(137 days)
The Super Distal Access (SDA) is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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.
The provided text describes the non-clinical performance testing for the Super Distal Access (SDA) device to demonstrate its substantial equivalence to a predicate device. It includes acceptance criteria and conclusions for various tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Biocompatibility - Material Mediated Pyrogen | 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 | 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 | 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) | 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 | 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. |
| Biocompatibility - Complement Activation | 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 | 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 | 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 | 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 | 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. |
| Animal Testing - Angiographic Evaluation | 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 | 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 | 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 | 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 | 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. |
| Hub compatibility | 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 | 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 | 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 | 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 | 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 | Test samples must meet predetermined user needs. | SDA test samples met the acceptance criteria for Simulated Use - Bench to demonstrate that the SDA is substantially equivalent to the predicate device. |
| Catheter Burst | 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 | 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 | 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 | 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 | 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. |
| Kink Resistance | 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 | 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 | 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 | 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 | 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 | 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. |
| Sterilization | 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 | 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. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document repeatedly states "SDA test samples met the acceptance criteria". However, it does not specify the exact sample size (N) used for each test.
- Data Provenance: The biocompatibility tests were "conducted pursuant to 21CFR58, Good Laboratory Practices." The animal testing occurred in a "porcine model". Other non-clinical tests mention "conditioned samples" or "test samples". The origin of the data (country) is not explicitly stated, but the submission is to the U.S. FDA. The tests are prospective as they were conducted for the purpose of this submission to demonstrate substantial equivalence of the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- For the "Simulated Use - Bench" test, it states the product was evaluated "by a physician in a benchtop model." It does not specify the number or qualifications of this physician or any other experts involved in establishing ground truth for other tests. These appear to be laboratory and engineering tests rather than requiring expert clinical "ground truth" in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method. The tests are primarily objective performance metrics against pre-defined acceptance criteria, not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this document does not describe an MRMC comparative effectiveness study. This is a 510(k) submission for a medical catheter (Super Distal Access), not an AI-powered diagnostic device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this document does not describe any algorithm-only or human-in-the-loop performance studies. As mentioned, this is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by objective measurements and observations against engineering standards, biocompatibility guidelines (e.g., ISO 10993 series, ASTM standards, USP 788), and pre-defined specifications. For example, for "Biocompatibility - Material Mediated Pyrogen", the ground truth is the measured febrile reaction in test subjects. For "Radiographic Detectability", the ground truth is visibility under fluoro imaging. In some cases, such as "Animal Testing - Angiographic Evaluation", the "ground truth" is absence of vessel injury observed in a porcine model.
8. The sample size for the training set:
- This concept is not applicable here. This is a physical medical device undergoing non-clinical performance testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- This concept is not applicable here, as there is no training set for a machine learning model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract 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
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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)
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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
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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.
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Comparison to Predicate Device
| Predicate DeviceInNeuroCo, 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 isindicated for the introductionof interventional devices intothe peripheral and neurovasculature. | The Super Distal Access (SDA)is indicated for the introductionof interventional devices into theperipheral and neurovasculature. |
| Components Supplied | Catheter, Peel AwayIntroducer, Hemostasis Valve | Catheter, Peel AwayIntroducer, Hemostasis Valve |
| Catheter Shaft Material | Polyimide, Polyether BlockAmide (PEBAX), PET,Polycarbonate/Urethane,Nylon | Polyimide, Polyether BlockAmide (PEBAX), PET,Polycarbonate/Urethane |
| Inner Liner | PTFE | Distal: PTFEProximal: PTFE/Polyimide |
| Hub Material | Polycarbonate | Polycarbonate |
| Strain Relief | Polyolefin | Polyolefin |
| Catheter ShaftReinforcement | Stainless Steel/Nitinol | Stainless Steel/Nitinol |
| Lubricious Coating | Hydrophilic Coating | Hydrophilic Coating |
| Radiopaque MarkerBand | 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 DeviceInNeuroCo, 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 distal0.062 inches proximal | 0.062 inches distal0.068 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 introductionduring procedure | Aid in catheter introductionduring procedure |
| Hemostasis Valve | Minimizes blood loss | Minimizes blood loss |
| Luer Tapered Hub | Yes | Yes |
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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.
