(39 days)
No
The device description and performance studies focus on mechanical safety features and fluid delivery, with no mention of AI or ML.
No.
A therapeutic device is one that treats or manages a disease or condition, which this device does not do. This device is used for administration of fluids or withdrawal of blood, and primarily functions as a safety mechanism to prevent needlesticks.
No
The device is an infusion set used to administer fluids or withdraw blood, not to diagnose a medical condition.
No
The device description clearly outlines a physical medical device consisting of a needle, hub, tubing, connector, and a hinged shield cover. The performance studies also focus on physical characteristics and functionality of these hardware components. There is no mention of any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices." This describes a device used for collecting a sample from the body, not for performing a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description focuses on the physical components and safety features related to needle insertion and withdrawal. There is no mention of reagents, test strips, or any components used for analyzing a biological sample.
- Lack of IVD-related information: The text does not mention any aspects typically associated with IVDs, such as:
- Specific analytes being measured.
- Diagnostic purposes (e.g., detecting a disease, monitoring a condition).
- Performance metrics like sensitivity, specificity, or accuracy in relation to a diagnostic test.
- Training or test sets related to diagnostic performance.
The device is a tool for collecting a sample (blood) or administering a substance, which are procedures performed in vivo (within the body). The subsequent analysis of the collected blood sample would be an in vitro diagnostic process, but the winged infusion set itself is not the IVD.
N/A
Intended Use / Indications for Use
The Surshield Safety Winged Infusion Set is intended for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. The winged infusion set may be used for any patient population with consideration given to patient size. 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 needlestick.
Product codes
80FPA
Device Description
The Surshield Safety Winged Infusion Set is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, connector and connector cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction. The Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou, China is the same as the Surshield Winged Infusion Set manufactured by Terumo Corporation in Kofu, Japan and cleared under K010103.
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 both 90 and 300mm length tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
for any patient population with consideration given to patient size.
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
The following tests were performed on the Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou, China:
- Shield cover/Needle Locking Strength.
- Break strength of the shield cover joint
- Force to lock the needle in the shield cover (Force to activate safety feature).
- Puncture Resistance of Shield Cover
- Flow Rate
- Priming Volume
- Wing to Tubing Connection Strength
- Tubing to Connector Connection Strength
- Needle to Wing Connection Strength
- . Needle Penetration Resistance
- Wing Needle Protector Fit
- . Leak Test
- . Blockage Test
Additionally, a risk analysis was conducted and no new issues were identified since the Surshield China device is identical to the cleared Surshield Kofu. None of the data raises any new issues of safety and effectiveness.
Key Metrics
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
KO31266
TERUMO MEDICAL PRODUCTS - HANGZHOU CHINA SURSHIELD™ SAFETY WINGED INFUSION SET Section II - Summary and Certification
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
DEVICE NAME
Proprietary Name
SURSHIELD™ Safety Winged Infusion Set
Classification Name
Intravascular Administration Set (80FPA) 21CFR, Section 880.5440 Classification: Class II
Common Name
Intravascular Administration Set
INTENDED USE
The Surshield Safety Winged Infusion Set is intended for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. The winged infusion set may be used for any patient population with consideration given to patient size. 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 needlestick.
DESCRIPTION
The Surshield Safety Winged Infusion Set is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, connector and connector cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction. The Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou, China is the same as the Surshield Winged Infusion Set manufactured by Terumo Corporation in Kofu, Japan and cleared under K010103.
1
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 both 90 and 300mm length tubing.
SUBSTANTIAL EQUIVALENCE
The Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou. China is substantially equivalent to the Surshield Winged Infusion set manufactured by Terumo Corporation in Kofu, Japan and cleared under K010103.
PRINCIPLE OF OPERATION/TECHNOLOGY
Both devices are operated manually.
MATERIALS
The materials used in the Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou, China are the same as the predicate devices, which do not raise any new issues of safety or effectiveness.
