(99 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical safety needle and does not mention any AI or ML components or functionalities.
No.
The device is described as safety needles used for injecting/withdrawing fluids, and a safety shield, none of which explicitly describe a therapeutic function.
No
The device, "AutoSafe Safety Needles," is described as being used to inject or withdraw fluids from the body and to prevent needlestick injuries. There is no mention of it being used for diagnosis or to identify any condition.
No
The device description clearly indicates a physical medical device (safety needles) and does not mention any software component.
Based on the provided information, the AutoSafe Safety Needle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "inject fluids into or withdraw fluid from the body." This describes a device used for direct interaction with the patient's body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to examine specimens derived from the human body to provide information for clinical purposes. The AutoSafe Safety Needle is a device used for administering or collecting substances directly from the body.
N/A
Intended Use / Indications for Use
AutoSafe Safety Needles are indicated to be used to inject fluids into or withdraw fluid from the body. They are compatible for use with standard luer slip and luer lock syringes. Additionally, the passive needle safety shield is designed to help prevent needlestick injuries by shielding the needle before use, between steps and after use.
Product codes
FMI
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
Public Health Service
SEP 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Autosafe-Reflex, Incorporated C/O Mr. J A. Van Vugt Responsible Third Party Official Kema Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914
Re: K071567
Trade/Device Name: AutoSafe-Reflex® Safety Needle, AutoSafe Advantage Safety Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 30, 2007 Received: August 31, 2007
Dear Mr. Van Vugt:
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 - Mr. Van Vugt
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 yours,
Chiu-Yue, 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
K$\phi$7/567
Indications for Use
510(k) Number (if known):
Unknown
Device Name:
AutoSafe-Reflex® Safety Needle
Indications for Use:
AutoSafe Safety Needles are indicated to be used to inject fluids into or withdraw fluid from the body. They are compatible for use with standard luer slip and luer lock syringes. Additionally, the passive needle safety shield is designed to help prevent needlestick injuries by shielding the needle before use, between steps and after use.
Prescription Use X (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)
Am
்லா Sign-Off) vision of Anesthesiology, General Hospital, Infection Control, Dental Devices
610(k) Number:_______________________________________________________________________________________________________________________________________________________________