(609 days)
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No
The summary describes a single-use, sterile device for blood pheresis used with a hemodialysis machine. There are no mentions of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
No.
The device is used in conjunction with a hemo-dialysis machine for blood pheresis, implying it's a component or accessory rather than a standalone therapeutic device that directly treats a condition. It facilitates a medical procedure but doesn't independently exert a therapeutic effect.
No
The device description states it is used "IN CONJUNCTION WITH A HEMO-DIALYSIS MACHINE FOR BLOOD PHERESIS." Blood pheresis is a treatment, not a diagnostic procedure. The information provided does not suggest the device is used to detect, diagnose, or monitor a disease or condition.
No
The device description explicitly states "EXEL SINGLE NEEDLE AVF," which is a physical medical device (a needle) used in conjunction with a hemodialysis machine. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "IN CONJUNCTION WITH A HEMO-DIALISIS MACHINE FOR BLOOD PHERESIS." This describes a procedure performed on the patient's blood outside the body, but it's a therapeutic procedure (blood pheresis) and not a diagnostic test performed on a sample to gain information about a patient's health status.
- Device Description: "EXEL SINGLE NEEDLE AVF" further supports this. An AVF (Arteriovenous Fistula) is a surgical connection created for hemodialysis access. A single needle AVF is a type of access used for this procedure.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.) to detect or measure specific substances.
- Providing information for diagnosis, monitoring, or screening.
- Using reagents or assays.
In summary, this device is a component used in a therapeutic procedure (blood pheresis during hemodialysis) and does not perform a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
THIS DEVICE IS USED IN CONJUNCTION WITH A HEMO-DIALISIS MACHINE FOR BLOOD PHERESIS. THIS DEVICE IS A STERILE, SINCLE USE DEVICE.
Product codes
78 LBW
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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§ 880.5570 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
Image /page/0/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH &" are written vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 5 1008
Mr. Armand Hamid Exel International, Inc. P.O. Box 3194 Culver City, CA 90231-3194 Re: K963658
Excel AVF Single Needle for Blood Pheresis Dated: March 9, 1998 Received: March 23, 1998 Regulatory Class: II 21 CFR & 876.5540/Procode: 78 LBW
Dear Mr. Hamid:
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 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 requirements, as set forth in the Quality System Regulation (QS) 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 vou might have under sections 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) 594-4613. 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/dsmaldsmam.html".
Sincerely yours
Lillian Yin, Ph.D.
Director. Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page J
510(k) Number (if known): x963658
Device Name: EXEL SINGLE NEEDLE AVF
Indications For Use:
THIS DEVICE IS USED IN CONJUNCTION WITH A HEMO-DIALISIS MACHINE FOR BLOOD PHERESIS. THIS DEVICE IS A STERILE, SINCLE USE DEVICE.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter R. Salling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963658
Prescription Use U (Per 21 CFR 801.109)
ರಿನ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)