(880 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the mechanical function of the device.
No.
The device is an automatic injection device for insulin and needle withdrawal, which is not considered a therapeutic device. It delivers medication (which is therapeutic), but the device itself is a delivery mechanism, not a therapy.
No
Explanation: The device is described as an automatic injection device with a cooling mechanism for insulin injection and needle withdrawal. Its purpose is to administer a substance (insulin), not to diagnose a condition or disease.
No
The device description explicitly states it is an "automatic injection device with a cooling mechanism," which are hardware components.
Based on the provided information, the Easy-Ject device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for insulin injection and needle withdrawal." This describes a device used for administering a substance into the body, not for examining specimens taken from the body (which is the core function of an IVD).
- Device Description: The description "automatic injection device with a cooling mechanism" further reinforces its function as an injection device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information based on sample analysis
Therefore, the Easy-Ject device falls under the category of a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Easy-Ject device is an automatic injection device with a cooling mechanism, for insulin injection and needle withdrawal.
Product codes (comma separated list FDA assigned to the subject device)
KLZ
Device Description
The Easy-Ject device is an automatic injection device with a cooling mechanism, for insulin injection and needle withdrawal.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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 a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
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
1
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
2
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.
(PLEASE DO NOT WRITE BELOW THIS IJINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 _