FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device

K180588 · Teleflex Medical · FMI · Apr 17, 2018 · General Hospital

Device Facts

• Record ID: K180588
• Device Name: FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device
• Applicant: Teleflex Medical
• Product Code: FMI · General Hospital
• Decision Date: Apr 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 fluid 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 Story

FAST1 and FASTResponder are manual sternal intraosseous infusion devices; provide alternative to intravenous access for emergency drug/fluid administration. Used on manubrium; designed for adult/adolescent patients. Devices penetrate 6mm into manubrium. Operated by qualified professionals in emergency settings. Output is established vascular access route. Benefits include rapid circulatory access during resuscitation. This submission updates labeling to include specific contraindications; no physical device modifications.

Clinical Evidence

No clinical data or performance testing provided; submission is limited to labeling updates.

Technological Characteristics

Manual sternal intraosseous infusion devices; molded plastics and stainless steel construction. Penetration depth 6mm. Sterilization via radiation (SAL 10^-6). Single-use. No software or electronic components.

Indications for Use

Indicated for adult and adolescent patients (12+ years) requiring vascular access for emergency resuscitation via sternal intraosseous route. Contraindications: fracture in target bone; excessive tissue/obesity or lack of landmarks; osteoporosis; infection at insertion site; previous significant orthopedic procedure at site; IO in target bone within past 48 hours.

Regulatory Classification

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.

Predicate Devices

• FAST1™ Intraosseous Infusion System (K080865)
• FASTResponder™ Sternal Intraosseous Device (K130487)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 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: [e-mail] Phone: [phone] Fax: [phone]

Date Prepared: April 05, 2018

#### II. DEVICES

| Trade Name: | <i>FASTI</i> ™ 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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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.

### V. INDICATIONS FOR USE

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 fluid 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.

