(265 days)
The Jet Power Injectable PICC is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter.
The maximum recommended infusion rate varies by catheter. The maximum recommended infusion rate for the 3F Jet Power Injectable PICC is 1cc/sec and 5.0cc/sec for the 4F and 5F Jet Power Injectable PICC.
A family of trimmable peripherally inserted central catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger Technique).
This document is a 510(k) Pre-market Notification for the Jet Power Injectable PICC, demonstrating its substantial equivalence to a predicate device (Pro-PICC® CT). The information provided focuses on the safety and performance of the medical device itself, rather than an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies are not applicable.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Study for a Medical Device (Non-AI/ML context):
The "acceptance criteria" for a medical device cleared via the 510(k) pathway are generally demonstrated through substantial equivalence to a legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. The "study" for this type of device typically involves a combination of bench testing, biocompatibility testing, and sterilization validation, rather than clinical efficacy studies on patient data that would be relevant for AI/ML performance.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML model's metrics (e.g., sensitivity, specificity). Instead, it lists the bench testing standards and the outcome (e.g., "Passed Per Internal Requirements", testing against specific ISO/ASTM standards).
Here's an interpretation of the requested table based on the provided "Performance Standards" (Table 6.2) and "Biocompatibility" sections:
| Acceptance Criteria (Relevant Standards/Tests) | Reported Device Performance (Outcome) |
|---|---|
| Liquid Leakage (EN ISO 10555-1:2009) | Tested and presumably passed (implied by 510(k) clearance) |
| Air Leakage (EN ISO 10555-1:2009) | Tested and presumably passed |
| Force at Break (EN ISO 10555-1:2009) | Tested and presumably passed |
| Gravity Flow (EN ISO 10555-1:2009) | Tested and presumably passed |
| Chemical Exposure (EN ISO 10555-1:2009) | Tested and presumably passed |
| Max Static Burst (EN ISO 10555-1:2009) | Tested and presumably passed |
| Power Injection (EN ISO 10555-1:2009) | Tested and presumably passed |
| Elongation (EN ISO 10555-1:2009) | Tested and presumably passed |
| Accelerated Aging (ASTM F 1980:2016) | Tested and presumably passed |
| Suture Wing Integrity | Passed Per Internal Requirements |
| Pump Flow Rate | Tested and presumably passed |
| Priming Volume | Tested and presumably passed |
| Catheter Collapse Test | Tested and presumably passed |
| Catheter Stiffness | Tested and presumably passed |
| Interaction Testing | Tested and presumably passed |
| Simulated Use | Tested and presumably passed |
| Tip Displacement During Power Injection | Tested and presumably passed |
| Power Injection Flow Rate | Tested and presumably passed |
| Dynamic Failure | Tested and presumably passed |
| Power Injection Simulation Testing | Tested and presumably passed |
| Cyclic Flexure / Kink Test | Tested and presumably passed |
| Biocompatibility (ISO 10993-1, -5, -10, -11, -3, -6, -4, ASTM F756, OECD Guidelines, USP) | Performed on final finished device, outcomes not explicitly detailed but implied to be compliant for permanent contact with circulating blood. |
| Sterilization Validation (ANSI/AAMI/ISO 11135-1:2014, AAMI TIR 28:2009(R)2013) | SAL is 10-6 |
| ETO Residual Level (AAMI/ANSI/ISO 10993-7:2008) | Maximum level less than 4 mg/device |
| Pyrogen Test Method (ANSI/AAMI ST72:2011) | Non-pyrogenic |
| Endotoxin (ANSI/AAMI ST72:2011) | Maximum level is 20 EU/device |
| Shelf Life (ASTM 1980F:2016, EN ISO 10555-1) | Tested and presumably passed |
For AI/ML Specific Questions (N/A for this document):
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study involving a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a medical device like this is conformance to engineering and biocompatibility standards and comparison to a predicate device.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
November 21, 2018
Jet Medical, Inc. % Courtney Nix Regulatory Affairs Manager, North America and Europe Medical Components Inc. (dba Medcomp®) 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K180546
Trade/Device Name: Jet Power Injectable PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: October 22, 2018 Received: October 23, 2018
