(179 days)
The Digi-Injector is indicated for use as a general purpose injector of fluids It is to be used with single-use, disposable needles of any gauge size. It is to be used wherever precise control of injection rate or volume is required. The Digi-Injector is also indicated for use for injection of fluids (high or low viscosity) during ophthalmic surgery.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, any specific study, sample sizes, expert involvement, or ground truth establishment.
The document is a FDA 510(k) clearance letter for a device called "Digi-Injector." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It also includes the "Indications for Use" for the device.
However, a 510(k) clearance typically involves a demonstration of substantial equivalence, which often relies on comparison to a predicate device rather than presenting detailed performance data from a standalone study with specific acceptance criteria as requested in your prompt. The letter itself does not contain the specifics of any performance study that would establish acceptance criteria.
Therefore, I cannot fill out the requested table or answer any of the questions related to the study design, sample size, or ground truth.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 1997
Mr. Julian M. Cortella Sr. Mechanical Engineer Medical Instrument Development Laboratories, Inc. 14477 Catalina St. San Leandro, CA 94577
Re: K971067 Trade Name: Digi-Injector Regulatory Class: II Product Code: 86 MRH Dated: April 28, 1997 Received: May 5, 1997
Dear Mr. Cortella:
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 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 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 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. Julian M. Cortella
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/dsmamain.html".
Sincerely yours,
A. Roerl. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
September 16, 1997
| 510(k) Number: | K971067 |
|---|---|
| Device Name: | Digi-Injector |
INDICATIONS FOR USE
The Digi-Injector is indicated for use as a general purpose injector of fluids It is to be used with single-use, disposable needles of any gauge size. It is to be used wherever precise control of injection rate or volume is required. The Digi-Injector is also indicated for use for injection of fluids (high or low viscosity) during ophthalmic surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Everett T Beelin
(Division Sign-Off) Division of Ophthalmic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).