(72 days)
The Dragon Heart Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.
The syringe has a graduated barrel, a plunger, a hub and a needle.
I apologize, but the provided text from the FDA 510(k) clearance letter for the Dragon Heart Piston Syringe does not contain the information needed to answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.
This document is a clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It does not typically include the detailed technical study reports or performance data that would address your specific questions about acceptance criteria and study methodologies.
To obtain that information, you would generally need to refer to the full 510(k) submission document, which is not provided here.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2004
Dragon Heart Medical Device Company Limited C/O Ms. Jina Yu President Dragon Heart Medical, Incorporated 188 Industrial Drive, Suite 108 Elmhurst, Illinois 60126
Re: K042547
Trade/Device Name: Dragon Heart Piston Syringe Regulation Number: Piston Syringe Regulation Name: 880.5860 Regulatory Class: II Product Code: FMF Dated: September 15, 2004 Received: September 20, 2004
Dear Ms. Yu:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becales been be is substantially equivalent (for the relerenced above and nave determined are to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale conmisee pror to that have been reclassified in accordance with the provisions of Amendinents, or to devroos that have a act (Act) that do not require approval of a premarket the rederal I vou, Drug, und Commons , therefore, market the device, subject to the general approval appreation (1171). The general controls provisions of the Act include Controls provisions of the vistration, 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 If your device is chasined (see as over additional controls. Existing major regulations affecting ( (FMA), it may be subject to have adam f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sous nouncements 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 Please be advised that I DA 3 issualled or a bases on plies with other requirements meall that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and regaratents, including, but not limited to: registration You music colliply with an the Fect 5 requirements (art 801); good manufacturing practice and listing (21 CFK Pat 807), laooling (21 CFR Pat 820); and if and 820); and if requirements as set forth in the quality systems (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) I his letter will anow you to begin malicomig your ence of your device to a premarket notification. The PDF maining or obsision 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), If you desire specific advice to: your de at (240) 276-0115. Also, please note the regulation in please contact the Office or Comphanes are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general mionnation in the mational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Anthony D. Watson for
Charles R. Byrd
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.
510(k) Piston syringes Submission Application
Statement of Indications for Use
510(k) Number :
Device Name: Dragon Heart Piston Syringe
Intended Use:
The Dragon Heart Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.
Prescription Use v (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ and/or (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)
Anthen D. m
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: JEPY 2547
Dragonheart Ver: 1/0
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§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).