Dear Courtney Nix:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020 | ||
|---|---|---|---|
| Indications for Use | See PRA Statement below. | ||
| 510(k) Number (if known) | K180546 | ||
| Device Name | Jet Power Injectable PICC | ||
| Indications for Use (Describe) | The Jet Power Injectable PICC is indicated for short term or long term peripheral access to the central venous system forintravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For bloodsampling, infusion, or therapies, use a 4F or larger catheter. | ||
| The maximum recommended infusion rate varies by catheter. The maximum recommended infusion rate for the 3F JetPower Injectable PICC is 1cc/sec and 5.0cc/sec for the 4F and 5F Jet Power Injectable PICC. | |||
| Type of Use (Select one or both, as applicable) | 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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: | |||
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov | |||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number." | |||
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740EF |
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Image /page/3/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "G" or an arrow pointing upwards. Below the geometric shape, the word "medCOMP" is written in a combination of red and black letters.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
| Jet Power Injectable PICCSection 6 | 510(k) SUMMARYK180546 | Traditional 510K |
|---|---|---|
| A. Submitter Information | ||
| Submitter Name: | Jet Medical Inc | |
| Address: | 97 Main StreetSchwenksville, PA, 19473 USA | |
| Registration Number: | 3007345394 | |
| Contact Person: | Courtney NixCnix@medcompnet.comMedical Components Inc (dba Medcomp®)Regulatory Affairs Manager, North Americaand EU (Est. Registration Number: 2518902) | |
| Date of Preparation: | 19NOV2018 | |
| B. Subject Device | ||
| Trade Name:Common Name:Regulation Name: | Jet Power Injectable PICCCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysPercutaneous, Implanted, Long-TermIntravascular Catheter | |
| Product Code:21 CFR Regulation:Class:Classification Panel: | LJS880.5970IIGeneral Hospital | |
| C. Predicate Device | ||
| PredicateTrade Name:510(k) Number:510(k) Holder:Common Name: | PRO-PICC® CTK091953Medical Components Inc.Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | |
| Regulation Name:Product Code:21 CFR Regulation:Class:Classification Panel: | Percutaneous, Implanted, Long-TermIntravascular CatheterLJS880.5970IIGeneral Hospital |
- D. Device Description:
A family of trimmable peripherally inserted central catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray
Jet Power Injectable PICC Section 6: 510(k) Site Summary
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Image /page/4/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "M" or a series of interconnected arrows. Below the geometric shape, the word "medCOMP" is written in a combination of red and black letters. The "med" portion is in red, while the "COMP" portion is in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Jet Power Injectable PICC
with accessories necessary for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger Technique).
E. Indications For Use
The Jet Power Injectable PICC is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter.
The maximum recommended infusion rate varies by catheter. The maximum recommended infusion rate for the 3F Jet Power Injectable PICC is 1cc/sec and 5.0cc/sec for the 4F and 5F Jet Power Injectable PICC.
F. Intended Use
The Jet Power Injectable PICC is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter.
G. Comparison to Predicate Device(s):
| Attribute | Jet PowerInjectable PICC(Proposed Device) | Predicate DevicePro-PICC® CT(K091953) | Status |
|---|---|---|---|
| Indications forUse | The Jet PowerInjectable PICC isindicated for shortterm or long termperipheral access tothe central venoussystem forintravenous therapyand power injectionof contrast media,and allows forcentral venouspressure monitoring.For blood sampling,infusion, ortherapies, use a 4For larger catheter.The maximumrecommendedinfusion rate variesby catheter. Themaximum | The Pro-PICC® CT isindicated for short orlong term peripheralaccess to the centralvenous system forintravenous therapyand power injection ofcontrast media, andallows for centralvenous pressuremonitoring, when a 20gauge or larger lumenis used. For bloodsampling, infusion, ortherapies, use a 4F orlarger catheter.The maximumrecommended infusionrate varies by catheterFrench size and isprinted on thecatheter. | Substantiallyequivalent; bothdevices areintended for shortor long termperipheral accessto the centralvenous systemfor infusion, bloodsampling, andinjection ofcontrast media. |
