(42 days)
No
The summary describes a mechanical device for intraosseous access and does not mention any AI/ML components or related concepts like image processing, training data, or performance metrics associated with AI/ML.
No.
The device facilitates the administration of drugs or fluids for resuscitation, but it does not directly perform the therapeutic action itself.
No
This device is designed to establish an intraosseous access route for administering drugs or fluids in emergency resuscitation, not for diagnosing medical conditions.
No
The device description clearly describes a physical device ("Sternal Intraosseous Devices") used to establish an intraosseous access route, which involves hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the FASTI™ and FASTResponder™ devices are used to establish an intraosseous access route for administering drugs or fluids directly into the bone marrow. This is a method of delivering substances into the circulatory system, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for "establishing a sternal intraosseous access route" and "requiring vascular administration of drugs or fluids." This is a therapeutic or procedural use, not a diagnostic one.
Therefore, the device's function and intended use fall outside the scope of an in vitro diagnostic.
N/A
Intended Use / 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 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.
Product codes
FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternal intraosseous access route; manubrium, the upper (superior) portion of the sternum.
Indicated Patient Age Range
adult and adolescent patients (12 years of age and older)
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)
No performance testing was needed to support this change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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)
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: 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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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
Characteristics | Predicate Device
FASTIT™ intraosseous
Infusion System
K080865 | Predicate Device
FASTResponder™ Sternal
Intraosseous Device
K130487 | Proposed
FASTIT™ Intraosseous
Infusion System
&
FASTResponder™ Sternal
Intraosseous Device |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Needle, Hypodermic, Single
Lumen | Needle, Hypodermic, Single
Lumen | Same |
| Product Code/ CFR
Indications for Use | FMI, 880.5570
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. | FMI, 880.5570
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. | Same
Same |
| Prescription | Yes | Yes | Same |
| Patient Population | For adult and adolescent
patients (12 years of age and
older) requiring vascular
administration of drugs or
fluids to facilitate emergency
resuscitation. | For adult and adolescent
patients (12 years of age and
older) requiring vascular
administration of drugs or
fluids to facilitate emergency
resuscitation. | Same |
| Contraindications | Not covered in predicate. | Not covered in predicate. | ● Fracture in target bone
● Excessive tissue (severe |
| Comparative
Characteristics | Predicate Device
FASTITM intraosseous
Infusion System
K080865 | Predicate Device
FASTResponder™ Sternal
Intraosseous Device
K130487 | Proposed
FASTITM Intraosseous
Infusion System
&
FASTResponder™ Sternal
Intraosseous Device |
| | | | obesity) and/or absence
of adequate anatomical
landmarks
● Osteoporosis
● Infection at the area of
insertion
● Previous, significant
orthopedic procedure at
the site
● IO in past 48 hours of the
target bone |
| Precautions/Warnings | Precautions Section:
The FASTITM Intraosseous
Infusion System is designed
to penetrate 6 mm into the
manubrium. Adult and
adolescent* patients are
expected to have a
manubrium thickness greater
than 6 mm. Qualified
professionals should
determine any appropriate or
necessary exceptions, either
inclusions or exclusions, to
the criterion "For use with
adult and adolescent*
patients." | Precautions Section:
● The FASTResponder™
is designed to penetrate
6mm into the
manubrium. Qualified
professionals should
determine any
appropriate or necessary
exceptions, either
inclusions or exclusions,
to the criterion "for
patients 12 years and
older".
● Proximal tip of Infusion
Tube contains metal. | FAST1:
Precautions Section:
The FASTITM Intraosseous
Infusion System is designed to
penetrate 6 mm into the
manubrium. Adult and
adolescent* patients are
expected to have a manubrium
thickness greater than 6 mm.
Qualified professionals should
determine any appropriate or
necessary exceptions, either
inclusions or exclusions, to the
criterion "For use with adult
and adolescent* patients." |
| | Severe skin compromise
such as trauma, infection or
burns over the infusion site
may interfere with use of the
device. Check for fracture of
the sternum or vascular
injury which may
compromise the integrity of
the manubrium or its
vascularization. Check for
midline sternotomy scars –
the device may be less
effective in patients with a
previous midline
sternotomy. | The function of the device
may be affected by:
● Compromised skin over
the insertion site such as
trauma, infection or
burns
● Fracture of the sternum
or vascular injury which
may compromise the
integrity of the
manubrium or its
vascularization
● Midline sternotomy scars
Warnings Section:
● Safety in patients with
very severe osteoporosis
has not been proven
● Insertion in sites other
than the manubrium may
result in ineffective
infusion and/or serious
injury to the patient
● Reuse of
FASTResponder™ is
not recommended due to
the potential of cross- | The FASTITM Intraosseous
Infusion System is intended
for use only with adult and
adolescent* patients. i.e.
patients 12 years of age and
older.
The FASTITM is not to be left
in situ for more than 24 hours.
DESIGNATED INSERTION
SITE: The single designated
site of insertion is the adult
and adolescent* manubrium,
on the midline and 1.5 cm (5/8
inch) below (inferior to) the
supra-sternal notch (sternal
notch). Proper placement of
the Patch helps ensure
insertion at this site.
WARNING: Insertion of the
FAST1TM Intraosseous
Infusion System in sites other
than the manubrium may
result in ineffective infusion
and may result in
overpenetration of the Infusion |
| Comparative
Characteristics | Predicate Device
FASTITM intraosseous
Infusion System
K080865 | Predicate Device
FASTResponder™ Sternal
Intraosseous Device
K130487 | Proposed
FASTITM Intraosseous
Infusion System
&
FASTResponder™ Sternal
Intraosseous Device |
| | older.
The FASTITM is not
intended to be left in situ for
more than 24 hours.
DESIGNATED
INSERTION SITE: The
single designated site of
insertion is the adult and
adolescent* manubrium, on
the midline and 1.5 cm (5/8
inch) below (inferior to) the
supra-sternal notch (sternal
notch). Proper placement of
the Patch helps ensure
insertion at this site.
WARNING: Insertion of
the FAST1TM Intraosseous
Infusion System in sites
other than the manubrium
may result in ineffective
infusion and may result in
overpenetration of the
Infusion Tube with
consequent serious injury to
the patient. | contamination, which
may lead to serious
injury or death. The
FASTResponder™ is
unlikely to function after
use.
Do not insert finger(s) in
the open end of the
device due to the
potential of needle stick. | Tube with consequent serious
injury or death to the patient.
FASTR:
Precautions Section:
The FASTResponderTM
is designed to penetrate
6mm into the manubrium.
Qualified professionals
should determine any
appropriate or necessary
exceptions, either
inclusions or exclusions,
to the criterion "for
patients 12 years and
older". Proximal tip of Infusion
Tube contains metal. The FASTResponder™
is not to be left in situ for
more than 24 hours.
Warnings Section:
Insertion in sites other
than the manubrium may
result in ineffective
infusion and/or serious
injury or death to the
patient. Single use: Do not reuse,
reprocess or re-sterilize.
Reuse of device creates a
potential risk of serious
injury and/or infection
which may lead to death.
Reprocessing of medical
devices intended for
single use only may result
in degraded performance
or a loss of functionality. Do not insert finger(s) in
the open end of the device
due to the potential of
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
level (SAL) | 10-6 | 10-6 | Same |
| Materials | Molded plastics and stainless
steel | Molded plastics and stainless
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.