2
TERUMO MEDICAL PRODUCTS - HANGZHOU CHINA SURSHIELD™ SAFETY WINGED INFUSION SET Section II - Summary and Certification
SPECIFICATIONS
| Cannula
gauge | Color code | Product code | Winged
type
hub | Cannula
length | Tube
length |
|------------------|------------|--------------|-----------------------|-------------------|----------------|
| 19G | Cream | SVS19BL | C type | 3/4"(19mm) | 300mm |
| | | SVS19DL | D type | 5/8"(16mm) | |
| | | SVS19BLS | C type | 3/4"(19mm) | 90mm |
| 21G | Green | SVS21BL | C type | 3/4"(19mm) | 300mm |
| | | SVS21DL | D type | 5/8"(16mm) | |
| | | SVS21BLS | C type | 3/4"(19mm) | 90mm |
| 23G | Light blue | SVS23BL | C type | 3/4"(19mm) | 300mm |
| | | SVS23DL | D type | 5/8"(16mm) | |
| | | SVS23BLS | C type | 3/4"(19mm) | 90mm |
| 25G | Orange | SVS25BL | C type | 3/4"(19mm) | 300mm |
| | | SVS25DL | D type | 5/8"(16mm) | |
| | | SVS25BLS | C type | 3/4"(19mm) | 90mm |
PERFORMANCE
The following tests were performed on the Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou, China:
- Shield cover/Needle Locking Strength .
- Break strength of the shield cover joint
- Force to lock the needle in the shield cover (Force to activate safety feature) .
- Puncture Resistance of Shield Cover
- Flow Rate
- Priming Volume
- Wing to Tubing Connection Strength
- Tubing to Connector Connection Strength
- Needle to Wing Connection Strength
- . Needle Penetration Resistance
- Wing Needle Protector Fit
- . Leak Test
- . Blockage Test
3
TERUMO MEDICAL PRODUCTS - HANGZHOU CHINA SURSHIELD™ SAFETY WINGED INFUSION SET Section II - Summary and Certification
Additionally, a risk analysis was conducted and no new issues were identified since the Surshield China device is identical to the cleared Surshield Kofu. None of the data raises any new issues of safety and effectiveness.
The Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou. China is substantially equivalent to the Surshield Winged Infusion set manufactured by Terumo Corporation in Kofu, Japan and cleared under K010103.
ADDITIONAL SAFETY INFORMATION
The sterilization conditions are validated according to EN550 to provide a Sterility Assurance Level (SAL) of 104.
Ethylene Oxide residual levels resulting from EtO sterilization will not exceed the maximum residue levels proposed for Part 821 of Title 21 in the Federal Register Notice issued June 23, 1978, and indicated as follows:
| Ethylene Oxide | 25 ppm |
|---|---|
| Ethylene Chlorohydrin | 25 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 ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing. Results of the testing demonstrate that the blood contacting materials are biocompatible.
CONCLUSION
The Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou. China is substantially equivalent to the Surshield Winged Infusion set manufactured by Terumo Corporation in Kofu, Japan and cleared under K010103 with respect to intended use, design, technology/principles of operation, materials and performance. Differences between the devices do not raise any new issues of safety or effectiveness.
Date Prepared: 04/17/03
- Prepared by: Barbara Smith Sr. Regulatory Affairs Specialist 125 Blue Ball Rd Elkton, MD 21921 Phone: 410-392-7241
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
MAY 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara Smith Senior Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921
Re: K031266
Trade/Device Name: SURSHIELD™ Safety Winged Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 18, 2003 Received: April 22, 2003
Dear Ms. Smith:
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.
5
Page 2 - Ms. Smith
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 (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.
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Suvor Russer
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K 03/2 66
510(k) Number (if known):
SURSHIELD™ SAFETY WINGED INFUSION SET Device Name:
Indications For Use:
The Surshield Safety Winged Infusion Set is intended for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. The winged infusion set may be used for any patient population with consideration given to patient size. 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 needlestick.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Pattuce Cucenit
(Optional Format 1-2-96)
n of Anesthesiology. General Hospital
510(k) Number: K031266
003