(165 days)
Not Found
No
The device description focuses on a mechanical, spring-loaded mechanism for injection and explicitly states "Similar technology characteristics are found in various commercially marketed auto-injectors which operate on the same principle." There is no mention of AI, ML, or any computational processing beyond a simple mechanical function.
No.
The device is an auto-injector designed to assist in the delivery of drugs or biologics, not to provide therapy itself. The therapeutic effect comes from the drug or biologic injected, not the auto-injector.
No
The device is an auto-injector designed to assist in the self-administration of drugs or biologics, not to diagnose a medical condition.
No
The device description explicitly states it is made of "molded plastic parts and springs," indicating it is a physical hardware device, not software only.
Based on the provided information, the B-D® Auto-Injector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to assist in the injection of a drug or biologic into a patient. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically in a lab) diagnostic test.
- Device Description: The device is described as a "syringe needle introducer" that uses a spring-loaded mechanism to perform an injection. This aligns with drug delivery, not diagnostic testing.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The B-D® Auto-Injector's function is solely to facilitate the delivery of a therapeutic substance.
N/A
Intended Use / Indications for Use
The intended use is to provide to patients a safe, simple and easy subcutaneous injection system in order to self-administer injectable drugs or biologics.
The B-D® Auto-Iniector is intended to be used exclusively with drugs or biologics packaged in the HYPAK® cartridge system which contains a HYPAK® prefilled syringe. It is intended for use only with FDA approved drugs or biologics in dosages indicated in their labeling.
The B-D® Auto-Injector is indicated for assisting the injection of a fixed dose of an approved drug or biologic packaged in a HYPAK® Cartridge component which contains a HYPAK® syringe prefilled with the drug or biologic.
Product codes (comma separated list FDA assigned to the subject device)
KZH
Device Description
The B-D® Auto-Injector is a syringe needle introducer. Syringe needle introducers are devices that use a spring-loaded mechanism to perform an injection at a predetermined depth with an hypodermic needle.
The B-D® Auto-Injector is made of molded plastic parts and springs. Similar technology characteristics are found in various commercially marketed auto-injectors which operate on the same principle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The product has been tested in terms of biocompatibility and conforms to ISO standard 10993-1.
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.
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
Page 25 of 34
BECTON DICKINSON PHARMACEUTICAL SYSTEMS
MAY 2 9 1998
510(k) SUMMARY
Date of preparation: December 11, 1997
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
- REASON FOR 510(k): Introduction of a new product. A.
- B. NAME OF DEVICE:
- B-D® Auto-Injector · Proprietary name :
- Syringe needle introducer · Classification name :
- · Common or usual name : auto-injector
- Class II · Class :
General Hospital, Panel 80; Classification panel: Regulation Number 21 C.F.R § 880.6920
ESTABLISHMENT REGISTRATION NUMBER: D. 8023072
E. SUBMITTER'S NAME AND ADDRESS:
Becton Dickinson and Company Pharmaceutical Systems Division 1 Becton Drive Franklin Lakes, New Jersey 07417-1886
| Contact person: | Michael Gross, Ph.D. | |
|---|---|---|
| Tel : | 201-847-5930 | |
| Fax : | 201-847-4854 |
に MANUFACTURING FACILITIES:
Becton Dickinson France SA Pharmaceutical Systems Division BP4 38800 Le Pont-de-Claix, France Tel : 33 4 76 68 36 36 33 4 76 68 37 88 Fax : FDA Device Establishment Registration Number: 8023072
1
BECTON DICKINSON PHARMACEUTICAL SYSTEMS
Page 26 of 34
G. PERFORMANCE STANDARD(S) :
No performance standards applicable to syringe needle introducers or similar products have been promulgated under Section 514 of the Food, Drug and Cosmetic Act. The product has been tested in terms of biocompatibility and conforms to ISO standard 10993-1.
DEVICE DESCRIPTION AND INTENDED USE : H.
The intended use is to provide to patients a safe, simple and easy subcutaneous injection system in order to self-administer injectable drugs or biologics.
The B-D® Auto-Injector is a syringe needle introducer. Syringe needle introducers are devices that use a spring-loaded mechanism to perform an injection at a predetermined depth with an hypodermic needle.
The B-D® Auto-Iniector is intended to be used exclusively with drugs or biologics packaged in the HYPAK® cartridge system which contains a HYPAK® prefilled syringe. It is intended for use only with FDA approved drugs or biologics in dosages indicated in their labeling.
The B-D® Auto-Injector is made of molded plastic parts and springs. Similar technology characteristics are found in various commercially marketed auto-injectors which operate on the same principle.
ﻨﮯ ﺳﮯ SUBSTANTIAL EQUIVALENCE
The BD Auto-Injector is substantially equivalent to Ulster Scientific Inc.'s Diamatic "" autoinjector, (K860284) which was cleared by FDA in April 1986.
The term " substantial equivalence " as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Druq, and Cosmetic Act, as amended and as supplied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statement related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the court.
[END OF SUMMARY]
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 a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1998
Dr. Michael Gross, Ph.D. · Director, Corporate Regulatory Affairs Becton Dickinson and Company Pharmaceutical Systems Division One Becton Drive Franklin Lakes, New Jersey 07417-1886
Re : K974678 B-D® Auto-Injector Trade Name: Requlatory Class: II Product Code: KZH Dated: April 8, 1998 Received: April 9, 1998
Dear Dr. Gross:
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 general controls provisions of the Act. The general controls com 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. ਰੇ 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
3
Page 2 - Dr. Gross
through 542 of the Act for devices under the Electronic Product Radiation Control 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 regulation (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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Time thy 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):
Device Name:
Indications for Use:
The B-D® Auto-Injector is indicated for assisting the injection of a fixed dose of an approved drug or biologic packaged in a HYPAK® Cartridge component which contains a HYPAK® syringe prefilled with the drug or biologic.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use
(Per 21 CRF 801.109)
(Optional Format 1-2-96)
Palacio Queceritz
(Division Sign-Off) (Division of Dental, Infection Control, Divisioneral Hospital Devices 510(k) Number _