The FASTI™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

The FASTResponder™ Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluid to facilitate emergency resuscitation.

Device Description

The FASTITM and FASTResponder™ Sternal Intraosseous Devices were designed to provide an alternative to intravenous infusion access of the circulatory system. The devices utilize intraosseous infusion to facilitate emergency resuscitation with the use of fluids and drugs. They were designed for use on the manubrium, the upper (superior) portion of the sternum.

AI/ML Overview

The provided text is a 510(k) summary for the Teleflex Medical FAST1™ Intraosseous Infusion System and FASTResponder™ Sternal Intraosseous Device. It is a submission to the FDA for a labeling change to an existing device, not for a new device requiring extensive performance data or clinical trials for substantial equivalence.

Therefore, the document explicitly states: "No performance testing was needed to support this change." (Page 7, Section VII. Performance Data).

This means the document does not contain information regarding:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set or data provenance for such a test.
Number of experts used to establish ground truth or their qualifications.
Adjudication methods for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
Standalone performance studies (i.e., algorithm only without human-in-the-loop performance).
The type of ground truth used.
The sample size for a training set.
How the ground truth for a training set was established.

The entire submission is focused on demonstrating substantial equivalence based on the device's technological characteristics remaining unchanged, with the only modification being the addition of contraindications to the product's labeling. The "Performance Data" section explicitly confirms that no new performance testing was conducted or required for this specific 510(k) submission.

Summary

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April 17, 2018

Teleflex Medical Ying Zhao Regulatory Affairs Specialist 3015 Carrington Mill Blvd. Morrisville, North Carolina 27560

Re: K180588

Trade/Device Name: FAST1™ Intraosseous Infusion System FASTResponder™ Sternal Intraosseous Device Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 1, 2018 Received: March 6, 2018

Dear Ying Zhao:

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.

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Tina
Kiang-S

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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Indications for Use

510(k) Number (if known) K180588

Device Name

FAST1™ Intraosseous Infusion System and FASTResponder™ Sternal Intraosseous Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K180588 510(k) SUMMARY

I. SUBMITTER

Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA

Contact Person: Ying Zhao, Regulatory Affairs Specialist Email: ying.zhao@teleflex.com Phone: 919-361-3941 Fax: 919-433-4996

Date Prepared: April 05, 2018

II. DEVICES

Trade Name:	FASTI ™ Intraosseous Infusion System
Classification Name:	Needle, Hypodermic, Single Lumen
Product Code:	FMI
Regulation Number:	880.5570
Classification:	Class II
Review Panel:	General Hospital

Trade Name:	FASTResponder™ Sternal Intraosseous Device
Classification Name:	Needle, Hypodermic, Single Lumen
Product Code:	FMI
Regulation Number:	880.5570
Classification:	Class II
Review Panel:	General Hospital

III. PREDICATE DEVICES

	FASTIT™ Intraosseous Infusion System cleared in submission K080865
Classification Name:	Needle, Hypodermic, Single Lumen
Product Code:	FMI
Regulation Number:	880.5570
Classification:	Class II
Review Panel:	General Hospital

FASTResponder™ Sternal Intraosseous Device cleared in submission K130487

Classification Name:	Needle, Hypodermic, Single Lumen
Product Code:	FMI
Regulation Number:	880.5570
Classification:	Class II
Review Panel:	General Hospital

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

VI. TECHNOLOGICAL CHARACTERISTICS COMPARISON TO THE PREDICATE DEVICES

This submission only affects the labeling of these products by adding contraindications to the IFUs. This submission is being submitted as "Change Being Effected" to add Contraindications due to the potential risk to public health. There were no modifications made to the FASTI™ and FASTResponder™ Sternal Intraosseous Devices.

