(19 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 Iml Terumo Syringe with/without Needle consists of 3 main parts or 4 parts, i.e., a barrel, plunger, gasket and a hypodermic needle (for with needle type). 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 needle is made from stainless steel. The 1 ml Terumo Syringe with/without Needle is individually packed in 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.
Here's an analysis of the provided 510k summary regarding the acceptance criteria and the study that proves the device meets those criteria:
This document is a 510(k) premarket notification for a medical device that demonstrates substantial equivalence to a predicate device, rather than proving performance against novel acceptance criteria through a clinical study. Therefore, many of the requested fields related to AI/MRMC studies or detailed ground truth establishment for novel algorithms are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Performance Section) | Reported Device Performance (from Performance Section) |
|---|---|
| Leakage (Aspiration and Injection) | Subjected to testing |
| Plunger Mobility | Subjected to testing |
| Plunger Gasket Fit | Subjected to testing |
| Plunger Stopper Strength | Subjected to testing |
| Deadspace | Subjected to testing |
| Nominal Graduation Capacity | Subjected to testing |
| Packaging Seal Strength | Subjected to testing |
| Biocompatibility (blood contacting materials) | Tested in accordance with ISO 10993-1; results demonstrate materials are biocompatible. |
| Sterility (SAL) | Validated in accordance with ISO 11137-1995 to a SAL of 10⁻⁶. |
| Manufacturing Controls | Included visual, functional, dimensional, and sterility tests. |
Study Proving Acceptance Criteria:
The document states that the "1ml Terumo Syringe with/without needle submitted in this premarket notification was subjected to the following tests," listing the performance criteria mentioned above. It also explicitly states, "The 1ml Terumo Syringe with/without needle is substantially equivalent in intended use, materials, design, technology and principles of operation and performance to cleared Terumo Syringes with/without needle cleared under K023271."
This indicates that the "study" proving acceptance criteria is bench testing for the listed performance characteristics and material biocompatibility/sterility validation as per international standards, followed by a demonstration of substantial equivalence to an already cleared predicate device (K023271). The specific numerical results or detailed methodology for each test are not provided in this summary but would have been part of the full submission.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the bench tests. Data provenance is not applicable in the context of bench testing for a physical medical device; the tests would have been performed in a laboratory setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable since this is a physical medical device undergoing bench testing and not an AI/diagnostic device requiring expert ground truth establishment for a test set.
4. Adjudication method for the test set
This is not applicable as there is no 'ground truth' in the sense of expert review for diagnostic output. Bench testing results would be objective measurements against defined 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
No, an MRMC comparative effectiveness study was not done. This device is a manual syringe and does not involve AI or human "readers" in its operation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical, manually operated syringe.
7. The type of ground truth used
The "ground truth" for this device's performance is based on predefined engineering specifications and international standards, such as ISO 10993-1 for biocompatibility and ISO 11137-1995 for sterilization. For example, for "deadspace," the ground truth is a specific maximum allowable volume. For "leakage," the ground truth is a pass/fail against a specific pressure or volume.
8. The sample size for the training set
This is not applicable as there is no "training set" for a physical medical device like a syringe.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" for this device.
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510k Summary
Device Name
Proprietary Name: TERUMO® Syringe with/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 (K023271).
Device Description
The Iml Terumo Syringe with/without Needle consists of 3 main parts or 4 parts, i.e., a barrel, plunger, gasket and a hypodermic needle (for with needle type). 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 needle is made from stainless steel. The 1 ml Terumo Syringe with/without Needle is individually packed in 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 Iml Terumo Syringe with/without needle is operated manually.
Materials
The materials used in the Iml Terumo Syringe with/without needle are substantially equivalent to the materials used in the predicate Terumo Syringe with/without needle device cleared under K023271.
Specifications
| PRODUCT DESCRIPTION |
|---|
| 1ml Luer Slip Tip syringe without needle |
| 1 ml Luer Slip Tip syringe with 23g x 1" needle |
| 1 ml Luer Slip Tip syringe with 25g x 5/8" needle |
| 1ml Luer Slip Tip syringe with 25g x 1" needle |
| 1 ml Luer Slip Tip syringe with 26g x 3/8" needle |
| 1 ml Luer Slip Tip syringe with 26g x 1/2" needle |
| 1 ml Luer Slip Tip with 27g x 1/2" needle |
ct 2
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Performance
The Iml Terumo Syringe with/without needle submitted in this premarket notification was subjected to the following tests:
- Leakage (Aspiration and Injection) ●
- . Plunger Mobility
- Plunger Gasket Fit .
- Plunger Stopper Strength .
- Deadspace .
- Nominal Graduation Capacity .
- Packaging Seal Strength .
Substantial Equivalence
The Iml Terumo Syringe with/without needle is substantially equivalent in intended use, materials, design, technology and principles of operation and performance to cleared Terumo Syringes with/without needle cleared under K023271. Any differences raise no new issues of safety and effectiveness.
Additional Safety Information
Manufacturing controls included visual, functional, dimensional and sterility tests.
The Iml Terumo Syringe with/without needle is 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".
Submitter Information
Prepared by: Barbara Smith Sr. Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, Maryland 21921
- Prepared for: Terumo (Philippines) Corporation #124 East Main Ave., Laguna Technopark, Biñan, Laguna, Philippines 4026
Date Prepared: July 26, 2005
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AUG 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara Smith Senior Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Rd. Elkton, Maryland 21921
Re: K052034
Trade/Device Name: Terumo Syringe with/without needle Regulation Number: 21 CFR 880.5860 Regulation Name: Hypodermic Syringe with/without needle Regulatory Class: II Product Code: FMF Dated: July 27, 2005 Received: July 29, 2005
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.
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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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cure
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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KOSZO34 ાં રી (
Indications for Use
510(k) Number (if known): ... . . . . . . . .
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)
Set Roll for now
(Division Sign-Off) Division of Anesthesiology. General Mospital, Infection Control, Dental Devices
:
510(k) Number: Kos 3 034
Page 00008
§ 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).