(163 days)
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.
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. 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.
This is an interesting case where the provided text is a 510(k) summary for a medical device, which means it describes the device itself and its equivalence to a predicate device, but it does not include a detailed study proving the device meets specific acceptance criteria in the way a clinical or performance study report would. Instead, it lists various types of testing that will be included to demonstrate the device's substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested items regarding specific study methodologies (sample size for test/training sets, data provenance, number of experts, adjudication, MRMC studies, standalone performance) cannot be extracted directly from this document. This summary outlines the plan for testing and the performance characteristics of the device, rather than the results of a conducted study with defined acceptance criteria.
Here's an analysis based on the provided text, highlighting what is present and what is not:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for a study in the form of pre-defined thresholds. Instead, it provides performance specifications for the submitted device and compares them to the predicate device. The implicit acceptance criterion is that the new device performs at least as well as, or better than, the predicate device, especially regarding volume accuracy and pumping life.
It's crucial to understand that for a 510(k) submission, the "study" is often a series of verification and validation activities (testing) to demonstrate substantial equivalence to a predicate device, rather than a single clinical trial with pre-defined primary and secondary endpoints.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate & New Device Specs) | Reported Device Performance (New Device) |
|---|---|---|
| Minimum Dispensing Volume | Predicate: 0.2 mL | 0.2 mL |
| Volume Accuracy (0.2-2mL) | Predicate: +/- 10% @ 0.2 mL, +/- 5% @ 0.5 mL, +/- 3% @ 1.0 mL | +/- 0.02 mL |
| Volume Accuracy (>2mL) | Predicate: +/- 3% @ 1.0 mL (implied threshold from predicate) | +/- 1% |
| Maximum Flow Rate | Predicate: Over 14 mL per second at highest speed | Over 21 mL per second at highest speed |
| Pumping Life | Predicate: Up to 150 Liters of fluid | Up to 200 Liters of fluid |
| Sterilization Method | Predicate: Ethylene Oxide (ETO) | Gamma Radiation |
| Calibration Need | Predicate: Frequent calibration and flow factor adjustments normally required with peristaltic pumping (implying need for calibration) | Eliminates the need for frequent calibration and flow factor adjustments |
Study Details (Based on the provided K062909 Summary)
As noted, the document outlines the types of testing that will be included, rather than presenting the results of a specific study with the requested details.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. The document is a 510(k) submission from Baxa Corporation in Englewood, CO, USA. The testing listed (Biocompatibility, Sterilization validation, Endotoxin Test, Human Factors/System Validation Disposable Design Verification Microbial Ingress Validation System Design Verification, Packaging validation) are general categories of testing typically performed to demonstrate device safety and performance according to U.S. FDA requirements. It is a prospective submission about the device, but the testing itself would be conducted prospectively on manufactured units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a device performance verification document, not a diagnostic algorithm. The "ground truth" here would relate to whether the device meets its engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device performance verification.
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
- Not applicable. This device is an IV fluid transfer set, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm separate from its mechanical function. Its performance is inherent to its design and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device would be established by engineering and quality standards, such as:
- Precisely measured fluid volumes using calibrated equipment.
- Sterility testing according to established protocols (e.g., absence of microbial growth).
- Biocompatibility testing against recognized standards (e.g., ISO 10993-1).
- Physical strength and leak testing.
- The "ground truth" is adherence to these measurable, objective criteria.
8. The sample size for the training set
- Not applicable. This device does not use an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable as there is no training set for an AI model.
Summary of what the document confirms:
- Device: Repeater Pump II Tube Sets (IV fluid transfer set, Class II device).
- Intended Use: Fluid transfer in hospital pharmacies for repeatable drug dosage distribution and reconstitution.
- Comparison: Substantially equivalent to the Repeater™ Pump Tube Sets (predicate device).
- Key Performance Improvements over Predicate:
- Piston pump methodology (vs. peristaltic) eliminates need for recalibration with different viscosities/flow rates.
- Improved volume accuracy (+/- 0.02mL for 0.2-2mL, +/- 1% for >2mL, compared to +/- 10% for 0.2mL, +/- 5% for 0.5mL, +/- 3% for 1.0mL for predicate).
- Higher max flow rate (over 21mL/sec vs. over 14mL/sec).
- Longer pumping life (200L vs. 150L).
- Sterilized by Gamma Radiation (vs. ETO for predicate).
- Planned Testing: Biocompatibility, Sterilization validation, Endotoxin Test, Human Factors/System Validation, Disposable Design Verification, Microbial Ingress Validation, System Design Verification, Packaging validation.
