(120 days)
The 50 ml Terumo Syringes for administration of UV sensitive medicines are sterile hypodermic syringes for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. Intended for manual use or for use with power driven syringe pumps. The opaque color of the barrel allows the administration of UV sensitive medicines.
The 50 ml Terumo Syringe for Administration of UV Sensitive Medicines is a hypodermic standard piston syringe for single use, with a 6 % luer lock tip, made of plastic material and a synthetic rubber gasket. The barrel of the syringes has an opaque color to avoid the transmission of UV light. The 6% luer lock tip allows the use with power driven syringe pumps.
The provided text describes a 510(k) summary for the "50 ml Terumo Syringe for Administration of UV Sensitive Medicines." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study against specific acceptance criteria for algorithm performance.
Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them, particularly those related to AI algorithm performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established), are not applicable to this type of medical device submission.
The "Performance" section explicitly states: "The 50 ml Terumo Syringe was tested in accordance with EN ISO 7886-1 (1997) and EN ISO 7886-2 (1997). Other testing included barrel transmission and UV protection of the opaque barrel." This indicates that the acceptance criteria are defined by these international standards for syringes and specific tests related to the UV-sensitive aspect of the device.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| EN ISO 7886-1 (1997) | Tested in accordance |
| EN ISO 7886-2 (1997) | Tested in accordance |
| Barrel Transmission | Tested (implied satisfactory) |
| UV Protection (Opaque Barrel) | Tested (implied satisfactory) |
| EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide" | Sterility assured to SAL of 10⁻⁶ |
| ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" | Sterility assured to SAL of 10⁻⁶ |
| EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices" | Sterility assured to SAL of 10⁻⁶ |
| EN ISO 10993-7: "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals" | Ethylene oxide residual levels in compliance |
| 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" | Blood contacting materials biocompatible |
| Expiration Dating | Established at 5 years |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the performance testing. The provenance of the data is implicit as it's a device manufactured by Terumo Europe N.V., suggesting the testing was conducted to European and international standards. It's a new device, so the testing would be prospective in nature, demonstrating compliance with specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for a medical device like a syringe. Performance is measured against predefined engineering and biological standards, not expert interpretations of medical images or conditions.
4. Adjudication method for the test set
Not applicable. Performance is based on direct physical and chemical measurements against established 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 physical syringe, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical syringe, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for this device is defined by the requirements outlined in the referenced international standards (e.g., ISO, EN standards) and FDA biocompatibility guidelines. For example, for sterility, the ground truth is a sterility assurance level (SAL) of 10⁻⁶ as defined in EN 556-1. For biocompatibility, the ground truth is "biocompatible" as determined by tests recommended in FDA guidance and ISO 10993-1.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information
-
- Device Name
MAY 2 9 2007
Proprietary Name
50 ml Terumo Syringe for Administration of UV Sensitive Medicines
Classification Name
Piston Syringe (80FMF) 21CFR, Section 880.5860 Classification: Class II
2. Reason for Submission
New device
3. Intended Use
The 50 ml Terumo Syringe for Administration of UV Sensitive Medicines are hypodermic syringes for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. Intended for manual use with power driven syringe pumps. The opaque color of the barrel allows the administration of UV sensitive medicines.
4. Description
The 50 ml Terumo Syringe for Administration of UV Sensitive Medicines is a hypodermic standard piston syringe for single use, with a 6 % luer lock tip, made of plastic material and a synthetic rubber gasket. The barrel of the syringes has an opaque color to avoid the transmission of UV light. The 6% luer lock tip allows the use with power driven syringe pumps.
న్. Performance
The 50 ml Terumo Syringe was tested in accordance with EN ISO 7886-1 (1997) and EN ISO 7886-2 (1997). Other testing included barrel transmission and UV protection of the opaque barrel.
6. Substantial Equivalence
The 50 ml (with scale extension up to 60 ml) Terumo Syringe for administration of UV sensitive medicines is substantially equivalent in intended use, design, technology/principals of operation, materials and performance to the following cleared devices:
- Terumo Syringe for Administration of UV Sensitive Medicines, manufactured by 1. Terumo Europe N.V. (K053413)
- 60 mL BD syringe with BD Luer-Lok tip, manufactured by Becton Dickinson & 2. Company (Note: we presume that this syringe is covered by the 510(k) number K980987, but we were unable to verify this based on the published resources)
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KU70a64
6. Additional Safety Information
The sterility of the 50 ml Terumo Syringe for Administration of UV Sensitive Medicines 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 EN ISO 10993-7: " Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals"
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 testine". Results of the testing demonstrate that the blood contacting materials are biocompatible.
The expiration dating for the 50 ml Terumo Syringe for Administration of UV Sensitive Medicines has been established at 5 years.
7. Conclusion
In summary, the 50 ml (with scale extension up to 60 ml) Terumo Syringe for Administration of UV Sensitive Medicines are substantially equivalent in intended use, design, technology/principals of operation, materials and performance to the following cleared devices:
- Terumo Syringe for Administration of UV Sensitive Medicines, manufactured by 1. Terumo Europe N.V. (K053413)
-
- 60 mL BD syringe with BD Luer-Lock tip, manufactured by Becton Dickinson & Company (Note: we presume that this syringe is covered by the 510(k) number K980987, but we were unable to verify this based on the published resources)
Differences between the devices do not raise any new or different 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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2007
Mrs. M.J. Aerts Manager Regulatory Affairs Terumo Europe N.V. Researchpark Zone 2 Haasrode Interleuvenlaan 40 B-3001 Leuven BELGIUM
Re: K070264
Trade/Device Name: 50 ml Terumo® Syringe for Administration of UV Sensitive Medicines Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 21, 2007 Received: May 23, 2007
Dear Mrs. Acrts:
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 - Mrs. Aerts
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 CIFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Chris Lins, Ph.D.
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: 50 ml Terumo® Syringe for administration of UV sensitive medicines
Indications for Use:
The 50 ml Terumo Syringes for administration of UV sensitive medicines are sterile hypodermic syringes for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. Intended for manual use or for use with power driven syringe pumps. The opaque color of the barrel allows the administration of UV sensitive medicines.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony D. m
ா Sign-Off) on of Anesthesiology, General Hospital, Control, Dental Devices
(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).