(56 days)
No
The description details a mechanical safety mechanism for a winged infusion set and does not mention any computational or data-driven components.
No
The device is described as being used for the administration of fluids and withdrawal of blood specimens, and for needle stick protection. These are not therapeutic uses.
No
The device is used for administering fluids or withdrawing blood specimens, and for needle stick protection, not for diagnosing a condition or disease.
No
The device description clearly outlines a physical medical device consisting of a needle, winged hub, tubing, adapter, and a hinged shield cover. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access the peripheral vascular system for intravenous administration of fluids and/or withdrawal of blood specimens. This is a procedure performed directly on the patient's body.
- Device Description: The description details a device for accessing veins and administering/withdrawing substances. It focuses on the physical components used for this process and needle protection.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, analyzers, or other components used to test biological samples.
This device is a medical device used for a clinical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.
Product codes
FPA
Device Description
The Terumo Surflo Winged Infusion Set with Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-towing junction.
The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or two- handed technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.
The device possesses 350 mm length tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
Indicated Patient Age Range
Not Found
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)
Not Found
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
§ 880.5440 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.
0
K05-2887
JEC: 8 2005
510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information
- l . Device Name
Proprietary Name
SURFLO® Winged Infusion Set with Needle Protection (Surshield")
Classification Name
Intravascular Administration Set (80FPA) 21CFR, Section 880.5440 Classification: Class II
-
- Reason for Submission New Device
-
- Intended Use
The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.
-
- Description
The Terumo Surflo Winged Infusion Set with Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-towing junction.
- Description
The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or two- handed technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.
The device possesses 350 mm length tubing.
1
ર. Substantial Equivalence
The "Surflo Winged Infusion Set with Needle Protection (Surshield)", manufactured by Tcrumo Europe N.V., submitted in this 510(k) file is substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the cleared "Surshield Safety Winged Infusion Set", manufactured by Terumo Medical Products in Hangzhou, China, which is the subject of K031266.
Additional Safety Information 6.
The sterility of the Surflo Winged Infusion Set with Needle Protection (Surshield) is assured by using a validated sterilization method qualified in accordance with EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide" and ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization' to a sterility assurance level (SAL) of 10° as required by EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices".
Ethylene oxide residual levels resulting from EtO sterilization are in compliance with ISO 10993-7: " Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals" and do not exceed the level proposed in the European Pharmacopeia monograph 3.2.6:
| Ethylene Oxide | ≤ 10 ppm |
|---|---|
| Ethylene Chlorohydrin | ≤ 10 ppm |
The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard EN ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing. Results of the testing demonstrate that the blood contacting materials are biocompatible.
The expiration dating for the Surflo Winged Infusion Set with Needle Protection (Surshield) has been established at 5 years.
7. Conclusion
The Surflo Winged Infusion Set with Needle Protection (Surshield) manufactured by Tcrumo Europe N.V. and submitted in this 510(k) file is substantially equivalent in intended use, description, specifications, technology/principles of operation, materials and performance to the cleared Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou, China, which is the subject of K031266. Differences between the devices do not raise any new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the symbol.
2005 DEC 8
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mrs. M.J. Aerts Manager Regulatory Affairs Terurmo Europe N.V. Researchpark Zone 2, Interleuvenlaan 40, 3001 Leuven BELGIUM
Re: K052887
K032867
Trade/Device Name: Surflo® Winged Infusion Set with Needle Protection (Surshield TM) Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 7, 2005 Received: October 13, 2005
Dear Mrs. Aerts:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becares is ne the device is substantially equivalent (for the referenced above and have determined the as neves and the marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to thay 20, 1978, as a secondance with the provisions of Americallients, or to devices that nave ooch (Act) that do not require approval of a premarket the Federal Pood, Drug, and Oosmette : 100 (10) ...
approval application (PMA). You may, therefore, market the device, subject to the general approval application (x may). The general controls provisions of the Act include controls provisions of the Fet. "The genting 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 II your device is classified (500 a0010) into controls. Existing major regulations affecting (PMA), it may be subject to sach additions, Title 21, Parts 800 to 898. In your device can be found in the South vements concerning your device in the Federal Register.
3
Page 2 - Mrs. Aerts
Please be advised that FDA's issuance of a substantial equivalence determination does not I Joast that FDA has made a determination that your device complies with other requirements moun that 1 Dr may Federal statutes and regulations administered by other Federal agencies. or the Act of any I ederal title Act's requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF read 807), equality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form moduct 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) I mis letter will and A your began finding of substantial equivalence of your device to a premaired predicate in - 11 - 11 - 11 - 11 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rr you democ 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Divisor (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
4
Indications for Use Statement
510(k) Number (if known): K052887
Device Name: Surflo® Winged Infusion Set with Needle Protection (Surshield™)
Indications for Use:
The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.
Prescription Use (Part 21 CFR 801 Subpart D)
MODELER CONSULTION CONSULTION CONSULTION THE THE THE THE THE THE FORMICITED ACCREASE CONSULTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION C
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
William M. Burdick 12/8/65
Sincol Den i Bo
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