(15 days)
Not Found
No
The device is a mechanical safety mechanism for syringes and the summary contains no mention of AI or ML.
No.
The device is a safety mechanism designed to prevent accidental needlesticks during the disposal of used syringes, not to treat a medical condition or restore health.
No
Explanation: The device is a needle guard designed to prevent accidental needlesticks during syringe disposal, not to diagnose medical conditions. Its function is purely protective and mechanical in nature.
No
The device description clearly indicates a physical, mechanical device ("snapped onto the barrel," "passively activates and covers the exposed needle"). There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a safety mechanism to reduce accidental needlesticks during the disposal of a used syringe and needle assembly. This is a physical safety function, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is described as an accessory for pre-filled glass syringes, designed to cover the needle after injection. This aligns with its safety function.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on safety, performance, and usability in a simulated clinical setting, not on the accuracy or reliability of a diagnostic result.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device's purpose is solely to enhance safety during the disposal of used needles.
N/A
Intended Use / Indications for Use
The UltraSafe Passive™, X-Series, Needle Guard is intended for use as a safety mechanism designed to reduce the occurrence of accidental needlesticks to healthcare professionals during disposal of a used syringe and needle assembly. The UltraSafe Passive, X-Series, Needle Guard is snapped onto the barrel of an ISO Standard pre-filled glass syringe, in a retracted position. Upon completing the injection, the UltraSafe Passive, X-Series, Needle Guard passively activates and covers the exposed needle. When the Passive Needle Guard is activated, it provides protection from an accidental needlestick. The healthcare professional disposes the used syringe and needle assembly in a sharps container.
The intended patient population is unrestricted and includes children and adults.
The intended environment of use is where healthcare professionals are required to administer medication, including vaccines, by means of a syringe.
UltraSafe Passive™, X-Series, Needle Guards are single use devices that are indicated for use as an accessory with ISO Standard pre-filled glass syringes to protect healthcare professionals from accidental needle sticks.
This device is used on a wide range of patients, including children and adults, and parenteral methods of administration.
Product codes (comma separated list FDA assigned to the subject device)
80 FMF, MEG
Device Description
The UltraSafe Passive™, X-Series, Needle Guard is an accessory for ISO Standard pre-filled glass syringes. ISO Standard pre-filled glass syringes are supplied in multiple sizes. They fit with ISO Standard pre-filled glass syringes ranging from 0.5 mL to 5.0 mL of fill volume.
The guards are designed to meet the requirements specified in ISO 11040-4 Prefilled syringes - Part 4 Glass barrels for injectables (March 1995).
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
unrestricted and includes children and adults, children and adults
Intended User / Care Setting
healthcare professionals, where healthcare professionals are required to administer medication
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
A controlled simulated clinical use test was conducted with the UltraSafe Passive, X-Series, Needle Guard to validate the product in the hands of typical users. The UltraSafe Injection System Needle Guard, B-Series, was used as the control.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety Syringes, Inc. conducted iterative user evaluations of the X-Series needle guard. A controlled simulated clinical use test was conducted with the UltraSafe Passive, X-Series, Needle Guard to validate the product in the hands of typical users. The UltraSafe Injection System Needle Guard, B-Series, was used as the control.
In the controlled simulated clinical use test, each of the specified acceptance criteria were either met or exceeded. The nurses involved in this study rated the X-Series to be equal to, or better than, the B-Series on all of the parameters related to safety, performance, and usability.
In addition to evaluating safety, performance, and usability parameters, there were questions of the study participants regarding the clarity and adequacy of the written and illustrated Directions for Use, and the participants' response to the need for in-service training. On each of the parameters, the X-Series rated as equal to, or better, than the B-Series.
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
§ 880.5860 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
510(k) Summary
OCT 15 2004
Special 510(k) summary of safety and effectiveness
Company information
Safety Syringes, Inc. 1925 Palomar Oaks Way, Suite 204 Carlsbad, CA 92008 USA
Device Identification
Trade Name - UltraSafe Passive™, X-Series, Needle Guard - Models X50, X100, X100L, X150, X225, X300, X500 Classification Name - Syringe, Piston (accessory) Classification - Class II Product Code - 80 FMF
Predicate Device
The UltraSafe® Injection System Needle Guard - Models B50, B100L. B150, B225, and B300
Device Description
The UltraSafe Passive™, X-Series, Needle Guard is an accessory for ISO Standard pre-filled glass syringes. ISO Standard pre-filled glass syringes are supplied in multiple sizes. They fit with ISO Standard pre-filled glass syringes ranging from 0.5 mL to 5.0 mL of fill volume.
