(26 days)
The addEASE 20 mm Binary Connector with 17 Ga. Needle is a double ended transfer device intended for use in a pharmacy setting to connect a B. Braun 250mL Excel® IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
The addEASE 20 mm Binary Connector with 17 Ga. needle is a double ended transfer device intended to connect a B. Braun 250 mL Excel® IV solution bag to a 20 mm drug vial. The device contains a bag spike on one end and a vial spike on the other end. The vial spike is composed of polycarbonate and the bag spike is composed of a 17 Ga. stainless steel needle. The device contains a plunger which keeps the contents of the connected containers separate until the plunger is purposely deployed and the contents of the bag and vial are mixed. The bag spike and vial spike are protected with caps that maintain the sterility of the device until the caps are removed prior to use.
The provided documentation is a 510(k) Premarket Notification for the addEASE 20mm Binary Connector with 17 Ga. Needle. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data or detailed performance metrics against specific acceptance criteria.
Therefore, the information required to fully answer your questions regarding acceptance criteria, study details, and ground truth establishment is not available within this document. This submission primarily focuses on the device's design, intended use, and its similarities to a previously cleared predicate device.
However, I can extract the available information and highlight what is missing:
1. Table of acceptance criteria and the reported device performance
The document states: "Design verification testing has been completed and all specifications have been met." However, the specific acceptance criteria and the detailed performance results are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "All specifications have been met." |
| (e.g., Sterility, Leakage, Flow rates, Compatibility with specific vials/bags, etc.) | (Specific quantitative results are not provided in this document) |
2. Sample size used for the test set and the data provenance
The document mentions "Design verification testing," but does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes a device for transferring fluids, not an AI/diagnostic device that would typically involve expert-established ground truth. No experts for ground truth establishment are mentioned.
4. Adjudication method for the test set
This information is not applicable as the document describes a device for transferring fluids, not an AI/diagnostic device that would typically involve adjudication for ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This information is not applicable as the document describes a device for transferring fluids, not an AI/diagnostic device that would typically involve MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the document describes a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
This information is not applicable as the document describes a physical medical device. The "ground truth" for such a device would be based on engineering specifications, material properties, and functional testing rather than expert consensus or pathology.
8. The sample size for the training set
This information is not applicable as the document describes a physical medical device, not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document describes a physical medical device.
Summary of the study conducted (as per the document):
The only study mentioned is "Design verification testing." The purpose of this testing was to demonstrate that the modified device (with the 17 Ga. needle) did not introduce new safety or effectiveness issues compared to the predicate device.
- Study Objective: To demonstrate that the addition of a 17 Ga. needle to the addEASE 20mm Binary Connector does not significantly impact the fundamental technology and does not raise new issues of safety or effectiveness compared to the predicate device (Add-A-Vial II, K900865).
- Methodology: "Design verification testing has been completed." The specific tests performed are not detailed, but would typically include tests related to mechanical integrity, sterility, leakage, function (e.g., successful transfer of fluids), and material compatibility.
- Results: "all specifications have been met." It further states that "The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness."
In conclusion, this 510(k) summary provides evidence of design verification testing to support substantial equivalence but does not offer the detailed performance metrics, sample sizes, or ground truth methodologies that would be typical for an AI/ML-based device submission.
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B. Braun Medical Inc. Special 510(k) Premarket Notification addEASE 20mm Binary Connector with 17 Ga. Needle
March 27, 2009
Koroops
5. 510(k) SUMMARY
| APPLICANT/SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500 |
|---|---|
| CONTACT: | Angela J. CaravellaSr. Regulatory Affairs AnalystPhone: 610-596-2966Fax: 610-596-2502E-mail: Angela.Caravella@bbraun.com |
| DEVICE NAME: | addEASE 20mm Binary Connector with 17 Ga. Needle |
| COMMON ORUSUAL NAME: | Binary Connector |
| DEVICECLASSIFICATION: | Class II per 21 CFR § 880.5440Product Code LHI |
| CURRENTLYMARKETEDDEVICE (PREDICATE): | addEASE Binary Connector, 13 and 20 mm (Add-A-Vial II510(k) K900865) |
| DESCRIPTION: | The addEASE 20 mm Binary Connector with 17 Ga. needleis a double ended transfer device intended to connect a B.Braun 250 mL Excel® IV solution bag to a 20 mm drugvial. The device contains a bag spike on one end and a vialspike on the other end. The vial spike is composed ofpolycarbonate and the bag spike is composed of a 17 Ga.stainless steel needle. The device contains a plunger whichkeeps the contents of the connected containers separateuntil the plunger is purposely deployed and the contents ofthe bag and vial are mixed. The bag spike and vial spikeare protected with caps that maintain the sterility of thedevice until the caps are removed prior to use. |
| INTENDED USE: | The addEASE 20 mm Binary Connector with 17 Ga. needleis a double ended transfer device intended for use in apharmacy setting to connect a B. Braun 250mL Excel® IVsolution bag to a 20 mm drug vial for reconstituting ormixing the drug in the vial with the solution in the bag. |
APR 2 7 2009.... . .
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B. Braun Medical Inc. Special 510(k) Premarket Notification addEASE 20mm Binary Connector with 17 Ga. Needle
SUBSTANTIAL EQUIVALENCE:
The addEASE 20mm Binary Connector with 17 Ga. needle has the same intended use and utilizes the same fundamental technology as the predicate device, the currently marketed addEASE device cleared in B. Braun 510(k) K900865 (entitled Add-A-Vial II). The addEASE 20 mm Binary Connector with 17 Ga. needle is similar to the predicate device in material composition and components except for the 17 Ga. needle that replaced one of the polycarbonate spikes. The addition of a 17 Ga. needle to the device does not have a significant impact upon the fundamental technology of the addEASE product. Design verification testing has been completed and all specifications have been met. The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.
Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2009
Ms. Angela Caravella Senior Regulatory Affairs Analyst B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K090905
Trade/Device Name: addEASE 20 mm Binary Connector with 17 Ga. Needle Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 27, 2009 Received: April 21, 2009
Dear Ms. Caravella:
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 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.
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
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Page 2- Ms. Caravella
and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Suarez
Susan Runner, D.D.S., MA Acting 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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4. INDICATIONS FOR USE STATEMENT
Page __ 1 _ of _ 1_
510(k) Number (if known):
109 09 05
addEASE 20 mm Binary Connector with 17 Ga. Needle Device Name:
Indications For Use:
The addEASE 20 mm Binary Connector with 17 Ga. Needle is a double ended transfer device intended for use in a pharmacy setting to connect a B. Braun 250mL Excel® IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
Prescription Use _ X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090905
. 11
§ 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.