(291 days)
The high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media (at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation of ICU proprietary connectors such as the CLAVE; MicroCLAVE; Y-CLAVE; and CLC2000 with the extension sets, allows for needleless connectivity to other devices via universal luer connection. The maximum pressure is 400 psi and other ancillary devices must also be rated for pressure up to 400 psi.
The High Pressure Sets are a group of luer compatible connection devices that aid in the prevention of needlesticks and offer ease of use in the environment for the healthcare professional. The use of the CLAVE®; MicroCLAVE™; Y-CLAVE™; and CLC2000™ is a natural fit with the high pressure sets. Testing included with this submission, validates the 400 psi claim with these unique connectors. The functional technology of the high pressure set has not changed but is augmented by the addition of the ICU connectors. The devices are sterilized to ensure a 10⁻⁶ SAL and they have been tested under the ISO 10993-1:2003 ~ Biological evaluation of medical devices ~ Part 1: Evaluation and resting and the results from these tests were found to be acceptable and are enclosed in this submission.
The provided document describes the ICU Medical High Pressure Sets - 400 psi, which are luer compatible connection devices intended for use in cardiovascular procedures where contrast media is injected using control syringes or power injectors. The document focuses on demonstrating the substantial equivalence of this device to existing predicate devices.
Here's an analysis of the acceptance criteria and the study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for performance that are then directly compared to "reported device performance" in a typical table format. Instead, it relies on demonstrating that the device has undergone "non-clinical testing (simulated use) ... according to the product specification and that testing demonstrates that the device is safe and effective by meeting predefined criteria." The key performance claim is its ability to safely handle up to 400 psi.
Based on the information provided, we can infer the following:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Maximum Pressure Rating | 400 psi | Validated to 400 psi |
| Sterilization | Sterile (10⁻⁶ SAL) | Sterilized to 10⁻⁶ SAL |
| Biocompatibility | Acceptable | Found acceptable per ISO 10993-1:2003 |
Note: The document emphasizes substantial equivalence to predicate devices for characteristics like materials, functional use (high-pressure infusion), sterilization method (Gamma), and packaging (Peel pouch). While not explicit acceptance criteria, demonstrating equivalence implies meeting the safety and performance standards of these legally marketed devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the "non-clinical testing (simulated use)." It only states that "Test data is part of this submission as evidence."
The data provenance is retrospective as the testing was conducted on the device to demonstrate compliance with specifications for the purpose of the 510(k) submission. There is no mention of country of origin for the data, but it is implied to be from testing conducted by ICU Medical Inc., a US-based company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described is non-clinical, simulated use testing against product specifications. This typically does not involve human experts establishing "ground truth" in the way a clinical study might for diagnostic accuracy. The "ground truth" for the performance characteristics (e.g., pressure resistance, sterility) would be the physical measurements and results of the laboratory tests.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. As the testing is non-clinical, simulated use, and involves objective measurements (e.g., pressure, sterility), an adjudication method as typically defined for human-expert validation is not applicable or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or prognostic devices that involve human interpretation of images or data. The ICU Medical High Pressure Sets are infusion sets, and their effectiveness is determined by their physical performance (e.g., pressure resistance, biocompatibility), not by human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study (or rather, standalone testing in this context) was done. The "non-clinical testing (simulated use)" evaluates the device's inherent performance characteristics, such as its ability to withstand 400 psi pressure and its sterility, without human intervention or interaction as part of the performance evaluation. The device itself is evaluated in isolation against its predefined criteria.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective physical and chemical measurements and engineering standards. This includes:
- Pressure Resistance: Verification that the device can safely handle up to 400 psi.
- Sterility: Confirmation that the device meets a Sterility Assurance Level (SAL) of 10⁻⁶.
- Biocompatibility: Results from tests conducted according to ISO 10993-1:2003, ensuring materials are safe for biological contact.
- Luer Compatibility: Adherence to industry standards like ISO 594-1 and ISO 594-2 for luer connections.
8. The Sample Size for the Training Set
This question is not applicable as the ICU Medical High Pressure Sets are medical devices with mechanical and material properties, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
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510(K) Summary
ICU MEDICAL INC.
4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1332, Phone (801) 264 - 1755, Fax Tracy S. Best, Sr. Regulatory Affairs Specialist Preparation Date: 05/28/2010
DEC 1 7 2010
Summary of Safety and Effectiveness for the:
| Trade Name: | High Pressure Sets - 400 psi |
|---|---|
| Common Name: | High Pressure Infusion Devices |
| Classification Name: | Primary 21 CFR 880.5440, Class II Device, 80FPASecondary 21 CFR 870.4290, Class II Device, 74DTL |
Legally Marketed Predicate Devices for Substantial Equivalence:
*K061285 - Smart Site Valve Sets - Cardinal Health, Inc.
*K941978 - High Pressure Tubing, - Abbott Labs (submission acquired by ICU Medical Inc.) *K963749 - High Pressure Injection Linc, Maxim Medical, Inc.
