(33 days)
Not Found
Not Found
No
The description focuses on a mechanical injection device and does not mention any AI/ML components or functionalities.
Yes
The device is intended for the subcutaneous injection of Insulin and other approved drugs to aid and support compliance with a recommended treatment regime, which directly relates to therapy.
No
The device is described as a hand-held mechanical device for the subcutaneous injection of insulin and other approved drugs. Its purpose is to administer medication, not to diagnose a condition.
No
The device is described as a "hand-held mechanical device" and a "mechanical injection device," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous injection of Insulin and other approved drugs. This is a therapeutic action, delivering a substance into the body.
- Device Description: It's described as a mechanical injection device. This further reinforces its function as a delivery system.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
The device is clearly intended for administering medication, which falls under the category of a therapeutic or drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A general purpose hand-held mechanical device intended for the subcutaneous injection of Insulin and other approved drugs. The device is designed for use with disposable Iml non-fixed needle syringe and to accommodate self use in the home by the patient in order to aid and support compliance with the recommended treatment regime,
Product codes (comma separated list FDA assigned to the subject device)
KZH
Device Description
A hand-held general purpose mechanical injection device for the sub-cutaneous injection of Insulin and other approved medicines.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sub-cutaneous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self use in the home by the patient
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
NON-CLINICAL TRIAL DATA.
The correspondence included in section 9 of this submission, referencing the study carried out in Australia, clearly indicates the success of the device when used in the application of the medicament
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Autoject ®2 (Fixed Needle type)
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 1 0 1999
AUTOJECT ®2 NON-FIXED NEED Is
10. 510K) SUMMARY
Submitted by:
Robert Shaw Director/ Vice President Owen Mumford Incorporated 849 Pickens Industrial Drive Suite 14 Marietta GA 30062
Tel: 770 425 5138
Device Name: Substantial Equivalence: Classification Name:
Autoject .2 (Non-Fixed Needle type) Autoject ®2 (Fixed Needle type) Syringe Needle Introducer
Owen Mumford have successfully been marketing the Autoject® 2 device throughout the world for several years. The Autoject ®2 (Non-Fixed Needle type) is simply a member of the same family of devices. The product has been widely accepted as an excellent medium for the administration of drugs via automatic injection throughout the EEC, Israel, Canada and Australia
. ..
1
510(K) SUBMISSION AUTOJECT® 2 NON-FIXED NEEDLE
10. 510(K) SUMMARY
DESCRIPTION
A hand-held general purpose mechanical injection device for the sub-cutaneous injection of Insulin and other approved medicines.
The Autoject® 2 (Non-fixed Needle type) is visually identical to and has the same area of intended use i.e. for the sub-cutaneous injection of medicament, as the current 510(K) approved Autoject® 2 (Fixed Needle type) device to which substantial equivalence is claimed. The firing mechanisms of both devices are identical, the only difference being the design changes necessary for the syringe housing to accommodate and make safe the use of Non-Fixed needle type syringe,
INTENDED USE
Both the Autoject 62 (Non-Fixed Needle type) and the Autoject® 2 (Fixed Needle type) devices are intended for the sub-cutaneous injection of drug treatments.
OPERATIONAL
The principle, design concepts and applications of the Autoject 62 (Non-Fixed Needle type) and the Autoject 02 (Fixed Needle type) devices are substantially equivalent.
PERFORMANCE
Performance of both devices is substantially equivalent, the difference in ability to empty the contents of the syringe is due to the limitations of the type of syringe, i.e. Fixed or Non-fixed needle syringes. Due to a small amount of residual drug being left in the space between the syringe and the needle hub the dose accuracy results show a slightly lower level of performance. However, if this residue is taken into account the performance of both types of devices are extremely close,
NON-CLINICAL TRIAL DATA.
The correspondence included in section 9 of this submission, referencing the study carried out in Australia, clearly indicates the success of the device when used in the application of the medicament
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1999
Mr. Robert Shaw Director Owen Mumford, Incorporated 849 Pickens Industrial Drive Suite 14 Marietta, Georgia 30062-3165
Re: K993385
Autojet®2 (Non-Fixed Needle type) Syringe Trade Name: Needle Introducer II Requlatory Class: Product Code: KZH September 24, 1999 Dated: Received: October 8, 1999
Dear Mr. Shaw:
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, Druq, 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 aqainst 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
3
Page 2 - Mr. Shaw
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.
This letter will allow you to begin marketinq 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 diaqnostic 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K993385
Device Name: Autoject 2, Non-fixed Needle
Indications For Use:
A general purpose hand-held mechanical device intended for the subcutaneous injection of Insulin and other approved drugs. The device is designed for use with disposable Iml non-fixed needle syringe and to accommodate self use in the home by the patient in order to aid and support compliance with the recommended treatment regime,
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of the CDRH,Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Patraux OR Vincenti 0
Division Sinn-Off n of Dental, Infection Control, al Hospits 510(k) Numbe
Over-The-Counter Use
(Optional Formal 1-2-96)