Testing - Dimensions
Test Method: completed per ISO 10555-1
Acceptance Criteria: Test samples should be within existing dimensional specifications.
Conclusions: 091 Long Sheath test samples met the acceptance criterial for dimensions. Test results for the InNeuroCo Super Distal Access (K161262) were leveraged for the Hemostasis Valve, which met the dimensional acceptance criteria.
Bench Testing - Hub compatibility
Test Method: completed per ISO 594-1 and ISO 594-2
Acceptance Criteria: Hub shall meet existing Luer specifications.
Conclusions: All tested samples met the acceptance criteria for Hub compatibility.
Bench Testing - Leak - Air
Test Method: completed per ISO 10555-1
Acceptance Criteria: Test samples should be within existing Air – Leak specifications.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Leak - Air.
Bench Testing - Leak - Liquid
Test Method: completed per ISO 10555-1
Acceptance Criteria: Test samples should be within existing Leak - Liquid specifications.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Leak - Liquid.
Bench Testing - Particulates
Test Method: completed per USP 788
Acceptance Criteria: Test samples should be within existing Particulate specifications.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Particulates.
Bench Testing - Simulated Use
Test Method: LS underwent simulated use testing by a physician in a benchtop model.
Acceptance Criteria: Test samples must meet predetermined user needs
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Simulated Use - Bench.
Bench Testing - Catheter Burst
Test Method: completed per ISO 10555-1
Acceptance Criteria: Test sample burst pressures must meet or exceed existing minimum burst pressure specification.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Catheter Burst.
Bench Testing - Tensile
Test Method: completed per ISO 10555-1
Acceptance Criteria: Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications.
Conclusions: 091 Long Sheath test samples met the acceptance criteria.
Bench Testing - Corrosion
Test Method: completed per ISO 10555-1
Acceptance Criteria: Test samples shall exhibit no evidence of corrosion.
Conclusions: All samples met the acceptance criteria.
Bench Testing - Packaging - Dye Leak
Test Method: completed per ASTM F1929-12
Acceptance Criteria: Test sample shall not exhibit any visual leaks or channels
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Packaging - Dye Leak.
Bench Testing - Packaging - Peel
Test Method: completed per ASTM F88-09
Acceptance Criteria: Test sample tensile strength must meet or exceed existing tensile strength specifications.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Packaging - Peel.
Bench Testing - Kink Resistance
Test Method: Samples are subjected to different diameters until kink is observed.
Acceptance Criteria: Test sample kink resistance must meet or exceed existing Kink Resistance specifications.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Kink Resistance.
Bench Testing - Torque
Test Method: Conditioned samples are torqued to failure
Acceptance Criteria: Test sample torque results must meet or exceed existing torque specifications.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Torque.
Bench Testing - PTFE Liner inspection
Test Method: LS was challenged to demonstrate liner adherence.
Acceptance Criteria: Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for PTFE Liner inspection.
Bench Testing - Hydrophilic Coating Integrity
Test Method: Conditioned samples were repeatedly exposed to friction to demonstrate that the hydrophilic coating is not affected.
Acceptance Criteria: Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for Hydrophilic Coating Integrity.
Bench Testing - Labeling Legibility
Test Method: Label is legible after printing.
Acceptance Criteria: Test samples shall demonstrate text legibility.
Conclusions: 091 Long Sheath test samples met the acceptance criteria for labeling legibility.
Bench Testing - Barcode
Test Method: Barcode is readable with a standard barcode reader.
Acceptance Criteria: Test samples shall demonstrate readily readable barcodes
Conclusions: 091 Long Sheath test samples met the acceptance criteria for barcode testing.
Sterilization
Test Method: ISO 11135 and AAMI TIR 28
Acceptance Criteria: Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads.
Conclusions: 091 Long Sheath sterilization load met the acceptance criteria for sterilization.
