(163 days)
Not Found
No
The document describes a mechanical fluid transfer system and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device description states that the tube sets are used in conjunction with a pharmacy pump to transfer fluid from one container to another, and are used by pharmacists and pharmacy technicians in a hospital setting for sterile transfer and reconstitution of pharmaceutical liquids. It does not mention any direct therapeutic application to a patient.
No
The device is a fluid transfer tube set used for "sterile transfer and reconstitution of pharmaceutical liquids" and "does not have direct contact with a patient." It is not described as analyzing or interpreting biological signals or data to diagnose a condition.
No
The device description explicitly details physical components like a plastic piston, pump core, and tube set connections, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "fluid transfer tube sets used in conjunction with the Repeater Pump II pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container." This describes a device used for preparing and transferring pharmaceutical liquids, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the mechanical aspects of fluid transfer, pumping, and sterile handling of pharmaceutical liquids. There is no mention of analyzing biological samples or providing diagnostic information.
- Intended User / Care Setting: The intended users are pharmacists and pharmacy technicians in hospital and home care settings. This aligns with the preparation and handling of medications, not diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a component of a system used for preparing and dispensing medications, which falls under the category of medical devices used in pharmacy practice, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Repeater Pump II tube set tube sets are fluid transfer tube sets used in conjunction with the Repeater Pump II pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.
Product codes (comma separated list FDA assigned to the subject device)
LHI, FPA
Device Description
The Repeater Pump II tube set provides the fluid pathway, pump cavity, valving, and tube set for the Repeater Pump II system. The tube set and pump platform work together to provide sterile transfer and reconstitution of pharmaceutical liquids. The tube set utilizes a plastic piston to mechanically pump required amounts of fluid from 0.2mL to 10mL with each piston stroke. A plastic pump core works in conjunction with the piston to provide appropriate fluid pathways for the draw and discharge strokes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
N/A
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Customers for the tube sets are Baxa pharmacy pump users, including hospital and home care pharmacists and pharmacy technicians. These tube sets are used by trained personnel, and do not have direct contact with a patient.
This product would be used by Pharmacists and Pharmacy technicians both inside and outside of flow hoods.
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
Sterilization validation -- ANSI/AAMI/ISO11137
Endotoxin Test - Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices. U.S. Dept. of Health and Human Services and Drug Administration, December 1987.
Human Factors/System Validation Disposable Design Verification Microbial Ingress Validation System Design Verification
Packaging validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum dispensing volume of 0.2mL.
+/- 0.02ml for .2ml to 2ml pumping
+/- 1% for >2ml pumping
High flow tube set allows over 21ml per second to be pumped at highest speed
The pump tube set will perform to specification for up to 200 liters of fluid. Pump automatically alerts users when end of tube set life is met
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
Kola2909
1 of 4
SECTION 5: 510(k) SUMMARY
| Submitted by: | Baxa Corporation | MAR 09 2007 |
|---|---|---|
| Contact Person: | ||
| Phone: | ||
| Fax: | Kimberly Zizik, Regulatory Assurance Supervisor | |
| (303) 617 2242 | ||
| (303) 690 4904 | ||
| Date Prepared: | ||
| Manufacturing Facility: | Baxa Corporation | |
| 14445 Grasslands Drive | ||
| Englewood, CO 80112 | ||
| Submitted Device: | Trade Name: Repeater Pump II Tube Sets | |
| (Baxa Tubing Sets for Pump) | ||
| Common Name: Set, IV Fluid Transfer | ||
| Device Classification: | 21 CFR § 880.5440 Intravascular administration set, | |
| Product Code LHI | ||
| (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 | ||
| Predicate Device: | Trade Name: Repeater™ Pump Tube Sets | |
| (Baxa Tubing Sets for Pump) | ||
| Common Name: Set, IV Fluid Transfer | ||
| Predicate Device | ||
| Classification: | 21 CFR § 880.5440 Intravascular administration set | |
| Product Code LHI | ||
| (b) Classification. Class II | ||
| Manufacturer: Baxa Corporation | ||
| 510(k) Number: K872743 | ||
| Product Description: | The Repeater Pump II tube set provides the fluid pathway, pump | |
| cavity, valving, and tube set for the Repeater Pump II system. | ||
| The tube set and pump platform work together to provide sterile | ||
| transfer and reconstitution of pharmaceutical liquids. The tube | ||
| set utilizes a plastic piston to mechanically pump required | ||
| amounts of fluid from 0.2mL to 10mL with each piston stroke. A | ||
| plastic pump core works in conjunction with the piston to provide | ||
| appropriate fluid pathways for the draw and discharge strokes. |
1
There are two tube set connections for inlet and outlet fluid pathways. The Repeater Pump II tube set will be available in eight (8) unique configurations to accommodate various source and final container connections.
