(88 days)
Not Found
No
The summary describes a mechanical anti-needle stick accessory for syringes and makes no mention of AI or ML technology.
No
Explanation: The device is described as an "anti-needle stick accessory" designed to protect users from accidental needle sticks by covering the needle after use. Its primary function is safety (sharps injury prevention), not to treat or prevent a disease or condition for the patient. It's an accessory to a prefilled syringe, which delivers medication (a therapeutic function), but the accessory itself is not therapeutic.
No
This device is described as an "anti-needle stick accessory" for syringes, designed to protect users from accidental needle sticks by covering the needle after use. Its purpose is injury prevention, not diagnosis.
No
The device description explicitly states it is made of molded plastic and has a stainless steel spring, indicating it is a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an accessory for prefilled syringes to prevent accidental needle sticks during parenteral administration of medications. This is a physical safety mechanism related to drug delivery, not a diagnostic test performed on samples from the body.
- Device Description: The description details a mechanical device made of plastic and a spring that covers a needle after injection. This aligns with a physical safety accessory, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on mechanical function (ISO standards for syringes and sharps injury prevention) and biocompatibility, not diagnostic accuracy metrics like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely related to the safe delivery of medication and the prevention of sharps injuries.
N/A
Intended Use / Indications for Use
Single use devices that are indicated for use as an accessory with prefilled ISO Standard plastic 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 needle sticks. The intended patient population is unrestricted and may include children and adults, for parenteral methods of administration.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
This submission is provided for modifications to the predicate device, which includes design changes and addition of an optional loose extended finger flange. Details are provided in Table 1 hereafter.
The Safe'n'Sound® Staked Passive Delivery System - Plajex® Version is a non-sterile single use anti-needle stick accessory for use with Plajex® sterile prefilled ISO Standard plastic syringes. It fits with Plajex® 1 mL-long staked syringes with a maximum needle length of ½". It consists of a subassembly with a loose plunger rod and an optional loose extended finger flange. The proposed device will be assembled along with the prefilled syringe by the pharmaceutical company. Upon completion of the injection, the needle is then covered by the body protecting the user from potential sharps needle stick injury.
The device is made of molded plastic and have a stainless steel spring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
unrestricted and may include children and adults
Intended User / Care Setting
healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance has being tested on the Safe'n'Sound® Staked Passive Delivery System -Plajex® version following ISO 23908:2011. Bench testing has been performed following ISO7886-4 and ISO 8537 standards. 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® Staked Passive Delivery System - Plajex® version could be used to shield needles inside the protection device after use. The study follows Guidance for Industry and FDA Staff for Medical Devices with Sharps Injury Prevention Features dated August 9, 2005 and ISO 23908:2011 standard. It demonstrates that the device is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2015
Nemera Ms. Beatrice Grand Demars Regulatory Compliance Manager 20 Avenue de La Gare La Verilliere, 38292 FRANCE
Re: K150562
Trade/Device Name: Safe'n'Sound® Staked Passive Delivery System - Plajex® Version Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: February 27, 2015 Received: March 6, 2015
Dear Ms. Grand Demars:
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.
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Safe'n'Sound® Staked Passive Delivery System - Plajex® version
Indications for Use (Describe)
Single use devices that are indicated for use as an accessory with prefilled ISO Standard plastic 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 needle sticks. The intended patient population is unrestricted and may include children and adults, for parenteral methods of administration.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 5: 510(k) Summary
| Assigned 510(k) number: | K150562 |
|---|---|
| Company: | Nemera |
| 600 Deerfield Parkway | |
| Buffalo Grove, IL 60089 | |
| Phone: (800) 537-0178 | |
| Fax: (847) 325-3795 | |
| Contact: | Beatrice GRAND DEMARS |
| Date Prepared: | June 1, 2015 |
| Trade/Proprietary Name: | Safe'n'Sound® Staked Passive Delivery System – |
| Plajex® version | |
| Classification Name: | Piston syringe |
| Classification/Product Code: | 21 CFR 880.5860, Class II, Product Code MEG |
| Predicate Device: | K141664 Safe'n'Sound® Passive Delivery System |
| – Cone version by Nemera |
Device Description:
This submission is provided for modifications to the predicate device, which includes design changes and addition of an optional loose extended finger flange. Details are provided in Table 1 hereafter.
The Safe'n'Sound® Staked Passive Delivery System - Plajex® Version is a non-sterile single use anti-needle stick accessory for use with Plajex® sterile prefilled ISO Standard plastic syringes. It fits with Plajex® 1 mL-long staked syringes with a maximum needle length of ½". It consists of a subassembly with a loose plunger rod and an optional loose extended finger flange. The proposed device will be assembled along with the prefilled syringe by the pharmaceutical company. Upon completion of the injection, the needle is then covered by the body protecting the user from potential sharps needle stick injury.
