Who is the manufacturer of Jet Power Injectable PICC?

Jet Medical, Inc. filed the 510(k) submission for Jet Power Injectable PICC (K180546).

What is the FDA product code for Jet Power Injectable PICC?

LJS. It is classified under 21 CFR 880.5970 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Jet Power Injectable PICC?

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

Who can help prepare an FDA 510(k) submission like Jet Power Injectable PICC?

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.

Jet Power Injectable PICC

K180546 · Jet Medical, Inc. · LJS · Nov 21, 2018 · General Hospital

Device Facts

Record ID	K180546
Device Name	Jet Power Injectable PICC
Applicant	Jet Medical, Inc.
Product Code	LJS · General Hospital
Decision Date	Nov 21, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5970
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Jet Power Injectable PICC is a trimmable, peripherally inserted central catheter (PICC) used for short or long-term central venous access. It facilitates intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The device is inserted via the basilic, median cubital, or cephalic vein using the Modified Seldinger or Seldinger technique, with the tip placed in the superior vena cava. It is intended for use in adults. The catheter is provided sterile and includes accessories for percutaneous introduction. Healthcare providers use the device to deliver fluids, medications, or contrast media, or to withdraw blood samples. The device benefits patients by providing reliable, long-term venous access for various clinical therapies.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including liquid/air leakage, force at break, gravity flow, chemical exposure, static burst, power injection performance, accelerated aging, and comprehensive biocompatibility testing per ISO 10993 standards.

Technological Characteristics

Trimmable PICC made of biocompatible medical-grade materials. Available in 3F (single lumen), 4F (single lumen), and 5F (double lumen) configurations. Features depth markings every 1cm with numerical markings every 5cm. Sterilized via 100% Ethylene Oxide (EO) gas. Complies with EN ISO 10555-1 for intravascular catheters.

Indications for Use

Indicated for adult patients requiring short or long-term peripheral access to the central venous system for IV therapy, power injection of contrast media, and central venous pressure monitoring. 4F or larger catheters required for blood sampling, infusion, or therapies.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

PRO-PICC® CT (K091953)

