(177 days)
The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.
The Terumo Syringe with/without needle is a hypodermic standard piston syringe, available in volumes from 1 ml, 2 ml, 10 ml and 50 ml, with a luer taper tip for single use, made of plastic material and a synthetic rubber gasket. The needle is made from stainless steel.
The provided text describes a 510(k) submission for a medical device, the Terumo® Syringe with/without Needle. It focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than presenting a study of the device's diagnostic performance or algorithm effectiveness. As such, many of the requested categories for acceptance criteria and study details are not relevant or cannot be extracted from this type of regulatory document.
However, I can extract information related to the device's performance testing against a recognized standard, which serves as its primary acceptance criteria in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Mechanical Performance: EN ISO 7886-1 (1993) (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use) | "The Terumo syringe with/without needle was tested in accordance with EN ISO 7886-1 (1993)." Implicitly, the device meets the performance requirements of this standard for its mechanical and functional aspects. The submission states, "None of the obtained data raises any new issues of safety and effectiveness." |
| Needle Properties: (Reference to cleared Neolus Needles, K001572) | "For the needle properties, reference is made to the cleared Neolus Needles compared to in the submitted file K001572." This indicates that the needles used with the syringe meet the established properties of the predicate Neolus Needles. |
| Hemocompatibility: EN ISO 10993-4 (2002) and amendment (2006) (Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood) | "In accordance with the new requirements stipulated in EN ISO 10993-4 (2002) and its amendment (2006) the hypodermic needles were also subjected to additional hemocompatibility testing. A declaration for compliance with the requirements of these tests can be found on page 177." This indicates testing was performed and compliance was declared, implying the device meets these criteria. |
| Sterility Assurance Level (SAL): EN 550 ("Sterilization of Medical Devices: Validation and routine control of ethylene oxide sterilization") ISO 11135 ("Medical Devices: Validation and routine control of ethylene oxide sterilization") EN 556-1 ("Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices") | "The sterility of the Terumo Syringe with/without needle is assured by using a validated sterilization method qualified in accordance with EN 550... and ISO 11135... to a sterility assurance level (SAL) of 10^-6 as required by EN 556-1..." This confirms the device achieves the required SAL. |
| Ethylene Oxide Residual Levels: ISO 10993-7 ("Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals") | "Ethylene oxide residual levels and Ethylene Chlorohydrin residual levels resulting from EtO sterilization are in compliance with ISO 10993-7..." This confirms the device complies with the residual limits. |
| Biocompatibility: EN ISO 10993-1 ("Biological Evaluation of Medical Devices. Part-1: Evaluation and testing.") | "The device is tested for biocompatibility requirements in accordance with the tests stipulated in EN ISO 10993-1... The results of the testing demonstrate that the device is biocompatible." This confirms the device meets biocompatibility requirements. |
| Expiration Dating: (No specific standard mentioned, but a characteristic of medical devices) | "The expiration dating for the Terumo Syringe with/without needle has been established at 5 years." This indicates a tested and validated shelf-life. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "testing" and "data" but does not quantify the sample sizes used for each specific test (e.g., how many syringes were tested for dimensional accuracy, or how many batches for sterility).
- Data Provenance: The device is manufactured by Terumo Europe N.V., in Belgium. The submission states the device "was tested in accordance with EN ISO 7886-1 (1993)", suggesting the testing was performed, or overseen, by the manufacturer or a certified testing facility in relation to its European operations. The description is of the device's inherent physical and material properties, rather than clinical data from human subjects. It's a laboratory/engineering performance study, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes laboratory and engineering performance testing against established international standards. There is no "ground truth" established by human experts in the sense of clinical diagnoses or interpretations. The "truth" is defined by the objective pass/fail criteria of the scientific/engineering standards.
4. Adjudication method for the test set:
- Not applicable. This relates to clinical studies with human review, which is not what this document describes. Performance is assessed against quantitative metrics and methods specified within the referenced ISO/EN standards.
5. 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:
- Not applicable. This device is a manual syringe, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual syringe, not an algorithm.
