The Terumo Allergy Syringe with fixed hypodermic single lumen needle is a sterile, single use, standard piston syringe, designed for manual use. The syringe is available in Icc volumes with 23G, 26G and 27G, 1/2" and 3/8" fixed hypodermic single lumen needles. These needles have either a regular or intradermal bevel.

AI/ML Overview

This document is a 510(k) summary for a medical device, specifically the Terumo Allergy Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than defining new acceptance criteria and conducting a study against them in the traditional sense of a novel AI/software product. Therefore, many of the requested categories are not applicable or cannot be fully answered from the provided text.

However, I can extract information related to the device's performance and the comparison to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" is demonstrating substantial equivalence in performance to the predicate device, the B-D® Allergy Syringe (K941657). The reported device performance is that it is substantially equivalent. Specific numerical acceptance criteria are not provided in this summary.

Performance Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Volume	Substantially equivalent to predicate B-D® Allergy Syringe	Demonstrated substantial equivalence through testing
Cannula/barrel adherence	Substantially equivalent to predicate B-D® Allergy Syringe	Demonstrated substantial equivalence through testing
Maximum penetration force	Substantially equivalent to predicate B-D® Allergy Syringe	Demonstrated substantial equivalence through testing
Leakage	Substantially equivalent to predicate B-D® Allergy Syringe	Demonstrated substantial equivalence through testing
Aspiration initial	Substantially equivalent to predicate B-D® Allergy Syringe	Demonstrated substantial equivalence through testing
breakaway force
Aspiration	Substantially equivalent to predicate B-D® Allergy Syringe	Demonstrated substantial equivalence through testing
Injection force	Substantially equivalent to predicate B-D® Allergy Syringe	Demonstrated substantial equivalence through testing
Residual volume	Substantially equivalent to predicate B-D® Allergy Syringe	Demonstrated substantial equivalence through testing
Sterility	Sterility Assurance Level (SAL) of 10-6 (ISO 11137 validated)	Achieved SAL of 10-6, monitored with dosimeters
Biocompatibility	Compliance with ISO-10993 (External Communicating, Blood Path Indirect, Limited Duration)	Blood contacting materials found to be biocompatible
Expiration Dating	Establish a viable expiration date	Established to be 5 years (60 months)

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes used for each performance test (e.g., number of syringes tested for volume, leakage, etc.). It only states that "The following tests were performed demonstrating the substantial equivalence..."

Data provenance (country of origin, retrospective/prospective) is not mentioned. These are likely prospective tests conducted on manufactured devices in a lab setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a physical medical device. Ground truth for its performance characteristics (like leakage or force) would be established by direct physical measurement, not by expert consensus on observational data.

4. Adjudication Method for the Test Set

Not applicable. As above, performance is measured objectively.

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 is not an AI/software device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance tests mentioned (Volume, Cannula/barrel adherence, Maximum penetration force, Leakage, Aspiration initial breakaway force, Aspiration, Injection force, Residual volume, Sterility, Biocompatibility, Expiration Dating) would be based on:

Direct Physical Measurement: Using calibrated equipment to measure forces, volumes, and integrity.
Standardized Sterility Testing Methods: Following ISO 11137 protocols.
Biological Testing: As per ISO 10993 for biocompatibility.
Stability Testing: To establish expiration dating.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. (See #8)

Summary

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SECTION II: Summary of Safety and Effectiveness

K980796 APR - 2 1998

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Proprietary Device Name: Terumo Allergy Syringe or similar proprietary name Syringe, piston with fixed hypodermic single lumen needle Classification Name:

INTENDED USE

The Terumo Allergy Syringe is intended for the preparation/mixing of allergenic extracts/prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The syringe is designed for manual use. These allergy syringes will be sold by prescription only, and the labeling will bear the Federal law restricts this device to sale by or on the order of a statement "Caution: physician. "

DESCRIPTION

PROPOSED:

