(241 days)
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No
The provided text describes a phlebotomy device with a powered needle retraction feature and does not mention any AI or ML capabilities.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used for phlebotomy procedures, which involve collecting blood, and is not described as treating or preventing any condition.
No
The primary purpose of the device, as described, is for blood collection during phlebotomy procedures with a safety feature for needle retraction, not for detecting or identifying a medical condition or disease.
No
The intended use and description clearly indicate a physical device with a powered needle retraction feature, which is a hardware component.
Based on the provided information, the ExtreSafe™ Phlebotomy device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in the process of collecting blood (phlebotomy) using vacuum tubes and a safety feature for needle retraction. This is a procedure performed on a patient to obtain a sample, not a test performed on a sample in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of substances, diagnosis of conditions, or any other activity typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The ExtreSafe™ Phlebotomy device is a tool used to collect the specimen, not to analyze it.
N/A
Intended Use / Indications for Use
The ExtreSafe™ Phlebotomy device is intended to be used in phlebotomy procedures using vacuum blood collection tubes. A powered needle retraction feature provided a shield for the necure f 11 following use.
Product codes
FMI
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).
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other. The symbol is rendered in a dark color, contrasting with the white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Mr. William E. McKay Specialized Health Products, Incorporated C/O RCMDI 9721 S. Altamont Drive Sandy, Utah 06066
K964042 Re : ﻪ ﮐ Trade Name: Extresafe™ Phlebotomy Requlatory Class: II Product Code: FMI Dated: April 21, 1997 Received: April 23, 1997
Dear Mr. McKay:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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.
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Page 2 - Mr. McKay
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 leqally 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) 594-4618. 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) 63842041 or at (301) 443-6597.
Sincerely yours,
K. Childress
Timothy K. Ulatowski Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page _ 1 _of _ 1 _
510(k) Number (if known K 964042
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
- ** The ExtreSafe™ Phlebotomy device is intended to be used in phlebotomy procedures using vacuum blood collection tubes. A powered needle retraction feature provided a shield for the necure
f 11 following use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Patricia Cossette
Division of Dental, Infection Control, Concurrence of CDRH, Office of Device Evaluation (ODE)
and General Hospital Devices
| 510(k) Number | K914042 |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) | ✓ OR Over-The Counter Use ______ |
(Optinal Format 1-2-96)