Who is the manufacturer of Super Distal Access (SDA)?

Inneuroco, Inc. filed the 510(k) submission for Super Distal Access (SDA) (K161262).

What is the FDA product code for Super Distal Access (SDA)?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Super Distal Access (SDA)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Super Distal Access (SDA)?

INTERMEDIATE CATHETER (K152202).

Who can help prepare an FDA 510(k) submission like Super Distal Access (SDA)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Super Distal Access (SDA)

K161262 · Inneuroco, Inc. · DQY · Sep 19, 2016 · Cardiovascular

Device Facts

Record ID	K161262
Device Name	Super Distal Access (SDA)
Applicant	Inneuroco, Inc.
Product Code	DQY · Cardiovascular
Decision Date	Sep 19, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Indications for Use

The Super Distal Access (SDA) is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Device Story

Super Distal Access (SDA) is a single-lumen, variable-stiffness catheter; used for accessing peripheral and neuro vasculature; inserted via guide catheter or vascular sheath; provides reinforcing conduit for other intravascular devices. Features stainless steel/Nitinol coil-reinforced shaft; radiopaque Platinum/Iridium distal marker; hydrophilic coating; PTFE-lined distal lumen; Polyimide/PTFE-lined proximal lumen. Operated by physicians in clinical settings. Accessories include Tuohy-Borst hemostasis valve and split sheath introducer. Device facilitates delivery of interventional tools to target sites, potentially improving procedural access and patient outcomes.

Clinical Evidence

Bench testing only. No human clinical data. Testing included biocompatibility (ISO 10993-1, -4, -5, -10, -11), mechanical performance (ISO 10555-1), and simulated use in a benchtop model. Animal testing (porcine model) performed for angiographic evaluation to confirm no vessel injury. All tests met predetermined acceptance criteria.

Technological Characteristics

Single-lumen catheter; stainless steel/Nitinol coil reinforcement; Platinum/Iridium radiopaque marker; PTFE/Polyimide liners; hydrophilic coating; Polycarbonate hub; Polyolefin strain relief. Dimensions: 115-135 cm length, 0.084" max OD. Sterilization: Ethylene Oxide. Standards: ISO 10993 (biocompatibility), ISO 10555-1 (catheter performance), ISO 594-1/2 (Luer), ASTM F1929/F88 (packaging).

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neuro vasculature for patients requiring such access.

