(22 days)
The SURGUARD2™ SAFETY NEEDLE device for 26 to 30gauge needles is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdraw of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The SURGUARD2™ SAFETY NEEDLE consists of a hypodermic needle with a hinged safety sheath attached to the connector hub. The safety sheath contains a locking mechanism which is activated when the sheath is manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath against a firm surface. The locking mechanism is located at a designated position within the body of the short or long sheath appropriate for the needle size it is to contain. The needle gauge sizes are 26gauge to 30gauge and the needle lengths are 3/8" (9mm) to 1" (13mm). The hinge feature allows the user to set the sheath to the desired position for use. For user convenience, when the needle is in the "bevel up" position the sheath is located to the right. The SURGUARD2™ SAFETY NEEDLE will be individually packaged and sterilized as a safety needle only or as a safety needle with attached Terumo syringe.
The Terumo SURGUARD2™ Safety Needle is an existing device (K031453) that the manufacturer is trying to expand to cover 26-gauge to 30-gauge needles. The safety and effectiveness of these additional needle sizes are being demonstrated through performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present acceptance criteria in a quantitative table format. Instead, it states that tests were performed and implies successful completion by declaring substantial equivalence. However, we can infer the tested parameters and the general intention, which is to demonstrate performance comparable to the predicate device and ensure safety.
| Test Parameter | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Activation Force | Consistent and adequate force for safe, manual activation | Performance found to be acceptable; contributes to substantial equivalence. |
| Deactivation Force | Appropriate force to indicate proper locking without premature deactivation | Performance found to be acceptable; contributes to substantial equivalence. |
| Puncture Resistance | Sufficient resistance to prevent accidental needlesticks | Performance found to be acceptable; contributes to substantial equivalence. |
| Simulated Use Study | Demonstrates effective and safe use in simulated clinical settings | Performance found to be acceptable, addressing safety and effectiveness concerns for smaller needles. |
| Biocompatibility | Meet ISO-10993 requirements for blood-contacting materials | Results demonstrate that blood-contacting materials are biocompatible. |
| Sterility | Sterility Assurance Level (SAL) of 10^-6 | Sterilized using a validated method to achieve SAL of 10^-6. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for each performance test (Activation Force, Deactivation Force, Puncture Resistance, Simulated Use Study). It only states that "The following tests were performed on the SURGUARD2™ SAFETY NEEDLE for 26 to 30gauge needles."
- Data Provenance: The data is prospective, generated specifically for this 510(k) submission by Terumo Medical Corporation in Elkton, Maryland, USA. The testing was conducted to prove the safety and effectiveness of the extended product line.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a medical needle, and the "ground truth" is established through engineering and biological performance testing, not expert interpretation of outputs like images.
4. Adjudication Method for the Test Set:
Not applicable for this type of device and testing. Performance data is generated directly from physical tests, not through expert adjudication of subjective assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/algorithm-based diagnostic device where human reader performance would be a relevant metric.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted. The tests listed (Activation Force, Deactivation Force, Puncture Resistance, Simulated Use Study, Biocompatibility, Sterility) are all standalone evaluations of the device's physical and biological properties. There is no human-in-the-loop component in these specific tests determining the core performance of the safety mechanism.
7. Type of Ground Truth Used:
The ground truth used is based on:
- Engineering Specifications/Standards: For tests like Activation Force, Deactivation Force, and Puncture Resistance, the ground truth is the measured physical property against predefined engineering limits or industry standards for safety needles.
- Simulated Clinical Scenarios: For the Simulated Use Study, the "ground truth" would be the observed successful activation and prevention of needlestick injuries under controlled, simulated conditions.
- Biological Standards: For Biocompatibility, the ground truth is compliance with ISO-10993 standards, demonstrated through specific in-vitro and/or in-vivo tests.
- Sterilization Standards: For Sterility, the ground truth is achieving a specified Sterility Assurance Level (SAL) through a validated process according to ANSI/AAMI/ISO 11137-1998.
Essentially, the ground truth is derived from objective, measurable physical, chemical, and biological properties and adherence to established regulatory and industry standards for medical devices.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and manufacturing process are established through engineering principles.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device. The design and validation are based on established engineering, manufacturing, and regulatory compliance practices.
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TERUMO MEDICAL CORPORATION SPECIAL 510(k) - SURGUARD2™ SAFETY NEEDLE Section II. Summary & Certification
MAR 2 3 2004
SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
A. Device Name
Proprietary Device Name: TERUMO® SURGUARD2™ SAFETY NEEDLE
Needle, Hypodermic, Single Lumen with antistick Classification Name:
B. Reason for Submission:
This 510k is being submitted to extend the cleared SURGUARD2™ Safety Needle (K031453) product line to include 26 to 30gauge needle sizes taking into consideration the potential issues of safety and effectiveness specific for sheathing a smaller/thinner needles after use. This 510k will provide supporting information that the SURGUARD2™ Safety Needle design is safe and effective for smaller needle sizes (26 to 30g) and an acceptable extension of the current cleared SURGUARD2™ Safety Needle device (K031453).
