(135 days)
The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Administration Set is also intended for use with a peristaltic pump for IV purposes only.
The Promepla Intravascular administration and extension sets contain components that are commonly found in this category of IV sets. The IV Administration (pump tube) Set belongs to a full line of intravenous fluid delivery sets. It is an infusion set intended to deliver fluids, medications, blood and blood products, using continuous or intermittent delivery through clinically acceptable routes of administration (e.g. intravenous, intra-arterial, subcutaneous, epidural, enteral or irrigation of fluid spaces). An optional component, a flow controller allows the use with a peristaltic pump. The Extension Set device is a triple lumen peripheral set with two detachable long lines, belonging to a family of extension tubing sets. This device uses a main gravity drip line, plus the two long extension limbs. It is a connector system, which has anti free-flow valves and line clamps, which are common in intravascular extension sets on the market. The extension set allows IV fluids to be given simultaneously by way of the same connector. Both the IV Administration Set and Extension Set are provided sterile (by Eto) and are for single use only. They are intended only for use by trained professionals in a clinic or hospital environment.
This 510(k) submission (K071421) for the Promepla Intravascular Administration Set and Extension Set describes a conventional predicate device comparison and does not involve a study to prove the device meets acceptance criteria for an AI/ML powered device. The document is for a medical device that administers fluids and is not an AI/ML powered device.
Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert involvement, and MRMC studies for AI/ML devices is not applicable to this submission.
The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, materials, and conducted bench testing (implied, though not detailed in the provided snippets).
The relevant sections from the input that are applicable are:
- Device Trade Name: Promepla Intravascular Administration Set and Extension Set
- Intended Use: "The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Administration Set is also intended for use with a peristaltic pump for IV purposes only."
- Comparison to Predicate Devices: "Based upon the intended use, design, materials, and the testing conducted, it can be concluded the Promepla Intravascular Administration Set and Extension Set are substantially equivalent to the predicate devices."
Since this is a traditional 510(k) for a non-AI/ML device, the detailed questions about AI/ML specific study design are not applicable.
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Intravascular Administration Set and Extension Set Submitter: Traditional 510(k) Promepla 510(k) SUMMARY K071421 Submitter Name: Promepla ్రాలు 9 Avenue Prince Albert II Submitter Address: Monaco 98000 Contact Person: Patsy Trisler, J.D., RAC (US Agent) Phone Number: 301-652-5344 301-654-6976 Fax Number: Date Prepared: September 6, 2007 Device Trade Name: Intravascular Administration Set and Extension Set Device Common Name: Intravascular Administration Set Classification Number: 21 CFR 880.5440 Classification Name: Set, Administration, Intravascular Product Code: FPA K051499. Intravascular Administration Set and Extension Set. Medegen Predicate Devices: Medical Manufacturing Services K970255, KippMed I.V. Manifold, The Kipp Group The Intravascular Administration Set and Extension Set is a device used Statement of Intended to administer fluids from a container to a patient's vascular system Use: through a needle or cathefer inserted into the patient's artery or vein. The Administration Set is also intended for use with a peristaltic pump for IV purposes only. Device Description: The Promepla Intravascular administration and extension sets contain components that are commonly found in this category of IV sets. The IV Administration (pump tube) Set belongs to a full line of intravenous fluid delivery sets. It is an infusion set intended to deliver fluids, medications, blood and blood products, using continuous or intermittent delivery through clinically acceptable routes of administration (e.g. intravenous, intra-arterial, subcutaneous, epidural, enteral or irrigation of fluid spaces). An optional component, a flow controller allows the use with a peristaltic pump. The Extension Set device is a triple lumen peripheral set with two detachable long lines, belonging to a family of extension tubing sets. This device uses a main gravity drip line, plus the two long extension limbs. It is a connector system, which has anti free-flow valves and line clamps, which are common in intravascular extension sets on the market. The extension set allows IV fluids to be given simultaneously by way of the same connector. Both the IV Administration Set and Extension Set are provided sterile (by Eto) and are for single use only. They are intended only for use by trained professionals in a clinic or hospital environment. Comparison to the Based upon the intended use, design, materials, and the testing conducted, it can be concluded the Promepla Intravascular Predicate Devices: Administration Set and Extension Set are substantially equivalent to the predicate devices.
Section 5.0
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Promepla C/O Ms. Patsy J. Trisler, J.D., RAC Regulatory Consultant and US Agent 5600 Wisconsin Avenue, Suite 509 Chevy Chase, Maryland 20815
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Re: K071421
Trade/Device Name: Promepla Intravascular Administration Set and Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 6, 2007 Received: September 10, 2007
Dear Ms. Trisler:
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. Trisler
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clu C
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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510(k) Number (if known): K071421
Device Name:
Promepla Intravascular Administration Set and Extension Set
Indications for Use:
The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Administration Set is also intended for use with a peristaltic pump for IV purposes only.
Prescription Use _ ਮ (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Anten Dini
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.