TERUMO ALLERGY SYRINGE

K980796 · Terumo Corp. · FMF · Apr 2, 1998 · General Hospital

Device Facts

• Record ID: K980796
• Device Name: TERUMO ALLERGY SYRINGE
• Applicant: Terumo Corp.
• Product Code: FMF · General Hospital
• Decision Date: Apr 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

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 physician.

Device Story

Sterile, single-use, manual piston syringe; 1cc volume; fixed hypodermic single lumen needle (23G, 26G, 27G; 1/2" or 3/8" lengths). Used by clinicians for preparation/mixing of allergenic extracts and manual aspiration/injection of fluids below skin surface. Operates via manual pressure. Provides precise delivery of prescribed substances. Benefits patient through accurate, sterile administration of allergy treatments.

Clinical Evidence

Bench testing only. Performance verified through testing of volume, cannula/barrel adherence, maximum penetration force, leakage, aspiration initial breakaway force, aspiration, injection force, and residual volume. Biocompatibility testing performed per ISO-10993 for limited duration blood-contacting devices.

Technological Characteristics

Materials: Polypropylene barrel, Polystyrene plunger, Thermoplastic elastomer gasket, Stainless steel needle. Manual operation. Sterilization: Gamma radiation (ISO 11137, SAL 10^-6). Dimensions: 1cc volume, 23G-27G needles. Standalone device.

Indications for Use

Indicated for patients requiring subcutaneous or intradermal injection of allergenic extracts or prescribed fluids. Designed for manual use by clinicians.

Regulatory Classification

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.

Predicate Devices

• B-D Allergy syringe (K941657)

Submission Summary (Full Text)

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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

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. See following chart:

### 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 Wagner<br>Regulatory Affairs Specialist |
| Prepared for | Terumo Medical Corporation<br>125 Blue Ball Road<br>Elkton, MD 21921<br>Phone [phone] or [phone]<br>Fax [phone] |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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. This syringe is designed for manual 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)