(21 days)
The Terumo syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
The Terumo 30 and 60cc/mL Syringes consist of 3 main parts, a barrel, plunger, and gasket. Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material. The syringes are individually packed in a peel blister that ensures the sterility of the device until the package is opened. The product is sterilized by electron beam sterilization. The product is for single use only and is not intended for reuse.
The provided document is a 510(k) summary for the TERUMO® Syringe with/without needle, which is a medical device. This type of device is a physical product and not an AI/ML-driven software device. Therefore, the questions related to AI/ML specific performance, such as sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable to this submission.
However, I can extract the acceptance criteria and performance information relevant to this physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the Terumo Syringe without needle, 30 and 60cc/mL, was "subjected to the following tests." While explicit numerical acceptance criteria values are not provided in this summary, the completion of these tests with acceptable results is implied for substantial equivalence.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Leakage (Aspiration and Injection) | Tested (implied to have met criteria for substantial equivalence) |
| Plunger Mobility | Tested (implied to have met criteria for substantial equivalence) |
| Tip-hub fitting | Tested (implied to have met criteria for substantial equivalence) |
| Gasket fit | Tested (implied to have met criteria for substantial equivalence) |
| Nominal graduation capacity | Tested (implied to have met criteria for substantial equivalence) |
| Plunger stopper strength | Tested (implied to have met criteria for substantial equivalence) |
| Dead Space | Tested (implied to have met criteria for substantial equivalence) |
| Conical fitting | Tested (implied to have met criteria for substantial equivalence) |
| Biocompatibility | Tested in accordance with ISO 10993-1, results demonstrate blood contacting materials are biocompatible. (Specifically for "Externally Communicating Device, Limited contact" classification) |
| Sterilization Assurance Level (SAL) | Validated in accordance with ISO 11137-1995 to a SAL of 10^-6. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a physical device submission, not an AI/ML software submission involving data sets. Device testing would typically involve a sample size of physical units to perform the listed tests. The document does not specify the exact number of units tested for each criterion, but it confirms the tests were conducted. The device manufacturer is Terumo (Philippines) Corporation, and the product is manufactured in Biñan, Laguna, Philippines.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as there is no "ground truth" in the context of an AI/ML algorithm for a physical syringe. The tests are directly measuring the physical properties and performance of the device against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no "adjudication" in the context of an AI/ML algorithm for a physical syringe. Device testing results are typically objectively measured against specifications.
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
This is not applicable as this is a physical device and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a physical device and does not involve a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for a physical syringe is its adherence to engineering specifications and performance standards established by regulatory bodies (e.g., ISO, FDA).
8. The sample size for the training set
This is not applicable as this is a physical device and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
This is not applicable as this is a physical device and does not involve a training set or its associated ground truth establishment.
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KO63613
Section II. 510 (k) Summary and Certification Terumo® Syringe with/without needle Terumo (Philippines) Corporation
DEC 2 6 2006
510k Summary
Device Name
Proprietary Name: TERUMO® Syringe without Needle
Classification Name: Syringe, Piston with or without hypodermic single lumen needle
Common Name: Hypodermic Syringe with/without needle
Intended Use
The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Note: This is the same intended use as the predicate device, Terumo Syringe with/without needle cleared under K023271 and K051864.
Device Description
The Terumo 30 and 60cc/mL Syringes consist of 3 main parts, a barrel, plunger, and gasket. Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material. The syringes are individually packed in a peel blister that ensures the sterility of the device until the package is opened. The product is sterilized by electron beam sterilization. The product is for single use only and is not intended for reuse.
Principles of Operation/Technology
The 30 and 60cc/mL Terumo Syringes without needle are manually operated.
Materials
The materials used in the 30 and 60cc/mL Terumo Syringes without needle are substantially equivalent to the materials used in the predicate Terumo Syringe with/without needle devices cleared under K023271 and K052034.
Specifications
| PRODUCT DESCRIPTION |
|---|
| 30cc/ml luer slip syringe |
| 30cc/ml luer lock syringe |
| 30cc/ml eccentric luer syringe |
| 60cc/ml luer lock syringe |
| 60cc/ml eccentric luer syringe |
| 60cc/ml catheter tip syringe |
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Section II. 510 (k) Summary and Certification Terumo® Syringe with/without needle Terumo (Philippines) Corporation
Performance
The Terumo Syringe without needle, 30 and 60cc/mL submitted in this premarket notification was subjected to the following tests:
- Leakage (Aspiration and Injection) ●
- Plunger Mobility .
- Tip-hub fitting �
- . Gasket fit
- Nominal graduation capacity .
- Plunger stopper strength .
- Dead Space .
- Conical fitting .
Substantial Equivalence
The 30 and 60cc/mL Terumo Syringes without needle are substantially equivalent in intended use, materials, design, technology and principles of operation and performance to cleared Terumo Syringes with/without needle cleared under K023271 and K052034. Any differences raise no new issues of safety and effectiveness.
Additional Safety Information
Manufacturing controls included visual, functional, dimensional and sterility tests.
The Terumo Syringe without needle 30 and 60cc/mL are classified as an Externally Communicating Device, Limited contact. 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 10993-1' "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Results of the testing demonstrate that the blood contacting materials are biocompatible.
Sterilization conditions have been validated in accordance with ISO 11137-1995, Medical Devices - Validation and Routine control of Radiation Sterilization. The device is sterilized to a SAL of 10 -6 .
Submitter Information
| Prepared by: | Barbara SmithSr. Regulatory Affairs SpecialistTerumo Medical Corporation950 Elkton BoulevardElkton, Maryland 21921 |
|---|---|
| Prepared for: | Terumo (Philippines) Corporation#124 East Main Ave., Laguna Technopark |
Biñan, Laguna, Philippines 4026
December 4, 2006 Date Prepared:
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sandi Hartka Regulatory Affairs Manager Terumo Medical Corporation 950 Elkton Boulevard Elkton, Maryland 21921
Re: K063613
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: December 4, 2006 Received: December 12, 2006
Dear Ms. Hartka:
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. Hartka
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 (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 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): _
TERUMO® Syringe with/without Needle Device Name:
Indications For Use:
The Terumo syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Prescription Use (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)
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§ 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).