7. The type of ground truth used:
- For the performance testing, the "ground truth" is defined by the objective, quantitative criteria and test methods specified in the referenced international standards (e.g., EN ISO 7886-1, EN ISO 10993 series, EN 550, ISO 11135, EN 556-1). This includes measurements of physical properties, chemical residual levels, and biological responses.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this device.
{0}------------------------------------------------
ﺎﻟﻔ
510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information
Submitter Information
| Prepared for: | TERUMO EUROPE N.V.Researchpark Zone 2,Interleuyenlaan 40,3001 Leuven,BELGIUM |
|---|---|
| Prepared by: | Mrs. M.J. Aerts – Manager Regulatory AffairsTel. (+32) 16 38 13 53Fax (+32) 16 40 02 49 |
| Date prepared: | November 2008 |
-
- Device Name
Proprietary Name
Terumo® Syringe with/without Needle
Classification Name
Piston syringe (80FMF)
21CFR, Section 880.5860
Classification: Class II
Common Name
Sterile hypodermic syringe with/without needle
2. Reason for Submission New Device
3. Intended Use
The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.
4. Description & Materials
The Terumo Syringe with/without needle is a hypodermic standard piston syringe, available in volumes from 1 ml, 2 ml, 10 ml and 50 ml, with a luer taper tip for single use, made of plastic material and a synthetic rubber gasket. The needle is made from stainless steel.
| Syringe sizes | Needle gauges | Exposed needle lengths |
|---|---|---|
| 1, 2 (including specialgraduations), 5, 10, 50 ml | 20 - 26G | 12 mm (1/2") - 40 mm (1 1/2") |
MAY 22 2009
{1}------------------------------------------------
5. Technology/Principles of operation
The Terumo Syringe with/without needle is operated manually.
6. Performance
ﻟﻨﻘ
The Terumo syringe with/without needle was tested in accordance with EN ISO 7886-1 (1993).
For the needle properties, reference is made to the cleared Neolus Needles compared to in the submitted file K001572. In accordance with the new requirements stipulated in EN ISO 10993-4 (2002) and its amendment (2006) the hypodermic needles were also subjected to additional hemocompatibility testing. A declaration for compliance with the requirements of these tests can be found on page 177.
None of the obtained data raises any new issues of safety and effectiveness.
7. Substantial Equivalence
The "Terumo Syringe with/without Needle", manufactured by Terumo Europe N.V., is submitted in this 510(k) file is substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the following devices:
-
- 50 ml Terumo Syringe for administration of UV sensitive medicines, manufactured by Terumo Europe N.V. (K070264)
Any differences raise no new issues of safety and effectiveness.
8. Additional Safety Information
The sterility of the Terumo Syringe with/without needle 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 sterilization" 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 and Ethylene Chlorohydrin residual levels resulting from EtO sterilization are in compliance with ISO 10993-7: "Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals".
The device is tested for biocompatibility requirements in accordance with the tests stipulated in EN ISO 10993-1, "Biological Evaluation of Medical Devices. Part-1: Evaluation and testing." The results of the testing demonstrate that the device is biocompatible.
The expiration dating for the Terumo Syringe with/without needle has been established at 5 years.
{2}------------------------------------------------
III. DRAFT LABELLING
- Blister paper unit packaging III.1.
- Ш.2. Unit box
ﺮ ﻟﻤ
- Label unit box Ш.3.
- III 4.
III 5. - Shipping carton
Label shipping carton
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. M.J. Aerts Regulatory Affairs Manager Terumo Europe N.V. Researchpark Zone 2 Haasrode Interleuvenlaan 40 B-3001 LEUVEN - BELGIE BELGIUM
MAY 2 2 2009
Re: K083514
Trade/Device Name: Terumo® Syringe With/Without Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 7, 2009 Received: May 11, 2009
Dear Ms. Aerts:
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 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.
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
{4}------------------------------------------------
Page 2- Ms. Aerts
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Penner
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indication for Use
510(k) Number (if known):
Device Name: Terumo® Syringe with/without needle
Indication For Use:
The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.
Prescription Use x (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)__ and the other side is the signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of 1 . .
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).