(60 days)
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Not Found
No
The summary describes a simple mechanical device (aspiration needle) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technology.
No
The device, an aspiration needle, is used to inject or retract fluids, which are diagnostic or procedural functions rather than therapeutic ones.
No
The device is described as an "aspiration needle to attach to a syringe to inject fluids into, or retract fluids from the body." This functionality is for therapeutic or procedural purposes (injecting/retracting fluids), not for diagnosing a condition or disease.
No
The intended use describes a physical aspiration needle, which is a hardware device. There is no mention of software in the provided text.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "Single use disposable aspiration needle to attach to a syringe to inject fluids into, or retract fluids from the body." This describes a device used for direct interaction with the body (injecting or withdrawing fluids), which is a characteristic of a medical device used in vivo (within a living organism).
- Lack of IVD Characteristics: IVDs are typically used to examine specimens outside the body (in vitro) to provide information about a patient's health. The description doesn't mention any analysis of samples or diagnostic testing.
Therefore, based on the provided information, this device falls under the category of a general medical device used for fluid management in vivo, not an IVD.
N/A
Intended Use / Indications for Use
"Single use disposable aspiration needle to attach to a syringe to inject fluids into, or retract fluids from the body"
Product codes
FMF
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
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
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Image /page/0/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle-like symbol with three profiles facing right, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the symbol.
AUG - 7 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas L. Parker Directory of Regulatory Affairs MINRAD, Inc. 6576 East Quaker Street Orchard Park, New York 14127
Re: K982018
Trade Name: Light Saber™ Aspiration Needle Regulatory Class: II Product Code: FMF Dated: May 30, 1998 Received: June 8, 1998
Dear Mr. Parker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Thomas L. Parker
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
-Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Kagzoig
Page 12
SECTION 5
INDICATIONS FOR USE
LIGHT SABER ASPIRATION NEEDLE
"Single use disposable aspiration needle to attach to a syringe to inject fluids into, or retract fluids from the body"
A Prescription Use . (Per 21 CFR 801.109)
basello
198201