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

INTERMEDIATE CATHETER (K152202)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 image of a stylized eagle or bird, formed by three human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 19, 2016 InNeuroCo, Inc. Ms. Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs 4635 NW 103td Avenue Sunrise. Florida 33351 Re: K161262 Trade/Device Name: Super Distal Access (SDA) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, DTL Dated: August 15, 2016 Received: August 17, 2016 Dear Ms. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Michael J.Hoffmann -A - for Carlos L. Peña, Ph.D., M.S. 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) K161262 Device Name Super Distal Access (SDA) Indications for Use (Describe) The Super Distal Access (SDA) is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. 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 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: 1-305-495-3883 Facsimile: 1-954-742-5989 E-Mail: Marianne@InNeuroCo.com Date Prepared September 16, 2016 Device Trade or Proprietary Name Super Distal Access (SDA) Device Common or Classification Name: Catheter, Percutaneous, 21CFR870.1250, Class II Hemostasis Valve, 21CFR870.4290, Class II {4}------------------------------------------------ #### Product Code: DQY(Catheter) DTL (Hemostasis Valve) #### Identification of the Legally Marketed Devices to which Equivalence is Being Claimed | Name of Predicate Device | Name of Manufacturer | 510(k) Number | |--------------------------|----------------------|---------------| | INTERMEDIATE CATHETER | InNeuroCo | K152202 | #### Device Description The Super Distal Access (SDA) is a single lumen, variable stiffness catheter and has a shaft reinforced with a Stainless Steel/Nitinol coil. The SDA has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a maximum outer diameter of 0.084 inches. It has a tapered design that includes a nominal inner diameter of 0.062 inches in the distal end and 0.068 inches in the proximal end. There are three working lengths available: 115 cm, 125 cm, and 135 cm. The Super Distal Access has a PTFE-lined lumen in the distal end a Polyimide/PTFE-lined lumen in the proximal end. The catheter is flexible and has a hydrophilic coating. The SDA is inserted through a guide catheter or vascular sheath, provides 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 with an extension luer and a split sheath introducer. The SDA is supplied sterile, non-pyrogenic, and intended for single use only. #### Indications for Use The Super Distal Access (SDA) is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. {5}------------------------------------------------ ## Comparison to Predicate Device | | Predicate Device InNeuroCo, Inc. Intermediate Catheter | InNeuroCo, Inc. Super Distal Access | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K152202 | K161262 | | Classification | 21CFR870.1250, Class II | 21CFR870.1250, Class II | | Product Code | DQY | DQY | | Review Panel | Cardiovascular | Cardiovascular | | Indication For Use | The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. | The Super Distal Access (SDA) is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. | | Components Supplied | Catheter, Peel Away Introducer, Hemostasis Valve | Catheter, Peel Away Introducer, Hemostasis Valve | | Catheter Shaft Material | Polyimide, Polyether Block Amide (PEBAX), PET, Polycarbonate/Urethane, Nylon | Polyimide, Polyether Block Amide (PEBAX), PET, Polycarbonate/Urethane | | Inner Liner | PTFE | Distal: PTFE Proximal: PTFE/Polyimide | | Hub Material | Polycarbonate | Polycarbonate | | Strain Relief | Polyolefin | Polyolefin | | Catheter Shaft Reinforcement | Stainless Steel/Nitinol | Stainless Steel/Nitinol | | Lubricious Coating | Hydrophilic Coating | Hydrophilic Coating | | Radiopaque Marker Band | Platinum/ Iridium | Platinum/ Iridium | | Packaging | Tyvek/Nylon Pouch, polyethylene support hoop, packaging card, SBS Carton | Tyvek/Nylon Pouch, polyethylene support hoop, packaging card, SBS Carton | | | Predicate Device InNeuroCo, Inc. Intermediate Catheter | InNeuroCo, Inc. Super Distal Access | | Sterilization | Ethylene Oxide | Ethylene Oxide | | Pyrogenicity | Nonpyrogenic | Nonpyrogenic | | Working Lengths | 105, 115, 125 cm | 115, 125, 135 cm | | Compatible Guidewire | 0.038 inches | 0.038 inches | | Internal Diameter | 0.060 inches distal 0.062 inches proximal | 0.062 inches distal 0.068 inches proximal | | Proximal Outer Diameter | 0.079 inches | 0.084 inches | | Distal Outer Diameter | 0.072 inches | 0.078 inches | | Shelf Life | 3 years | 3 years | | Split Sheath Introducer | Aid in catheter introduction during procedure | Aid in catheter introduction during procedure | | Hemostasis Valve | Minimizes blood loss | Minimizes blood loss | | Luer Tapered Hub | Yes | Yes | {6}------------------------------------------------ #### Summary of Non Clinical Data Biocompatibility tests conducted with the Super Distal Access (SDA) and its accessories were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for limited duration (<24 hours), external communicating devices, contacting