Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01

K041564 · Bioject Medical Technologies, Inc. · LHI · Jul 16, 2004 · General Hospital

Device Facts

• Record ID: K041564
• Device Name: Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
• Applicant: Bioject Medical Technologies, Inc.
• Product Code: LHI · General Hospital
• Decision Date: Jul 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter is intended to allow needle-free withdrawal, reconstitution and transfer of Repronex® (menotropins for injection, USP) and/or Bravelle® (urofollitropin for injection, purified) and diluent from vials into an injection syringe for administration.

Device Story

Q•Cap™ is a sterile, injection-molded vial adapter; enables needle-free withdrawal, reconstitution, and transfer of lyophilized fertility drugs (Repronex®, Bravelle®) and diluent from vials into syringes. Used in clinical or home settings by patients or healthcare providers. Device attaches to 13mm vials; eliminates needle use during drug preparation; reduces risk of needlestick injury. Output is a reconstituted drug solution ready for injection. Biocompatible polycarbonate construction ensures safety during drug contact.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (cytotoxicity), ETO residual testing, and LAL pyrogen testing. No clinical data presented.

Technological Characteristics

Injection-molded polycarbonate (General Electric Lexan® 144R). 13mm vial adapter form factor. Ethylene oxide (ETO) sterilization. Mechanical fluid transfer interface. No electronic components or software.

Indications for Use

Indicated for patients requiring administration of Repronex® or Bravelle®; facilitates needle-free reconstitution and transfer of lyophilized drugs and diluent from vials into an injection syringe.

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

• Bioject Needle-Free Vial Adapter (13mm) (K963012)
• Reconstitution Kit & Vial Connector (K010623)

Submission Summary (Full Text)

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# JUL 1 6 2004

#### 510(k) Summary Safety and Effectiveness Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter [per FD&C Act, Section 513 (I)(3)(A) and 21CFR Section 807.3]

| Applicant: | Bioject Medical Technologies Inc.<br>211 Somerville Road<br>Bedminster, New Jersey 07921 |
|--------------------------------|------------------------------------------------------------------------------------------|
| Contact Person: | Laurence A. Potter<br>Director, Regulatory Affairs |
| Telephone: | 908-470-2800 |
| Fax: | 908-470-1728 |
| Email: | [e-mail] |
| Manufacturer: | Bioject, Inc.<br>20245 S.W. 95th Avenue<br>Tualatin, Oregon 97062 |
| Establishment Registration No. | 3023012 |
| Sterilization Site: | Dravon Medical<br>11465 SE Highway 212<br>Clackamas, Oregon |
| Establishment Registration No. | 3021634 |
| Device Trade Name: | Q•Cap™ Needle-Free<br>Reconstitution 13mm Vial Adapter |
| Device Classification: | Class II, Special Controls |
| Common Name: | Vial Adapter |
| Regulatory Status: | |
| Product Code: | LHI |
| C.F.R. Regulation No.: | 880.5440 |
| Description: | Intravascular Administration Set |
| Medical Specialty | General Hospital and Personal Use<br>Devices |

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510(k) Summary Safety and Effectiveness Q. Cap™ Needle-Free Reconstitution 13mm Vial Adapter (con't)

### Indications for Use:

The Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter is intended to allow needle-free withdrawal, reconstitution and transfer of Repronex® (menotropins for injection, USP) and/or Bravelle® (urofollitropin for injection, purified) and diluent from vials into an injection svringe for administration.

#### Predicate Device(s):

| Bioject Needle-Free Vial Adapter (13mm) | K963012 |
|-----------------------------------------|---------|
| Bioject, Incorporated, Portland, Oregon | |

Reconstitution Kit & Vial Connector K010623 Bioject, Incorporated. Portland, Oregon For use with Serono, Inc.'s, Serojet™ and Serostim® Human Growth Hormone Starter Kits.

Ferring Pharmaceutical's Repronex® (menotropins for iniection, USP) was previously approved by FDA's Center for Drug Evaluation and Research (CDER) under NDA 21-047.

Ferring Pharmaceutical's Bravelle® (urofollitropin for injection, purified) was previously approved by FDA's Center for Drug Evaluation and Research (CDER) under NDA 21-484.

#### Device Design and Performance:

The device which is the subject of this Notification is a sterile, injection molded component, which will be included into Ferring Pharmaceutical's Repronex® and Bravelle® drug kits to assist in needle-free reconstitution of these lyophilized drugs for injection.

The Vial Adapter component's physical design, description and performance are identical to that of a previously cleared device, Bioject Reconstitution Kit & Vial Connector (K010623). Packaging and sterilization of the Vial Adapter are identical to that of a previously cleared devices, Bioject Needle-Free Vial Adapter, (13mm); K963012.

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The biocompatibility of the clear polycarbonate component (General Electric Lexan® 144R), is demonstrated for both Cytotoxicity and for each specific Ferring fertility druq used for reconstitution. No color additives are present in this component.

Ethylene oxide sterilization, ETO residual testing, and LAL Pyrogen testing support additional product safety. No other safety issues have been identified for the device component subject to this Notification.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2004

Mr. Laurence A. Potter Director, Regulatory Affairs Bioject Medical Technologies, Incorporated 211 Somerville Road Route 202 North Bedminster, New Jersey 07921

Re: K041564

Trade/Device Name: Q Cap™ Needle-Free Reconstitution 13mm Vial Adapter Regulation Number: 21 CFR 880.5440, Regulation Name: Intravascular Administration Set, Regulatory Class: II Product Code: LHI, FMF Dated: June 8, 2004 Received: June 15, 2004

Dear Mr. Potter:

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. Potter

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 vour 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.

Kein Muly
for 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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## Statement of Indications for Use

510(k) Number (if known):

Device Name: Q•Cap™ Needle-Free Reconstitution 13mm Vial Adapter

Indications for Use: The Q•Cap™ Needle-Free Reconstitution 13mm Vial Adapter is intended to allow needle-free withdrawal, reconstitution and Adapter 13 Intendou to diffine morins for injection, USP) and/or Bravelle® transfor of Repronention, purified) and diluent from vials into an injection syringe for administration.

Signature

Laurence A. Potter Director, Regulatory Affairs

Date

Prescription Use X Or
(Per 21 CFR 801.109)

Over-the-Counter Use (Optional Format 1-2-96)

36

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sune Nareau for ADW
(Division Sign-Off)

Division of Anesthesiology, General H Infection Control, Dental De

510(k) Number: K041564