(106 days)
The Dragon Heart Intravascular Administration Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Not Found
This looks like a 510(k) clearance letter for an Intravascular Administration Set, not a study describing the acceptance criteria and performance of a device, especially not one that would involve AI or expert readers.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval letter from the FDA stating that the "Dragon Heart Intravascular Administration Set" is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for marketing. It does not contain information about:
- A table of acceptance criteria and reported device performance.
- Sample size for a test set or data provenance.
- Number of experts or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study or human reader improvement.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
MAR 8 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dragon Heart Medical Devices Company Limited C/O Ms. Jina Yu President Dragon Heart Medical, Incorporated 188 Industrial Drive, Suite 108 Elmhurst, Illinois 60126
Re: K043235
Trade/Device Name: Dragon Heart Intravascular Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 24, 2005 Received: February 25, 2005
Dear Ms. Yu:
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, IDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -- Ms. Yu
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 (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. 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 vours.
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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Dragon Heart Medical Device Co., Ltd.
Intravascular Administration Set 510(k) Application
Statement of Indications for Use
510(k) Number : K043235
Device Name: Dragon Heart Intravascular Administration Set
Indications For Use:
The Dragon Heart Intravascular Administration Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
| Prescription Use(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)
Anton Bauer
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Dragon heart Ver: 1/0
§ 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.