(31 days)
Not Found
No
The description focuses on mechanical components for drug transfer and mixing, with no mention of AI/ML terms or functionalities.
No
The device is described as a needleless transfer device for mixing and transferring drugs, not for therapeutic application to a patient.
No
The BAXJECT II Needleless Transfer Device is intended for transferring and mixing drugs. It does not perform any diagnostic function such as identifying, detecting, or measuring a medical condition or disease.
No
The device description clearly outlines physical components such as piercing spikes, a deployable tube, a filter, and a luer connector, indicating it is a hardware device.
Based on the provided information, the BAXJECT II Needleless Transfer Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "transferring and mixing drugs contained in two vials into a syringe." This describes a process for preparing medications for administration to a patient, which is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description focuses on the physical mechanism for transferring and mixing substances between vials and a syringe. It doesn't mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing any kind of diagnostic result.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The BAXJECT II does not fit this description.
N/A
Intended Use / Indications for Use
The BAXJECT II Needleless Transfer Device is intended for transferring and mixing drugs contained in two vials into a syringe.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
BAXJECT II is a dual sided needleless transfer device designed for transferring and mixing drugs contained in two vials into a syringe. The double-sided device has a vial holder on each end. Siliconized plastic piercing spikes are designed for easy penetration into the rubber stopper of standard 20mm vials. A deployable tube reduces the potential for foaming during reconstitution of powdered materials. The device filters air passing into the system to relieve vacuum. A standard luer connector with embedded product filter allows for the mixed drug to be transferred into a syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
007 8 - 2004
'q'
510(k) Premarket Notification
Baxter BAXJECT II
BAXTER HEALTHCARE CORPORATION, Baxter BioScience
Page 27
510(k) SUMMARY
| Date Prepared | September 3, 2004 |
|---|---|
| 510(k) Number | |
| Submitter | Baxter Healthcare |
| Baxter BioScience | |
| One Baxter Way | |
| Westlake Village, CA 91362 | |
| Contact | Ron Lagerquist |
| Senior Manager, Regulatory Affairs | |
| Device Name | BAXJECT II Needleless Transfer Device |
| Common/Usual/ | |
| Classification Name | Set, I.V. Fluid Transfer |
| LHI | |
| Device Description | BAXJECT II is a dual sided needleless transfer device designed for transferring and mixing drugs contained in two vials into a syringe. The double-sided device has a vial holder on each end. Siliconized plastic piercing spikes are designed for easy penetration into the rubber stopper of standard 20mm vials. A deployable tube reduces the potential for foaming during reconstitution of powdered materials. The device filters air passing into the system to relieve vacuum. A standard luer connector with embedded product filter allows for the mixed drug to be transferred into a syringe. |
| Intended Use | The BAXJECT II Needleless Transfer Device is intended for transferring and mixing drugs contained in two vials into a syringe. |
| Predicate Device | Needleless Transfer Device |
| MediMop Medical Projects, LTD | |
| K001831 | |
| Substantial Equivalence | The BAXJECT II is substantially equivalent to the predicate device based on technological characteristics and intended use. The BAXJECT II Needleless Transfer Device conforms with the FDA Guidance Document, "Guidance for Industry and FDA Review Staff: Guidance on Premarket Notifications for Intravascular Administration Sets, October 12, 2000" |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 - 2004
Baxter Healthcare Corporation C/O Mr. Ronald F. Lagerquist Senior Manager, Regulatory Affairs Baxter BioScience One Baxter Way Westlake Village, California 91362
Re: K042410
Trade/Device Name: BAXJECT I I Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: September 28, 2004 Received: September 29, 2004
Dear Mr. Lagerquist:
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 (1 mr), ice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roulish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Lagerquist
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I DTC issuaires on that your device complies with other requirements Incall that I DA nas made a actessand regulations administered by other Federal agencies. of the Act of ally t oderal states are quirements, including, but not limited to: registration 1 ou inust comply with an are rabeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Pat (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by steam (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) This letter will anow you to obja. finding of substantial equivalence of your device to a premarket notification. The PDF 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), rr you desire specific at no for spliance at (240) 276-0115. 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 may obtain 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,
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
3
510(k) Premarket Notification Baxter BAXJECT II BAXTER HEALTHCARE CORPORATION, Baxter BioScience
Page 29
Indications for Use
510(k) Number (if known): Ko 42 410
Device Name: BAXJECT II
Indications for Use:
The BAXJECT II Needleless Transfer Device is intended for transferring and mixing drugs contained in two vials into a syringe.
Vick Hubbard for Anthony Wilson
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number Ko42 4/0
Prescription Use Over-The-Counter Use ಸ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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