Single use devices that are indicated for use as an accessory with pre-filled 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 intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Device Description

The SSI UltraSafe Passive Needle Guard (X-Series) is an anti-needlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is nonsterile and single use. The activation of the SSI UltraSafe Passive Needle Guard device remains the same. Upon completion of the injection, the guard will slide forward, cover and lock over the needle of the syringe. It is a tactile and visual recognition that the device safety feature has activated. The modifications to the predicate device include additional plungers manufactured from Purell PolyOne X50109 polypropylene homopolymer, Ineos H20Z-00 polypropylene homopolymer or medical grade Delrin SC690 NC010. The SSI devices are categorized as skin contact with a duration of category A- limited (< 24 h) as per ISO 10993 Biological evaluation of medical devices- Part 1: Evaluation and testing.

AI/ML Overview

The provided text describes the 510(k) summary for the UltraSafe Passive Needle Guard, a medical device designed to prevent accidental needlesticks. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a table format. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards. The "acceptance criteria" are implied by the performance data and the conclusion of substantial equivalence.

Aspect of Performance	Acceptance Criteria (Implied)	Reported Device Performance
Functionality	Function as intended; guard slides forward, covers, and locks over the needle upon injection completion; tactile and visual recognition of activation.	"Bench testing was performed on the UltraSafe Passive Needle Guard and confirms that the additional plungers functioned as intended... Upon completion of the injection, the guard will slide forward, cover and lock over the needle of the syringe."
Biocompatibility	Meet ISO 10993 requirements for skin contact (Category A - limited < 24h).	"Biocompatibility testing performed demonstrates that the additional plungers met 10993 requirements."
Premature Activation	Not activate prematurely under expected conditions of use.	"Simulated use studies were conducted to ensure that the additional plungers... did not activate prematurely under expected conditions of use..."
Sharps Injury Protection	Provide protection against unintended sharps injury until disposal.	"Simulated use studies were conducted to ensure that the additional plungers... provided protection against unintended sharps injury until disposal (Reference Guidance for Industry and FDA: Medical Devices with Sharps Injury Prevention Features and ISO 23908 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles...)"
Overall Equivalence	Substantially equivalent to the predicate device in technological features and principle of operation.	"The UltraSafe Passive Needle Guard is substantially equivalent to the predicate device in general technological features and principle of operation. The mechanism of the device does not change." and "Based upon the design, technology, performance, functional testing and intended use, the UltraSafe Passive Needle Guard device is substantially equivalent to predicate device..."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the sample size for the "bench testing" or "simulated use studies." It refers to "test procedures, test protocols, and reports" being maintained within the Quality System, but the specific number of units tested is not provided in this summary.
Data Provenance: The studies are described as "Bench testing" and "simulated use studies." The document implies these were conducted in-house by Safety Syringes, Inc., as they state, "Safety Syringes, Inc. maintains a Quality System compliant with 21 CFR 820..." and "The firm uses the standard elements of design control..." The data is prospective as it pertains to the evaluation of a new device. There is no mention of country of origin for the data or whether it was retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The testing involves evaluating the mechanical function and safety features of a needle guard, not the interpretation of medical images or diagnostic results that would require expert consensus for ground truth. The "ground truth" here is objective mechanical performance (e.g., does the guard lock?) and adherence to safety standards.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective mechanical testing and adherence to standards, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of medical data (e.g., radiologists reading images) to assess the impact of AI on reader performance. The UltraSafe Passive Needle Guard is a mechanical safety accessory, not a diagnostic tool requiring human interpretation in its primary function.

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 safety accessory, not an algorithm or AI system. Its performance is inherent in its design and mechanical function, not a software component.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the UltraSafe Passive Needle Guard is based on objective mechanical performance criteria and compliance with established standards.
- For functionality: Confirmation that the guard slides forward, covers, and locks over the needle as designed.
- For biocompatibility: Meeting the requirements of ISO 10993.
- For safety: Not activating prematurely and providing protection against sharps injury as defined by FDA guidance and ISO 23908.

8. The Sample Size for the Training Set

This question is not applicable as the UltraSafe Passive Needle Guard is a mechanical device, not an AI or machine learning system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

Summary

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K122SS8

SEP 2 0 2012

510(k) SUMMARY

UltraSafe Passive Needle Guard

Company:

Safety Syringes, Inc. 2875 Loker Avenue East Carlsbad, CA 92010 USA (760) 918-9908 Ph: (760) 918-0565 Fax:

Contact Person:

Suzanne Richardson Vice President, Quality Assurance and Regulatory Affairs

Mary Stanners, RAC Senior Regulatory Specialist

Date Prepared:

August 17, 2012

Trade/Proprietary Name: UltraSafe Passive Needle Guard

Common Name: Anti Stick Syringe

Classification Name: Piston Syringe

Classification Number(s)/Product Code(s): 21 CFR 880.5860 (MEG)

Legally Marketed Predicate Device: UltraSafe Passive Delivery System (510(k) K011369, K060743)

Device Description:

Intended Use/ Indications for Use:

The intended use remains the same. It is a safety mechanism to reduce occurrence of accidental needle sticks when using ISO standard glass prefilled syringes. The indications for use remain the same. The UltraSafe Passive Needle Guard is indicated for use as single use devices that are indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection

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of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Technical Characteristics Comparison Summary to Predicate Device:

The UltraSafe Passive Needle Guard is substantially equivalent to the predicate device in general technological features and principle of operation. The mechanism of the device does not change. Upon completion of the injection, the guard will slide forward, cover and lock over the needle of the syringe.

Performance Data:

Bench testing was performed on the UltraSafe Passive Needle Guard and confirms that the additional plungers functioned as intended and are substantially equivalent to the predicate device. Safety Syringes, Inc. maintains a Quality System compliant with 21 CFR 820, Quality System Regulation. The firm's Quality System is registered by a third-party to ISO 13485:2003, Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes. Test procedures, test protocols, and reports are maintained within the Quality System. The firm uses the standard elements of design control compliant to 21 CFR Part 820 and ISO 13485:2003 to develop its new products. Risk Management was conducted as per ISO 14971 Medical device-Application of risk management to medical devices. Biocompatibility testing performed demonstrates that the additional plungers met 10993 requirements.

Clinical Testing:

As per FDA guidance and ISO 23908, simulated use studies were conducted to ensure that the additional plungers did not impede or adversely affect the intended clinical performance of the device, did not activate prematurely under expected conditions of use and provided protection against unintended sharps injury until disposal (Reference Guidance for Industry and FDA: Medical Devices with Sharps Injury Prevention Features and ISO 23908 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles. introducers for catheters and needles used for blood sampling).

Conclusion:

Based upon the design, technology, performance, functional testing and intended use, the UltraSafe Passive Needle Guard device is substantially equivalent to predicate device previously cleared as 510(k)s K011369 and K0607043.

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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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a bird-like head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 20 2012

Safety Syringes. Incorporated Ms. Suzanne Richardson Vice President, Quality Assurance and Regulatory Affairs 2875 Loker Avenue East Carlsbad, California 92010

Re: K122558

Trade/Device Name: UltraSafe Passive Needle Guard Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: August 17, 2012 Received: August 22, 2012

Dear Ms. Richardson:

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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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 tó

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.

For

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

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INDICATIONS FOR USE

510(k) Number (if known): TBD

Device Name: UltraSafe Passive Needle Guard

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

Over-The Counter Use

(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

199 258 510(k) Number:_

Regulation Number and Section

§ 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).