091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm

K172468 · Inneuroco, Inc. · DQY · Dec 6, 2017 · Cardiovascular

Device Facts

• Record ID: K172468
• Device Name: 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
• Applicant: Inneuroco, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.

Device Story

Variable stiffness catheter; reinforced with stainless steel double-coil; PTFE-lined lumen; hydrophilic coating on distal 10 cm; radiopaque Platinum/Iridium marker band. Used in clinical settings by physicians to provide vascular access and a reinforcing conduit for other intravascular devices. Supplied sterile, non-pyrogenic, single-use. Includes Tuohy-Borst Hemostasis Valve and Vessel Dilator. Facilitates navigation and delivery of interventional tools; minimizes blood loss via hemostasis valve; aids introduction via dilator.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993), mechanical performance (ISO 10555-1), chemical compatibility, and simulated use testing. Animal testing (porcine model) performed for angiographic evaluation. All tests met predetermined acceptance criteria.

Technological Characteristics

Variable stiffness catheter; stainless steel double-coil reinforcement; PTFE-lined lumen; hydrophilic coating; Platinum/Iridium marker band. Dimensions: 0.109" OD, 0.091" ID, 70/90 cm lengths. Sterilization: Ethylene Oxide. Standards: ISO 10993 (biocompatibility), ISO 10555-1 (catheter performance), ISO 594-1/2 (Luer), ASTM F1929-12 (packaging), USP 788 (particulates).

Indications for Use

Indicated for introduction of interventional devices into peripheral, coronary, and neuro vasculature.

Regulatory Classification

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.

Predicate Devices

• AXS Infinity LS (K152876)

Reference Devices

• InNeuroCo Super Distal Access (K161262)
• Zenith Catheter (K171672)
• InNeuroCo Intermediate Catheter (K152202)

Submission Summary (Full Text)

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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);

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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 ([e-mail]) or phone [phone] 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

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## 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)

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### 510(k) SUMMARY

#### Submitter's Name and Address

InNeuroCo, Inc. 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: [phone] Facsimile: 1-954-742-5989

#### Contact Information

Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: [phone] Facsimile: 1-954-742-5989 E-Mail: [e-mail]

#### 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

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### 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.

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Comparison to Predicate Device

| | Stryker<br>AXS Infinity LS | InNeuroCo 091 Long<br>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<br>indicated for the<br>introduction of<br>interventional devices<br>into the peripheral,<br>coronary, and neuro<br>vasculature. | The 091 Long Sheath is<br>indicated for the<br>introduction of<br>interventional devices<br>into the peripheral,<br>coronary, and neuro<br>vasculature. |
| Components<br>Supplied | Sheath, Vessel Dilator,<br>Hemostasis Valve | Same |
| Catheter Shaft<br>Material | Polyether Block Amide,<br>(PEBAX) and<br>Chronoflex | Same |
| Inner Liner | PTFE | Same |
| Hub Material | Polycarbonate | Same |
| Strain Relief | Polyolefin | Same |
| Catheter Shaft<br>Reinforcement | Stainless Steel Braid | Stainless Steel Double-<br>Coil |
| Lubricious Coating | Harland Hydrophilic<br>Coating | Same |
| Radiopaque Marker<br>Band | Platinum/ Iridium | Same |
| | Stryker<br>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 |

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## 091 Long Sheath Performance Testing

| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate<br>Device Testing<br>(Yes/Unknown) |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Biocompatibility-Material<br>Mediated Pyrogen | Testing<br>completed per<br>ISO 10993-11 | The test article<br>extracts must not<br>cause a febrile<br>reaction greater<br>than 0.5°C in any<br>individual subject. | Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) and the<br>Zenith Catheter<br>(K171672) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate<br>Device Testing<br>(Yes/Unknown) |
| Biocompatibility-<br>Cytotoxicity MEM Elution | Testing<br>completed per<br>ISO 10993-5 | The cultures<br>treated with the test<br>article must not<br>have a reactivity<br>grade greater than<br>2. | Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) and the<br>Zenith Catheter<br>(K171672) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are<br>equivalent. Test<br>articles met the<br>acceptance<br>criteria for<br>Cytotoxicity MEM<br>Elution. | Yes |
| Biocompatibility-<br>Hemolysis ASTM<br>Method, extract human<br>blood | Testing<br>completed per<br>ISO 10993-4 | The hemolytic<br>index above the<br>negative control<br>article must be less<br>than 5%. | Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) and the<br>Zenith Catheter<br>(K171672) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are<br>equivalent. Test<br>articles met the<br>acceptance<br>criteria for<br>Hemolysis ASTM | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate<br>Device Testing<br>(Yes/Unknown) |
| Biocompatibility-<br>Hemolysis, ASTM<br>method, direct contact<br>(human blood) | Testing<br>completed per<br>ISO 10993-4 | The hemolytic<br>index above the<br>negative control<br>article must be less<br>than 5%. | Method, extract<br>human blood.<br>Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) and the<br>Zenith Catheter<br>(K171672) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are<br>equivalent. Test<br>articles met the<br>acceptance<br>criteria for<br>Hemolysis, ASTM<br>method, direct<br>contact (human<br>blood). | Yes |
| Biocompatibility-<br>Unactivated Partial<br>Thromboplastin Time | Testing<br>completed per<br>ISO 10993-4 | There must be no<br>statistical decrease<br>between the UPTT<br>of plasma exposed<br>to the test article<br>and to the negative<br>or untreated<br>control. | Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) and the<br>Zenith Catheter<br>(K171672) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are<br>equivalent. Test<br>article met the<br>acceptance<br>criteria for<br>Unactivated<br>Partial<br>Thromboplastin<br>Time. | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate<br>Device Testing<br>(Yes/Unknown) |
| Biocompatibility-<br>Complement Activation | Testing<br>completed per<br>ISO 10993-4 | There must be no<br>statistical increase<br>between either the<br>C3a or SC5b-9<br>concentrations in<br>plasma exposed to<br>the test article as<br>compared to the<br>negative and<br>untreated controls. | Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) and the<br>Zenith Catheter<br>(K171672) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are<br>equivalent. Test<br>article met the<br>acceptance<br>criteria for<br>Complement<br>Activation. | Yes |
| Biocompatibility-Dog<br>Thrombogenicity | Testing<br>completed per<br>ISO 10993-4 | The test articles<br>must receive a<br>thrombus formation<br>score less than or<br>equal to that of the<br>control. | Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) and the<br>Zenith Catheter<br>(K171672) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are<br>equivalent. Test<br>article met the<br>acceptance<br>criteria for Dog<br>Thromboresistanc<br>e. | Yes |
| Biocompatibility-<br>Maximization<br>Sensitization | Testing<br>completed per<br>ISO 10993-10 | The test article<br>must elicit a<br>positive response<br>in less than 10% of<br>the test animals. | Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) and the<br>Zenith Catheter<br>(K171672) were | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate<br>Device Testing<br>(Yes/Unknown) |
| | | | leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are<br>equivalent. Test<br>article met the<br>acceptance<br>criteria for<br>Maximization<br>Sensitization. | |
| Biocompatibility-<br>Intracutaneous<br>Toxicity/Reactivity | Testing<br>completed per<br>ISO 10993-10 | The test article<br>extracts must not<br>induce a<br>significantly greater<br>biological reaction<br>than the control. | Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) and the<br>Zenith Catheter<br>(K171672) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are<br>equivalent. Test<br>article met the<br>acceptance<br>criteria for<br>Intracutaneous<br>Toxicity/Reactivity. | Yes |
| Biocompatibility-Acute<br>Systemic Toxicity Test | Testing<br>completed per<br>ISO 10993-11 | The test article<br>extracts must not<br>induce a<br>significantly greater<br>biological reaction<br>than the control. | Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) and the<br>Zenith Catheter<br>(K171672) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are<br>equivalent. Test | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate<br>Device Testing<br>(Yes/Unknown) |
| Animal Testing-<br>Angiographic Evaluation | Product<br>evaluated within<br>a porcine model<br>for clinically<br>significant<br>injury. | No units tested can<br>cause vessel injury. | Test article met<br>the acceptance<br>criteria for Animal<br>Testing-<br> | Yes |
| Bench Testing -<br>Chemical Compatibility | Catheter<br>exposed to<br>chemicals<br>readily available<br>in a clinical<br>setting. | Chemicals have no<br>negative effect on<br>the catheter or<br>accessories. | Test results for the<br>InNeuroCo Super<br>Distal Access<br>(K161262) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are<br>equivalent. Test<br>articles met the<br>acceptance<br>criteria for<br>Chemical<br>Compatibility | Yes |
| Bench Testing - Visual<br>Inspection | Testing<br>completed per<br>ISO 10555-1 | Catheter shall<br>appear free from<br>damage, including<br>a rounded tip and<br>smooth transition<br>points. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for Visual<br>Inspection. | Yes |
