(109 days)
Single use devices that are indicated for use as an accessory with BD Hypak Sterile Clean Fill (SCF) glass Prefilled Syringes 1 mL long to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The devices can be used on a wide range of patients including children and adults.
The Safe'n'Sound® Luer Lock Passive Delivery System is an anti-needlestick accessory for use with BD Hypak SCF glass Prefilled Syringes. It fits with needles 1" long maximum, and consists of a body assembly and a loose plunger rod.
The Safe'n'Sound® Luer Lock Passive Delivery System is and anti-needlestick accessory for use with BD Hypak SCF glass Prefilled Syringes and is intended to protect healthcare professionals, patients who self-inject doctor prescribed medication, and individuals that assist self-injecting patients, from accidental needlesticks. The device can be used on a wide range of patients including children and adults.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Standard/Acceptance Criteria | Reported Device Performance |
|---|---|
| Product functions as intended | Confirmed by bench testing |
| Biocompatibility (ISO 10993-5) | Meets requirements |
| Biocompatibility (ISO 10993-10) | Meets requirements |
| Safe to use | Confirmed by simulated clinical use testing |
| Effective in shielding needles | Confirmed by simulated clinical use testing |
| Substantially equivalent to predicate devices | Concluded based on functional testing, design, technology, performance, and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the bench testing or simulated clinical use testing. It generally states that "Bench testing has been performed" and "Simulated clinical use testing has been performed."
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, "simulated clinical use testing" suggests a prospective, controlled environment, rather than retrospective real-world data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned (bench testing, simulated clinical use testing) would likely involve technical personnel and possibly healthcare professionals for the simulated use, but specific details are absent.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No information about a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance is provided. This device is a mechanical accessory, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a mechanical anti-needlestick accessory, not an algorithm or software.
7. The Type of Ground Truth Used
Based on the description of the testing, the "ground truth" for this device would be established through:
- Engineering specifications and objective measurements: For bench testing, ensuring the device components function as designed and meet specific technical parameters.
- Observational data/expert assessment: For simulated clinical use, verifying that the device effectively shields the needle and can be used safely and effectively by users in a controlled environment.
8. The Sample Size for the Training Set
This question is not applicable as the device is a mechanical accessory and does not involve AI/machine learning training sets.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a mechanical accessory and does not involve AI/machine learning training sets or associated ground truth establishment.
Summary of the Study Proving Device Meets Acceptance Criteria:
The device's performance was assessed through two primary types of studies:
- Bench Testing: This confirmed that the "product functions as intended" and demonstrated substantial equivalence to predicate devices in "general technological features and principle of operation." This testing would have involved evaluating mechanical integrity, activation mechanisms, and general functionality. Biocompatibility testing (meeting ISO 10993-5 and ISO 10993-10) was also performed as part of the bench tests.
- Simulated Clinical Use Testing: This testing confirmed that the device "could be used safely and effectively to shield needles inside the protection device after use." This likely involved users (potentially healthcare professionals or simulated users) performing injection actions with the device and verifying that the needle retraction/shielding mechanism activated correctly to prevent needlesticks.
Based on the results of these tests, the manufacturer concluded that "the Safe'n'Sound® Luer Lock Passive Delivery System is substantially equivalent to predicate devices currently marketed under the Food, Drug and Cosmetic Act" and "raises no new issues of safety or effectiveness."
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Abbreviated 510(k)
Safe'n'Sound® Luer Lock Passive Delivery System Page 1 of 2
JAN 2 0 2012
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Section 5: 510(k) Summary
| Assigned 510(k) number: | K112936 |
|---|---|
| Company: | Rexam Healthcare800 Corporate Grove DriveBuffalo Grove, IL 60089Phone: 847-325-3016Fax: 847-325-3911 |
| Contact: | Sandra Anderson, M.J., RAC |
| Date Prepared: | December 21, 2011 |
| Proprietary Names: | Safe'n'Sound® Luer Lock Passive Delivery System |
| Classification Name: | Piston syringe accessory |
| Classification: | 21 CFR 880.5860, Class II, Product Code MEG |
| Predicate Devices: | K060743 UltraSafe® Passive Delivery System by SafetySyringes, Inc.; K101233 Safe'n'Sound® Passive DeliverySystem by Rexam Pharma |
| Device Description: | The Safe'n'Sound® Luer Lock Passive Delivery System isan anti-needlestick accessory for use with BD Hypak SCFglass Prefilled Syringes. It fits with needles 1" longmaximum, and consists of a body assembly and a looseplunger rod. |
| Intended Use: | Single use devices that are indicated for use as an accessorywith BD Hypak Sterile Clean Fill (SCF) glass PrefilledSyringes 1 mL long to aid in the protection of healthcareprofessionals, patients who self-inject doctor prescribedmedications, and individuals that assist self-injectingpatients, from accidental needlesticks. The devices can beused on a wide range of patients including children andadults. |
| TechnologicalCharacteristic ComparisonSummary to Predicate Devices |
Summary to Predicate Device:
The Safe'n'Sound® Luer Lock Passive Delivery System is similar to predicate devices in general technological features and principle of operation. All are molded plastic
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Abbreviated 510(k) K112936 Safe'n'Sound® Luer Lock Passive Delivery System Page 2 of 2
assemblies consisting of a body, sleeve, plunger rod, and spring that activates upon injection completion to fully contain the needle. Minor differences with the predicates in technological features and performance have been demonstrated to be insignificant based upon bench testing and simulated clinical use studies performed.
Performance Testing:
Bench testing has been performed on the Safe'n'Sound® Luer Lock Passive Delivery System. It confirmed the product functions as intended and is substantially equivalent to the predicate device. Biocompatibility testing performed demonstrates that the product meets ISO 10993-5 and ISO 10993-10 requirements.
Simulated clinical use testing has been performed. It confirmed that the Safe'n'Sound® Luer Lock Passive Delivery System could be used safely and effectively to shield needles inside the protection device after use.
the design, technology, performance, Based upon functional testing, and intended use, the Safe'n'Sound® Luer Lock Passive Delivery System is substantially equivalent to predicate devices currently marketed under the Food, Drug and Cosmetic Act. The Safe'n'Sound® Luer Lock Passive Delivery System raises no new issues of safety or effectiveness.
Clinical Testing:
Conclusion:
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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" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 0 2012
Ms. Sandra Anderson Regulatory Compliance Manager Rexam Consumer Plastics Incorporated d/b/a Rexam Pharma 800 Corporate Grove Drive Buffalo Grove, Illinois 60089
Re: K112936
Trade/Device Name: Safe'n'Sound® Luer Lock Passive Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 21, 2011 Received: December 22, 2011
Dear Ms. Anderson:
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 - Ms. Anderson
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 (QS) 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 vours.
Ciprian D.avat
nthony D. Watson, B.S., M.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
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Indications for Use
510(k) Number (if known): K112936
Device Name: Safe'n'Sound® Luer Lock Passive Delivery System
Indications for Use:
Single use devices that are indicated for use as an accessory with BD Hypak Sterile Clean Fill (SCF) glass Prefilled Syringes 1 mL long to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The devices can be used on a wide range of patients including children and adults.
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)
Rell C. 1/12/12
(Division Suppor CDRH, Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112936
Page 1 of
§ 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).