(90 days)
The Devon SafeTip Safety Syringe is indicated for use in the administration of an intramuscular (IM) injection. The SafeTip Safety Syringe aids in the prevention of accidental needle sticks by passively and automatically deploying a sheath that covers the sharp needle upon completion of the injection.
The SafeTip Safety Syringe is a piston syringe that features a passive sharp safety feature which covers the needle after injection. The syringe automatically deploys a plastic cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the tissue. The sheath protrudes beyond the end of the needle, shielding the user and patient from the sharp needle after removal.
Here's an analysis of the provided text regarding the Devon SafeTip Safety Syringe, focusing on its acceptance criteria and the study that proves its performance:
The provided text describes a 510(k) premarket notification for the Devon SafeTip Safety Syringe. It highlights the device's description, indications for use, and a summary of testing. However, the document does not explicitly state specific numerical acceptance criteria or detail a comprehensive study to prove the device meets such criteria. It references adherence to "internationally recognized standards" and FDA Guidance but doesn't provide the quantitative results or the methodology of the study.
Based on the provided information, I can answer some of your questions and identify the information that is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative metrics within the provided text. The text indicates general compliance with "internationally recognized standards for syringe performance and labeling characteristics" and reliability of the safety feature. | "Simulated clinical use testing has demonstrated the performance of the SafeTip syringe and reliability of the safety feature in accordance with the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005." |
Missing Information: Specific numerical thresholds for performance (e.g., success rate of needle cover deployment, force required for activation, leakage rates, etc.) are not provided. The term "demonstrated performance" is qualitative.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document states "Simulated clinical use testing" but provides no details on the sample size (number of syringes tested, number of simulated injections), the country of origin of the data, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing Information: This information is entirely absent. The testing described is for a physical device (syringe, safety feature), not one that requires expert interpretation for "ground truth" in the way an AI diagnostic tool would. "Simulated clinical use testing" would likely involve objective measurements rather than expert consensus on subjective findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: Adjudication methods are typically relevant for studies involving subjective human assessment or disagreement, particularly in diagnostic imaging or clinical trials. Since the testing is for the performance of a physical device and its safety mechanism, an adjudication method like 2+1 or 3+1 is not applicable and not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable/Missing Information: An MRMC comparative effectiveness study is used for evaluating human reader performance, often with and without AI assistance, particularly in diagnostic fields. This is not relevant to a physical medical device like a safety syringe. The document does not describe any such study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable/Missing Information: This question applies to AI algorithms. The Devon SafeTip Safety Syringe is a physical device, not an AI algorithm, so the concept of "standalone performance" for an algorithm is not relevant here. The device itself (the safety mechanism) acts "standalone" in its deployment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would likely be objective physical measurements and observations of the syringe's functional performance and safety feature deployment. For example:
- Successful deployment of the sheath: Yes/No
- Completeness of sheath coverage over the needle: Yes/No
- Force required to activate the safety feature (if applicable)
- Integrity of the syringe body and needle after use
- Absence of leakage
However, the document does not explicitly state the specific types of "ground truth" or measurement criteria used beyond mentioning "performance of the SafeTip syringe and reliability of the safety feature."
8. The sample size for the training set
Not Applicable/Missing Information: The concept of a "training set" applies to machine learning or AI models. This is a physical device and does not have a training set in that sense. Any manufacturing or design validation would involve internal testing and iteration, but not a "training set" in the context of AI.
9. How the ground truth for the training set was established
Not Applicable/Missing Information: As mentioned above, a training set is not applicable to this physical device.
Summary of what is known from the provided text:
- Device: Devon SafeTip Safety Syringe, a piston syringe with a passive sharp safety feature.
- Purpose of Safety Feature: Automatically deploys a plastic cover (sheath) over the needle after injection to prevent accidental needle sticks.
- Indications for Use: Administration of intramuscular (IM) injections.
- Testing Performed: "Simulated clinical use testing" was conducted.
- Compliance: The testing demonstrated performance and reliability in accordance with "internationally recognized standards for syringe performance and labeling characteristics" and the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005.
Key Missing Information: The provided text lacks the detailed, quantitative information typically found in a comprehensive study report, such as specific acceptance criteria values, sample sizes, detailed methodology, and the actual results of the "simulated clinical use testing." It acts more as a high-level summary of compliance.
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Submitted on behalf of:
Devon Safety Products DBA Devon Medical Supplies 1100 First Avenue, Suite 100 King Of Prussia, PA 19406 Telephone: 1-800-431-2273 610-768-4509 Fax:
JUN 12 2006
| Submitted by: | Paladin Medical, Inc. |
|---|---|
| P.O. Box 560 | |
| Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
CONTACT PERSON: Elaine Duncan
DATE PREPARED: March 10, 2006 TRADE NAME: SafeTip Safety Syringe COMMON NAME: Safety Syringe REGULATION: Piston Syringe: 21 CFR 880.5860: Class II General Hospital Product code: MEG and FMI
SUBSTANTIALLY EQUIVALENT TO:
The Devon Medical Supplies SafeTip Syringe is substantially equivalent to the Medisys Tech. CoverTip Safety Syringe for technological features, the Becton Dickinson Integra Syringe in performance and the Devon Standard Syringe for materials.
DESCRIPTION of the DEVICE:
The SafeTip Safety Syringe is a piston syringe that features a passive sharp safety feature which covers the needle after injection. The syringe automatically deploys a plastic cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the tissue. The sheath protrudes beyond the end of the needle, shielding the user and patient from the sharp needle after removal.
INDICATIONS FOR USE:
The SafeTip Syringe is indicated for use in the administration of an intramuscular (IM) injection. The SafeTip Safety Syringe aids in the prevention of accidental needle sticks by passively and automatically deploying a sheath that covers the sharp needle upon completion of the injection
SUMMARY of TESTING:
The Devon SafeTip Safety Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics. Simulated clinical use testing has demonstrated the performance of the SafeTip syringe and reliability of the safety feature in accordance with the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three parallel lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
JUN 1 2 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Devon Safety Products, Incorporated C/O Ms. Elaine Duncan President Paladin Medical®, Incorporated PO Box 560 Stillwater, Minnesota 55082
Re: K060668
Trade/Device Name: Devon SafeTip Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMI Dated: March 10, 2006 Received: March 14, 2006
Dear Ms. Duncan:
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.
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Page 2 - Ms. Duncan
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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) 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), please contact the Office 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 Division of 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/industry/support/index.html.
Sincerely yours.
Senate Y. Michael Onid.
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
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Indications for Use
510(k) Number (if known):
Device Name: Devon SafeTip Safety Syringe
The Devon SafeTip Safety Syringe is indicated for use in the administration of an The Devon Barely Safety Symge interest Syringe aids in the prevention of accidental meedle sticks by passively and automatically deploying a sheath that covers the needle upon completion of the injection.
Prescription Use X (Part 21 CFR 801 Subpart D)
..
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Catan v.m
Ju Sign-Cit) of Anesthesiology, General Hospital, ction Control, Dental Devices
) 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).