(14 days)
The Blood Sampling Set is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
The Blood Sampling Set consists of non-DEHP PVC tubing, and configured with one or more stopcocks with needleless valves, and a male luer lock for connection with the patients catheter. An optional configuration includes check valves, non-DEHP PVC tubing and transfer spike to allow for withdrawing flush solution from an IV bag into a syringe. All sets can be ordered with a choice of various on/off clamps, depending on the clinician's and hospital protocol. The Blood Sampling Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Blood Sampling Set":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Bond Joint Strength | Met the acceptance criteria as outlined in ISO 8536-4 |
| Fluid Flow Leak Testing | Met the acceptance criteria as outlined in ISO 8536-4 |
| Flow Rate Comparison | Met the acceptance criteria as outlined in ISO 8536-4 (comparison between proposed and predicate device) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance tests (Bond Joint Strength, Fluid Flow Leak Testing, Flow Rate Comparison). The data provenance is implied to be directly from testing conducted by Acacia, Inc., as these tests were performed to assure substantial equivalence. It's not specified as retrospective or prospective, but as performance testing for a new device, it would inherently be prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The described tests are not clinical studies requiring expert ground truth establishment. They are engineering performance tests against a standard (ISO 8536-4).
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against a standard, not requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a medical accessory (Blood Sampling Set / IV Extension Set), not an imaging or diagnostic AI device that would typically require such a study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance tests (Bond Joint Strength, Fluid Flow Leak Testing, Flow Rate Comparison) are standalone performance evaluations of the device itself, without human-in-the-loop interaction in an interpretive sense.
7. The Type of Ground Truth Used
The ground truth for the performance tests was established by the ISO 8536-4 standard. This standard defines the requirements and acceptance criteria for infusion equipment, and the device's performance was measured against these objective, pre-defined technical specifications.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical accessory, not an AI or machine learning model that would require 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/ML model, there is no ground truth to establish for it. The "ground truth" for the device's design and manufacturing is adherence to relevant standards and established engineering best practices.
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SECTION 5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
5. 510(k) Summary of safety and effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Acacia, Inc.785 Challenger StreetBrea, CA 92821(714) 257-0470Contact: Fergie Ferguson | NOV 10 2010 |
|---|---|---|
| DATE PREPARED: | September 13, 2010 | |
| TRADE NAME: | Blood Sampling Set | |
| COMMON NAME: | IV Extension Set | |
| CLASSIFICATION NAME: | Intravascular Administration Set | |
| DEVICE CLASSIFICATION: | Class II | |
| PRODUCT CODE | FPA | |
| PREDICATE DEVICES: | Elcam Medical Closed Swabable Stopcock and Minimal ResidualVolume Luer Activated Swabable Stopcock (K060231) |
Acacia IV Extension Set (K895367)
Substantially Equivalent To:
The Acacia, Inc. Blood Sampling Set is substantially equivalent in intended use, principal of operation and technological characteristics to the Elcam Medical Closed Swabable Stopcock and Minimal Residual Volume Luer Activated Swabable Stopcock (K060231) and Acacia IV Extension Set (K895367).
Description of the Device Subject to Premarket Notification:
The Blood Sampling Set consists of non-DEHP PVC tubing, and configured with one or more stopcocks with needleless valves, and a male luer lock for connection with the patients catheter. An optional configuration includes check valves, non-DEHP PVC tubing and transfer spike to allow for withdrawing flush solution from an IV bag into a syringe. All sets can be ordered with a choice of various on/off clamps, depending on the clinician's and hospital protocol.
The Blood Sampling Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.
Indications for Use:
The Blood Sampling Set is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Technical Characteristics:
The Blood Sampling Set has the same physical and technical characteristics to the predicate devices, since the proposed device integrates both of the predicate devices.
Biological Evaluation:
The materials used to manufacture the blood sampling set were originally evaluated and tested per ISO 10993 for the predicate Acacia IV Extension Set. None of the materials, manufacturing process, or sterilization process has changed since the testing was performed, therefore biocompatibility testing was leveraged from the previous 510(k) K895367. The following is a
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SECTION 5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
summary of testing performed on all of the materials used in the manufacture of the Acacia, Inc. predicate device:
Cyctotoxicity Sensitization Irritation/Intracutaneous Toxicity Systemic Toxicity Sub-chronic Toxicity Hemocompatibility Pyrogenicity
None of the materials, manufacturing process, or sterilization process has changed from the approval of the predicate Elcam device for distribution, therefore biocompatibility testing was leveraged from the previous 510(k) K060231.
Performance Data:
All necessary verification and validation testing has been performed for the Blood Sampling Set to assure substantial equivalence to the predicate devices.
The following tests were performed and met the acceptance criteria as outlined in ISO 8536-4:
Bond Joint Strength Fluid Flow Leak Testing Flow Rate Comparison (between proposed and predicate device)
Basis for Determination of Substantial Equivalence:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Blood Sampling Set is determined by Acacia, Inc., to be substantially equivalent to the existing tegally marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized emblem. The emblem features an abstract representation of a human figure with outstretched arms, symbolizing care and protection. The overall design is simple and conveys a sense of government authority and public service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ACACIA, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street, NW Buffalo, Minnesota 55313
NOV 1 0 2010
Re: K103165
Trade/Device Name: Acacia Blood Sampling Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 26, 2010 Received: October 27, 2010
Dear Mr. Job:
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, forvever, 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 1 addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Mr. Job
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Punrer
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
510(k) Number (if known): _ K | O 3 | ك
Device Name: Acacia Blood Sampling Set
NOV 1 0 2010
Indications for Use:
The Blood Sampling Set is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Division Sign-Off)
vision of Anesthesiology, General Hospital
rection Control, Dental Devices
| 10(k) Number: | K103165 |
|---|---|
| --------------- | --------- |
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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.