Related Devices

K210264 — BD PowerPiCC Catheter · Bard Access Systems, Inc. · Jul 30, 2021
K172899 — Vygon PICCs · Vygon USA · Feb 26, 2018
K180548 — 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology · C.R. Bard, Inc (Bard Has Joined Bd) · Apr 26, 2018
K092347 — PRO-PICC CT · Medcomp · Sep 16, 2009
K152409 — Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC · Navilyst Medical, Inc. · Sep 24, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ | | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration | | Form Approved: OMB No. 0910-0120 Expiration 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 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. | | | | | | | | | | | | | | | | | | | | | | | | Type of Use (Select one or both, as applicable) | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | <input type="checkbox"/> 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." | | | | FORM FDA 3881 (7/17) | Page 1 of 1 | | PSC Publishing Services (301) 443-6740 EF | {3}------------------------------------------------ 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 www.medcompnet.com | Jet Power Injectable PICC Section 6 | 510(k) SUMMARY K180546 | Traditional 510K | |--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | A. Submitter Information | | | | Submitter Name: | Jet Medical Inc | | | Address: | 97 Main Street Schwenksville, PA, 19473 USA | | | Registration Number: | 3007345394 | | | Contact Person: | Courtney Nix Cnix@medcompnet.com Medical Components Inc (dba Medcomp®) Regulatory Affairs Manager, North America and EU (Est. Registration Number: 2518902) | | | Date of Preparation: | 19NOV2018 | | | B. Subject Device | | | | Trade Name: Common Name: Regulation Name: | Jet Power Injectable PICC Catheter, Intravascular, Therapeutic, Long- Term Greater Than 30 Days Percutaneous, Implanted, Long-Term Intravascular Catheter | | | Product Code: 21 CFR Regulation: Class: Classification Panel: | LJS 880.5970 II General Hospital | | | C. Predicate Device | | | | Predicate Trade Name: 510(k) Number: 510(k) Holder: Common Name: | PRO-PICC® CT K091953 Medical Components Inc. Catheter, Intravascular, Therapeutic, Long- Term Greater Than 30 Days | | | Regulation Name: Product Code: 21 CFR Regulation: Class: Classification Panel: | Percutaneous, Implanted, Long-Term Intravascular Catheter LJS 880.5970 II General 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 {4}------------------------------------------------ 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 www.medcompnet.com 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 Power Injectable PICC (Proposed Device) | Predicate Device Pro-PICC® CT (K091953) | Status | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 | The Pro-PICC® CT is indicated for short 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, when a 20 gauge or larger lumen is used. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter. | Substantially equivalent; both devices are intended for short or long term peripheral access to the central venous system for infusion, blood sampling, and injection of contrast media. | | Jet Power Injectable PICC | | | | | | 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 | | | | Catheter OD | 3F Single Lumen 4F Single Lumen 5F Double Lumen | 4F Single Lumen 5F Single and Double Lumen 6F Double Lumen | Substantially Equivalent | | Lengths | 3F Single Lumen, 4F Single Lumen, and 5F Double Lumen: 55CM | 4F Single Lumen: 50CM 5F Single Lumen 60 CM 5F and 6F Double Lumen 55CM | Substantially Equivalent | | Duration of Use | Short Term: Greater than 24 hours but less than or equal to 30 days) Long Term: Greater than 30 days | Short Term: Greater than 24 hours but less than or equal 30 days Long Term: Greater than 30 days | Identical | | Means of Insertion | Modified Seldinger or Seldinger Technique | Modified Seldinger or Seldinger Technique | Identical | | Vascular Access Placement | Basilic vein Median Cubital Vein Cephalic Vein | Basilic vein Median Cubital Vein Cephalic Vein | Identical | | Preferred Location | Basilic vein | Basilic Vein | Identical | | Final anatomical location of Tip | Superior Vena Cava | Superior Vena Cava | Identical | | Patient Population | Adults | Adults | Identical | | Material Colors | 3F and 4F Single Lumen Tubing Clamp: Purple Extension: Clear Luer: Red | 4F and 5F Single Lumen Luer: Purple Tubing Clamp: Purple Extension: Translucent Purple | Substantially Equivalent; biocompatibility testing | | Jet Power Injectable PICC | | | | | | Single Lumen | Hub | | | | Tubing W/ Taper: | Purple | | | | White | Lumen | | | | Hub: | Light Purple | | | | White | | | | | | 5F and 6F Double Lumen | | | | 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 are marked every 1cm. Numerical markings are placed every 5cm | Depth markings are marked every 1cm. Numerical markings are placed every 5cm. | Identical | | Catheter | Single Lumen Double Lumen | Single Lumen Double Lumen | Identical | | Sterility | EO | EO | Identical | # Table 6.1: 510(k) Summary Design Comparison Matrix {5}------------------------------------------------ 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 www.medcompnet.com {6}------------------------------------------------ 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 www.medcompnet.com ### H. Bench/ Performance Data/ Non-Clinical Testing: # Table 6.2: Performance Standards | Bench Testing | Applicable Performance Standard | Standard Title | Revision/Date | |----------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------| | Liquid Leakage Air Leakage | EN ISO 10555-1 | Intravascular Catheter - Sterile and Single - Use Intravascular Catheters – Part 1 General Requirements | 2009 | | Force at Break Gravity Flow Chemical Exposure Max Static Burst Power Injection Elongation | | | | | Accelerated Aging | ASTM F 1980 | Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Devices | 2016 | Jet Power Injectable PICC Section 6: 510(k) Site Summary 6-4 {7}------------------------------------------------ | | Jet Power Injectable PICC | | |--|-----------------------------------------------|----------------------------------| | | Suture Wing Integrity | Passed Per Internal Requirements | | | Pump Flow Rate | | | | Priming Volume | | | | Catheter Collapse Test | | | | Catheter Stiffness | | | | Interaction Testing | | | | Simulated Use | | | | Tip Displacement During Power Injection | | | | Power Injection Flow Rate | | | | Dynamic Failure | | | | Power Injection Simulation 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 {8}------------------------------------------------ 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 www.medcompnet.com 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 TIR 28:2009(R)2013 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterility Assurance Level | SAL is 10-6 | | Sterilization Method: | The product is sterilized by 100% Ethylene Oxide (EO) Gas in a fixed chamber | | ETO Residual Level: | In accordance with AAMI/ANSI/ISO 10993- 7:2008, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, the maximum level is less than to 4 mg/device. | {9}------------------------------------------------ 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 www.medcompnet.com 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.

Jet Power Injectable PICC

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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Jet Power Injectable PICC

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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