(430 days)
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No
The 510(k) summary describes a mechanical safety syringe and contains no mention of AI, ML, or related concepts like image processing or data analysis.
No
The device is a syringe, which is used to administer substances (e.g., medication) for therapeutic purposes, but it is not itself a therapeutic device. Its primary function is delivery and safety, not therapy.
No
The provided text describes the Perfect Safety Syringe as a device for "IM/SC use only" with features for needlestick protection and prevention of reuse. There is no mention of it being used to identify or analyze diseases or conditions, which are characteristics of a diagnostic device.
No
The 510(k) summary describes a "Perfect Safety Syringe," which is a physical medical device (syringe) with features for safety and reuse prevention. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "for IM/SC use only" (intramuscular/subcutaneous injection) and for "needlestick protection" and "prevention of reuse". These are all related to administering substances into the body and preventing injury, not to testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention anything about:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in those samples.
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
The Perfect Safety Syringe is a medical device designed for drug delivery and safety during injection, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The primary intended use for the Perfect Safety Syringe is for IM/SC use only. The secondary intended use for the Perfect Safety Syringe is for needlestick protection, the device may aid in the reduction of needlestick injuries. In addition, when the syringe user breaks off the plunger, reuse of the syringe is prevented.
Product codes
MEG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2004
Perfect Medical Industry Company Limited C/O Dr. Eric Luo Lodestar Products, Incorporated 6833 Saint Lawrence Street Plano, Texas 75024
Re: K030604
Trade/Device Name: Perfect Safety Syringe Regulation Number: 880.5860 Regulation Name: AntiStick Syringe Regulatory Class: II Product Code: MEG Dated: March 17, 2004 Received: March 19, 2004
Dear Dr. Luo:
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.
1
Page 2 - Dr. Luo
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 mean that I Dr mas may Federal statutes and regulations administered by other Federal agencies. or the Free of any I vith all the Act's requirements, including, but not limited to: registration r ou into comply with 807); labeling (21 CFR Part 801); good manufacturing practice and insting (x as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form 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) rine letet notification. The FDA finding of substantial equivalence of your device to a premaired predicated. - 11 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), 11 you deather the Office of Compliance at (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours.
Ching-Lin, Ph.D.
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
2
Indications for Use Statement
510(k) Number (if known): __ K030604
Device Name: Perfect Safety Syringe
Indications for Use:
The primary intended use for the Perfect Safety Syringe is for IM/SC use only. The secondary intended use for the Perfect Safety Syringe is for needlestick protection, the device may aid in the reduction of needlestick injuries. In addition, when the syringe user breaks off the plunger, reuse of the syringe is prevented.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-Thc-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)
Therese Nadeau for ADW 4/29/04
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
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