The guards are designed to meet the requirements specified in ISO 11040-4 Prefilled syringes - Part 4 Glass barrels for injectables (March 1995).
Intended Use
The UltraSafe Passive™, X-Series, Needle Guard is intended for use as a safety mechanism designed to reduce the occurrence of accidental needlesticks to healthcare professionals during disposal of a used syringe and needle assembly. The UltraSafe Passive, X-Series, Needle Guard is snapped onto the barrel of an ISO Standard pre-filled glass syringe, in a retracted position. Upon completing the injection, the UltraSafe Passive, X-Series, Needle Guard passively activates and covers the exposed needle. When the Passive Needle Guard is activated, it provides protection from an accidental needlestick. The healthcare professional disposes the used syringe and needle assembly in a sharps container.
The intended patient population is unrestricted and includes children and adults.
1
K042712
292
The intended environment of use is where healthcare professionals are required to administer medication, including vaccines, by means of a syringe.
Indications for Use
UltraSafe Passive™, X-Series, Needle Guards are single use devices that are indicated for use as an accessory with ISO Standard pre-filled glass syringes to protect healthcare professionals from accidental needle sticks.
This device is used on a wide range of patients, including children and adults, and parenteral methods of administration.
Comparison of the UltraSafe® Injection System Needle Guard - B-Series to the UltraSafe Passive™, X-Series, Needle Guard
The UltraSafe Passive™ X-Series, Needle Guards are modifications of the previously cleared (K002070) UltraSafe Injection System Needle Guard, B-Series. The B-Series are manually activated needle guards. The X-Series are passively (automatically) activated needle guards.
The basic design, function, intended use, and indications for use of the B-Series and X-Series are similar.
Safety Syringes, Inc. conducted iterative user evaluations of the X-Series needle guard. A controlled simulated clinical use test was conducted with the UltraSafe Passive, X-Series, Needle Guard to validate the product in the hands of typical users. The UltraSafe Injection System Needle Guard, B-Series, was used as the control.
In the controlled simulated clinical use test, each of the specified acceptance criteria were either met or exceeded. The nurses involved in this study rated the X-Series to be equal to, or better than, the B-Series on all of the parameters related to safety, performance, and usability.
In addition to evaluating safety, performance, and usability parameters, there were questions of the study participants regarding the clarity and adequacy of the written and illustrated Directions for Use, and the participants' response to the need for in-service training. On each of the parameters, the X-Series rated as equal to, or better, than the B-Series.
- K9722878 Thomas L. Hale 10/07/04
03 10
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" around the perimeter. Inside the circle is a stylized image of three horizontal lines curving upwards, resembling a person with outstretched arms.
OCT 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas L. Hall Director, Regulatory Affairs and Quality Assurance Safety Syringes, Incorporated 1939 Palomar Oaks Way, Suite A, Carlsbad, California 92009
Re: K042712
Trade/Device Name: Tamper Evident UltraSafe® Passive™ Delivery System Syringe, Piston (Accessory) Regulation Number: 880.5860 Regulation Name: Antistick Syringe, Piston Syringe Regulatory Class: II Product Code: MEG, FMF Dated: September 27, 2004 Received: September 30, 2004
Dear Mr. Hall:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Hall
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements nean that 1 Dr mas made statutes and regulations administered by other Federal agencies. or the Act of ally I outstar the Act's requirements, including, but not limited to: registration r ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 er result in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as be former product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) Prinstet notification. The FDA finding of substantial equivalence of your device to a promative noticate 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), rr you decire spiee of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj count Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K0427/2
Indications for Use Statement
510(k) Number: _
Tamper Evident Device Name: UltraSafe® Passive™ Delivery System Syringe, Piston (Accessory)
Indications for Use:
Single Use devices that are indicated for use as an accessory with pre-filled \SO
le from that are indicated for use of he diberary professionals from Single Ose devices that are indication for ass as the althcare professionals from accidental needlesticks.
These devices can be used on a wide range of patients, including children and adults, and parenteral methods of administration.
Anew Navesse for Adw 10/14/04
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042712
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use × (Per 21 CFR 801.109 OR
Over the Counter______________________________________________________________________________________________________________________________________________________________