(39 days)
Single use devices that are indicated for use as an accessory with 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 intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
The Safety Syringes UltraSafe Delivery System/Needle Guard devices are antineedlestick accessories for pre-filled ISO Standard glass syringes. ISO Standard glass syringes are supplied in multiple sizes. These devices are designed to fit syringe sizes 0.5 mL, 1.0 mL, 1.0 mL long, 1.5 mL, 2.25 mL, 3.00 mL, and 5.0 mL.
This 510(k) summary describes a modification to an existing medical device, the Safety Syringes UltraSafe Delivery System/Needle Guard devices, which are anti-needlestick accessories for pre-filled ISO Standard glass syringes. The modification is an expansion of the Indications for Use to include self-injecting patients and those who assist them, beyond the original limitation to healthcare professionals.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a formal table of acceptance criteria or specific quantitative performance metrics for the device. Instead, it describes a qualitative assessment related to the expanded user group.
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Non-healthcare personnel can understand and follow Instructions for Use (IFU) effectively. | "the results of that testing indicates that the devices will perform as intended in the hands of typical nonhealthcare users." |
| Device performance remains safe and effective for the expanded user group. | "No issues have arisen to indicate that this labeling change poses unreasonable risks to non-healthcare professional users." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the "testing" mentioned. It refers to "typical nonhealthcare users" without providing a number.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a premarket notification for a US FDA approval, it's highly likely the testing was conducted in the US. The "testing" appears to be a prospective assessment of user comprehension and device interaction.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not describe the use of "experts" to establish ground truth for the usability testing with non-healthcare personnel. The assessment appears to be based on the ability of the users themselves to perform the task as intended. If "ground truth" refers to the correct execution of the device's function, it's implied that the device design and IFU served as the standard.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Given the nature of the evaluation (user comprehension and device interaction), it's unlikely a formal adjudication process (like 2+1 or 3+1) was used as would be common in diagnostic AI studies. The "testing" would more likely involve observation and direct assessment of task completion and understanding.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and their performance is compared with and without AI assistance. This device is an anti-needlestick accessory, not a diagnostic tool requiring interpretation.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone study was not done. This concept is relevant for AI algorithms. The device itself is a physical accessory designed to be used by humans. The "testing" mentioned focuses on human-in-the-loop performance, specifically the ability of non-healthcare users to correctly use the device.
7. Type of Ground Truth Used
The "ground truth" for the "testing" described is implicitly the intended and correct use of the device as per its design and Instructions for Use (IFU). It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic medical device study. Instead, it's about evaluating user compliance and understanding.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning algorithms. This document describes a physical medical device. Therefore, there is no "training set" in the context of AI/ML. The device's design would have undergone engineering and design validation, but not "training" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML context for this device, a method for establishing its ground truth is not applicable or described. The performance of the device itself (e.g., its anti-needlestick effectiveness) would have been established through prior design verification and validation activities for the original device, likely involving engineering tests, material compatibility tests, and potentially simulated use tests. However, the document focuses only on the change in Indications for Use and the associated human factor/usability testing for the new user population.
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510(k) Summary
Special 510 (k) Summary of Safety and Effectiveness
Company and Contact Information
Safety Svringes, Inc. 1939 Palomar Oaks Way, Suite A Carlsbad, CA 92011
Voice 760.918.9908 Fax 760.918.0565
Thomas L. Hall Sr. Director, Regulatory Affairs & Quality Assurance
Device Identification
Trade Names:
-
- Tamper Evident UltraSafe® Passive™ Delivery System
- UltraSafe® Passive™ Delivery System (X-Series) Regulation Number - 21 CFR 880.5860 Regulation Name - Syringe, Piston (accessory) Classification - Class II Product Code - MEG
Predicate Devices
-
- Tamper Evident UltraSafe® Passive™ Delivery System
-
- UltraSafe® Passive™ Delivery System (X-Series) (Subsequent to the submission of the premarket notification for this device, the trade name was changed from UltraSafe® Passive™ X-Series Needle Guard)
Description of Modified Devices
The Safety Syringes UltraSafe Delivery System/Needle Guard devices are antineedlestick accessories for pre-filled ISO Standard glass syringes. ISO Standard glass syringes are supplied in multiple sizes. These devices are designed to fit syringe sizes 0.5 mL, 1.0 mL, 1.0 mL long, 1.5 mL, 2.25 mL, 3.00 mL, and 5.0 mL.
The only change from the currently legally marketed devices, and the subject of this premarket notification is the expansion of the Indications for Use, that is currently limited to healthcare professionals, to include physician prescribed medication selfinjecting patients and individuals who assist self-injecting patients. There are no changes to the design of these devices, materials used to produce these devices, or to their fundamental technology.
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Indications for Use
Single use devices that are indicated for use as an accessory with prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist selfiniecting patients, from accidental needlesticks.
The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
Compliance with Design Controls
Design Control activities for this device have been performed in conformance with the design control procedure requirements as specified in 21 CFR part 820.30.
Risk Management
Risks associated with each product family have been identified, evaluated and, after mitigation, the risks fall into the "Broadly Acceptable Region" following ISO 14971.
Conclusion
The expansion of the indications for use to include patients who self-inject doctor prescribed medications and individuals who assist self-injecting patients provides needed protection to an expanding population of users who can benefit with the use of anti-needlestick devices. The ability of non-healthcare personnel to understand and follow the Instructions for Use has been tested and the results of that testing indicates that the devices will perform as intended in the hands of typical nonhealthcare users.
This labeling change brings the safety benefits to a new user group. No issues have arisen to indicate that this labeling change poses unreasonable risks to nonhealthcare professional users.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
APR 2 8 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas L. Hall Senior Director, Regulatory Affairs and Quality Assurance Safety Syringes, Incorporated 1939 Palomar Oaks Way, Suite A Carlsbad, California 92011
Re: K060743
Trade/Device Name: Tamper Evident UltraSafe® Passive™ Delivery System UltraSafe® Passive™ Delivery System (X-Series) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: April 12, 2006 Received: April 14, 2006
Dear Mr. Hall:
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 Federa! Register.
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Page 2 - Mr. Hall
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 (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.
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 vours.
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:
Device Name:
UltraSafe® Passive™ Delivery System
Indications for Use:
Single use devices that are indicated for use as an accessory with 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 intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antony D. ins
Ancolliesiology, General Hospital, : Connol Dental Devices
大46φ743
000 03
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Indications for Use
510(k) Number:
K060743 .
Device Name:
Tamper Evident UltraSafe® Passive™ Delivery System
Indications for Use:
Single use devices that are indicated for use as an accessory with 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 intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ching veng
ാത്രം (1) അടിമൃത്രം (General Hospital) In Com.of Dental Devices
K06243
000 02
§ 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).