(180 days)
The Med-Lok™ Safety Needle Device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
The Med-Lok is a hypodermic needle with protection device that allows full use of the needle and covers the needle after use to help prevent needle sticks and touch contamination.
The provided text describes the 510(k) summary for the Med-Lok Safety Needle. However, it does not contain the detailed information necessary to complete a comprehensive table of acceptance criteria and reported device performance, nor does it describe specific studies with the requested level of detail. The document emphasizes substantial equivalence to a predicate device based on technological characteristics, indications for use, and general performance testing.
Here's an attempt to answer your questions based only on the provided text, highlighting what is missing:
1. Table of acceptance criteria and reported device performance
The document states: "Performance Testing: Testing was performed to demonstrate the product functions as intended and is shown to be substantially equivalent. These tests included extensive laboratory testing." and "Clinical Testing: Simulated clinical use studies were conducted which confirmed that the device could be used effectively with the needle shielded inside the protection device after use."
This indicates that acceptance criteria likely revolved around demonstrating functionality and effectiveness in preventing needle sticks, but the specific metrics or thresholds for these criteria are not provided in the text. Therefore, a table cannot be fully constructed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific functional metrics for needle use and shielding effectiveness (e.g., force to activate shield, percentage of successful shield activations, resistance to accidental shield deactivation, etc.) | "Functions as intended" |
| Specific clinical effectiveness metrics (e.g., 100% successful shielding in simulated use, or a defined percentage) | "Could be used effectively with the needle shielded inside the protection device after use." |
| Specific safety criteria related to prevention of needle sticks (e.g., rate of accidental needle sticks during simulated use) | "Covers the needle after use to help prevent needle sticks." |
2. Sample size used for the test set and the data provenance
The text mentions "extensive laboratory testing" and "Simulated clinical use studies."
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The text implies prospective testing (laboratory and simulated clinical use).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes performance and simulated clinical use studies, not a diagnostic or AI-driven system requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. The document describes performance and simulated clinical use studies, not an assessment requiring adjudication of interpretations.
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. This device is a mechanical safety needle, not an AI-driven diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical safety needle, not an AI-driven system. The "standalone" performance would refer to the device's mechanical function by itself, which is what the "extensive laboratory testing" likely evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing, the ground truth would have been the successful mechanical function of the device (e.g., deployment of the safety mechanism, fluid aspiration/injection capabilities). For the simulated clinical use studies, the ground truth would have been the successful and effective operation of the device by users in a simulated environment, specifically that "the device could be used effectively with the needle shielded inside the protection device after use." This is based on observation of the device's function rather than a diagnostic 'truth'.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a mechanical device, not an AI system.
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093176
STA-MED, LLC 41197 Golden Gate Circle, Suite 102 Murrieta, CA 92562
Attachment 2 - 510(k) Summary
5. 510(k) Summary
APR - 6 2010
STA-MED, LLC. 41197 Golden Gate Circle, Suite 102 Murrieta, CA 92562
SUMMARY
Submitter's name: Address:
Phone: Fax number:
Name of contact person:
STA-MED, LLC. 41197 Golden Gate Circle, Suite 102 Murrieta, CA 92562 951-445-4601 951-445-4602
Greg Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 greg@regulatoryspecialists.com
| Name of the device: | Med-Lok, Safety Needle |
|---|---|
| Classification name: | Piston Syringe |
| Product code | MEG |
| Device Class | Class 2 |
Date
December 21, 2009
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
| Reference # ! | Device Name | Company of Canadian Company of Concession Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company CompApplicant |
|---|---|---|
| K063755 Portex Hypodermic Needle-Pro SMITHS MEDICAL ASD, INC |
Description of the device:
The Med-Lok is a hypodermic needle with protection device that allows full use of the needle and covers the needle after use to help prevent needle sticks and touch contamination.
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093176
page 2 of 2
Indications:
The Med-Lok Safety Needle Device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Summary of the technological characteristics of our device compared to the predicate device:
Technological Characteristics
This proposed device has the same technological characteristics as the predicate device.
Indications for Use
The Indications for Use for this proposed device has the same Indications for Use as the predicate device.
Performance Testing
Testing was performed to demonstrate the product functions as intended and is shown to be substantially equivalent. These tests included extensive laboratory testing.
Clinical Testing
Simulated clinical use studies were conducted which confirmed that the device could be used effectively with the needle shielded inside the protection device after use.
CONCLUSION
Based on the design, technology, performance, functional testing, and intended use, the Med-Lok, Safety Needle is substantially equivalent to the predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. The Med-Lok, Safety Needle raises no new issues of safety or effectiveness. Therefore, safety and effectiveness are reasonably assured, and substantial equivalence is supported, justifying 510(k) clearance of Med-Lok, Safety Needle.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with three stripes on its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
STA-MED. LLC C/O Mr. Greg Holland Regulatory Consultant Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606
APR - 6 2010
Re: K093176
Trade/Device Name: Med-Lok Regulation Number: 21CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: March 19, 2010 Received: March 23, 2010
Dear Mr. Holland:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Holland
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
far.
Anthony D. Watson, B.S., M.S., M.B.A. 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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STA-MED, LLC 41197 Golden Gate Circle, Suite 102 Murrieta, CA 92562
Attachment 1 - Revised Indications for Use Statement.
4. Indications for Use Statement Indications for Use
510(k) Number (if known): K093176
Device Name: Med-Lok
Indications for Use: The Med-Lok™ Safety Needle Device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093176
Page 1 of 1
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§ 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).