(291 days)
Single use devices that are indicated for use as an accessory with sterile 1 mL long staked needle prefilled ISO Standard glass syringes 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 Passive Delivery System is an antineedlestick accessory for use with sterile prefilled ISO Standard glass syringes. It fits 1 mL long staked needle syringes, and consists of a body assembly and a loose plunger rod.
The provided document describes the "Safe'n'Sound Passive Delivery System," an antineedlestick accessory for prefilled syringes. However, it does not explicitly state acceptance criteria in a quantitative manner (e.g., specific percentages for sensitivity, specificity, accuracy, or failure rates) or present a formal study with a detailed methodology, sample sizes, and statistical results in the way typically required for AI/ML device evaluations.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:
- Technological Characteristic Comparison: Stating similarity in general technological features and principle of operation, with minor differences deemed insignificant based on testing.
- Performance Testing: Bench testing confirmed the product functions as intended.
- Biocompatibility Testing: Demonstrated meeting ISO 10993-5 and ISO 10993-10 requirements.
- Clinical Testing: Simulated clinical use testing confirmed safe and effective needle shielding.
Given this, I cannot fully complete the requested table and details as if it were a typical AI/ML device study with precise acceptance criteria and performance metrics. I will interpret the available information to best fit the request.
Acceptance Criteria and Study Details for Safe'n'Sound Passive Delivery System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from Report) | Reported Device Performance |
|---|---|
| Functional as intended (e.g., proper activation, needle shielding) | Confirmed by Bench Testing. Device functions as intended. |
| Biocompatibility (non-toxic, non-irritating, non-sensitizing) | Meets ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) requirements. |
| Safe and Effective Needle Shielding (in simulated clinical use) | Confirmed by Simulated Clinical Use Testing. Device safely and effectively shields needles inside the protection device after use. |
| Substantial Equivalence to predicate device (UltraSafe® Passive Delivery System) | Based upon design, technology, performance, functional testing, and intended use, the device is substantially equivalent to the predicate device. |
| No New Issues of Safety or Effectiveness | No new issues of safety or effectiveness are raised by the device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a quantitative "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective) in the context of an AI/ML study.
- Bench Testing: No specific sample size is provided. The testing confirmed intended function.
- Simulated Clinical Use Testing: No specific sample size is provided. The testing confirmed safe and effective needle shielding.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to the information provided. The study described relies on bench testing and simulated clinical use, not expert-labeled ground truth for an AI algorithm. The evaluation is based on device performance against physical and biological standards.
4. Adjudication Method for the Test Set
This is not applicable. There was no "test set" requiring expert adjudication for ground truth establishment. Performance was assessed through physical and biological tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed to evaluate the impact of an AI system on human reader performance in diagnostic tasks, which is outside the scope of this device (a physical anti-needlestick accessory).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the "Safe'n'Sound Passive Delivery System" is a physical medical device, not an AI algorithm. Its performance is inherent to its mechanical design and function.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on:
- Physical Functionality: Whether the device physically performed its intended action (e.g., successful shielding, proper activation) as determined by engineering and performance tests.
- Biological Standards: Compliance with recognized biocompatibility standards (ISO 10993-5 and ISO 10993-10) for material safety.
- Predicate Device Performance: Comparison to the known performance and safety profile of the legally marketed predicate device to establish substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI/ML algorithm.
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Abbreviated 510(k) Safe'n'Sound Passive Delivery System
FEB 1 8 201
Section 5: 510(k) Summary
Assigned 510(k) number: K101233
Company: Rexam Healthcare 600 Deerfield Parkway Buffalo Grove, IL 60089 Phone: 317-346-5178 Fax: 317-736-9016
- Contact: Jeffrey Burris Date Prepared: March 23, 2010 Proprietary Names: Safe'n'Sound Passive Delivery System Classification Name: Piston syringe accessory 21 CFR 880.5860, Class II, Product Code MEG Classification: K060743 UltraSafe® Passive Delivery System by Predicate Device: Safety Syringes, Inc. Device Description: The Safe'n'Sound Passive Delivery · System is an antineedlestick accessory for use with sterile prefilled ISO
Standard glass syringes. It fits 1 mL long staked needle
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syringes, and consists of a body assembly and a loose plunger rod.
Intended Use:
Single use devices that are indicated for use as an accessory with sterile 1 mL long staked needle prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist selfinjecting patients, from accidental needlesticks. The devices can be used on a wide range of patients including children and adults.
Technological Characteristic Comparison Summary to Predicate Device:
The Safe'n'Sound Passive Delivery System is similar to the predicate device in general technological features and principle of operation. Both are molded plastic assemblies consisting of a body, sleeve, plunger rod, and spring that activates upon injection completion to fully contain the Minor differences between the devices in needle. 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 Passive Delivery System. It confirmed the product functions as intended and is substantially equivalent to the predicate device. Biocompatibility testing has been performed demonstrating that the product meets ISO 10993-5 and ISO 10993-10 requirements.
- Clinical Testing: Simulated clinical use testing has been performed. It confirmed that the Safe'n'Sound Passive Delivery System could be used safely and effectively to shield needles inside the protection device after use.
Conclusion: Based upon the design, technology, performance, functional testing, and intended use, the Safe'n'Sound Passive Delivery System is substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act. The Safe'n'Sound Passive Delivery System raises no new issues of safety or effectiveness.
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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD_20993-0002
Mr. Jeffrey Burris Global Regulatory Affairs Manager Rexam Pharma 600 Deerfield Parkway Buffalo Grove, Illinois 60089
. FEB 18 201
Re: K101233
Trade/Device Name: Safe'n'Sound Passive Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Accessory Regulatory Class: II Product Code: MEG Dated: February 9, 2011 Received: February 11, 2011
Dear Mr. Burris:
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 vour 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. Burris
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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
J. Kosol
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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Indications for Use
510(k) Number (if known): K101233
Device Name: Safe'n'Sound Passive Delivery System
Indications for Use:
Single use devices that are indicated for use as an accessory with sterile 1 mL long staked needle prefilled ISO Standard glass syringes 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)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| 2/18/14 |
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k/01233
§ 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).