The Repeater Pump II tube set:
- . Provides an integrated pump body/cavity, piston, pump core, and tube set that are used with standard pharmaceutical fluid and drug administration containers
- . Utilizes standard connections in different configurations to meet different pumping requirements
- Eliminates the need for frequent calibration and flow . factor adjustments normally required with peristaltic pumping
- Designed for pumping life of 200L. Pump . automatically alerts users when end of tube set life is met
The Repeater Pump II tube set is for use with Repeater Pump II Intended Use: device. This device provides piston pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The Repeater Pump II tube set provides the fluid pathway and pumping mechanism for the pump system. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Some sets are sold sterile and others are not based on the requirements for the end use of the set.
Statement of substantial equivalence:
A summary of the essential features between the Repeater Pump Tube sets (Predicate Device) and the Baxa Corporation Repeater Pump II Tube sets (New Device) is contained in below:
| Feature | Repeater Pump II Tube Set
(Piston Pump New Device) | Repeater Pump Fluid Transfer Tube Set
(Peristaltic Pump Predicate Device) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | The Repeater Pump II tube sets are fluid
transfer tube sets used in conjunction with the
Repeater Pump II pharmacy pump in hospital
pharmacies to provide a pathway through
which fluid is transferred from one source
container into another suitable container. | The Repeater Pump tube set is part of the
Repeater Pump™ device. This device
provides peristaltic pump driven fluid
transfer that facilitates repeatable drug
dosage distribution and reconstitution in
hospital pharmacies. The Repeater Pump
tube set provides the fluid pathway and
pumping mechanism for the pump system.
The device is for use with IV bags,
syringes, elastomeric infusers, and other
drug administration containers. Some sets
are sold sterile and others are not based on
the end use of the set. |
| Intended
Use | This product would be used for fluid transfer in
hospital pharmacies | This product would be used for fluid transfer
in hospital pharmacies |
| Capacity | 10mL per stroke with min/max delivery of
2mL/10mL per stroke and a maximum flow | Inner diameter of pump tube set allows over
14 mL per second to be pumped at the |
| | rate of over 21mL per second. | highest speed. |
| Tubing | Various Durometer Non-DEHP PVC tubing | Various durometer PVC and silicone tubing |
| Connections | Model #3601 | Model #11 |
| | Vented Spike/Male Luer Lock Connectors
Fluid Transfer with Vented Spike | Vented Spike/Male Luer Lock Connectors
Fluid Transfer with Vented Spike |
| | Model #3603
Male Luer Lock/Male Luer Lock Connectors
Fluid Transfer with Luer Lock Connectors | Model #21
Male Luer Lock/Male Luer Lock Connectors
Fluid Transfer with Luer Lock Connectors |
| | Model #3605
Male Luer Lock/Male Luer Lock Connectors
Low Prime Volume Fluid Transfer | Model #331
Male Luer Lock/Male Luer Lock Connectors
Low Prime Volume Fluid Transfer |
| | Model #3612
Vented Spikes (2)/Male Luer Lock
Bifurcated Tube Set | Model #62
Vented Spikes (2)/Male Luer Lock
Bifurcated Tube Set |
| | Model #3614
Vented Spike (3)/Male Luer Lock
Trifurcated Tube Set | Model #63
Vented Spike (3)/Male Luer Lock
Trifurcated Tube Set |
| | Model #3623
SS Weight Inlet/Male Luer Lock
Oral Liquid Transfer | Model #13
SS Weight Inlet/Male Luer Lock
Oral Liquid Transfer |
| | Model #3620
Male Luer Lock Connector
Top Fill Bag
Gel Bag | Model #26
Male Luer Lock Connector
Top Fill Bag
Gel Bag |
| | Model #3625
Male Luer Lock Connector
Top Fill Bag
Gel Bag | Model #46
Male Luer Lock Connector
Top Fill Bag
Gel Bag |
| Target
Population | Customers for the tube sets are Baxa
pharmacy pump users, including hospital and
home care pharmacists and pharmacy
technicians. These tube sets are used by
trained personnel, and do not have direct
contact with a patient. | Customers for the tube sets are Baxa
pharmacy pump users, including hospital
