INTRADERMAL ADAPTER

K123588 · West Pharmaceutical Services, Inc. · FMF · Feb 19, 2013 · General Hospital

Device Facts

• Record ID: K123588
• Device Name: INTRADERMAL ADAPTER
• Applicant: West Pharmaceutical Services, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Feb 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Intradermal Adapter is an accessory to a 1 ml, ½ inch fixed-needle allergy syringe indicated for use as a guide for performing intradermal injections.

Device Story

Intradermal Adapter is a single-part, injection-molded medical-grade polycarbonate accessory for 1ml allergy syringes with ½ inch (27g-29g) needles. Device functions as a snap-fit guide to control needle insertion depth and angle, ensuring minimal needle length exposure for successful intradermal injections via Mantoux technique. Provided sterile. Used by clinicians in general hospital or clinical settings to assist in administering intradermal injections. By standardizing insertion depth and angle, the adapter facilitates consistent delivery, potentially improving injection accuracy and patient outcomes.

Clinical Evidence

Performance testing included bench, animal, and simulated-use studies to assess safety and effectiveness. Results demonstrated the adapter is safe and effective for its intended use as a guide for intradermal injections.

Technological Characteristics

Medical-grade polycarbonate; snap-fit form factor; accessory to 1ml piston syringe; sterile; non-electronic; mechanical guide.

Indications for Use

Indicated for use as a guide for performing intradermal injections when using a 1 ml, ½ inch fixed-needle allergy syringe.

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

• BD-Microfine, Ultrafine; and Allergy Syringe (K941657)

Submission Summary (Full Text)

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## West Intradermal Adapter

K123588

Traditional 510(k) West Pharmaceutical Services, Inc.

## 510(k) Summary

# FEB 1 9 2013

Device: Intradermal Adapter

Company Name:

WEST PHARMACEUTICAL SERVICES, INC. 101 Gordon Dr. Lionville, PA 19341

Contact Person: Kevin Lentz Director of Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

Preparation date: 19 November 2012

Classification:

Classification name: Trade name: Common/usual name: Product Code: Regulation No .: Class: Panel Identification:

Syringe, Piston (Accessory) Intradermal Adapter Intradermal Adapter (ID Adapter) FMF 21 CFR 880.5860 II General Hospital

BD-Microfine, Ultrafine; and Allergy Syringe K941657 Predicate Devices:

#### Device Description:

The Intradermal Adapter consists of a single injection molded part manufactured from a medical grade polycarbonate. The Intradermal Adapter is a piston syringe accessory which is designed for use with 1ml allergy syringes with ½ inch (27g), (28g), (29g) needles, which are commonly used for intradermal injections given with a traditional Mantoux technique.

The Intradermal Adapter has been designed to snap-fit on to the end of the syringe forming an injection guide to control the depth and angle of needle insertion exposing only the minimal needle length required to perform a successful intradermal injection. The Intradermal Adapter is provided sterile in an individually packaged configuration.

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# West Intradermal Adapter

Traditional 510(k)
*West Pharmaceutical Services, Inc.*

### Indications for Use:

The Intradermal Adapter is an accessory to a 1 ml, ½ inch fixed-needle allergy syringe indicated for use as a guide for performing intradermal injections.

# Technological Characteristics and Substantial Equivalence:

The Intradermal Adapter utilized as an accessory to the piston syringe has the same intended purpose and principle of operation as the predicate device with respect to performing an injection below the surface of the skin including intradermally and is therefore substantially equivalent to the cleared device referenced: K941657 (BD Microfine, Ultrafine, and Allergy Syringe).

#### Performance Testing:

Performance testing including bench, animal and simulated use was conducted to assess the safety and effectiveness of the Intradermal Adapter for the stated indications for use. Results of performance testing demonstrated that the Intradermal Adapter used as an accessory to the piston syringe is safe and effective in administering intradermal injections.

#### Conclusion:

Comparative analysis of the technological characteristics between the proposed and predicate device and results of verification testing performed demonstrate that the subject device is substantially equivalent to the legally marketed predicate device. Any differences between the proposed and predicate device do not raise any additional concerns regarding safety and effectiveness; therefore the Intradermal Adapter used as an accessory to the disposable allergy syringe may be considered substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

#### February 19, 2013

Mr. Kevin Lentz Director of Regulatory Affairs West Pharmaceutical Services, Incorporated 101 Gordon Drive Lionville, Pennsylvania 19341

Re: K123588

Trade/Device Name: Intradermal Adapter Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 19, 2012 Received: November 21, 2012

#### Dear Mr. Lentz:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Lentz

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/3/Picture/6 description: The image contains a handwritten inscription that appears to be a signature or a personalized message. The text includes the word "For" at the top left, followed by a more stylized word, possibly a name, in the center. Below this, the words "with" and "urohity" are written, and there is a signature at the bottom right. The overall style suggests a personal note or autograph.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# West Intradermal Adapter

# Indications for Use

510(k) Number (if known): ¥123 588

Device Name: Intradermal Adapter

## Indications for Use:

The Intradermal Adapter is an accessory to a 1 ml, ½ inch fixed-needle allergy syringe indicated for use as a guide for performing intradermal injections.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Richard C. Chapman | Page 1 of 1 |
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(Division Sign-Off)
vision of Anesthesiology, General Hospital
ifection Control, Dental Devices

| 510(k) Number | K123588 |
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