(53 days)
Not Found
No
The document describes a mechanical syringe with a retracting needle mechanism for safety and does not mention any AI or ML components or functions.
Yes
The device's primary intended use is "to inject fluid into, or withdraw fluid from the body," which are therapeutic actions.
No
The device is described as an "EasySafe® Retracting Needle Syringe" intended for injecting fluid into, or withdrawing fluid from the body, and for preventing sharps injuries and reducing wasted medication. There is no mention of it diagnosing any condition or disease.
No
The device is described as a "Retracting Needle Syringe" and its intended use involves injecting/withdrawing fluids, which are physical actions performed by a hardware device. The performance studies also describe physical testing and biocompatibility, further indicating a hardware component.
Based on the provided information, the EasySafe® Retracting Needle Syringe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to "inject fluid into, or withdraw fluid from the body." This describes a device used on or in a patient for therapeutic or diagnostic purposes related to the body itself, not for examining samples outside the body.
- Device Description (Not Found): While the description is missing, the intended use is the key factor.
- No mention of analyzing samples: IVD devices are designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. The provided text does not mention any such analysis.
- Anatomical Site: "into the body" further reinforces that it's used directly on the patient.
Therefore, the EasySafe® Retracting Needle Syringe is a medical device used for administering or withdrawing substances from the body, which falls under the category of devices used in vivo or for direct patient care, not IVDs.
N/A
Intended Use / Indications for Use
The primary intended use of the EasySafe® Retracting Needle Syringe is to inject fluid into, or withdraw fluid from the body. The secondary intended uses are:
-
- to help prevent sharps injuries when using the product for its primary intended use, and;
-
- to help reduce wasted medication when using the product for its primary intended use.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
Not Found
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)
Effectiveness:
In two recent simulated use studies, over 1,500 injections/fluid withdrawals were administered by a wide variety of clinicians to test the effectiveness of the product in injecting fluids into or withdrawing fluids from a patient. All injections/withdrawals were successfully completed.
Bench testing of the product confirms its compliance with the applicable performance standards established by the International Standards Organization (ISO).
In focus groups twenty clinicians indicated that they saw no impediments to being able to effectively administer injections to patients using the product.
Safety:
In two recent simulated use studies, over 1,500 injections/fluid withdrawals were administered by a wide variety of clinicians to test the safety of the product when used to inject fluids into or withdraw fluids from a patient. No injuries of any kind were reported.
Bench testing of the product confirms its comparability with legally-marketed predicate devices for a variety of safety factors, including but not limited to graduation accuracy and needle guard puncture resistance.
Biocompatability testing was performed by outside contract laboratories, with the results indicating that, from a biocompatability standpoint, the product is safe for its intended purpose.
A variety of design factors are intended to improve upon patient and clinician safety during use of the product. While sample size requirements have precluded a broad statistical study of the impact of such factors on injury rates, clinicians have reacted in a unanimous fashion to those factors.
A detailed risk analysis was performed on the product and, based on information currently available, the risk of harm from the product appears to be relatively low.
Sterilization validation was conducted by an outside contract laboratory. Stenlization to a SAL of 10° was confirmed during the tests. Pyrogenicity was also evaluated and acceptable results obtained.
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.
USMI SafeSnap™ Syringe, K925039, BD syringe (pre-Ammendment device)
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
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION [21 CFR 807.92]
| 510(k) Number: | Pending |
|---|---|
| Proprietary Name: | EasySafe™ Retracting Needle Syringe |
| Common Name: | Retracting Needle Syringe |
| Manufacturer: | Saf-T-Med, Inc. |
| 1250 South Grove, Suite 200 | |
| Barrington, IL 60010 | |
| Predicate Device Information: | A claim of substantial equivalence is made to: |
| USMI SafeSnap™ Syringe, K925039 | |
| BD syringe (pre-Ammendment device) | |
| Device Claims: | For the injection of fluid intramuscularly (IM) into |
| the body, while helping to reduce the risk of sharps | |
| injuries and reducing the amount of wasted | |
| medication. |
In compliance with the requirements of the Safe Medical Device Act (SMDA) of 1990, the following information is submitted as a summary of safety and effectiveness information for this 510(k) premarket notification.
Effectiveness
In two recent simulated use studies, over 1,500 injections/fluid withdrawals were administered by a wide variety of clinicians to test the effectiveness of the product in injecting fluids into or withdrawing fluids from a patient. All injections/withdrawals were successfully completed.
Bench testing of the product confirms its compliance with the applicable performance standards established by the International Standards Organization (ISO).
In focus groups twenty clinicians indicated that they saw no impediments to being able to effectively administer injections to patients using the product.
Safety
In two recent simulated use studies, over 1,500 injections/fluid withdrawals were administered by a wide variety of clinicians to test the safety of the product when used to inject fluids into or withdraw fluids from a patient. No injuries of any kind were reported.
Bench testing of the product confirms its comparability with legally-marketed predicate devices for a variety of safety factors, including but not limited to graduation accuracy and needle guard puncture resistance.
1
Biocompatability testing was performed by outside contract laboratories, with the results indicating that, from a biocompatability standpoint, the product is safe for its intended purpose.
A variety of design factors are intended to improve upon patient and clinician safety during use of the product. While sample size requirements have precluded a broad statistical study of the impact of such factors on injury rates, clinicians have reacted in a unanimous fashion to those factors.
A detailed risk analysis was performed on the product and, based on information currently available, the risk of harm from the product appears to be relatively low.
Sterilization validation was conducted by an outside contract laboratory. Stenlization to a SAL of 10° was confirmed during the tests. Pyrogenicity was also evaluated and acceptable results obtained.
2
Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the logo is a stylized symbol consisting of three curved lines that resemble a person or figure. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
MAY 2 1 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Erbs President Saf-T-Med, Incorporated 1250 South Grove, Suite 200 Barrington, Illinois 60010
Re : K991039 Trade Name: EasySafe® Retracting Needle Syringe Regulatory Class: II Product Code: FMF March 25, 1999 Dated: March 29, 1999 Received:
Dear Mr. Erbs:
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 general 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 Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Erbs
this response to your premarket notification Please note: submission does not affect any obliqation you miqht 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 labelinq 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" (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.gov/cdrh/dsmamain.html".
Sincerely yours, unotis
t 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): _________
Device Name: EasySafe® Retracting Needle Syringe
Indications For Use:
The primary intended use of the EasySafe® Retracting Needle Syringe is to inject fluid into, or withdraw fluid from the body. The secondary intended uses are:
-
- to help prevent sharps injuries when using the product for its primary intended use, and;
-
- to help reduce wasted medication when using the product for its primary intended use.
(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) OH
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Paltone Cucente
(Division Sign-Off Division of Dental, Info and General Hospital D 510(k) Number