(78 days)
The SureFlow™ Safety Infusion Device is a device intended to allow a health care practitioner to administer multiple intravenous medications simultaneously to a patient's vascular system utilizing needleless components and an I.V. manifold via syringe, gravity or infusion pump.
By being needleless, it operates as a safety device which is designed to aid in reducing the possibility of accidental needle sticks.
The SureFlow™ Safety Infusion Device is a needleless, sterile, non-pyrogenic single use intravenous fluid administration set which provides multiple access ports and regulates the directional flow of fluids for simultaneous intravenous therapy. It has 3 ports with swabable luers, integrated check valves, and pre-attached needleless injection ports all connecting to a drip chamber. A 4th port with a swabable luer and pre-attached needleless injection port allows for flushing of the chambers.
It is manufactured with conventional medical grade, biocompatible materials. It operates as a safety device by eliminating the use of needles in the delivery of medications via IV infusion, thus eliminating the opportunity for accidental needlesticks.
In addition, the SureFlow™ aids in reducing nosocomial infections by not requiring a break in the fluid path once the needleless syringes are connected to the SureFlow™. The valves are swabbed prior to connection which provides an uninterrupted, sterile fluid path versus the current practice of repetitive access to the IV port with needles which are exposed to airborne contamination.
It is supplied sterile for single use only
The provided text is a 510(k) summary for the SureFlow™ Safety Infusion Device, which is an intravascular administration set. This document is a premarket notification for a medical device and describes its intended use, technological characteristics, and comparison to a predicate device.
However, the document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How training set ground truth was established.
The document states:
- "The SureFlow™ Safety Infusion Device has been shown to be substantially equivalent to the predicate device by non-clinical performance data. The testing involved performance testing, and biocompatibility testing."
- "A summary of the technological characteristics of this device compared to the predicate device can be seen in the Comparison Table in the Specifications Section." (This section is not included in the provided text.)
Therefore, based on the provided text alone, it is not possible to answer the specific questions about the acceptance criteria and the study that proves the device meets them. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical data, rather than detailing specific performance metrics against defined acceptance criteria in the manner requested (e.g., for an AI/ML device).
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510(k) SUMMARY
| Submitted by: | Intrasafe Medical, LLC13601 Preston Road, Suite #900WDallas, Texas 75240(972) 233-1081 Phone(972) 233-0224FAX |
|---|---|
| Contact Person: | Shepard G. BentleySynergy Biomedical, LLC28202 Cabot Road, Suite 300Laguna Niguel, CA 92677(949) 365-5790 Phone(949) 365-5791 FAXE:Mail sbentley@synergybiomed.com |
| Date Prepared: | 16 July 2005 |
| Device Name: | SureFlow™ Safety Infusion Device |
| Trade Name: | SureFlow™ Safety Infusion Device |
| Common Name: | Intravascular Administration Set, Needleless |
| Classification Name: | Set, Administration, Intravascular |
| Device Class: | II (two) |
| Procode: | FPA |
| CFR Reference: | 880.5440 |
| Predicate Device: | Multiport® Manifold Set with Swabable Valves, Mode |
| Predicate 510(k) #: | K040385 |
| Device Description: | The SureFlow™ Safety Infusion Device is a needleless, sterile,non-pyrogenic single use intravenous fluid administration setwhich provides multiple access ports and regulates thedirectional flow of fluids for simultaneous intravenous therapy.It has 3 ports with swabable luers, integrated check valves, andpre-attached needleless injection ports all connecting to a dripchamber. A 4th port with a swabable luer and pre-attachedneedleless injection port allows for flushing of the chambers.It is manufactured with conventional medical grade,biocompatible materials. It operates as a safety device byeliminating the use of needles in the delivery of medicationsvia IV infusion, thus eliminating the opportunity for accidentalneedlesticks.In addition, the SureFlow™ aids in reducing nosocomialinfections by not requiring a break in the fluid path once the |
Synergy Biomedical
Page 15 of 78
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needleless syringes are connected to the SureFlow™. The valves are swabbed prior to connection which provides an uninterrupted, sterile fluid path versus the current practice of repetitive access to the IV port with needles which are exposed to airborne contamination.
It is supplied sterile for single use only
The SureFlow™ Safety Infusion Device is a device intended to Intended Use: allow a health care practitioner to administer multiple intravenous medications simultaneously to a patient's vascular system utilizing needleless components and an I.V. manifold via syringe, gravity or infusion pump.
It is manufactured with conventional medical grade, biocompatible materials. By being needleless, it operates as a safety device which is designed to aid in reducing the possibility of accidental needle sticks, as well as, aiding in reducing nosocomial infections by not requiring a break in the fluid path once the needleless syringes are connected to the SureFlow™ .
When the infusion is complete, the device is discarded according to the appropriate disposal procedure for the health care provider.
Technological Comparison: A summary of the technological characteristics of this device compared to the predicate device can be seen in the Comparison Table in the Specifications Section. This device and the predicate have similar technological characteristics and are substantially equivalent.
Non-Clinical Data: The SureFlow™ Safety Infusion Device has been shown to be substantially equivalent to the predicate device by non-clinical performance data. The testing involved performance testing, and biocompatibility testing.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the logo in a circular fashion.
Public Health Service
OCT 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intrasafe Medical, LLC C/O Mr. Shepard G. Bentley Regulatory Consultant to Intrasafe Medical, LLC. Synergy Biomedical, LLC. 28202 Cabot Road, Suite 300 Laguna Niguel, California 92677
Re: K051943
Trade/Device Name: SUREFLOW SAFETY INFUSION DEVICE Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: July 16, 2005 Received: July 18, 2005
Dear Mr. Bentley:
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 - Mr. Bentley
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,
Saytie y. Michael Oms.
Chiú 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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Indications for Use
510(k) Number (if known): K051943
SureFlow™ Safety Infusion Device Device Name:
Indications for Use:
The SureFlow™ Safety Infusion Device is a device intended to allow a health care practitioner to administer multiple intravenous medications simultaneously to a patient's vascular system utilizing needleless components and an I.V. manifold via syringe, gravity or infusion pump.
By being needleless, it operates as a safety device which is designed to aid in reducing the possibility of accidental needle sticks.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Arter U, nate
(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: __
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§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.