(34 days)
Not Found
No
The device description and intended use focus on the physical components and function of an infusion set, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is an infusion set used to deliver substances (fluids, blood, drugs, contrast media) to the body, withdraw substances, and facilitate power injection. It is an accessory to infusion therapy and diagnostic procedures rather than a device that provides therapy itself.
No
This device is an infusion set used to deliver fluids, blood, or drugs, and for power injection of contrast media; it does not perform any diagnostic functions.
No
The device description clearly outlines physical components (female luer lock, tubing, clamp, male luer lock/Huber needle) and mentions it is a sterile, single-use, disposable device, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "Infusion Set" used for delivering fluids, blood, blood products, drugs, and contrast media into the central venous system, or withdrawing fluids from it. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
- Lack of Diagnostic Purpose: The intended use and device description focus on the delivery and withdrawal of substances, not on analyzing samples to diagnose or monitor a condition.
Therefore, the Power Injectable Infusion Set is a medical device used for therapeutic and procedural purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Power Injectable Infusion Set with Huber Needle is indicated for:
- Use with implanted infusion ports for continuous or intermittent infusion therapy. .
- Infusion or withdrawal of IV fluids, blood, blood products, or drugs. .
- Use with ports that are indicated for power injection of contrast media into the central . venous system. For power injection of contrast media, the maximum recommended infusion rate is 5ml /sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles.
- Power injection of contrast media up to 325 PSI. .
The Power Injectable Infusion Set with male luer lock is indicated for:
- Use with central venous catheters for continuous or intermittent infusion therapy. .
- Infusion or withdrawal of IV fluids, blood, blood products, or drugs. ●
- Use with central venous catheters that are indicated for power injection of contrast media . into the central venous system.
- . Power injection of contrast media up to 325 PSI.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Power Injectable Infusion Set, consists of a female luer lock, non-DEHP PVC tubing, on/off clamp, and either a male luer lock for connection to female hub central venous catheters or Huber needle for insertion into implanted port catheters.
The Power Injectable Infusion Set will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
All necessary verification and validation testing has been performed for the Power Injectable Infusion Set to assure substantial equivalence to the predicate devices.
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
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: | MPS Acacia | APR 2 8 2009 |
|---|---|---|
| TRADE NAME: | Power Injectable Infusion Set | |
| COMMON NAME: | IV Extension Set | |
| CLASSIFICATION NAME: | Intravascular Administration Set | |
| DEVICE CLASSIFICATION: | Class II | |
| PRODUCT CODE | FPA | |
| PREDICATE DEVICES: | MPS Acacia Safeguard Huber Device (K032934) | |
| SafeStep Max Power Injectable Infusion Set (K073050) | ||
| Medegen Pressure Rated Extension Set (K083472) |
Substantially Equivalent To:
The MPS Acacia Power Injectable Infusion Set is substantially equivalent in intended use, principal of operation and technological characteristics to the MPS Acacia Safeguard Huber Needle Device (K032934), the SHPI SafeStep Max Power Injectable Infusion Set (K073050), and the Medegen Pressure Rated Extension Set (K083472).
Description of the Device Subject to Premarket Notification:
The Power Injectable Infusion Set, consists of a female luer lock, non-DEHP PVC tubing, on/off clamp, and either a male luer lock for connection to female hub central venous catheters or Huber needle for insertion into implanted port catheters.
The Power Injectable Infusion 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 Power Injectable Infusion Set with Huber Needle is indicated for:
- Use with implanted infusion ports for continuous or intermittent infusion therapy. .
- Infusion or withdrawal of IV fluids, blood, blood products, or drugs. .
- Use with ports that are indicated for power injection of contrast media into the central . venous system. For power injection of contrast media, the maximum recommended infusion rate is 5ml /sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles.
- Power injection of contrast media up to 325 PSI. .
The Power Injectable Infusion Set with male luer lock is indicated for:
- Use with central venous catheters for continuous or intermittent infusion therapy. .
- Infusion or withdrawal of IV fluids, blood, blood products, or drugs. ●
- Use with central venous catheters that are indicated for power injection of contrast media . into the central venous system.
- . Power injection of contrast media up to 325 PSI.
1
SECTION 5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Technical Characteristics:
The Power Injectable Infusion Set has similar physical and technical characteristics to the predicate devices.
Performance Data:
All necessary verification and validation testing has been performed for the Power Injectable Infusion Set to assure substantial equivalence to the predicate devices.
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 Power Injectable Infusion Set is determined by MPS Acacia, to be substantially equivalent to the existing legally marketed devices.
(050809
247
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered horizontally.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MPS Acacia C/o Mr. Mark Job Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
APR 2 8 2009
Re: K090809
Trade/Device Name: MPS Acacia Power Injectable Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 16, 2009 Received: April 20, 2009
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.
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.
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
3
Page 2- Mr. Job
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony D. Watson ber
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO90809
Device Name: MPS Acacia Power Injectable Infusion Set
Indications for Use:
The Power Injectable Infusion Set with Huber Needle is indicated for:
- Use with implanted infusion ports for continuous or intermittent infusion therapy. .
- Infusion or withdrawal of IV fluids, blood, blood products, or drugs.
- Use with ports that are indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5mL/sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles.
- Power injection of contrast media up to 325 PSI.
The Power Injectable Infusion Set with male luer lock is indicated for:
- Use with central venous catheters for continuous or intermittent infusion therapy. .
- Infusion or withdrawal of IV fluids, blood, blood products, or drugs. .
- Use with central venous catheters that are indicated for power injection of contrast media into the central venous system.
- Power injection of contrast media up to 325 PSI.
Prescription Use × (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)
signature
(Duision Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K090809 510(k) Number:
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