Bacterial Endotoxin
Test Method: AAMIST72
Acceptance Criteria: Test samples must meet the bacterial endotoxin acceptance criteria
Conclusions: The 091 Long Sheath samples met the acceptance criteria for bacterial endotoxins.
Shelf Life
Test Method: ASTM F1980
Acceptance Criteria: Aged test samples must meet or exceed existing specifications
Conclusions: 091 Long Sheath test samples met the acceptance criteria for shelf life.
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
§ 870.1250 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/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2017
InNeuroCo, Inc. Marianne Grunwaldt Director, Quality Assurance and Regulatory Affairs 4635 NW 103rd Avenue Sunrise, Florida 33351
Re: K172468
Trade/Device Name: 091 Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY, DTL, GCC Dated: November 3, 2017 Received: November 6, 2017
Dear Marianne Grunwaldt:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K172468
Device Name 091 Long Sheath
Indications for Use (Describe)
The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
Submitter's Name and Address
InNeuroCo, Inc. 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-954-742-5988 Facsimile: 1-954-742-5989
Contact Information
Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-954-703-5271 Facsimile: 1-954-742-5989 E-Mail: Marianne@InNeuroCo.com
Date Prepared
December 4, 2017
Device Trade or Proprietary Name
091 Long Sheath
Device Common or Classification Name:
Catheter, Percutaneous, 21CFR870.1250, Class II Hemostasis Valve, 21CFR870.4290, Class II Vessel Dilator, 21 CFR 870.4200, Class I
4
Product Code:
DQY (Catheter) DTL (Hemostasis Valve) GCC (Vessel Dilator)
Identification of the Legally Marketed Devices to which Equivalence is Being Claimed
| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|---|---|---|
| AXS Infinity LS | Stryker | K152876 |
Device Description
The InNeuroCo, Inc. 091 Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless steel double coil. It has a radiopaque Platinum/lridium marker band on the distal end. The distal 10 cm of the 091 Long Sheath Catheter has a hydrophilic coating. The catheter has a nominal outer diameter of 0.109 inches and a nominal inner diameter of 0.091 inches. It is available in three working lengths: 70 cm, and 90 cm. The 091 Long Sheath has a PTFE-lined lumen. The 091 Long Sheath is inserted at a vascular access point to provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and a Vessel Dilator. The 091 Long Sheath is supplied sterile, non-pyrogenic, and intended for single use only.
Indications for Use
The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
5
Comparison to Predicate Device
| | Stryker
AXS Infinity LS | InNeuroCo 091 Long
Sheath |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K152876 | K172468 |
| Classification | 21CFR870.1250, Class II | 21CFR870.1250, Class II |
| Product Code | DQY | Same |
| Review Panel | Cardiovascular | Same |
| Indications For Use | The AXS Infinity LS is
indicated for the
introduction of
interventional devices
into the peripheral,
coronary, and neuro
vasculature. | The 091 Long Sheath is
indicated for the
introduction of
interventional devices
into the peripheral,
coronary, and neuro
vasculature. |
| Components
Supplied | Sheath, Vessel Dilator,
Hemostasis Valve | Same |
| Catheter Shaft
Material | Polyether Block Amide,
(PEBAX) and
Chronoflex | Same |
| Inner Liner | PTFE | Same |
| Hub Material | Polycarbonate | Same |
| Strain Relief | Polyolefin | Same |
| Catheter Shaft
Reinforcement | Stainless Steel Braid | Stainless Steel Double-
Coil |
| Lubricious Coating | Harland Hydrophilic
Coating | Same |
| Radiopaque Marker
Band | Platinum/ Iridium | Same |
| | Stryker
AXS Infinity LS | InNeuroCo 091 Long Sheath |
| Packaging | Tyvek/Nylon Pouch, polyethylene support tube, packaging card, SBS carton | Same |
| Sterilization | Ethylene Oxide | Same |
| Pyrogenicity | Nonpyrogenic | Same |
| Working Lengths | 70, 80, 90 cm | Same |
| Internal Diameter | 0.088 inches | 0.091 inches |
| Outer Diameter | 0.109 inches | Same |
| Vessel Dilator | Aid in sheath introduction during procedure | Same |
| Hemostasis Valve | Minimizes blood loss | Same |
| Luer Tapered Hub | Yes | Same |
6
091 Long Sheath Performance Testing