blood. Studies were conducted pursuant to 21CFR58, Good Laboratory Practices. Biocompatibility testing found the Super Distal Access and its accessories to be biocompatible and non-pyrogenic. The conclusions drawn from the physical, mechanical, and performance testing of the subject SDA and accessories demonstrates that the product is Substantially Equivalent to the legally marketed predicate device. {7}------------------------------------------------ Super Distal Access Performance Testing | Test | Test Method Summary | Acceptance Criteria | Conclusions | |---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | SDA test samples met the acceptance criteria for Material Mediated Pyrogen to demonstrate that the SDA is substantially equivalent to the predicate device. | | 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. | SDA test samples met the acceptance criteria for Cytotoxicity MEM Elution to demonstrate that the SDA is substantially equivalent to the predicate device. | | 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%. | SDA test samples met the acceptance criteria for Hemolysis ASTM Method, extract human blood to demonstrate that the SDA is substantially equivalent to the predicate device. | | 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%. | SDA test samples met the acceptance criteria for Hemolysis, ASTM method, direct contact (human blood) to demonstrate that the SDA is substantially equivalent to the predicate device. | | 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. | SDA test samples met the acceptance criteria for Unactivated Partial Thromboplastin Time to demonstrate that the SDA is substantially equivalent to the predicate device. | | Test | Test Method Summary | Acceptance Criteria | Conclusions | | 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. | SDA test samples met the acceptance criteria for Complement Activation to demonstrate that the SDA is substantially equivalent to the predicate device. | | Biocompatibility-Dog Thromboresistance | Testing completed per ISO 10993-4 | The test articles must receive a thrombus formation score less than or equal to that of the control. | SDA test samples met the acceptance criteria for Dog Thromboresistance to demonstrate that the SDA is substantially equivalent to the predicate device. | | 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. | SDA test samples met the acceptance criteria for Maximization Sensitization to demonstrate that the SDA is substantially equivalent to the predicate device. | | 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. | SDA test samples met the acceptance criteria for Intracutaneous Toxicity/Reactivity to demonstrate that the SDA is substantially equivalent to the predicate device. | | 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. | SDA test samples met the acceptance criteria for Acute Systemic Toxicity Test to demonstrate that the SDA is substantially equivalent to the predicate device. | | Test | Test Method Summary | Acceptance Criteria | Conclusions | | Animal Testing- Angiographic Evaluation | Product evaluated within a porcine model for clinically significant injury. | No units tested can cause vessel injury. | SDA test samples met the acceptance criteria for Animal Testing- Angiographic Evaluation to demonstrate that the SDA is substantially equivalent to the predicate device. | | Chemical Compatibility | Catheter exposed to chemicals readily available in a clinical setting. | Chemicals have no negative effect on the catheter or accessories. | SDA test samples met the acceptance criteria for Chemical Compatibility to demonstrate that the SDA is substantially equivalent to the predicate device. | | Radiographic Detectability | Testing completed per ISO 10555-1 | Product shall be visible under fluoro imaging. | SDA test samples met the acceptance criteria for Radiographic Detectability to demonstrate that the SDA is substantially equivalent to the predicate device. | | Visual Inspection | Testing completed per ISO 10555-1 | Catheter shall appear free from damage, including a rounded tip and smooth transition points. | SDA test samples met the acceptance criteria for Visual Inspection to demonstrate that the SDA is substantially equivalent to the predicate device. | | Working Length | Testing completed per ISO 10555-1 | Test samples should be within existing working length specification. | SDA test samples met the acceptance criteria for Working Length to demonstrate that the SDA is substantially equivalent to the predicate device. | | Test | Test Method Summary | Acceptance Criteria | Conclusions | | Hub compatibility | Testing completed per ISO 594-1 and ISO 594-2 | Hub shall meet existing Luer specifications. | SDA test samples met the acceptance criteria for Hub compatibility to demonstrate that the SDA is substantially equivalent to the predicate device. | | Outside diameter | Testing completed per ISO 10555-1 | Test samples should be within existing outside diameter specification. | SDA test samples met the acceptance criteria for Outside diameter to demonstrate that the SDA is substantially equivalent to the predicate device. | | Leak - Air | Testing completed