K Number
K180546
Device Name
Jet Power Injectable PICC
Manufacturer
Date Cleared
2018-11-21

(265 days)

Product Code
Regulation Number
880.5970
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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. 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.
Device Description
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).
More Information

No
The summary describes a physical medical device (a PICC catheter) and its performance characteristics through bench testing. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.

No.
Explanation: The device is a Peripherally Inserted Central Catheter (PICC) used for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, which are diagnostic and procedural support functions rather than direct therapeutic treatments.

No

This device is a peripherally inserted central catheter (PICC) used for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, which are all therapeutic or interventional functions, not diagnostic ones.

No

The device description clearly states it is a "family of trimmable peripherally inserted central catheters made from specially formulated biocompatible medical grade materials," which are physical hardware components. The performance studies also focus on physical properties and testing of the catheter itself.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a device for accessing the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. These are all procedures performed in vivo (within the living body).
  • Device Description: The description details a catheter designed for insertion into the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body for therapeutic or diagnostic procedures like those described for this PICC line.

N/A

Intended Use / 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.

Product codes

LJS

Device Description

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Superior Vena Cava

Indicated Patient Age Range

Adults

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Testing was conducted for Liquid Leakage, Air Leakage, Force at Break, Gravity Flow, Chemical Exposure, Max Static Burst, Power Injection, Elongation, Accelerated Aging, Suture Wing Integrity, 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.

Biocompatibility testing 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). The biological end points include Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation, and Hemocompatibility.

Sterility validation was performed per ANSI/AAMI/ISO 11135-1:2014, AAMI TIR 28:2009(R)2013 with a Sterility Assurance Level (SAL) of 10-6. The sterilization method is 100% Ethylene Oxide (EO) Gas in a fixed chamber, with a maximum ETO Residual Level of less than 4 mg/device in accordance with AAMI/ANSI/ISO 10993-7:2008.

Pyrogenicity testing indicated the product is Non-pyrogenic, with endotoxin levels tested in accordance with ANSI/AAMI ST72:2011, showing a maximum level of 20 EU/device.

Shelf life testing was conducted per ASTM 1980F: 2016 and EN ISO 10555-1.

Key results indicate that the proposed device is substantially equivalent to the predicate device, Pro-PICC® CT (K091953), with no additional risks or different considerations regarding equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K091953

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.”

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) | 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." | | |
| 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
IntegrityPassed 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 , 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 , 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 . 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.