C. Intended Use:
The SURGUARD2™ SAFETY NEEDLE device for 26 to 30gauge needles is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdraw of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Note: This is the same intended use us the predicate device, SURGUARD2™ SAFETY NEEDLE (K031453).
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D. Description
The SURGUARD2™ SAFETY NEEDLE consists of a hypodermic needle with a hinged safety sheath attached to the connector hub. The safety sheath contains a locking mechanism which is activated when the sheath is manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath against a firm surface. The locking mechanism is located at a designated position within the body of the short or long sheath appropriate for the needle size it is to contain. The needle gauge sizes are 26gauge to 30gauge and the needle lengths are 3/8" (9mm) to 1" (13mm). The hinge feature allows the user to set the sheath to the desired position for use. For user convenience, when the needle is in the "bevel up" position the sheath is located to the right. The SURGUARD2™ SAFETY NEEDLE will be individually packaged and sterilized as a safety needle only or as a safety needle with attached Terumo syringe.
E. Substantial Equivalence
The SURGUARD2™ SAFETY NEEDLE is substantially equivalent in intended use, design, technology/principals of operation, materials, and performance to the SURGUARD2™ SAFETY NEEDLE cleared under K031453 and TERUMO® Hypodermic Needles cleared under K771203 and K012646.
Differences between the devices do not raise any significant issues of safety and effectiveness.
F. Principals of Operation/Technology
The proposed SURGUARD2™ SAFETY NEEDLE for 26 to 30g needles and the predicate SURGUARD2™ SAFETY NEEDLE (K031453) and TERUMO® Hypodermic Necdles (K771203 & K012646) are operated manually.
G. Materials
The materials used for the SURGUARD2™ SAFETY NEEDLE for 26 to 30gauge needles are identical to the materials used for the cleared SURGUARD2™ SAFETY NEEDLE (K031453) and TERUMO® Hypodermic Needles (K771203 & K012646).
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H. Specifications
| Product Description |
|---|
| 26gauge x 1" (13mm) safety needle |
| 27gauge x 1" (13mm) safety needle |
| 30gauge x 1" (13mm) safety needle |
| 26gauge x 3/8" (9mm) safety needle with attached 1cc syringe |
| 27gauge x 1" (13mm) safety needle with attached 1cc syringe |
I. Performance
The following tests were performed on the SURGUARD2™ SAFETY NEEDLE for 26 to 30gauge needles:
- Activation Force .
- Deactivation Force
- . Puncture Resistance
- Simulated Use Study ●
A risk analysis was conducted and any new or different issues of safety and effectiveness were identified and mitigated appropriately.
The SURGUARD2™ SAFETY NEEDLE submitted in this 510k for 26 to 30gauge needles is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the legally marketed predicate SURGUARD2™ SAFETY NEEDLE device (K031453) and TERUMO® Hypodermic Needles (K771203 & K012646).
J. Additional Safety Information
Manufacturing controls include visual, functional, and sterility tests.
The sterility of the device is assured using a sterilization method validated in accordance with ANSI/AAMI/ISO 11137-1998 Medical Devices – Validation and Routine Control of Radiation Sterilization. The SURGUARD2™ SAFETY NEEDLE is sterilized to provide a Sterility Assurance Level (SAL) of 10th.
The Terumo SURGUARD2™ SAFETY NEEDLE is classified as Externally Communicating Device, Blood Path Indirect. Limited Duration of Contact (< 24 hr). 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
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ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing". Results of the testing demonstrate that the blood contacting materials are biocompatible.
K. Conclusion
The SURGUARD2™ SAFETY NEEDLE for 26 to 30 gauge needles without or with syringe attached is substantially equivalent to the SURGUARD2™ SAFETY NEEDLE cleared under K031453 and TERUMO® Hypodcrmic Needles cleared under K771203 and K012646.
Differences between the devices do not raise any significant issues of safety or effectiveness.
Date Prepared: February 27, 2004
Prepared by: Barbara Smith Sr. Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921 Phone#: 410-392-7241 Fax#: 410-398-6079
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
MAR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara L. Smith Senior Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921
Re: K040531
Trade/Device Name: Terumo® Surguard2TM Safety Needle Regulation Number: 880.5570, 880.5860 Regulation Name: Hypodermic Single Lumen Needle, Piston Syringe Regulatory Class: II Product Code: FMI, MEG Dated: February 27, 2004 Received: March 1, 2004
Dear Mr. 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.
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Page 2 - Ms. Rivkowich
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 (301) 594-5618. 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.
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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Indications for Use
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The SURGUARD2™ SAFETY NEEDLE device for 26 to 30gauge needles is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdraw of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minize risk of accidental needlestick.
Prescription Use v (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)
Arts Dvorak
Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number 1894 0 5 )
08000
§ 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).