| Bench Testing -<br>Dimensions | Testing<br>completed per<br>ISO 10555-1 | Test samples<br>should be within<br>existing<br>dimensional<br>specifications. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criterial for<br>dimensions. Test<br>results for the | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate<br>Device Testing<br>(Yes/Unknown) |
| | | | InNeuroCo Super<br>Distal Access<br>(K161262) were<br>leveraged for the<br>Hemostasis Valve,<br>which met the<br>dimensional<br>acceptance<br>criteria. | |
| Bench Testing - Hub<br>compatibility | Testing<br>completed per<br>ISO 594-1 and<br>ISO 594-2 | Hub shall meet<br>existing Luer<br>specifications. | Test results for the<br>InNeuroCo<br>Intermediate<br>Catheter<br>(K152202) were<br>leveraged for the<br>091 Long Sheath<br>and the Dilator as<br>the materials and<br>manufacturing<br>processes are<br>equivalent. The<br>test results for the<br>Super Distal<br>Access (K161262)<br>were leveraged for<br>the 091 Long<br>Sheath<br>Hemostasis Valve.<br>All tested samples<br>met the<br>acceptance<br>criteria for Hub<br>compatibility. | Yes |
| Bench Testing - Leak -<br>Air | Testing<br>completed per<br>ISO 10555-1 | Test samples<br>should be within<br>existing Air – Leak<br>specifications. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for Leak -<br>Air. | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate<br>Device Testing<br>(Yes/Unknown) |
| Bench Testing - Leak -<br>Liquid | Testing<br>completed per<br>ISO 10555-1 | Test samples<br>should be within<br>existing Leak -<br>Liquid<br>specifications. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for Leak -<br>Liquid. | Yes |
| Bench Testing -<br>Particulates | Testing<br>completed per<br>USP 788 | Test samples<br>should be within<br>existing Particulate<br>specifications. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for<br>Particulates. | Yes |
| Bench Testing -<br>Simulated Use | LS underwent<br>simulated use<br>testing by a<br>physician in a<br>benchtop model | Test samples must<br>meet<br>predetermined user<br>needs | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for<br>Simulated Use -<br>Bench. | Yes |
| Bench Testing - Catheter<br>Burst | Testing<br>completed per<br>ISO 10555-1 | Test sample burst<br>pressures must<br>meet or exceed<br>existing minimum<br>burst pressure<br>specification. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for<br>Catheter Burst. | Yes |
| Bench Testing - Tensile | Testing<br>completed per<br>ISO 10555-1 | Test sample<br>ultimate tensile<br>strength must meet<br>or exceed existing<br>tensile strength<br>specifications. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria. | Yes |
| Bench Testing -<br>Corrosion | Testing<br>completed per<br>ISO 10555-1 | Test samples shall<br>exhibit no evidence<br>of corrosion. | Test results for the<br>InNeuroCo<br>Intermediate<br>Catheter<br>(K152202) were<br>leveraged for the<br>091 Long Sheath<br>as the materials<br>and manufacturing<br>processes are | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate<br>Device Testing<br>(Yes/Unknown) |
| Bench Testing -<br>Packaging - Dye Leak | Testing<br>completed per<br>ASTM F1929-<br>12 | Test sample shall<br>not exhibit any<br>visual leaks or<br>channels | equivalent. All<br>samples met the<br>acceptance<br>criteria.<br>091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for<br>Packaging - Dye<br>Leak. | Yes |
| Bench Testing -<br>Packaging - Peel | Testing<br>completed per<br>ASTM F88-09 | Test sample tensile<br>strength must meet<br>or exceed existing<br>tensile strength<br>specifications. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for<br>Packaging - Peel. | Yes |
| Bench Testing - Kink<br>Resistance | Samples are<br>subjected to<br>different<br>diameters until<br>kink is<br>observed. | Test sample kink<br>resistance must<br>meet or exceed<br>existing Kink<br>Resistance<br>specifications. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for Kink<br>Resistance. | Yes |
| Bench Testing - Torque | Conditioned<br>samples are<br>torqued to<br>failure | Test sample torque<br>results must meet<br>or exceed existing<br>torque<br>specifications. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for Torque. | Yes |
| Bench Testing - PTFE<br>Liner inspection | LS was<br>challenged to<br>demonstrate<br>liner adherence. | Test sample liner<br>adhesion must<br>meet or exceed<br>existing PTFE Liner<br>inspection<br>specifications. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for PTFE<br>Liner inspection. | Yes |
| Bench Testing -<br>Hydrophilic Coating<br>Integrity | Conditioned<br>samples were<br>repeatedly<br>exposed to<br>friction to | Test sample results<br>must meet or<br>exceed existing<br>Hydrophilic Coating | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for | Yes |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions | Predicate<br>Device Testing<br>(Yes/Unknown) |
| | demonstrate<br>that the<br>hydrophilic<br>coating is not<br>affected. | Integrity<br>specifications. | Hydrophilic<br>Coating Integrity. | |
| Bench Testing - Labeling<br>Legibility | Label is legible<br>after printing. | Test samples shall<br>demonstrate text<br>legibility. | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for labeling<br>legibility. | Yes |
| Bench Testing - Barcode | Barcode is<br>readable with a<br>standard<br>barcode reader. | Test samples shall<br>demonstrate<br>readily readable<br>barcodes | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for barcode<br>testing. | Yes |
| Sterilization | ISO 11135 and<br>AAMI TIR 28 | Sterilization load<br>shall pose an equal<br>or lesser challenge<br>to sterilize than<br>existing sterile<br>product loads. | 091 Long Sheath<br>sterilization load<br>met the<br>acceptance<br>criteria for<br>sterilization. | Yes |
| Bacterial Endotoxin | AAMIST72 | Test samples must<br>meet the bacterial<br>endotoxin<br>acceptance criteria | The 091 Long<br>Sheath samples<br>met the acceptance<br>criteria for bacterial<br>endotoxins. | Yes |
| Shelf Life | ASTM F1980 | Aged test samples<br>must meet or<br>exceed existing<br>specifications | 091 Long Sheath<br>test samples met<br>the acceptance<br>criteria for shelf<br>life. | Yes |

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#### 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.