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate
Device Testing
(Yes/Unknown) |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Biocompatibility-Material
Mediated Pyrogen | Testing
completed per
ISO 10993-11 | The test article
extracts must not
cause a febrile
reaction greater
than 0.5°C in any
individual subject. | Test results for the
InNeuroCo Super
Distal Access
(K161262) and the
Zenith Catheter
(K171672) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate
Device Testing
(Yes/Unknown) |
| Biocompatibility-
Cytotoxicity MEM Elution | Testing
completed per
ISO 10993-5 | The cultures
treated with the test
article must not
have a reactivity
grade greater than
2. | Test results for the
InNeuroCo Super
Distal Access
(K161262) and the
Zenith Catheter
(K171672) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are
equivalent. Test
articles met the
acceptance
criteria for
Cytotoxicity MEM
Elution. | Yes |
| Biocompatibility-
Hemolysis ASTM
Method, extract human
blood | Testing
completed per
ISO 10993-4 | The hemolytic
index above the
negative control
article must be less
than 5%. | Test results for the
InNeuroCo Super
Distal Access
(K161262) and the
Zenith Catheter
(K171672) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are
equivalent. Test
articles met the
acceptance
criteria for
Hemolysis ASTM | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate
Device Testing
(Yes/Unknown) |
| Biocompatibility-
Hemolysis, ASTM
method, direct contact
(human blood) | Testing
completed per
ISO 10993-4 | The hemolytic
index above the
negative control
article must be less
than 5%. | Method, extract
human blood.
Test results for the
InNeuroCo Super
Distal Access
(K161262) and the
Zenith Catheter
(K171672) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are
equivalent. Test
articles met the
acceptance
criteria for
Hemolysis, ASTM
method, direct
contact (human
blood). | Yes |
| Biocompatibility-
Unactivated Partial
Thromboplastin Time | Testing
completed per
ISO 10993-4 | There must be no
statistical decrease
between the UPTT
of plasma exposed
to the test article
and to the negative
or untreated
control. | Test results for the
InNeuroCo Super
Distal Access
(K161262) and the
Zenith Catheter
(K171672) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are
equivalent. Test
article met the
acceptance
criteria for
Unactivated
Partial
Thromboplastin
Time. | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate
Device Testing
(Yes/Unknown) |
| Biocompatibility-
Complement Activation | Testing
completed per
ISO 10993-4 | There must be no
statistical increase
between either the
C3a or SC5b-9
concentrations in
plasma exposed to
the test article as
compared to the
negative and
untreated controls. | Test results for the
InNeuroCo Super
Distal Access
(K161262) and the
Zenith Catheter
(K171672) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are
equivalent. Test
article met the
acceptance
criteria for
Complement
Activation. | Yes |
| Biocompatibility-Dog
Thrombogenicity | Testing
completed per
ISO 10993-4 | The test articles
must receive a
thrombus formation
score less than or
equal to that of the
control. | Test results for the
InNeuroCo Super
Distal Access
(K161262) and the
Zenith Catheter
(K171672) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are
equivalent. Test
article met the
acceptance
criteria for Dog
Thromboresistanc
e. | Yes |
| Biocompatibility-
Maximization
Sensitization | Testing
completed per
ISO 10993-10 | The test article
must elicit a
positive response
in less than 10% of
the test animals. | Test results for the
InNeuroCo Super
Distal Access
(K161262) and the
Zenith Catheter
(K171672) were | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate
Device Testing
(Yes/Unknown) |
| | | | leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are
equivalent. Test
article met the
acceptance
criteria for
Maximization
Sensitization. | |
| Biocompatibility-
Intracutaneous
Toxicity/Reactivity | Testing
completed per
ISO 10993-10 | The test article
extracts must not
induce a
significantly greater
biological reaction
than the control. | Test results for the
InNeuroCo Super
Distal Access
(K161262) and the
Zenith Catheter
(K171672) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are
equivalent. Test
article met the
acceptance
criteria for
