(27 days)
The FAST1™ 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 FASTI™ Intraosseous Infusion System has been designed to provide alternative access of the circulatory system to intravenous infusion. It utilizes intraosseous infusion in order to facilitate emergency resuscitation through the use of fluids and drugs. The device has been designed for use on the manubrium, the upper (superior) portion of the sternum.
The provided text is a 510(k) summary for the FAST1™ Intraosseous Infusion System. It details an expansion of the intended use population to include adult and adolescent patients (12 years and older).
Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in terms of quantitative performance metrics. The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria and results.
Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not present:
- Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a new study. The acceptance criterion for this 510(k) appears to be "Substantial Equivalence" to predicate devices.
- Reported Device Performance: The primary "performance" reported is that the device has the "same intended use and the same or similar technological characteristics as the predicate devices." (Section VII)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (FAST1™ Intraosseous Infusion System cleared under K072487 and EZ-IO Intraosseous Infusion System cleared under K052195) | The FAST1™ Intraosseous Infusion System (expansion of intended use population) has the same technological characteristics as the FAST1™ Intraosseous Infusion System cleared under K072487. The differences in technological characteristics between the modified and predicate devices do not raise issues with safety and effectiveness. |
- Sample size used for the test set and the data provenance: N/A. No specific test set or data from a performance study is described. The submission relies on the substantial equivalence to previously cleared devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No ground truth establishment by experts for a test set is described.
- Adjudication method for the test set: N/A. No test set requiring adjudication is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This device is not an AI-assisted diagnostic tool, but a medical device for intraosseous infusion. Therefore, an MRMC study as typically performed for AI products is not applicable here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. No ground truth is described in the context of a new performance study. The ground for decision-making is substantial equivalence.
- The sample size for the training set: N/A. No algorithm training is described.
- How the ground truth for the training set was established: N/A. No algorithm training or corresponding ground truth establishment is described.
Summary of the study that proves acceptance criteria (as per the document):
The "study" presented is a substantial equivalence argument. The manufacturer asserts that the FAST1™ Intraosseous Infusion System (with expanded intended use population) is substantially equivalent to two predicate devices:
- The original FAST1™ Intraosseous Infusion System cleared under K072487.
- The EZ-IO Intraosseous Infusion System from Vidacare Corporation cleared under K052195.
The basis for this "proof" is that the modified device has the "same intended use and the same or similar technological characteristics" as the predicate devices. The document explicitly states: "The differences in technological characteristics between the modified and the predicate devices do not raise issues with the safety and effectiveness of the modified FAST1™ Intraosseous Infusion System." This implies that prior safety and effectiveness data for the predicate devices, and the inherent similarities, are considered sufficient evidence for accepting this expansion of intended use. There is no new clinical or performance study detailed in this 510(k) summary to establish novel acceptance criteria or performance metrics.
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APR 2 4 2008
510(k) Summary
FOICAL
(per 21 CFR 807.92)
Applicant I.
Pyng Medical Corp. 7 - 13511 Crestwood Place Richmond, BC, V6V 2E9 Canada
Contact Person: Dr. Maya Butterfield Quality Assurance & Regulatory Affairs Manager Tel: 604.303.7964 Fax: 604.303.7987 Email: MButterfield@pyng.com
March 26, 2008 Date Prepared:
II. Device Name
Trade Name: Device Type: Classification Name: Regulation Number: Product Code: Class: Advisory Committee: FAST1 ™ Intraosseous Infusion System Intraosseous Infusion System Hypodermic Single Lumen Needle 880.5570 FMI Class II General Hospital
Predicate Devices III.
The FAST ™ Intraosseous Infusion System (expansion of intended use population) is substantially equivalent to the FAST1™ Intraosseous Infusion System cleared under K072487 and the EZ-MIO Intraosseous Infusion System from Vidacare Corporation cleared under K052195.
IV. Intended Use of the Device
The FAST1™ 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.
V. Description of the Device
The FASTI™ Intraosseous Infusion System has been designed to provide alternative access of the circulatory system to intravenous infusion. It utilizes intraosseous infusion in order to facilitate emergency resuscitation through the use of fluids and drugs. The device has been designed for use on the manubrium, the upper (superior) portion of the sternum.
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Summary of the Technical Characteristics VI.
The FAST'1™ Intraosseous Infusion System (expansion of intended use population) has the same technological characteristics as the FAST1™ Intraosseous Infusion System that has received FDA 510(k) clearance under K072487.
Safety & Effectiveness VII.
:
The FAST1 ™ Intraosseous Infusion System has the same intended use and the same or similar technological characteristics as the predicate devices. The differences in technological characteristics between the modified and the predicate devices do not raise issues with the safety and effectiveness of the modified FASTI™ Intraosseous Infusion System.
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APR 2 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Maya Butterfield Quality Assurance and Regulatory Affairs Manager PYNG Medical Corporation 7-13511 Crestwood Place Richmond, B.C., V6V 2E9 CANADA
Re: K080865
Trade/Device Name: FAST1™ Intraosseous Infusion System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single lumen Needle Regulatory Class: II Product Code: FMI Dated: March 26, 2008 Received: March 28, 2008
Dear Dr. Butterfield:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Dr. Butterfield
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutte Y. Michu OMD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indication for Use Statement
510(k) Number (if known):
Device Name:
FAST1™ Intraosseous Infusion System
Indications for Use:
The FAST1™ 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.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cinta Lomo
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: Ky80865
Page 1 of _
§ 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).