(98 days)
Not Found
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 device description is for a simple auto-injector.
Yes
The device is intended for self-injection of Insulin, which is a therapeutic intervention.
No
The device is described as an Auto Injector for self-injection of Insulin, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states "Auto Injector Pro-Ject 2000," which is a hardware device for injecting insulin. The summary does not mention any software component as the primary or sole function.
Based on the provided information, the Pro-Ject 2000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "self-injection of Insulin." This describes a device used to administer a substance into the body, not to perform tests on samples taken from the body.
- Device Description: The device is described as an "Auto Injector." This further supports its function as a delivery mechanism, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Analyzing biomarkers or other substances in samples
- Providing diagnostic information based on sample analysis
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. The Pro-Ject 2000's function is to deliver medication, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
The Pro-Ject 2000 is indicted for self-injection of Insulin
Product codes
KZH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-injection
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1998
Mr. John D'Angelo ·Chariman Mighty Mo, Corporation 150 2nd Avenue North, Suite 920 St. Petersburg, Florida 33701
Re : K981266 Trade Name: Auto-Injector, Sure-Inject 2000™ Regulatory Class: II Product Code: KZH Dated: May 8, 1998 Received: May 20, 1998
Dear Mr. D'Angelo:
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 legally marketed predicate 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 qeneral 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. ਰੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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
1
Page 2 - Mr. D'Angelo
through 542 of the Act for devices under the Electronic enrough 312 or chotrol provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro 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"(21CFR 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/dsma/dsmamajn.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page _________________________________________________________________________________________________________________________________________________________________________ of __
)510(k) Number (if known): K 981266
Device Name: Auto Injector Pro-Ject 2000
Indications For Use:
510 K # :K 981266
"Indications For Use"
The Pro-Ject 2000 is indicted for self-injection of Insulin
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patua Crescente
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K981266
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)