Rationale for SE:
The ICU Medical High Pressure Sets are substantially equivalent to the predicate devices that offer needleless connectivity and international lucr compatibility. The use of ICU's legacy line of connectors is complimentary to these pre-assembled, individually packaged, and pre-sterilized high pressure sets. High pressure sets are used in cardiovascular procedures where contrast media is injected using control syringes or power injectors is common among all devices, which are safe for use up to 400 psi. These features are substantially equivalent to the predicate devices in that they also utilize male luers; female luers or locking luer connectors. Components of the devices are made from materials that are substantially cquivalent to the predicate devices listed above and this submission includes comprehensive biocompatibility testing for all device materials included in this submission. Additionally, all devices have a proven and invaluable history in the medical device market.
Description of Submitted Device:
The High Pressure Sets are a group of luer compatible connection devices that aid in the prevention of needlesticks and offer ease of use in the environment for the healthcare professional. The use of the CLAVE®; MicroCLAVE™; Y-CLAVE™; and CLC2000™ is a natural fit with the high pressure sets. Testing included with this submission, validates the 400 psi claim with these unique connectors. The functional technology of the high pressure set has not changed but is augmented by the addition of the ICU connectors. The devices are sterilized to ensure a 10ª SAL and they have been tested under the ISO 10993-1:2003 ~ Biological evaluation of medical devices ~ Part 1: Evaluation and resting and the results from these tests were found to be acceptable and are enclosed in this submission.
Non-Clinical Testing:
Testing (simulated use) has been conducted according to the product specification and that testing demonstrates that the device is safe and effective by meeting predefined criteria. Test data is part of this submission as evidence.
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Intended Uses of the ICU Medical High Pressure Sets:
The high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media (at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation of ICU proprietary connectors such as the CLAVE; MicroCLAVE; Y-CLAVE; and CLC2000 with the extension sets, allows for needleless connectivity to other devices via universal luer connection. The maximum pressure is 400 psi and other ancillary devices must also be rated for pressure up to 400 psi.
| Component | ICU MedicalHigh PressureSets | Cardinal HealthSmart Site ValveSets | Abbott Labs(submissionacquired by ICUMedical) | Maxxim MedicalHigh PressureInjection Line |
|---|---|---|---|---|
| Materials | Tubing-PVCLuers - PC, PVC& proprietaryneedleless devices | Tubing - PVCLuers - PC &proprietaryneedleless devices | Tubing - PVCLuers - PC &PVC | Tubing - PVCLuers - Plastic (PCassumed) |
| Functionaluse | High pressureinfusion | High pressureinfusion | High pressureinfusion | High pressureinfusion |
| SterilizationMethod | Gamma | EtO | EtO and Gamma | Unknown |
| Packaging | Peel pouch | Peel pouch | Peel pouch | Peel pouch |
| 510(k)Approval | This submission | K061285 | K941978 | K963749 |
Technological Characteristics and Substantial Equivalence Table:
Safety and Performance:
ICU Medical's commitment to quality and the high pressure sets that we currently make with the acquired K941978 submission are part of this submission. The use of these devices at pressures up to 400 psi has been tested and thoroughly proven to be safe and effective when coupled with the CLAVE; MicroCLAVE; Y-CLAVE; and COC2000. These high pressure sets are individually packaged and pre-sterilized in a peel type pouch. Devices are obtainable at custom lengths, according to facility needs and physician preference, including the type of luer ends used. Additionally, ICU Mcdical performs analysis and design verification icsting based on predecermined criteria, which is presented in the Performance Specifications in this submission. All testing meets these performance criteria as defined for the high-pressure. The design of the proprietary needleless connectors allow lucr connections as defined by ISO 594-1 and ISO 594-2 which is considered to be an industry standard.
Conclusion:
The materials, performance, and operational features of the submitted devices and the predicate devices are substantially equivalent to one another and effective for their intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Tracy Best Senior Regulatory Affairs Specialist ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123
DEC 17 2010
Re: K100576
Trade/Device Name: High Pressure Sets - 400 psi Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 30, 2010 Received: November 5, 2010
Dear Mr. Best:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2- Mr. Best
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); 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. 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
DEC 17 2010
510(k) Number (if known): K100576
Device Name: High Pressure Sets - 400 psi
Indications for Use:
The high pressure extension set is a device used as conduit tubing to deliver fluids from an electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices. Fluids may include: Contrast media (at 10mL/second) or other medications, and blood or blood products as the physician may prescribe. The fluids are administered through a cannula or catheter placed in a vein or artery. The incorporation of ICU proprietary connectors such as the CLAVE; MicroCLAVE; Y-CLAVE; and CLC2000 with the extension sets, allows for needleless connectivity to other devices via universal luer connection. The maximum pressure is 400 psi and other ancillary devices must also be rated for pressure up to 400 psi.
Prescription Use XX (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)
Mih C. Chape 12/19/10
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K100576
§ 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.