NEEDLE GAUGE	NEEDLE LENGTH	NEEDLE BEVEL	SYRINGE PACKAGING
23	1/2"	Regular	Trays of 25
26	3/8"	Regular	Trays of 25
27	1/2"	Regular	Individual
27	1/2"	Regular	Trays of 25
27	1/2"	Intradermal	Trays of 25
27	3/8"	Intradermal	Trays of 25

PREDICATE:

NEEDLE GAUGE	NEEDLE LENGTH	NEEDLE BEVEL	SYRINGE PACKAGING
23	1"	Regular	Individual
25	5/8"	Regular	Individual
26	1/2"	Regular	Trays of 25
26	3/8"	Intradermal	Trays of 25
27	1/2"	Regular	Trays of 25
27	3/8"	Intradermal	Trays of 25

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SECTION II: Summary of Safety and Effectiveness

SUBSTANTIAL EQUIVALENCE

The Terumo Allergy syringe submitted in this 510k is substantially equivalent in intended use, design, specifications, technology/principles of operation, materials and performance to the cleared B-D® Allergy syringe which is the subject of K941657.

PRINCIPLE OF OPERATION/TECHNOLOGY

The Terumo Allergy Syringe and the B-D Allergy Syringe are both operated manually or by a manual process.

MATERIALS

MATERIALS	PROPOSED	PREDICATE
Barrel	Polypropylene	Polypropylene
Plunger	Polystyrene	Polystyrene
Gasket	Thermoplastic elastomer	Unknown
Needle	Stainless steel	Unknown

PERFORMANCE

The performance of the Terumo Allergy Syringe is substantially equivalent to the performance of the cleared B-D® Allergy Syringe (K941657).

The following tests were performed demonstrating the substantial equivalence of the Terumo Allergy Syringe submitted in this 510k to the B-D® Allergy Syringe (K941657).

Volume .
Cannula/barrel adherence .
Maximum penetration force .
Leakage .
Aspiration initial breakaway force ●
. Aspiration
Injection force ●
Residual volume .

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ADDITIONAL SAFETY INFORMATION

The sterility of the product is assured using a sterilization method validated and qualified in accordance with the ISO 11137- "Sterilization of Healthcare Products Requirements for Validation and Routine Control - Radiation Sterilization" to a sterility assurance level (SAL) of 10-6.

Additionally each lot is monitored with calibrated Harwell Red Perspex 4034 dosimeters to determine the Gamma radiation dose delivered. Critical parameters, such as exposure time and dose delivery interruption are confirmed to comply with procedure.

Manufacturing control test methods include functional tests.

LAL testing is performed on production samples from every lot number.

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 Testing." [External Communicating Devices, Blood Path Indirect, Limited Duration of Contact (<24 hours).] days). The blood contacting materials were found to be biocompatible.

The expiration dating for the Terumo Allergy Syringe has been established to be 5 years, or 60 months.

CONCLUSION

The Terumo Allergy syringe submitted in this 510(k) is substantially equivalent in intended use, design, specification, technology/principles of operation, materials and performance to the cleared B-D® Allergy syringe which is the subject of K941657. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Date Prepared	February 27, 1998
Prepared by	Kristine WagnerRegulatory Affairs Specialist
Prepared for	Terumo Medical Corporation125 Blue Ball RoadElkton, MD 21921Phone (410) 392-7241 or (410) 392-7231Fax (410) 398-6079

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, rendered in a simple, flowing design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 1998

Ms. Kristine Wagner Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921

Re : K980796 Terumo Allergy Syringe Trade Name: Regulatory Class: II Product Code: FMF Dated: February 27, 1998 Received: March 2, 1998

Dear Ms. Waqner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes complianee with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic

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Page 2 - Ms. Wagner

Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K980796 510(k) Number (if known):

Device Name: Terumo Allergy Syringe

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paluno Cuccinte
Division Sign Off

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K980796

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).