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

K043304 · Bioject Medical Technologies, Inc. · LHI · Jan 14, 2005 · General Hospital

Device Facts

• Record ID: K043304
• 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: Jan 14, 2005
• 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/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration.

Device Story

Q-Cap is a needle-free vial adapter used for the reconstitution and transfer of fertility medications (Repronex, Bravelle, Menopur) from vials to syringes. It facilitates needle-free access to medication vials, reducing needle-stick risks. The device is used in clinical or home settings by patients or healthcare providers. It functions as a mechanical interface between the drug vial and the syringe. The device does not alter the biological activity of the drugs, as confirmed by comparative assay testing against standard needle-and-syringe methods. It is a single-use, sterile, disposable component.

Clinical Evidence

Bench testing only. Comparative assay testing evaluated the biological activity of Menopur® when reconstituted using the Q-Cap versus a standard needle and syringe. Results showed FSH levels of 79.8 U/Vial (Q-Cap) vs 78.6 U/Vial (syringe) and LH levels of 77.4 U/Vial (Q-Cap) vs 77.1 U/Vial (syringe).

Technological Characteristics

Constructed from clear polycarbonate (General Electric Lexan® 144R). Mechanical vial adapter design. Sterilized via ethylene oxide (ETO). No color additives. Non-cytotoxic.

Indications for Use

Indicated for needle-free withdrawal, reconstitution, and transfer of specific fertility drugs (Repronex, Bravelle, Menopur) and diluent from vials into an injection syringe for administration.

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

• Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter (K041654)
• Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter (K041564)

Submission Summary (Full Text)

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## JAN 1 4 2005

# 510(k) Summary Safety and Effectiveness Q•Cap™ Needle-Free Reconstitution 13mm Vial Adapter ap ''" Needle-1 Tee Tree Treedrichton Tornity 978. 1973.
[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:<br>Product Code:<br>C.F.R. Regulation No.:<br>Description: | LHI<br>880.5440<br>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)

The device subject to this Notification is adding the fertility prescription drug Menopur® into it's Indication for Use, which is the only modification from the predicate device, Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter: K041664 K041564.

## 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/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration.

## Predicate Device:

Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter: Bioject Medical Technologies, Inc., K041654 K041544

## Pharmaceutical Drug Relating To The Device's Intended Use:

The addition of the Menopur® indication is the only change from the previously cleared K041654 Notification.

KO41564

Ferring Pharmaceutical's prescription drug Menopur® (menotropins for injection, USP) was previously approved by FDA's Center for Drug Evaluation and Research (CDER) under NDA 21-663.

## As in the original K041654 Notification: KO 41564

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

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

* Ferring Pharmaceuticals Inc., Suffern, New York 10901, U.S.A.

## Device Design and Performance:

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The Vial Adapter component's physical design, description and performance are identical to that of the previously cleared predicate device, Q-Cap ™ are rashtodi to the Reconstitution 13mm Vial Adapter: K041654 Ko4166 H

Packaging and sterilization of the Vial Adapter are identical to that of the previously cleared predicate device, Q•Cap™ Needle-Free Reconstitution 13mm Vial Adapter: K044654 Ko41564

In addition to the previously cleared Ferring fertility drugs in contact with the clear polycarbonate component (General Electric Lexan® 144R) and polycarbonate's non-cytotoxicity, this Notification provides testing which demonstrates that Menopur's®, biological activities are equivalent to a standard needle and syringe. The testing was performed to evaluate Menopur Assay results.

The data concludes that there are no substantial differences in the biological activity test results using a syringe with the Bioject vial adapter versus a syringe with needle.

The results, summarized in the following table, show that the assay numbers are virtually identical and within the experimental error range of the assay.

| Menopur® Analyte | Syringe | Q-Cap |
|------------------|-------------|-------------|
| FSH | 78.6 U/Vial | 79.8 U/Vial |
| LH | 77.1 U/Vial | 77.4 U/Vial |

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.

043304

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

JAN 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043304

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 Dated: November 29, 2004 Received: December 2, 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 approvisions 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 (1 Nr.), I hay be address 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 roplicable 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,

Clues

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 Indications for Use. The Q-Oap - Nocawal, reconstitution and transfer Adapter is Intended to allow necale iros with and/or Bravelle® (urofollitropin for of Repronex "(menotropins for Injoction) 0 0 - 7) (menotropins for injection, USP) and injection, punned) andrer merchinge for administration.

signature

Laurence A. Potter Director, Regulatory Affairs

NOVEMBER 29, 2004 Date

Or Prescription Use (Per 21 CFR 801.109)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tury W.O.m

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

510(k) Number: K44334