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Kola2909
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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 Corporation14445 Grasslands DriveEnglewood, 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 deviceused to administer fluids from a container to a patient's vascularsystem through a needle or catheter inserted into a vein. Thedevice may include the needle or catheter, tubing, a flowregulator, a drip chamber, an infusion line filter, an I.V. setstopcock, fluid delivery tubing, connectors between parts of theset, a side tube with a cap to serve as an injection site, and ahollow spike to penetrate and connect the tubing to an I.V. bagor 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 DeviceClassification: | 21 CFR § 880.5440 Intravascular administration setProduct Code LHI | |
| (b) Classification. Class II | ||
| Manufacturer: Baxa Corporation510(k) Number: K872743 | ||
| Product Description: | The Repeater Pump II tube set provides the fluid pathway, pumpcavity, valving, and tube set for the Repeater Pump II system.The tube set and pump platform work together to provide steriletransfer and reconstitution of pharmaceutical liquids. The tubeset utilizes a plastic piston to mechanically pump requiredamounts of fluid from 0.2mL to 10mL with each piston stroke. Aplastic pump core works in conjunction with the piston to provideappropriate fluid pathways for the draw and discharge strokes. |
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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 forUse | The Repeater Pump II tube sets are fluidtransfer tube sets used in conjunction with theRepeater Pump II pharmacy pump in hospitalpharmacies to provide a pathway throughwhich fluid is transferred from one sourcecontainer into another suitable container. | The Repeater Pump tube set is part of theRepeater Pump™ device. This deviceprovides peristaltic pump driven fluidtransfer that facilitates repeatable drugdosage distribution and reconstitution inhospital pharmacies. The Repeater Pumptube set provides the fluid pathway andpumping mechanism for the pump system.The device is for use with IV bags,syringes, elastomeric infusers, and otherdrug administration containers. Some setsare sold sterile and others are not based onthe end use of the set. |
| IntendedUse | This product would be used for fluid transfer inhospital pharmacies | This product would be used for fluid transferin hospital pharmacies |
| Capacity | 10mL per stroke with min/max delivery of2mL/10mL per stroke and a maximum flow | Inner diameter of pump tube set allows over14 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 ConnectorsFluid Transfer with Vented Spike | Vented Spike/Male Luer Lock ConnectorsFluid Transfer with Vented Spike | |
| Model #3603Male Luer Lock/Male Luer Lock ConnectorsFluid Transfer with Luer Lock Connectors | Model #21Male Luer Lock/Male Luer Lock ConnectorsFluid Transfer with Luer Lock Connectors | |
| Model #3605Male Luer Lock/Male Luer Lock ConnectorsLow Prime Volume Fluid Transfer | Model #331Male Luer Lock/Male Luer Lock ConnectorsLow Prime Volume Fluid Transfer | |
| Model #3612Vented Spikes (2)/Male Luer LockBifurcated Tube Set | Model #62Vented Spikes (2)/Male Luer LockBifurcated Tube Set | |
| Model #3614Vented Spike (3)/Male Luer LockTrifurcated Tube Set | Model #63Vented Spike (3)/Male Luer LockTrifurcated Tube Set | |
| Model #3623SS Weight Inlet/Male Luer LockOral Liquid Transfer | Model #13SS Weight Inlet/Male Luer LockOral Liquid Transfer | |
| Model #3620Male Luer Lock ConnectorTop Fill BagGel Bag | Model #26Male Luer Lock ConnectorTop Fill BagGel Bag | |
| Model #3625Male Luer Lock ConnectorTop Fill BagGel Bag | Model #46Male Luer Lock ConnectorTop Fill BagGel Bag | |
| TargetPopulation | Customers for the tube sets are Baxapharmacy pump users, including hospital andhome care pharmacists and pharmacytechnicians. These tube sets are used bytrained personnel, and do not have directcontact with a patient. | Customers for the tube sets are Baxapharmacy pump users, including hospitaland home care pharmacists and pharmacytechnicians. These tube sets are used bytrained personnel, and do not have directcontact with a patient. |
| Anatomicalsites | N/A | N/A |
| Where Used | This product would be used by Pharmacistsand Pharmacy technicians both inside andoutside of flow hoods | This product would be used by Pharmacistsand Pharmacy technicians both inside andoutside of flow hoods |
| Performance | • Using a rigid pumping cavity and pistonpump methodology, solutions of differentviscosities and flow rates can be pumpedwithout any recalibration due to tube setcharacteristic changes. | • Using different durometer PVC tubing,solutions of different viscosities can bepumped while minimizing dripping fromthe end of the tube set. Using differentsilicone tubing diameters, differingvolumes can be pumped with repeatableaccuracy. |
| • 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 persecond to be pumped at highest speed• The pump tube set will perform tospecification for up to 200 liters of fluid.Pump automatically alerts users when endof tube set life is met | • Inner diameter of pump tube set allowsover 14 mL per second to be pumped,highest speed.• The pump tube set will perform tospecification for up to 150 Liters of fluid. | |
| Materials | See Section 11, "Device Description" formaterial information | Fluid contact materials:Sunlite Plastics Vysun 102-85-22 MedicalGrade PVC resinMedical Grade silicone tubing |
| Biocompatibility | Materials will be tested per ISO 10993-1(2003): Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing | Materials have been tested per ISO 10993-1 (2003): Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing |
| Compatibilitywith theenvironmentand other | #3601, #3603, #3605, #3620, #3623connections are compatible with standard luer-lock connections per ISO 594-1 and -2. | #11 connections are compatible withstandard luer-lock connections per ISO594-1 and -2. |
| devices | #3612, #3614 use a 5mm large boreconnector and are compatible only with other5mm connectors | |
| Sterility | Sterilized using Gamma radiation | Sterilized using Ethylene Oxide (ETO) |
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K063909
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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
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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.
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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
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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
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§ 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.