(43 days)
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No
The summary describes a mechanical device with a shield mechanism and does not mention any AI or ML components or functionalities.
No
The device is a fistula needle used to provide access to a patient's blood for hemodialysis or plasmapheresis. Its primary function is to connect the patient to a machine, and its protective shield reduces needlesticks, which are mechanical functions rather than a direct therapeutic intervention.
No
The 'Intended Use / Indications for Use' section states that the device is "part of the hemodialysis system that connects patients to the machine and provides access to patient's blood" and is "also used in plasmapheresis for the same purpose." Its primary function is to facilitate blood access, not to diagnose a condition. The protection mechanism is for safety, not diagnosis.
No
The device description clearly states it is a "Fistula Needle" with a "shield," indicating a physical, hardware-based medical device.
Based on the provided information, the Shelly Protected Fistula Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is part of a hemodialysis system that connects patients to a machine and provides access to the patient's blood. It is also used in plasmapheresis for the same purpose. This describes a device used for accessing and manipulating blood within the body, not for testing or analyzing samples in vitro (outside the body).
- Device Description: The description focuses on the physical mechanism of the needle and its protective shield, which is relevant to its function in accessing blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze blood or other biological samples to provide diagnostic information. IVDs are typically used to detect, measure, or identify substances or characteristics in samples to diagnose, monitor, or screen for diseases or conditions.
Therefore, the Shelly Protected Fistula Needle is a medical device used for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Shelly Protected Fistula Needle is part of the hemodialysis system that connects patients to the machine and provides access to patient's blood, It is also used in plasmapheresis for the same purpose. Shelly Protected Fistula Needle has a shield that when activated enclose the needle. This mechanism is intended to reduce the incidence of accidental needlesticks.
Product codes
FPA
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 880.5440 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles three overlapping eagles in flight. The eagles are depicted with curved lines to represent their wings and bodies.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1999
Ms. Monica Abeles President Diasol Inc. 13212 Raymer Street North Hollywood, CA 91605
Re : K993187 Shelly Protected AV Fistula Needle Set Trade Name: Requlatory Class: II Product Code: FPA September 23, 1999 Dated: Received: September 23, 1999
Dear Ms. Abeles:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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
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Page 2 - Ms. Abeles
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.
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) 594-4692. 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 requlation entitled, "Misbranding by reference to oremarket 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,
Timc hy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K993187/Al
INDICATIONS FOR USE
510(k) Number: K993187 Device Name: Shelly Protected AV Fistula Needle
Indications for Use: Shelly Protected Fistula Needle is part of the hemodialysis system that connects patients to the machine and provides access to patient's blood, It is also used in plasmapheresis for the same purpose. Shelly Protected Fistula Needle has a shield that when activated enclose the needle. This mechanism is intended to reduce the incidence of accidental needlesticks.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use r (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
Patricio Giacerich
(Division Sign-Off) (Division of Dental, Infection Con and General Hospital Devi 510(k) Number