(53 days)
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.
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Here's an analysis of the provided text regarding the EasySafe™ Retracting Needle Syringe, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Device Performance for EasySafe™ Retracting Needle Syringe
Note: This device is a medical syringe, not a software or AI-powered device. Therefore, many of the typical questions for AI/software (e.g., number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable here. The focus is on physical device performance and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance | Supporting Study Type |
|---|---|---|---|
| Effectiveness | Successful Injection/Fluid Withdrawal: Ability to administer injections or withdraw fluids effectively. | "All injections/withdrawals were successfully completed." (across >1,500 procedures) | Simulated Use Studies (2) |
| Compliance with ISO Performance Standards: | "Bench testing of the product confirms its compliance with the applicable performance standards established by the International Standards Organization (ISO)." | Bench Testing | |
| No Impediments to Administration (Clinician Feedback): | "Twenty clinicians indicated that they saw no impediments to being able to effectively administer injections to patients using the product." | Focus Groups (Qualitative Feedback) | |
| Safety | No Reported Injuries: Absence of harm to users (clinicians) or patients during use. | "No injuries of any kind were reported." (across >1,500 procedures) | Simulated Use Studies (2) |
| Comparability to Predicate Devices (various safety factors): Includes graduation accuracy and needle guard puncture resistance. | "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." | Bench Testing | |
| Biocompatibility: Device materials are safe for biological contact. | "Biocompatibility testing was performed by outside contract laboratories, with the results indicating that, from a biocompatibility standpoint, the product is safe for its intended purpose." | Biocompatibility Testing (by outside contract labs) | |
| Low Risk of Harm (Risk Analysis): | "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." | Risk Analysis | |
| Sterilization Efficacy: Achieves required sterility assurance level. | "Sterilization to a SAL of 10⁻⁶ was confirmed during the tests." | Sterilization Validation (by outside contract lab) | |
| Apyrogenicity: Absence of pyrogens. | "Pyrogenicity was also evaluated and acceptable results obtained." | Sterilization Validation (by outside contract lab) | |
| Positive Clinician Reaction to Safety Features: | "Clinicians have reacted in a unanimous fashion to those factors." (referring to design factors intended to improve safety) | Qualitiative Clinician Feedback (though statistical study was not performed) |
2. Sample Size for Test Set and Data Provenance
- Sample Size (Simulated Use Studies): Over 1,500 injections/fluid withdrawals were administered across two simulated use studies.
- Data Provenance: The text does not explicitly state the country of origin. Given the manufacturer (Saf-T-Med, Inc. based in Barrington, IL) and the FDA submission, it is highly probable the studies were conducted in the United States. The studies were prospective as they were described as "simulated use studies" performed "to test the effectiveness" and "to test the safety" of the product.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This device is a physical syringe, not an algorithmic diagnostic device requiring expert interpretation for ground truth.
- For the simulated use studies, "a wide variety of clinicians" were used, but their qualifications other than being "clinicians" are not further specified.
- For the focus groups, "twenty clinicians" provided feedback. Their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a physical device testing scenario (simulated use, bench testing), an adjudication method in the context of diagnostic interpretation (like 2+1 radiology review) is not relevant. The "ground truth" for effectiveness was successful completion of the procedures, and for safety, the absence of reported injuries.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Performed. The studies described are not MRMC studies. They focus on the performance and safety of the device itself, rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance (Algorithm Only)
- Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance metrics described (e.g., successful injections, no injuries) are the standalone performance of the physical device.
7. Type of Ground Truth Used
- Observed Performance/Outcome:
- Effectiveness: "All injections/withdrawals were successfully completed" (direct observation of successful procedure execution).
- Safety: "No injuries of any kind were reported" (direct observation/reporting of adverse events).
- Bench Testing: Conformance to ISO standards, comparability to predicate devices, graduation accuracy, needle guard puncture resistance (measured physical properties).
- Biocompatibility: Laboratory test results.
- Sterilization/Pyrogenicity: Laboratory test results confirming SAL and acceptable pyrogenicity.
- Clinician Feedback: Subjective assessment from clinicians in focus groups and during simulated use regarding ease of use and safety features.
8. Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The design and development of the syringe would have involved engineering and design iterations, but these are distinct from an algorithmic training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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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 200Barrington, IL 60010 |
| Predicate Device Information: | A claim of substantial equivalence is made to:USMI SafeSnap™ Syringe, K925039BD syringe (pre-Ammendment device) |
| Device Claims: | For the injection of fluid intramuscularly (IM) intothe body, while helping to reduce the risk of sharpsinjuries and reducing the amount of wastedmedication. |
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.
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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.
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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.
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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
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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
§ 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).