ComparativeCharacteristics	Predicate DeviceFASTIT™ intraosseousInfusion SystemK080865	Predicate DeviceFASTResponder™ SternalIntraosseous DeviceK130487	ProposedFASTIT™ IntraosseousInfusion System&FASTResponder™ SternalIntraosseous Device
Classification Name	Needle, Hypodermic, SingleLumen	Needle, Hypodermic, SingleLumen	Same
Product Code/ CFRIndications for Use	FMI, 880.5570Indicated for use inestablishing a sternalintraosseous access route inadult and adolescent patients(12 years of age and older)requiring vascularadministration of drugs or fluidto facilitate emergencyresuscitation.	FMI, 880.5570Indicated for use inestablishing a sternalintraosseous access route inadult and adolescent patients(12 years of age and older)requiring vascularadministration of drugs orfluid to facilitate emergencyresuscitation.	SameSame
Prescription	Yes	Yes	Same
Patient Population	For adult and adolescentpatients (12 years of age andolder) requiring vascularadministration of drugs orfluids to facilitate emergencyresuscitation.	For adult and adolescentpatients (12 years of age andolder) requiring vascularadministration of drugs orfluids to facilitate emergencyresuscitation.	Same
Contraindications	Not covered in predicate.	Not covered in predicate.	● Fracture in target bone● Excessive tissue (severe
ComparativeCharacteristics	Predicate DeviceFASTITM intraosseousInfusion SystemK080865	Predicate DeviceFASTResponder™ SternalIntraosseous DeviceK130487	ProposedFASTITM IntraosseousInfusion System&FASTResponder™ SternalIntraosseous Device
			obesity) and/or absenceof adequate anatomicallandmarks● Osteoporosis● Infection at the area ofinsertion● Previous, significantorthopedic procedure atthe site● IO in past 48 hours of thetarget bone
Precautions/Warnings	Precautions Section:The FASTITM IntraosseousInfusion System is designedto penetrate 6 mm into themanubrium. Adult andadolescent* patients areexpected to have amanubrium thickness greaterthan 6 mm. Qualifiedprofessionals shoulddetermine any appropriate ornecessary exceptions, eitherinclusions or exclusions, tothe criterion "For use withadult and adolescent*patients."	Precautions Section:● The FASTResponder™is designed to penetrate6mm into themanubrium. Qualifiedprofessionals shoulddetermine anyappropriate or necessaryexceptions, eitherinclusions or exclusions,to the criterion "forpatients 12 years andolder".● Proximal tip of InfusionTube contains metal.	FAST1:Precautions Section:The FASTITM IntraosseousInfusion System is designed topenetrate 6 mm into themanubrium. Adult andadolescent* patients areexpected to have a manubriumthickness greater than 6 mm.Qualified professionals shoulddetermine any appropriate ornecessary exceptions, eitherinclusions or exclusions, to thecriterion "For use with adultand adolescent* patients."
	Severe skin compromisesuch as trauma, infection orburns over the infusion sitemay interfere with use of thedevice. Check for fracture ofthe sternum or vascularinjury which maycompromise the integrity ofthe manubrium or itsvascularization. Check formidline sternotomy scars –the device may be lesseffective in patients with aprevious midlinesternotomy.	The function of the devicemay be affected by:● Compromised skin overthe insertion site such astrauma, infection orburns● Fracture of the sternumor vascular injury whichmay compromise theintegrity of themanubrium or itsvascularization● Midline sternotomy scarsWarnings Section:● Safety in patients withvery severe osteoporosishas not been proven● Insertion in sites otherthan the manubrium mayresult in ineffectiveinfusion and/or seriousinjury to the patient● Reuse ofFASTResponder™ isnot recommended due tothe potential of cross-	The FASTITM IntraosseousInfusion System is intendedfor use only with adult andadolescent* patients. i.e.patients 12 years of age andolder.The FASTITM is not to be leftin situ for more than 24 hours.DESIGNATED INSERTIONSITE: The single designatedsite of insertion is the adultand adolescent* manubrium,on the midline and 1.5 cm (5/8inch) below (inferior to) thesupra-sternal notch (sternalnotch). Proper placement ofthe Patch helps ensureinsertion at this site.WARNING: Insertion of theFAST1TM IntraosseousInfusion System in sites otherthan the manubrium mayresult in ineffective infusionand may result inoverpenetration of the Infusion
ComparativeCharacteristics	Predicate DeviceFASTITM intraosseousInfusion SystemK080865	Predicate DeviceFASTResponder™ SternalIntraosseous DeviceK130487	ProposedFASTITM IntraosseousInfusion System&FASTResponder™ SternalIntraosseous Device
	older.The FASTITM is notintended to be left in situ formore than 24 hours.DESIGNATEDINSERTION SITE: Thesingle designated site ofinsertion is the adult andadolescent* manubrium, onthe midline and 1.5 cm (5/8inch) below (inferior to) thesupra-sternal notch (sternalnotch). Proper placement ofthe Patch helps ensureinsertion at this site.WARNING: Insertion ofthe FAST1TM IntraosseousInfusion System in sitesother than the manubriummay result in ineffectiveinfusion and may result inoverpenetration of theInfusion Tube withconsequent serious injury tothe patient.	contamination, whichmay lead to seriousinjury or death. TheFASTResponder™ isunlikely to function afteruse.Do not insert finger(s) inthe open end of thedevice due to thepotential of needle stick.	Tube with consequent seriousinjury or death to the patient.FASTR:Precautions Section:The FASTResponderTMis designed to penetrate6mm into the manubrium.Qualified professionalsshould determine anyappropriate or necessaryexceptions, eitherinclusions or exclusions,to the criterion "forpatients 12 years andolder". Proximal tip of InfusionTube contains metal. The FASTResponder™is not to be left in situ formore than 24 hours.Warnings Section:Insertion in sites otherthan the manubrium mayresult in ineffectiveinfusion and/or seriousinjury or death to thepatient. Single use: Do not reuse,reprocess or re-sterilize.Reuse of device creates apotential risk of seriousinjury and/or infectionwhich may lead to death.Reprocessing of medicaldevices intended forsingle use only may resultin degraded performanceor a loss of functionality. Do not insert finger(s) inthe open end of the devicedue to the potential ofneedle stick.
IO Insertion site	Sternum	Sternum	Same
Method of Insertion	Manual insertion	Manual insertion	Same
Duration of Use	Less than 24 hours	Less than 24 hours	Same
Number of Uses	Single use	Single use	Same
Sterilization Method	Radiation	Radiation	Same
Sterility Assurancelevel (SAL)	10-6	10-6	Same
Materials	Molded plastics and stainlesssteel	Molded plastics and stainlesssteel	Same

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VII. PERFORMANCE DATA

No performance testing was needed to support this change.

VIII. CONCLUSIONS

The proposed devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).