(43 days)
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.
Shelly Protected Fistula Needle has a shield that when activated enclose the needle.
This document is a 510(k) clearance letter from the FDA for a medical device called the "Shelly Protected AV Fistula Needle Set." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML or diagnostic device. The letter is a regulatory approval, not a scientific or clinical study report. Therefore, I cannot extract the requested information.
The document primarily focuses on:
- Device Identification: Shelly Protected AV Fistula Needle Set
- Regulatory Clearance: 510(k) clearance, indicating substantial equivalence to a predicate device.
- Indications for Use: Describing the device's purpose in hemodialysis and plasmapheresis, and its safety mechanism for preventing needlesticks.
- Regulatory Compliance: Mentioning general controls and good manufacturing practices.
There is no mention of:
- Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
- Any performance study results (e.g., test set sample size, data provenance, expert ground truth, adjudication methods).
- AI/ML components or comparative effectiveness studies with human readers.
- Training set details.
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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
§ 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.