Intracutaneous
Toxicity/Reactivity. | Yes |
| Biocompatibility-Acute
Systemic Toxicity Test | Testing
completed per
ISO 10993-11 | The test article
extracts must not
induce a
significantly greater
biological reaction
than the control. | Test results for the
InNeuroCo Super
Distal Access
(K161262) and the
Zenith Catheter
(K171672) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are
equivalent. Test | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate
Device Testing
(Yes/Unknown) |
| Animal Testing-
Angiographic Evaluation | Product
evaluated within
a porcine model
for clinically
significant
injury. | No units tested can
cause vessel injury. | Test article met
the acceptance
criteria for Animal
Testing-
| Yes |
| Bench Testing -
Chemical Compatibility | Catheter
exposed to
chemicals
readily available
in a clinical
setting. | Chemicals have no
negative effect on
the catheter or
accessories. | Test results for the
InNeuroCo Super
Distal Access
(K161262) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are
equivalent. Test
articles met the
acceptance
criteria for
Chemical
Compatibility | Yes |
| Bench Testing - Visual
Inspection | Testing
completed per
ISO 10555-1 | Catheter shall
appear free from
damage, including
a rounded tip and
smooth transition
points. | 091 Long Sheath
test samples met
the acceptance
criteria for Visual
Inspection. | Yes |
| Bench Testing -
Dimensions | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing
dimensional
specifications. | 091 Long Sheath
test samples met
the acceptance
criterial for
dimensions. Test
results for the | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate
Device Testing
(Yes/Unknown) |
| | | | InNeuroCo Super
Distal Access
(K161262) were
leveraged for the
Hemostasis Valve,
which met the
dimensional
acceptance
criteria. | |
| Bench Testing - Hub
compatibility | Testing
completed per
ISO 594-1 and
ISO 594-2 | Hub shall meet
existing Luer
specifications. | Test results for the
InNeuroCo
Intermediate
Catheter
(K152202) were
leveraged for the
091 Long Sheath
and the Dilator as
the materials and
manufacturing
processes are
equivalent. The
test results for the
Super Distal
Access (K161262)
were leveraged for
the 091 Long
Sheath
Hemostasis Valve.
All tested samples
met the
acceptance
criteria for Hub
compatibility. | Yes |
| Bench Testing - Leak -
Air | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing Air – Leak
specifications. | 091 Long Sheath
test samples met
the acceptance
criteria for Leak -
Air. | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate
Device Testing
(Yes/Unknown) |
| Bench Testing - Leak -
Liquid | Testing
completed per
ISO 10555-1 | Test samples
should be within
existing Leak -
Liquid
specifications. | 091 Long Sheath
test samples met
the acceptance
criteria for Leak -
Liquid. | Yes |
| Bench Testing -
Particulates | Testing
completed per
USP 788 | Test samples
should be within
existing Particulate
specifications. | 091 Long Sheath
test samples met
the acceptance
criteria for
Particulates. | Yes |
| Bench Testing -
Simulated Use | LS underwent
simulated use
testing by a
physician in a
benchtop model | Test samples must
meet
predetermined user
needs | 091 Long Sheath
test samples met
the acceptance
criteria for
Simulated Use -
Bench. | Yes |
| Bench Testing - Catheter
Burst | Testing
completed per
ISO 10555-1 | Test sample burst
pressures must
meet or exceed
existing minimum
burst pressure
specification. | 091 Long Sheath
test samples met
the acceptance
criteria for
Catheter Burst. | Yes |
| Bench Testing - Tensile | Testing
completed per
ISO 10555-1 | Test sample
ultimate tensile
strength must meet
or exceed existing
tensile strength
specifications. | 091 Long Sheath
test samples met
the acceptance
criteria. | Yes |
| Bench Testing -
Corrosion | Testing
completed per
ISO 10555-1 | Test samples shall
exhibit no evidence
of corrosion. | Test results for the
InNeuroCo
Intermediate
Catheter
(K152202) were
leveraged for the
091 Long Sheath
as the materials
and manufacturing
processes are | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate
Device Testing
(Yes/Unknown) |
| Bench Testing -
Packaging - Dye Leak | Testing
completed per
ASTM F1929-
12 | Test sample shall
not exhibit any
visual leaks or
channels | equivalent. All
samples met the
acceptance
criteria.