per ISO 10555-1 | Test samples should be within existing Air - Leak specifications. | SDA test samples met the acceptance criteria for Leak - Air to demonstrate that the SDA is substantially equivalent to the predicate device. | | Leak — Liquid | Testing completed per ISO 10555-1 | Test samples should be within existing Leak - Liquid specifications. | SDA test samples met the acceptance criteria for Leak – Liquid to demonstrate that the SDA is substantially equivalent to the predicate device. | | Particulates | Testing completed per USP 788 | Test samples should be within existing Particulate specifications. | SDA test samples met the acceptance criteria for Particulates to demonstrate that the SDA is substantially equivalent to the predicate device. | | Simulated Use - Bench | SDA underwent simulated use testing by a physician in a benchtop model | Test samples must meet predetermined user needs | SDA test samples met the acceptance criteria for Simulated Use - Bench to demonstrate that the SDA | | Test | Test Method Summary | Acceptance Criteria | Conclusions | | | | | is substantially equivalent to the predicate device. | | Catheter Burst | Testing completed per ISO 10555-1 | Test sample burst pressures must meet or exceed existing minimum burst pressure specification. | SDA test samples met the acceptance criteria for Catheter Burst to demonstrate that the SDA is substantially equivalent to the predicate device. | | Tensile | Testing completed per ISO 10555-1 | Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications. | SDA test samples met the acceptance criteria for Tensile to demonstrate that the SDA is substantially equivalent to the predicate device. | | Corrosion | Testing completed per ISO 10555-1 | Test samples shall exhibit no evidence of corrosion. | Test results for the predicate device were leveraged for the SDA as the materials and manufacturing processes are equivalent. | | Packaging - Dye Leak | Testing completed per ASTM F1929-12 | Test sample shall not exhibit any visual leaks or channels | Test results for the predicate device were leveraged for the SDA as the materials and manufacturing processes are equivalent. | | Packaging - Peel | Testing completed per ASTM F88-09 | Test sample tensile strength must meet or exceed existing tensile strength specifications. | Test results for the predicate device were leveraged for the SDA as the materials and manufacturing processes are equivalent. | | Test | Test Method Summary | Acceptance Criteria | Conclusions | | Kink Resistance | Samples are subjected to different diameters until kink is observed. | Test sample kink resistance must meet or exceed existing Kink Resistance specifications. | SDA test samples met the acceptance criteria for Kink Resistance to demonstrate that the SDA is substantially equivalent to the predicate device. | | Torque | Conditioned samples are torqued to failure | Test sample torque results must meet or exceed existing torque specifications. | SDA test samples met the acceptance criteria for Torque to demonstrate that the SDA is substantially equivalent to the predicate device. | | PTFE Liner inspection | SDA was challenged to demonstrate liner adherence. | Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications. | SDA test samples met the acceptance criteria for PTFE Liner inspection to demonstrate that the SDA is substantially equivalent to the predicate device. | | Hydrophilic Coating Integrity | Conditioned samples were repeatedly exposed to friction to demonstrate that the hydrophilic coating is not affected. | Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications. | SDA test samples met the acceptance criteria for Hydrophilic Coating Integrity to demonstrate that the SDA is substantially equivalent to the predicate device. | | Labeling Legibility | Label is legible after printing. | Test samples shall demonstrate text legibility . | SDA test samples met the acceptance criteria for labeling legibility to demonstrate that the SDA is substantially equivalent to the predicate device. | | Barcode | Barcode is readable with a standard barcode reader. | Test samples shall demonstrate readily readable barcodes | SDA test samples met the acceptance criteria for barcode testing to demonstrate that the SDA is substantially equivalent to the predicate device. | | Test | Test Method Summary | Acceptance Criteria | Conclusions | | Sterilization | ISO 11135 and AAMI TIR 28 | Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads. | SDA sterilization load met the acceptance criteria for sterilization to demonstrate that the SDA is substantially equivalent to the predicate device. | | Shelf Life | ASTM F1980 | Aged test samples must meet or exceed existing specifications | SDA test samples met the acceptance criteria for shelf life to demonstrate that the SDA is substantially equivalent to the predicate device. | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------

Super Distal Access (SDA)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Super Distal Access (SDA)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Submission Summary (Full Text)

Panel 1

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