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 Description

The Vial Adapter component's physical design, description and performance are identical to that of the previously cleared predicate device, Q-Cap ™ 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. The clear polycarbonate component is General Electric Lexan® 144R. No color additives are present in this component. Ethylene oxide sterilization, ETO residual testing, and LAL Pyrogen testing support additional product safety.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Biological Activity Equivalence	Menopur® Bioactivity Equivalent to Standard Needle and Syringe: - FSH: Syringe (78.6 U/Vial), Q-Cap (79.8 U/Vial) - LH: Syringe (77.1 U/Vial), Q-Cap (77.4 U/Vial) The results are virtually identical and within the experimental error range of the assay, demonstrating no substantial differences in biological activity.
Physical Design, Description, and Performance (Vial Adapter Component)	Identical to the previously cleared predicate device, Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter (K041654 K041564).
Packaging and Sterilization	Identical to the previously cleared predicate device, Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter (K041654 K041564). Ethylene oxide sterilization, ETO residual testing, and LAL Pyrogen testing support additional product safety.
Non-Cytotoxicity of Materials	The clear polycarbonate component (General Electric Lexan® 144R) in contact with the drug was previously established as non-cytotoxic with other cleared Ferring fertility drugs. No color additives are present.
No other safety issues	No other safety issues have been identified for the device component via the testing performed for this notification.

Study Details

Sample size used for the test set and the data provenance:
- The test set involved comparing the biological activity of Menopur® (FSH and LH) when prepared with the Q-Cap™ Vial Adapter versus a standard needle and syringe.
- The exact sample size (number of vials, number of tests performed) for this specific biological activity comparison is not explicitly stated in the provided text.
- The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be a prospective laboratory study conducted by the manufacturer or a contracted lab to generate data for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This was a laboratory assay for biological activity of a drug, not a diagnostic device requiring expert interpretation of images or patient data. Therefore, the concept of "experts establishing ground truth" in the typical sense (e.g., radiologists) does not apply.
- The ground truth was established by the quantifiable results of the Menopur® Assay, performed in a lab environment. The qualifications of the personnel conducting the assay are not provided but would typically involve trained laboratory scientists.
Adjudication method for the test set:
- Not applicable, as this was a quantitative biochemical assay, not a case-based interpretation requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical accessory for drug reconstitution, not an AI-powered diagnostic tool, and therefore does not involve human readers interpreting data or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this device is a physical vial adapter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was quantitative laboratory assay results for the Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) biological activities of Menopur®.
The sample size for the training set:
- Not applicable. This device is a physical product, not an AI algorithm requiring a training set. The "design and performance" were established based on the predicate device and physical/chemical testing.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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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.211 Somerville RoadBedminster, New Jersey 07921
Contact Person:	Laurence A. PotterDirector, Regulatory Affairs
Telephone:	908-470-2800
Fax:	908-470-1728
Email:	lpotter@bioject.com
Manufacturer:	Bioject, Inc.20245 S.W. 95th AvenueTualatin, Oregon 97062
Establishment Registration No.	3023012
Sterilization Site:	Dravon Medical11465 SE Highway 212Clackamas, Oregon
Establishment Registration No.	3021634
Device Trade Name:	Q-Cap™ Needle-FreeReconstitution 13mm Vial Adapter
Device Classification:	Class II, Special Controls
Common Name:	Vial Adapter
Regulatory Status:Product Code:C.F.R. Regulation No.:Description:	LHI880.5440Intravascular Administration Set
Medical Specialty	General Hospital and Personal UseDevices

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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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.