(36 days)
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.
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.
This 510(k) summary describes a medical device, the Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter, and references its performance by comparing it to predicate devices. It does not contain a study report with specific acceptance criteria and reported device performance in the format of a table as requested, nor does it detail a standalone algorithm performance study or an MRMC study.
However, based on the provided text, here's an attempt to extract the relevant information, with some sections marked as "Not Applicable" or "Not Provided" due to the nature of the document.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily relies on the equivalency to predicate devices rather than presenting explicit performance metrics against predefined acceptance criteria for the new device. The performance is assessed by stating that the device is "identical" or that certain aspects "support product safety."
| Acceptance Criteria Category | Specific Criteria (Implicitly from the document) | Reported Device Performance |
|---|---|---|
| Physical Design | Identical to predicate device (K010623) | Confirmed as identical |
| Description | Identical to predicate device (K010623) | Confirmed as identical |
| Performance | Identical to predicate device (K010623) | Confirmed as identical |
| Packaging | Identical to predicate device (K963012) | Confirmed as identical |
| Sterilization | Identical to predicate device (K963012) | Confirmed as identical |
| Biocompatibility | Absence of cytotoxicity with polycarbonate (Lexan® 144R) and with specific fertility drugs (Repronex®, Bravelle®) | Demonstrated for both cytotoxicity and compatibility with specific drugs |
| Safety (Sterilization) | Acceptable ETO residual levels | ETO residual testing supports product safety |
| Safety (Pyrogenicity) | Absence of pyrogens | LAL Pyrogen testing supports product safety |
| Other Safety Issues | No other identified safety issues | No other safety issues identified |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly provided. The document relies on equivalence to previously cleared devices rather than new extensive testing for this 510(k) application.
- Data provenance: Not explicitly provided for new testing. The reference to predicate devices implies that past testing data from these devices (Bioject Reconstitution Kit & Vial Connector (K010623) and Bioject Needle-Free Vial Adapter (K963012)) would be the primary provenance. The document indicates that biocompatibility was "demonstrated" and that "testing support(s) product safety," implying some form of testing was performed, but details on sample size or provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a medical accessory, and the regulatory submission focuses on physical and biological safety/performance equivalence, not diagnostic accuracy requiring expert ground truth establishment in the traditional sense of image analysis or diagnostic algorithms.
4. Adjudication method for the test set
- Not Applicable. See point 3.
5. 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. This is a medical device (vial adapter) and not an AI/software as a medical device (SaMD). Therefore, MRMC studies are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this type of device, "ground truth" relates more to material specifications, sterility, absence of extractables, and functionality (e.g., proper fit, ease of use, no leakage) as demonstrated by engineering and biological testing, rather than a diagnostic 'truth'. The document states that "biocompatibility...is demonstrated" and "testing support additional product safety," implying laboratory-based testing results served as the "ground truth" for these safety aspects.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device; hence, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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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.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: | LHI |
| C.F.R. Regulation No.: | 880.5440 |
| Description: | Intravascular 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)
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 (301) 594-4618. 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.
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
§ 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.