(206 days)
K944425, Sanofi-Winthrop Injector - Pre-amendment
Not Found
No
The description focuses on the mechanical function of a needle guard and injector, with no mention of AI or ML capabilities.
No
This device is an injector designed to deliver medication, but it does not directly treat or diagnose a medical condition itself. Its primary function is a delivery mechanism, not a therapeutic agent.
No
This device is designed to administer medication and protect against needle sticks, not to diagnose a medical condition.
No
The device description clearly indicates it is a physical injector made of K-Resin and ABS Resin, designed to hold a medication cartridge and deliver medication. It also includes a physical needle guard. There is no mention of software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to hold a medication cartridge and administer an injection into the patient's tissues. It also focuses on protecting the user from needle sticks.
- Device Description: The description reinforces its function as an injector for delivering medication and its safety features for needle disposal.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze these specimens. This device is used in vivo (within the body) to deliver medication.
Therefore, the UltraSafe® Model C200 Injector with Needle Guard is a medical device used for drug delivery and safety, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UltraSafe® Model C200 Injector with Needle Guard is designed to hold a sterile medication cartridge with needle in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit.
The UltraSafe® Model C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for a wide range of clinical conditions.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The UltraSafe® Model C200 Injector with Needle Guard is a product which is intended to be used with a sterile medication cartridge with needle to deliver medication from the cartridge into the tissues of the patient. The device is totally disposable and is equipped with a needle shield which consists of a safety guard that can be snapped into place after use of a syringe, thus protecting the caregiver by eliminating the need to recap the needle, and minimizing accidental needle stick injuries during disposal of the syringe/needle
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
The UltraSafe® Model C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for a wide range of clinical conditions.
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Model ( 200 needle guard has been tested and found to have considerably greater strength than the predicate device. The C200 Injector is as easy to assemble and use as the Sanofi-Winthrop Injector.
With the Mode! C200 needle guard in the "ready-to-use" position, it provides the same useable needle length as an unquarded needle. The user can perform typical hypodermic procedures equivalently to standard, unguarded needles.
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.
K944425, Sanofi-Winthrop Injector - Pre-amendment
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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
FEB 26 1998
510(k) Premarket Notification UltraSafe® Injection System Model C200 Injector with Needle Guard
9.0 Summary of Safety and Effectiveness
Safety Syringes Contact Person .1
David Mitchell Safety Syringes, Inc. 250 West Colorado Blvd. Suite # 101 Arcadia, CA 91007 (626) 821.1121 Phone (626) 821.1009 Fax
9.2 Device Name
UltraSafe® Injection System, Model C200 Injector with Needle Guard
9.3 Predicate Devices
Safety Syringes UltraSafe® Aspirating Syringe - K944425 Sanofi-Winthrop Injector - Pre-amendment
Product Description and Function 9.4
The UltraSafe® Model C200 Injector with Needle Guard is a product which is intended to be used with a sterile medication cartridge with needle to deliver medication from the cartridge into the tissues of the patient. The device is totally disposable and is equipped with a needle shield which consists of a safety guard that can be snapped into place after use of a syringe, thus protecting the caregiver by eliminating the need to recap the needle, and minimizing accidental needle stick injuries during disposal of the syringe/needle
9.5 Comparison to Predicate Devices/Equivalence
Descriptive Comparison to Legally Marketed Devices Model C200 Injectors with Needle Guard are intended to be used to deliver medication from a cartridge. The guard
Safety Syringes, Inc. UltraSafe C200 Injector 510(k) Submission
1
requires a two-handed action in order to cover the needle point after use.
The Model ( 200 needle guard has been tested and found to have considerably greater strength than the predicate device. The C200 Injector is as easy to assemble and use as the Sanofi-Winthrop Injector.
With the Mode! C200 needle guard in the "ready-to-use" position, it provides the same useable needle length as an unquarded needle. The user can perform typical hypodermic procedures equivalently to standard, unguarded needles.
9.6 Comparison of Materials
The UltraSate® Injection System, Model C200 Injector is made of K-Resin KR01, KR03, and ABS Resin which are the same materials as the Safety Syringes predicate device.
Safety and Efficacy Information 9.7
Biocompatibility:
The UltraSafe® Injection System, Model C200 Injector uses the same materials as the Safety Syringes predicate device. The materials have passed biocompatibility tests.
Labeled Warning Statements:
Hands must remain behind the needle at all times during use and disposal.
Safety Syringes, Inc. UltraSafe C200 Injector 510(k) Submission
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 stylized eagle with three lines representing its body and wings. The eagle's head is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 26 1998
Mr. Anthony R. Perez CEO & President Safety Syringes, Incorporated 250 West Colorado Boulevard, Suite 101 Arcadia, California 91007
K972877 Re : UltraSafe® Injection System Model C200 Trade Name: Injector with Needle Guard Regulatory Class: II Product Code: FMF Dated: January 6, 1998 Received: January 7, 1998
Dear Mr. Perez:
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 qeneral 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 Requlations, Title 21, Parts 800 to 895. And ----------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Perez
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 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) 594-4618. 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 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,
K. Whitworth
Ohy 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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1 Page 1 of
510(k) Number (if known): K972877
UltraSafe® Injection System Model C200 Injector With Needle Guard Device Name:
Indications For Use:
The UltraSafe® Model C200 Injector with Needle Guard is designed to hold a sterile medication cartridge with needle in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit.
The UltraSafe® Model C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for a wide range of clinical conditions.
Patricio Cucumita
(Division Sign-Off) (Division of Dinal, Infection Control, and General Trospital Devices 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)