DRUG ACCESS SPIKE

K051930 · Medegen Medical Manufacturing Services · FMF · Aug 16, 2005 · General Hospital

Device Facts

• Record ID: K051930
• Device Name: DRUG ACCESS SPIKE
• Applicant: Medegen Medical Manufacturing Services
• Product Code: FMF · General Hospital
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Drug Access Spike is a device used to aspirate solutions/medications from a drug container (drug vial/bag). The Drug Access Spike may incorporate componentry that aid in the prevention of accidental needle sticks.

Device Story

Drug Access Spike is a plastic conduit designed to access drug containers (vials/bags). Device is pushed through rubber stopper of container and locks into position. Syringe attaches to spike to draw medication; after detachment, solution is dispensed into needleless injection site. Some configurations incorporate NAC (Needleless Access Connector) to maintain physical barrier against microbial ingress on multi-dose containers. Device eliminates need for conventional needles, reducing accidental needle stick risk. Used in clinical settings by healthcare providers to facilitate safe drug withdrawal and administration.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics and intended use to legally marketed predicate devices.

Technological Characteristics

Plastic conduit device; incorporates needleless injection port (NAC) in some configurations. Materials meet ISO 10993 biocompatibility requirements for external communicating devices, indirect blood path. Mechanical interface for vial stopper penetration and syringe attachment.

Indications for Use

Indicated for the aspiration of solutions or medications from drug vials or bags. Intended for use by healthcare professionals to facilitate needleless drug access and reduce the risk of accidental needle sticks.

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

• CLAVE Vial Access Spike (K934591)
• One Time Vial Access Spike (K934561)
• Needle*Less Drug Vial Adapter (K894177)

Reference Devices

• NAC Needleless Access Connector (K011193)
• NAC Needleless Access Connector (K992268)

Submission Summary (Full Text)

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K051930

# AUG 1 6 2005

# 510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

| Name: | Medegen Medical Manufacturing Services |
|-----------------|-----------------------------------------|
| Address: | 930 Wanamaker Ave.<br>Ontario, CA 91761 |
| CONTACT PERSON: | SALVADORE F. PALOMARES, RAC |

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: Trade Name: Drug Access Spike Common Name: Accessory to Piston Syringe Classification Name: Same

Equivalent Devices:

| Manufacturer: | ICU Medical | ICU Medical | Baxter Healthcare Corp |
|---------------|----------------------------|-------------------------------|----------------------------------|
| Name: | CLAVE Vial Access<br>Spike | One Time Vial Access<br>Spike | Needle*Less Drug Vial<br>Adapter |
| 510(k) #: | K934591 | K934561 | K894177 |

## Device Description:

The Drug Access Spike is a plastic conduit that is a means to access drug containers. The device is center on top of the stopper of a drug container. The Drug Access Spike is pushed through the rubber stopper and locks into position. A syringe is attached to the Drug Access Spike in order to draw from the drug container. After detaching the syringe, solution/medications are dispensed into a needleless injection site. The use of a Drug Access Spike eliminates the need for a conventional needle.

On multi-dose containers, a needleless injection site is bonded to the Drug Access Spike. This allows the drug container to be accessed multiple times while maintaining a physical barrier to prevent microbial ingress.

The needleless injection port incorporated into some of the configurations of the Drug Access Spike is the NAC " Needleless Access Connector. The NAC " Needleless Access Connector was previously cleared under SE-K011193 and SE-K992268.

### Intended Use:

The Drug Access Spike is a device used to aspirate solutions/medications from a drug container (drug vial/bag). The Drug Access Spike may incorporate componentry that aid in the prevention of accidental needle sticks.

### Biocompatibility:

The materials used to manufacture the Drug Access Spike meet ISO 10993 Biocompatibility Requirements for External Communicating Devices, Indirect Blood Path.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with three lines representing the head, body, and legs. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the circle.

Public Health Service

AUG 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medegen Medical Manufacturing Services C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K051930

Trade/Device Name: Drug Access Spike Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Accessory Regulatory Class: II Product Code: FMF Dated: July 30, 2005 Received: August 1, 2005

Dear Mr. Job:

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 - Mr. Job

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 or any I vatuall 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 Orth 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 premance noticate 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Cures

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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510(k):

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Device Name:

Drug Access Spike

The Drug Access Spike is a device used to aspirate Indications for Use: The Drug A60000 Opins from a drug container (drug solutions: The Drug Access Spike may incorporate vialibag). The Brag 7 in the prevention of accidental needle sticks.

Prescription Use
(Per 21 CFR 801 Subpart D)

Over the Counter Use AND/OR (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton Vmax

(Division Sign-Off) (Division Sign-Oll)
Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: K951430