(880 days)
The Easy-Ject device is an automatic injection device with a cooling mechanism, for insulin injection and needle withdrawal.
automatic injection device with a cooling mechanism
Information about acceptance criteria and a study proving a device meets them is not available in the provided document.
The document is a 510(k) clearance letter from the FDA for the "Easy-Ject Device," an automatic injector with a cooling mechanism for insulin injection and needle withdrawal. It confirms the device's substantial equivalence to a predicate device and allows it to be marketed.
The FDA letter and the "Indications for Use Statement" do not contain:
- A table of acceptance criteria or reported device performance.
- Details about a study, sample sizes, data provenance, expert qualifications, or adjudication methods for establishing ground truth.
- Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on training set size or how ground truth was established for a training set.
The document focuses on the regulatory clearance process based on substantial equivalence, not on a detailed performance study against specific acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1999
A. Stein - Requlatory Affairs Consulting c/o Ahava Stein Requlatory Affairs Consultant for Mali-Tech Ltd. P.O.B. 454 Ginot Shomrom, 44853 Israel
K972383 Re : Easy-Ject Device Trade Name: Requlatory Class: II KLZ Product Code: Dated: August 20, 1999 August 30, 1999 Received:
Dear Ms. Stein:
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. A 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 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
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Page 2 - Ms. Stein
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 yitro 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 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,
Tim A. McIntosh
Timothy 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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A STEIN
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): K972383_______________________________________________________________________________________________________________________________________
Device Name: _Easy-Ject Automatic Injector Device
Indications for use:
The Easy-Ject device is an automatic injection device with a cooling mechanism, for insulin injection and needle withdrawal.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. 801.109)
ﺴﮧ ﺳﮯ ﺳﮯ ﺳ
OR
Over-The-Counter Use (Optional Format 1-2-96)
Patara Cucente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
§ 874.3850 Endolymphatic shunt tube with valve.
(a)
Identification. An endolymphatic shunt tube with valve is a device that consists of a pressure-limiting valve associated with a tube intended to be implanted in the inner ear to relieve symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in endolymphatic fluid) of Meniere's disease.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document “Class II Special Controls Guidance Document: Endolymphatic Shunt Tube With Valve; Guidance for Industry and FDA.”