#### 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.

| Comparative<br>Characteristics | Predicate Device<br>FASTIT™ intraosseous<br>Infusion System<br>K080865 | Predicate Device<br>FASTResponder™ Sternal<br>Intraosseous Device<br>K130487 | Proposed<br>FASTIT™ Intraosseous<br>Infusion System<br>&<br>FASTResponder™ Sternal<br>Intraosseous Device |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Needle, Hypodermic, Single<br>Lumen | Needle, Hypodermic, Single<br>Lumen | Same |
| Product Code/ CFR<br>Indications for Use | FMI, 880.5570<br>Indicated for use in<br>establishing a sternal<br>intraosseous access route in<br>adult and adolescent patients<br>(12 years of age and older)<br>requiring vascular<br>administration of drugs or fluid<br>to facilitate emergency<br>resuscitation. | FMI, 880.5570<br>Indicated for use in<br>establishing a sternal<br>intraosseous access route in<br>adult and adolescent patients<br>(12 years of age and older)<br>requiring vascular<br>administration of drugs or<br>fluid to facilitate emergency<br>resuscitation. | Same<br>Same |
| Prescription | Yes | Yes | Same |
| Patient Population | For adult and adolescent<br>patients (12 years of age and<br>older) requiring vascular<br>administration of drugs or<br>fluids to facilitate emergency<br>resuscitation. | For adult and adolescent<br>patients (12 years of age and<br>older) requiring vascular<br>administration of drugs or<br>fluids to facilitate emergency<br>resuscitation. | Same |
| Contraindications | Not covered in predicate. | Not covered in predicate. | ● Fracture in target bone<br>● Excessive tissue (severe |
| Comparative<br>Characteristics | Predicate Device<br>FASTITM intraosseous<br>Infusion System<br>K080865 | Predicate Device<br>FASTResponder™ Sternal<br>Intraosseous Device<br>K130487 | Proposed<br>FASTITM Intraosseous<br>Infusion System<br>&<br>FASTResponder™ Sternal<br>Intraosseous Device |
| | | | obesity) and/or absence<br>of adequate anatomical<br>landmarks<br>● Osteoporosis<br>● Infection at the area of<br>insertion<br>● Previous, significant<br>orthopedic procedure at<br>the site<br>● IO in past 48 hours of the<br>target bone |
| Precautions/Warnings | Precautions Section:<br>The FASTITM Intraosseous<br>Infusion System is designed<br>to penetrate 6 mm into the<br>manubrium. Adult and<br>adolescent* patients are<br>expected to have a<br>manubrium thickness greater<br>than 6 mm. Qualified<br>professionals should<br>determine any appropriate or<br>necessary exceptions, either<br>inclusions or exclusions, to<br>the criterion "For use with<br>adult and adolescent*<br>patients." | Precautions Section:<br>● The FASTResponder™<br>is designed to penetrate<br>6mm into the<br>manubrium. Qualified<br>professionals should<br>determine any<br>appropriate or necessary<br>exceptions, either<br>inclusions or exclusions,<br>to the criterion "for<br>patients 12 years and<br>older".<br>● Proximal tip of Infusion<br>Tube contains metal. | FAST1:<br>Precautions Section:<br>The FASTITM Intraosseous<br>Infusion System is designed to<br>penetrate 6 mm into the<br>manubrium. Adult and<br>adolescent* patients are<br>expected to have a manubrium<br>thickness greater than 6 mm.<br>Qualified professionals should<br>determine any appropriate or<br>necessary exceptions, either<br>inclusions or exclusions, to the<br>criterion "For use with adult<br>and adolescent* patients." |
| | Severe skin compromise<br>such as trauma, infection or<br>burns over the infusion site<br>may interfere with use of the<br>device. Check for fracture of<br>the sternum or vascular<br>injury which may<br>compromise the integrity of<br>the manubrium or its<br>vascularization. Check for<br>midline sternotomy scars –<br>the device may be less<br>effective in patients with a<br>previous midline<br>sternotomy. | The function of the device<br>may be affected by:<br>● Compromised skin over<br>the insertion site such as<br>trauma, infection or<br>burns<br>● Fracture of the sternum<br>or vascular injury which<br>may compromise the<br>integrity of the<br>manubrium or its<br>vascularization<br>● Midline sternotomy scars<br>Warnings Section:<br>● Safety in patients with<br>very severe osteoporosis<br>has not been proven<br>● Insertion in sites other<br>than the manubrium may<br>result in ineffective<br>infusion and/or serious<br>injury to the patient<br>● Reuse of<br>FASTResponder™ is<br>not recommended due to<br>the potential of cross- | The FASTITM Intraosseous<br>Infusion System is intended<br>for use only with adult and<br>adolescent* patients. i.e.<br>patients 12 years of age and<br>older.<br>The FASTITM is not to be left<br>in situ for more than 24 hours.<br>DESIGNATED INSERTION<br>SITE: The single designated<br>site of insertion is the adult<br>and adolescent* manubrium,<br>on the midline and 1.5 cm (5/8<br>inch) below (inferior to) the<br>supra-sternal notch (sternal<br>notch). Proper placement of<br>the Patch helps ensure<br>insertion at this site.<br>WARNING: Insertion of the<br>FAST1TM Intraosseous<br>Infusion System in sites other<br>than the manubrium may<br>result in ineffective infusion<br>and may result in<br>overpenetration of the Infusion |
| Comparative<br>Characteristics | Predicate Device<br>FASTITM intraosseous<br>Infusion System<br>K080865 | Predicate Device<br>FASTResponder™ Sternal<br>Intraosseous Device<br>K130487 | Proposed<br>FASTITM Intraosseous<br>Infusion System<br>&<br>FASTResponder™ Sternal<br>Intraosseous Device |
| | older.<br><br>The FASTITM is not<br>intended to be left in situ for<br>more than 24 hours.<br><br><b>DESIGNATED<br/>INSERTION SITE:</b> The<br>single designated site of<br>insertion is the adult and<br>adolescent* manubrium, on<br>the midline and 1.5 cm (5/8<br>inch) below (inferior to) the<br>supra-sternal notch (sternal<br>notch). Proper placement of<br>the Patch helps ensure<br>insertion at this site.<br><br><b>WARNING:</b> Insertion of<br>the FAST1TM Intraosseous<br>Infusion System in sites<br>other than the manubrium<br>may result in ineffective<br>infusion and may result in<br>overpenetration of the<br>Infusion Tube with<br>consequent serious injury to<br>the patient. | contamination, which<br>may lead to serious<br>injury or death. The<br>FASTResponder™ is<br>unlikely to function after<br>use.<br>Do not insert finger(s) in<br>the open end of the<br>device due to the<br>potential of needle stick. | Tube with consequent serious<br>injury or death to the patient.<br><br><b>FASTR:</b><br>Precautions Section:<br>The FASTResponderTM<br>is designed to penetrate<br>6mm into the manubrium.<br>Qualified professionals<br>should determine any<br>appropriate or necessary<br>exceptions, either<br>inclusions or exclusions,<br>to the criterion "for<br>patients 12 years and<br>older". Proximal tip of Infusion<br>Tube contains metal. The FASTResponder™<br>is not to be left in situ for<br>more than 24 hours.<br>Warnings Section:<br>Insertion in sites other<br>than the manubrium may<br>result in ineffective<br>infusion and/or serious<br>injury or death to the<br>patient. Single use: Do not reuse,<br>reprocess or re-sterilize.<br>Reuse of device creates a<br>potential risk of serious<br>injury and/or infection<br>which may lead to death.<br>Reprocessing of medical<br>devices intended for<br>single use only may result<br>in degraded performance<br>or a loss of functionality. Do not insert finger(s) in<br>the open end of the device<br>due to the potential of<br>needle 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 Assurance<br>level (SAL) | 10-6 | 10-6 | Same |
| Materials | Molded plastics and stainless<br>steel | Molded plastics and stainless<br>steel | 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.