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Super Distal Access Performance Testing
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
|---|---|---|---|
| Biocompatibility-Material MediatedPyrogen | Testing completedper ISO 10993-11 | The test article extractsmust not cause a febrilereaction greater than0.5°C in any individualsubject. | SDA test samples met theacceptance criteria forMaterial MediatedPyrogen to demonstratethat the SDA issubstantially equivalent tothe predicate device. |
| Biocompatibility-Cytotoxicity MEMElution | Testing completedper ISO 10993-5 | The cultures treated withthe test article must nothave a reactivity gradegreater than 2. | SDA test samples met theacceptance criteria forCytotoxicity MEM Elutionto demonstrate that theSDA is substantiallyequivalent to the predicatedevice. |
| Biocompatibility-Hemolysis ASTMMethod, extract humanblood | Testing completedper ISO 10993-4 | The hemolytic indexabove the negativecontrol article must beless than 5%. | SDA test samples met theacceptance criteria forHemolysis ASTM Method,extract human blood todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Biocompatibility-Hemolysis, ASTMmethod, direct contact(human blood) | Testing completedper ISO 10993-4 | The hemolytic indexabove the negativecontrol article must beless than 5%. | SDA test samples met theacceptance criteria forHemolysis, ASTMmethod, direct contact(human blood) todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Biocompatibility-Unactivated PartialThromboplastin Time | Testing completedper ISO 10993-4 | There must be nostatistical decreasebetween the UPTT ofplasma exposed to thetest article and to thenegative or untreatedcontrol. | SDA test samples met theacceptance criteria forUnactivated PartialThromboplastin Time todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Biocompatibility-ComplementActivation | Testing completedper ISO 10993-4 | There must be nostatistical increasebetween either the C3aor SC5b-9concentrations in plasmaexposed to the testarticle as compared tothe negative anduntreated controls. | SDA test samples met theacceptance criteria forComplement Activation todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Biocompatibility-DogThromboresistance | Testing completedper ISO 10993-4 | The test articles mustreceive a thrombusformation score less thanor equal to that of thecontrol. | SDA test samples met theacceptance criteria forDog Thromboresistanceto demonstrate that theSDA is substantiallyequivalent to the predicatedevice. |
| Biocompatibility-MaximizationSensitization | Testing completedper ISO 10993-10 | The test article mustelicit a positive responsein less than 10% of thetest animals. | SDA test samples met theacceptance criteria forMaximizationSensitization todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Biocompatibility-IntracutaneousToxicity/Reactivity | Testing completedper ISO 10993-10 | The test article extractsmust not induce asignificantly greaterbiological reaction thanthe control. | SDA test samples met theacceptance criteria forIntracutaneousToxicity/Reactivity todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Biocompatibility-AcuteSystemic Toxicity Test | Testing completedper ISO 10993-11 | The test article extractsmust not induce asignificantly greaterbiological reaction thanthe control. | SDA test samples met theacceptance criteria forAcute Systemic ToxicityTest to demonstrate thatthe SDA is substantiallyequivalent to the predicatedevice. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Animal Testing-AngiographicEvaluation | Product evaluatedwithin a porcinemodel for clinicallysignificant injury. | No units tested cancause vessel injury. | SDA test samples met theacceptance criteria forAnimal Testing-Angiographic Evaluationto demonstrate that theSDA is substantiallyequivalent to the predicatedevice. |
| Chemical Compatibility | Catheter exposed tochemicals readilyavailable in a clinicalsetting. | Chemicals have nonegative effect on thecatheter or accessories. | SDA test samples met theacceptance criteria forChemical Compatibility todemonstrate that the SDAis substantially equivalentto the predicate device. |
| RadiographicDetectability | Testing completedper ISO 10555-1 | Product shall be visibleunder fluoro imaging. | SDA test samples met theacceptance criteria forRadiographic Detectabilityto demonstrate that theSDA is substantiallyequivalent to the predicatedevice. |
| Visual Inspection | Testing completedper ISO 10555-1 | Catheter shall appearfree from damage,including a rounded tipand smooth transitionpoints. | SDA test samples met theacceptance criteria forVisual Inspection todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Working Length | Testing completedper ISO 10555-1 | Test samples should bewithin existing workinglength specification. | SDA test samples met theacceptance criteria forWorking Length todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Hub compatibility | Testing completedper ISO 594-1 andISO 594-2 | Hub shall meet existingLuer specifications. | SDA test samples met theacceptance criteria forHub compatibility todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Outside diameter | Testing completedper ISO 10555-1 | Test samples should bewithin existing outsidediameter specification. | SDA test samples met theacceptance criteria forOutside diameter todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Leak - Air | Testing completedper ISO 10555-1 | Test samples should bewithin existing Air - Leakspecifications. | SDA test samples met theacceptance criteria forLeak - Air to demonstratethat the SDA issubstantially equivalent tothe predicate device. |