and home care pharmacists and pharmacy
technicians. These tube sets are used by
trained personnel, and do not have direct
contact with a patient. |
| Anatomical
sites | N/A | N/A |
| Where Used | This product would be used by Pharmacists
and Pharmacy technicians both inside and
outside of flow hoods | This product would be used by Pharmacists
and Pharmacy technicians both inside and
outside of flow hoods |
| Performance | • Using a rigid pumping cavity and piston
pump methodology, solutions of different
viscosities and flow rates can be pumped
without any recalibration due to tube set
characteristic changes. | • Using different durometer PVC tubing,
solutions of different viscosities can be
pumped while minimizing dripping from
the end of the tube set. Using different
silicone tubing diameters, differing
volumes can be pumped with repeatable
accuracy. |
| | • Sterilized by Gamma Radiation
• Minimum dispensing volume of 0.2mL. | • Sterilized by ETO (ethylene oxide) gas.
• Minimum dispensing volume of 0.2 mL. |
| | +/- 0.02ml for .2ml to 2ml pumping
+/- 1% for >2ml pumping | • Volume accuracy:
+/- 10% @ 0.2 mL
+/- 5% @ 0.5 mL
+/- 3% @ 1.0 mL |
| | • High flow tube set allows over 21ml per
second to be pumped at highest speed
• The pump tube set will perform to
specification for up to 200 liters of fluid.
Pump automatically alerts users when end
of tube set life is met | • Inner diameter of pump tube set allows
over 14 mL per second to be pumped,
highest speed.
• The pump tube set will perform to
specification for up to 150 Liters of fluid. |
| Materials | See Section 11, "Device Description" for
material information | Fluid contact materials:
Sunlite Plastics Vysun 102-85-22 Medical
Grade PVC resin
Medical Grade silicone tubing |
| Biocompatibi
lity | Materials will be tested per ISO 10993-1
(2003): Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing | Materials have been tested per ISO 10993-
1 (2003): Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing |
| Compatibility
with the
environment
and other | #3601, #3603, #3605, #3620, #3623
connections are compatible with standard luer-
lock connections per ISO 594-1 and -2. | #11 connections are compatible with
standard luer-lock connections per ISO
594-1 and -2. |
| devices | #3612, #3614 use a 5mm large bore
connector and are compatible only with other
5mm connectors | |
| Sterility | Sterilized using Gamma radiation | Sterilized using Ethylene Oxide (ETO) |
2
K063909
3 of 4
. . .
יי
3
K062909
4.84
From the above table it can be seen that the two types of devices share basic features for fluid transfer applications.
Testing:
Testing will include:
Biocompatibility testing - ISO 10993-1
Sterilization validation -- ANSI/AAMI/ISO11137
Endotoxin Test - Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices. U.S. Dept. of Health and Human Services and Drug Administration, December 1987.
Human Factors/System Validation Disposable Design Verification Microbial Ingress Validation System Design Verification
Packaging validation
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kimberly Zizik Regulatory Assurance Supervisor Baxa Corporation 14445 Grasslands Drive Englewood, Colorado 80112
MAR 0 9 2007
Re: K062909
Trade/Device Name: Repeater Pump IITM Tube Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 16, 2007 Received: February 20, 2007
Dear Ms. Zizik:
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.
5
Page 2 -Ms. Zizik
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 (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), please contact the Office of Compliance 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 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/industry/support/index.html.
Sincerely yours,
Sutte G. Michan M.D.
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
6
Indications For Use
510(k) Number: K062909
Device Name: Repeater Pump II™ Tube Sets
Indications for Use: The Repeater Pump II tube set tube sets are fluid transfer tube sets used in conjunction with the Repeater Pump II pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anin Im
Lab/2020
Page 1 of 1