The device is made of molded plastic and have a stainless steel spring.
4
Abbreviated 510(k) Safe'n'Sound® Staked Passive Delivery System - Plajex® version K150562
Intended Use:
Single use devices that are indicated for use as an accessory with prefilled ISO Standard plastic syringes to aid in the protection of healthcare professionals, patients who selfinject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needle sticks. The intended patient population is unrestricted and may include children and adults, for parenteral methods of administration.
The subject of this premarket notification is an adjustment of device design in order to make it compatible with ISO Standard plastic syringe, while the legally marketed device is currently compatible with ISO Standard glass syringe. This premarket notification also covers the description of an optional loose extended finger flange. These changes imply slight modification of design but do not impact the fundamental technology of the device.
Technological Characteristic Comparison Summary to Predicate Device:
The Safe'n'Sound® Staked Passive Delivery System - Plajex® version is similar to the predicate device in general technological features and principle of operation. Both are molded plastic subassemblies and plunger rod. Both have a spring that activates upon injection completion to fully contain the needle. However, the Cone, Sleeve and Plunger Rod components has been slightly redesigned to fit with Plajex® syringe.
In addition, the Safe'n'Sound® Staked Passive Delivery System - Plajex® version proposes an optional loose Extended Finger Flange (EFF) to increase handle surface. EFF component is made in same material than Plunger Rod with addition of an orange dye.
A side by side comparison is available below in Table 1.
These changes do not raise new questions of safety and effectiveness of the device as proven by design and process validations, bench testing, biocompatibility testing and simulated clinical use studies performed.
5
Abbreviated 510(k)
Safe'n'Sound® Staked Passive Delivery System – Plajex® version
K150562
Side by Side Comparison with the Predicate Devic Table 1
| | New device
Safe'n'Sound® Staked Passive Delivery
System - Plajex® Version | Predicate device
Safe'n'Sound® Staked Passive Delivery
System - Cone version | Discussion |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| General
technological
features and
principle of
operation | Molded plastic assembly consisting of body, cone, sleeve, plunger rod, EFF (optional) and spring that activates upon injection completion to fully contain the needle | Molded plastic assembly consisting of body, cone, sleeve, plunger rod, and spring that activates upon injection completion to fully contain the needle | Same principle, EFF optional component has been added to the new device to increase finger flange surface. |
| Material composition | | | |
| Body | Polycarbonate (transparent, natural with no colorant) | | Same material |
| Cone | Polycarbonate (transparent, natural with no colorant) | | Same material |
| Sleeve | Polycarbonate (transparent, natural with no colorant) | | Same material |
| Spring | Bright stainless steel | | Same material |
| Plunger rod | Polypropylene with colorant (white masterbatch) | | Same material |
| Extended Finger
Flange (EFF) | Polypropylene with colorant (orange
masterbatch) | Not applicable | EFF component is made in same material than Plunger Rod with addition of an orange dye** |
| Mechanical specification | | | |
| Specifications | Internal specifications | | Same specifications unless 2 items (syringe loading and EFF disassembly) adapted due to the change in the design |
| | * Change has been assessed. Biocompatibility | tests conducted (cytotoxicity, irritation and sensitization) demonstrate that Safe'n'Sound® Plajex® version | |
ncluding EFF is biocompatible regarding the see Section 15. Design Vestig, bench testig, and testig and simulated dinial use sucer "Pajer" versio
6
Performance Testing:
Performance has being tested on the Safe'n'Sound® Staked Passive Delivery System -Plajex® version following ISO 23908:2011. Bench testing has been performed following ISO7886-4 and ISO 8537 standards. 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 Testing:
Simulated clinical use testing has been performed. It confirmed that the Safe'n'Sound® Staked Passive Delivery System - Plajex® version could be used to shield needles inside the protection device after use. The study follows Guidance for Industry and FDA Staff for Medical Devices with Sharps Injury Prevention Features dated August 9, 2005 and ISO 23908:2011 standard. It demonstrates that the device is as safe, as effective, and performs as well as the predicate device.
Conclusion:
Based upon the design, technology, performance, functional testing, and intended use, the Safe'n'Sound® Staked Passive Delivery System - Plajex® version is substantially equivalent to predicate device currently marketed under the Federal Food, Drug and Cosmetic Act. Tests performed demonstrates that Safe'n'Sound® Staked Passive Delivery System - Plajex® version is as safe and as effective as the predicate device.