| Leak — Liquid | Testing completedper ISO 10555-1 | Test samples should bewithin existing Leak -Liquid specifications. | SDA test samples met theacceptance criteria forLeak – Liquid todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Particulates | Testing completedper USP 788 | Test samples should bewithin existing Particulatespecifications. | SDA test samples met theacceptance criteria forParticulates todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Simulated Use - Bench | SDA underwentsimulated use testingby a physician in abenchtop model | Test samples must meetpredetermined userneeds | SDA test samples met theacceptance criteria forSimulated Use - Bench todemonstrate that the SDA |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| is substantially equivalentto the predicate device. | |||
| Catheter Burst | Testing completedper ISO 10555-1 | Test sample burstpressures must meet orexceed existing minimumburst pressurespecification. | SDA test samples met theacceptance criteria forCatheter Burst todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Tensile | Testing completedper ISO 10555-1 | Test sample ultimatetensile strength mustmeet or exceed existingtensile strengthspecifications. | SDA test samples met theacceptance criteria forTensile to demonstratethat the SDA issubstantially equivalent tothe predicate device. |
| Corrosion | Testing completedper ISO 10555-1 | Test samples shallexhibit no evidence ofcorrosion. | Test results for thepredicate device wereleveraged for the SDA asthe materials andmanufacturing processesare equivalent. |
| Packaging - Dye Leak | Testing completedper ASTM F1929-12 | Test sample shall notexhibit any visual leaksor channels | Test results for thepredicate device wereleveraged for the SDA asthe materials andmanufacturing processesare equivalent. |
| Packaging - Peel | Testing completedper ASTM F88-09 | Test sample tensilestrength must meet orexceed existing tensilestrength specifications. | Test results for thepredicate device wereleveraged for the SDA asthe materials andmanufacturing processesare equivalent. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Kink Resistance | Samples aresubjected to differentdiameters until kinkis observed. | Test sample kinkresistance must meet orexceed existing KinkResistancespecifications. | SDA test samples met theacceptance criteria forKink Resistance todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Torque | Conditioned samplesare torqued to failure | Test sample torqueresults must meet orexceed existing torquespecifications. | SDA test samples met theacceptance criteria forTorque to demonstratethat the SDA issubstantially equivalent tothe predicate device. |
| PTFE Liner inspection | SDA was challengedto demonstrate lineradherence. | Test sample lineradhesion must meet orexceed existing PTFELiner inspectionspecifications. | SDA test samples met theacceptance criteria forPTFE Liner inspection todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Hydrophilic CoatingIntegrity | Conditioned sampleswere repeatedlyexposed to friction todemonstrate that thehydrophilic coating isnot affected. | Test sample results mustmeet or exceed existingHydrophilic CoatingIntegrity specifications. | SDA test samples met theacceptance criteria forHydrophilic CoatingIntegrity to demonstratethat the SDA issubstantially equivalent tothe predicate device. |
| Labeling Legibility | Label is legible afterprinting. | Test samples shalldemonstrate textlegibility . | SDA test samples met theacceptance criteria forlabeling legibility todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Barcode | Barcode is readablewith a standardbarcode reader. | Test samples shalldemonstrate readilyreadable barcodes | SDA test samples met theacceptance criteria forbarcode testing todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Sterilization | ISO 11135 andAAMI TIR 28 | Sterilization load shallpose an equal or lesserchallenge to sterilizethan existing sterileproduct loads. | SDA sterilization load metthe acceptance criteria forsterilization todemonstrate that the SDAis substantially equivalentto the predicate device. |
| Shelf Life | ASTM F1980 | Aged test samples mustmeet or exceed existingspecifications | SDA test samples met theacceptance criteria forshelf life to demonstratethat the SDA issubstantially equivalent tothe predicate device. |
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§ 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).