| Jet Power Injectable PICC | |||
| recommendedinfusion rate for the3F Jet PowerInjectable PICC is1cc/sec and5.0cc/sec for the 4Fand 5F Jet PowerInjectable PICC | |||
| Catheter OD | 3F Single Lumen4F Single Lumen5F Double Lumen | 4F Single Lumen5F Single and DoubleLumen6F Double Lumen | SubstantiallyEquivalent |
| Lengths | 3F Single Lumen,4F Single Lumen,and 5F DoubleLumen:55CM | 4F Single Lumen:50CM5F Single Lumen60 CM5F and 6F DoubleLumen55CM | SubstantiallyEquivalent |
| Duration ofUse | Short Term:Greater than 24hours but less thanor equal to 30 days)Long Term:Greater than 30days | Short Term:Greater than 24 hoursbut less than or equal30 daysLong Term:Greater than 30 days | Identical |
| Means ofInsertion | Modified Seldingeror SeldingerTechnique | Modified Seldinger orSeldinger Technique | Identical |
| VascularAccessPlacement | Basilic veinMedian Cubital VeinCephalic Vein | Basilic veinMedian Cubital VeinCephalic Vein | Identical |
| PreferredLocation | Basilic vein | Basilic Vein | Identical |
| Finalanatomicallocation of Tip | Superior Vena Cava | Superior Vena Cava | Identical |
| PatientPopulation | Adults | Adults | Identical |
| MaterialColors | 3F and 4F SingleLumenTubing Clamp:PurpleExtension:ClearLuer:Red | 4F and 5F SingleLumenLuer:PurpleTubing Clamp:PurpleExtension:Translucent Purple | SubstantiallyEquivalent;biocompatibilitytesting |
| Jet Power Injectable PICC | |||
| Single Lumen | Hub | ||
| Tubing W/ Taper: | Purple | ||
| White | Lumen | ||
| Hub: | Light Purple | ||
| White | |||
| 5F and 6F DoubleLumen | |||
| 5F Double Lumen | |||
| Tubing Clamp: | Tubing Clamp: | ||
| Purple | Purple | ||
| Extension: | Luer: | ||
| Clear | White | ||
| Luer: | Luer: | ||
| Natural | Purple | ||
| Luer: | Extension: | ||
| Red | Translucent Purple | ||
| Double Lumen | Hub: | ||
| Tubing W/ Taper: | Purple | ||
| White | Lumen | ||
| Hub: | Light purple | ||
| White | |||
| Depth | Depth Markings aremarked every 1cm.Numerical markingsare placed every5cm | Depth markings aremarked every 1cm.Numerical markingsare placed every 5cm. | Identical |
| Catheter | Single LumenDouble Lumen | Single LumenDouble Lumen | Identical |
| Sterility | EO | EO | Identical |
Table 6.1: 510(k) Summary Design Comparison Matrix
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Image /page/5/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "G" or a square with a curved top. Below the geometric shape, the word "medCOMP" is written in a combination of red and black letters. The "med" portion is in red, while the "COMP" portion is in black.
- Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
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Image /page/6/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized house or arrow pointing upwards. Below the shape, the word "med" is written in red, followed by "COMP" in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
H. Bench/ Performance Data/ Non-Clinical Testing:
Table 6.2: Performance Standards
| Bench Testing | ApplicablePerformanceStandard | Standard Title | Revision/Date |
|---|---|---|---|
| Liquid LeakageAir Leakage | EN ISO 10555-1 | IntravascularCatheter - Sterileand Single - UseIntravascularCatheters – Part 1GeneralRequirements | 2009 |
| Force at BreakGravity FlowChemical ExposureMax Static BurstPower InjectionElongation | |||
| Accelerated Aging | ASTM F 1980 | Standard Guide forAccelerated Agingof Sterile BarrierSystem for MedicalDevices | 2016 |
Jet Power Injectable PICC Section 6: 510(k) Site Summary 6-4
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| Jet Power Injectable PICC | ||
|---|---|---|
| Suture WingIntegrity | Passed Per Internal Requirements | |
| Pump Flow Rate | ||
| Priming Volume | ||
| Catheter CollapseTest | ||
| Catheter Stiffness | ||
| Interaction Testing | ||
| Simulated Use | ||
| Tip DisplacementDuring PowerInjection | ||
| Power InjectionFlow Rate | ||
| Dynamic Failure | ||
| Power InjectionSimulation Testing | ||
| Cyclic Flexure /Kink Test |
All testing was conducted on dry catherers.
