ROBERTSITE VIAL ADAPTER, MODEL 245700021

K040634 · Halkey-Roberts Corp. · LHI · Mar 23, 2004 · General Hospital

Device Facts

• Record ID: K040634
• Device Name: ROBERTSITE VIAL ADAPTER, MODEL 245700021
• Applicant: Halkey-Roberts Corp.
• Product Code: LHI · General Hospital
• Decision Date: Mar 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Robertsite* Vial Adapter is indicated to allow multiple needleless access to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.

Device Story

Robertsite* Vial Adapter is a sterile, single-use device designed for needleless access to medication vials. It facilitates the transfer or withdrawal of fluids. The device features a stem and cap configuration with a split septum. It is used in clinical settings by healthcare providers to access medication vials safely. The device functions as an accessory to intravascular administration sets. By providing a needleless interface, it reduces the risk of needlestick injuries during medication preparation and administration.

Clinical Evidence

No clinical data. Bench testing only, including design verification and validation testing performed according to FDA's Draft October 12, 2000 Guidance on 510(k) Submissions for Intravascular Administration Sets and internal protocols.

Technological Characteristics

Sterile, single-use vial adapter. Features a stem and cap configuration with a split septum. Mechanical device for fluid transfer. No energy source or software components.

Indications for Use

Indicated for needleless access to medication vials for fluid transfer or withdrawal. No specific patient population or contraindications specified.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Alaris Smartsite® Needle-free Vial Access Device (K013087)

Submission Summary (Full Text)

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## MAR 2 3 2004

# APPENDIX 6

K040634

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

#### A. Submitter Information:

Submitter Name: Address:

Telephone Number: Fax Number: Contact Person: Date of Preparation

- B. Device Name: Trade Name: Common/Usual Name: Classification Name:
- C. Predicate Device Name: Trade Name: Predicate Device name: Trade Name:

Halkey-Roberts Corporation 11600 M. L. King Blvd., North St. Petersburg, FL 33716 727-577-1300 727-578-0450 John Sheldon January 14, 2004

Robertsite* Vial Adapter Robertsite* Vial Adapter Medication Vial Adapter Intravascular Administration Set Accessory

Robertsite* Needleless Injection site Swabable Luer Valve Alaris Smartsite® Needle-free Vial Access Device Vial Adapter with Smartsite®

#### D. Device Description:

Sterile single use device.

#### E. Intended Use:

Robertsite* Vial Adapter is indicated to allow multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.

#### F. Technological Characteristics Summary

#### 1. Does the new device have the same indication statements?

Yes. The Robertsite* Vial Adapter has the same indication for use as the Alaris Smartsite® Needle Free Vial Access device. Both vial adapter systems are indicated for multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.

## 2. Does the new device have the same technological characteristics, e.g. Design, Materials, etc?

No. The stem and cap configuration of the Robertsite* Vial Adapter is different from that of the Alaris Smartsite® Needle-free Vial Access Device in the length of the device and the configuration of the split septum. The principles of operation are unchanged from the predicate comparison device.

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### 3. Could the new characteristics affect safety or effectiveness?

Yes.

## 4. Do the new characteristics raise new types of safety or effectiveness questions?

No. The safety and effectiveness questions are the same for all vial adapter systems.

## 5. Do accepted scientific methods exist for assessing effects of the new characteristics?

Yes. The FDA's Draft October 12, 2000 "Guidance on 510(k) Submissions for Intravascular Administration Sets" and in house tests protocols were used to evaluate the device's performance.

### 6. Are performance data available to assess effects of new characteristics?

Yes.

### 7. Do performance data demonstrate equivalence?

Yes.

Based on FDA's decision tree, the Robertsite* Vial Adapter is substantially equivalent to the comparison predicate device, the Alaris Smartsite® Needle-free Vial Access Device system cleared for market on November 13, 2001 (K013087).

### ાન. Performance Data

Testing was performed using the FDA's Draft October 12, 2000 "Guidance on 510(k) submissions for Intravascular Administration Sets" and in house protocol performance data gathered in design verification and validation testing demonstrated that the Robertsite* Vial Adapter is substantially equivalent to the predicate Alaris Smartsite® Needle-free Vial Access Device and for met predetermined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.

### l. Clinical Performance Testing

Clinical performance testing was not required.

### J. Conclusion

The Robertsite* Vial Adapter meets all the acceptance criteria of the testing performed and, based on FDA's decision tree, the Robertsite* Vial Adapter is substantially equivalent to the predicate device, the Alaris Smartsite® Needle-free Vial Access Device cleared for market on November 13, 2001 (K013087).

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MAR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Halkey-Roberts Corporation C/O Ms. Susan Grill Responsible Third Party Official Underwriter Laboratories. Incorporated 12 Laboratory Drive Research Triangle Park, North Carolina 27709

Re: K040634

Trade/Device Name: Robertsite* Vial Adapter Model 245700021 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 8, 2004 Received: March 10, 2004

Dear Ms. Grill:

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. Gill

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 [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/dsma/dsmamain.html

Sincerely yours,

Clare

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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Ko40634

## INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

Indications for Use:

Robertsite* Vial Adapter

Robertsite* Vial Adapter is indicated to allow multiple needleless access to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.

(Please do not write below this line -continue on another page if needed)

Concurrence of Office of Device Evaluation

Prescription Use كار (Per 21 CFR 801.109)

OR

Over - The - Counter Use _____________________________________________________________________________________________________________________________________________________

Anton Dinar

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

510(k) Number: K040634