(13 days)
Not Found
No
The device description and intended use clearly define it as a fluid transfer tubeset for a pharmacy pump, with no mention of AI or ML capabilities.
No
The device is described as a fluid transfer device used in a pharmacy for transferring ingredients and filling syringes, not for direct therapeutic intervention on a patient.
No
The device description states it is a fluid transfer device used in the pharmacy for transferring ingredients, not for diagnosing medical conditions.
No
The device description explicitly states it is a "fluid transfer device" and a "tubeset," which are physical hardware components. The performance studies also mention biocompatibility, packaging, and sterilization validation, which are typical for physical medical devices, not software-only devices.
Based on the provided information, the Rapid-Fill Tubeset is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers." This is a mechanical function related to preparing medications, not performing diagnostic tests on biological samples.
- Device Description: The description reinforces its use in conjunction with a pharmacy pump for filling syringes, again pointing to a medication preparation function.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (or other organisms) to provide information for diagnostic, monitoring, or compatibility purposes.
The device is clearly intended for use in a pharmacy setting for preparing medications, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Rapid-Fill Tubeset, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The Rapid-Fill Tubeset, is a tubeset used in conjunction with the Rapid-Fill pharmacy pump to fill multiple syringes.
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
pharmacy
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)
Testing will include: Biocompatibility testing - ISO 10993-1 Packaging validation Sterilization validation
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
AUG 1 2 2002
510(k) Summary
| Submitted by: | Baxa Corporation
13760 E. Arapahoe Road
Englewood, CO 80112 | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Contact Person: | Karl Steineck | |
| Phone: | 303-617-2181 | |
| Fax: | 303-690-4804 | |
| Date Prepared: | July 26, 2001 | |
| Manufacturing Facility: | Baxa Corporation
13760 E. Arapahoe Road
Englewood, CO 80112 | |
| Submitted Device: | Trade Name: | Rapid-Fill™ Tubeset(s) |
| | Common Name: | Administration Set |
| Device Classification: | Class II
21 CFR § 880.5440 Intarvascular 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 (performance standards) | |
| Predicate Device: | Exacta-Mix™ 2400 Compounding System Administration Set
510(k): K002705, Cleared March 28, 2001
Baxa Corporation
Englewood, CO | |
| Product Description: | The Rapid-Fill Tubeset, is a tubeset used in conjunction with the
Rapid-Fill pharmacy pump to fill multiple syringes. | |
| Intended Use: | The Rapid-Fill Tubeset, is a fluid transfer device used in the
pharmacy to provide the fluid path for transferring large source
container ingredients into a smaller containers. | |
1
Statement of substantial equivalence-
The Rapid-Fill Tubeset is very similar to the Exacta-Mix 2400 Compounding System Administration set in the following areas; intended use, operation, and function. The Rapid-Fill Tubeset and the predicate device are both used to transfer large source into smaller containers.
A summary of the essential features between the Exacta-Mix 2400 Compounding System Administration set (predicate device) and the Rapid-Fill Tubeset is contained in Table 1
Table 1
Comparison between the Exacta-Mix™ 2400 Compounding System Administration Set and the new device, Rapid-Fill tubeset.
| Feature | Exacta-Mix Administration
Set
(Predicate Device) | Rapid-Fill™ Tubeset |
|--------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Intended use | used to transfer multiple large
container ingredients into one
final solution | Used to transfer one large
container ingredient to
multiple small containers. |
| Inlet Spike | Vented and non-Vented source
container spike | Vented and non-Vented
source container spike |
| Tubing | Non- DEHP Polyvinyl
Chloride (PVC) | Non- DEHP Polyvinyl
Chloride (PVC) |
| Sterile Fluid Path | Radiation Sterilized | Radiation Sterilized |
From Table 1 it can be seen that the two types of devices share the same basic features for fluid transfer.
Testing:
Testing will include: Biocompatibility testing - ISO 10993-1 Packaging validation Sterilization validation
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top and left side of the profile graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2002
Mr. Karl Steinbeck Baxa Corporation 13760 East Arapahoe Road Englewood. California 80112
Re: K022523
Trade/Device Name: Rapid-Fill Tubeset, Model 90005 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: July 19, 2002 Received: July 30, 2002
Dear Mr. Steinbeck:
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 vour 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 and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice
3
Page 2 - Mr. Steinbeck
requirements as set forth in the quality systems (OS) 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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely vours.
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION I: PRE-MARKET SUBMISSION (CONTINUED)
Indications for Use Statement (New and Predicate Device)
. .
.
..
1
New Device
:
・・.
:
.
.
| Applicant: | Baxa Corporation |
|---|---|
| 510(k) Number (if known) | |
| New Device Name: | Rapid-Fill™ Tubeset |
| Indications For Use: | The Rapid-Fill Tubeset, manufactured by Baxa Corporation, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers. |
Patricia Curenite
(Division Sign. O.R.)
(Division Sign-Off) Division of Anesthesiology, Gener Infection Control, Dental Devices
510(k) Number: K022523
000011