Biocompatibility: -
Biocompatibility was performed for the 5F Jet Power Injectable PICC per ISO 10993-1 for an externally communicating device with permanent contact with circulating blood (greater than 30 days of contact). Biocompatibility was performed on the final finished device. The biological end points include:
Cytotoxicity
- ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for . In Vitro Cytotoxicity
Sensitization
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests . for irritation and Skin Sensitization
- OECD 406 Guidelines for Testing of Chemical, Test No. 406, Skin . Sensitization
Irritation
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests . for Irritation and Skin Sensitization
Acute Systemic Toxicity
- ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests 0 for Systemic Toxicity
- United States Pharmacopeia 40, National Formulary 35 (USP), General . Chapter <151>, Pyrogen Test
Subchronic Toxicity
Jet Power Injectable PICC Section 6: 510(k) Site Summary
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Image /page/8/Picture/0 description: The image shows the MedComp logo. The logo consists of a red geometric shape that resembles a stylized house or building, with an opening in the center. Below the shape, the word "medCOMP" is written in a combination of red and black letters. The "med" part is in red, while the "COMP" part is in black.
Harlevsville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Jet Power Injectable PICC
- ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests for 0 Systemic Toxicity
- OECD 407 Guidelines for the Testing of Chemicals, Test No. 407, Repeated . Dose 28-Day Oral Toxicity Study in Rodents
Genotoxicity
- ISO 10993-3 Biological Evaluation of Medical Devices Part 3: Tests for . Genotoxicity, Carcinogenicity, and Reproductive Toxicity
- OECD 471 Guidelines for Testing of Chemicals. Test No.471. Bacterial . Reverse Mutation Test
- OECD 490 Guidelines for the Testing of Chemicals. Test No. 490. In Vitro . Mammalian Cell Gene Mutation Test Using the Thymidine Kinase Gene.
Implantation
- ISO 10993-6 Biological Evaluation of Medical Devices Part 6: Tests for o Local Effects After Implantation
- United States Pharmacopeia 40. National Formulary 35 (USP). General . Chapter < 88>, Biological Reactivity Tests, In Vivo, Implantation Test, Table 6: Evaluation of Encapsulation in the Implantation Test
Hemocompatibility
- 0 ISO 10993-4 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood
- 0 ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials
Further Testing
- European Pharmacopoeia 9th edition, section 2,2,24, Absorption . Spectrophotometry, Infrared (2017)
- ISO 10993-18 Biological Evaluation of Medical Devices Part 18: Chemical . Characterization of Materials
- United States Pharmacopeia 40, National Formulary 35 (USP), General ® Chapter <197>. Spectrophotometric Identification Tests, Infrared Absorption
J. Sterility
| Sterilization Validation: | ANSI/AAMI/ISO 11135-1:2014, AAMI TIR28:2009(R)2013 |
|---|---|
| Sterility Assurance Level | SAL is 10-6 |
| Sterilization Method: | The product is sterilized by 100% EthyleneOxide (EO) Gas in a fixed chamber |
| ETO Residual Level: | In accordance with AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of MedicalDevices - Part 7: Ethylene Oxide SterilizationResiduals, the maximum level is less than to 4mg/device. |
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Image /page/9/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "M" or a medical symbol. Below the shape, the word "medCOMP" is written in a combination of red and black letters, with "med" in red and "COMP" in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Jet Power Injectable PICC
Pvrogen Test Method:
Tested in accordance with ANSI/AAMI ST72:2011 Bacterial Endotoxin-Test methods. routine monitoring, and alternatives to testing the product is Non-pvrogenic.
Endotoxin:
Tested in accordance with ANSI/AAMI ST72:2011 Bacterial Endotoxin-Test methods, routine monitoring, and alternatives to testing the maximum level is 20 EU/device.
K. Shelf Life
Shelf life testing was conducted per ASTM 1980F: 2016 Standard Guide for Accelerated Aaing of Sterile Barrier Systems for Medical devices as well as on the Jet Power Injectable PICC device using performance standard EN ISO 10555-1.
L. Summary of Substantial Equivalence:
In conclusion, the proposed device, Jet Power Injectable PICC, is considered substantially equivalent to the predicate devices, Pro-PICC® CT (K091953) as demonstrated through non-clinical testing performed.
The proposed device, Jet Power Injectable PICC, does not present any additional risks to patients or different considerations regarding equivalence than those presented by the predicate, Pro-PICC® CT (K091953). The proposed device. Jet Power Injectable PICC, and the predicate device, Pro-PICC® CT (K091953) are equivalent in terms of indications for use, intended use, specifications, anatomical location, biocompatibility, performance and labelling.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”