091 Long Sheath
test samples met
the acceptance
criteria for
Packaging - Dye
Leak. | Yes |
| Bench Testing -
Packaging - Peel | Testing
completed per
ASTM F88-09 | Test sample tensile
strength must meet
or exceed existing
tensile strength
specifications. | 091 Long Sheath
test samples met
the acceptance
criteria for
Packaging - Peel. | Yes |
| Bench Testing - Kink
Resistance | Samples are
subjected to
different
diameters until
kink is
observed. | Test sample kink
resistance must
meet or exceed
existing Kink
Resistance
specifications. | 091 Long Sheath
test samples met
the acceptance
criteria for Kink
Resistance. | Yes |
| Bench Testing - Torque | Conditioned
samples are
torqued to
failure | Test sample torque
results must meet
or exceed existing
torque
specifications. | 091 Long Sheath
test samples met
the acceptance
criteria for Torque. | Yes |
| Bench Testing - PTFE
Liner inspection | LS was
challenged to
demonstrate
liner adherence. | Test sample liner
adhesion must
meet or exceed
existing PTFE Liner
inspection
specifications. | 091 Long Sheath
test samples met
the acceptance
criteria for PTFE
Liner inspection. | Yes |
| Bench Testing -
Hydrophilic Coating
Integrity | Conditioned
samples were
repeatedly
exposed to
friction to | Test sample results
must meet or
exceed existing
Hydrophilic Coating | 091 Long Sheath
test samples met
the acceptance
criteria for | Yes |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions | Predicate
Device Testing
(Yes/Unknown) |
| | demonstrate
that the
hydrophilic
coating is not
affected. | Integrity
specifications. | Hydrophilic
Coating Integrity. | |
| Bench Testing - Labeling
Legibility | Label is legible
after printing. | Test samples shall
demonstrate text
legibility. | 091 Long Sheath
test samples met
the acceptance
criteria for labeling
legibility. | Yes |
| Bench Testing - Barcode | Barcode is
readable with a
standard
barcode reader. | Test samples shall
demonstrate
readily readable
barcodes | 091 Long Sheath
test samples met
the acceptance
criteria for barcode
testing. | Yes |
| Sterilization | ISO 11135 and
AAMI TIR 28 | Sterilization load
shall pose an equal
or lesser challenge
to sterilize than
existing sterile
product loads. | 091 Long Sheath
sterilization load
met the
acceptance
criteria for
sterilization. | Yes |
| Bacterial Endotoxin | AAMIST72 | Test samples must
meet the bacterial
endotoxin
acceptance criteria | The 091 Long
Sheath samples
met the acceptance
criteria for bacterial
endotoxins. | Yes |
| Shelf Life | ASTM F1980 | Aged test samples
must meet or
exceed existing
specifications | 091 Long Sheath
test samples met
the acceptance
criteria for shelf
life. | Yes |
7
8
9
10
11
12
13
14
15
Summary of Non-Clinical Data
The conclusions drawn from the physical, mechanical, and performance testing of the subject 091 Long Sheath along with the data leveraged from other commercially available products demonstrate that the product is Substantially Equivalent to the legally marketed predicate device.