(101 days)
Single use device that is 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 needle sticks. The devices can be used on a wide range of patients including children and adults.
This submission is provided for modifications to the predicate device, which includes design changes and a plunger rod raw material change. For details, please refer to Attachment 1 for Design Modifications Rationale. The Safe'n'Sound® Staked Passive Delivery System – Cone Version is a single use anti-needle stick accessory for use with sterile 1 mL-long staked needle prefilled ISO Standard glass syringes. It fits with 1 mL-long staked syringes with a maximum needle length of 1/2" and consists of a subassembly (body, cone, sleeve, and spring) and a loose plunger rod.
The provided document is a 510(k) summary for the Safe'n'Sound® Staked Passive Delivery System - Cone Version. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics in a quantitative manner, detailed study protocols, sample sizes for training or test sets, information on ground truth establishment, or expert involvement in adjudication for a medical image analysis or diagnostic AI device.
The document outlines performance testing in general terms: "Bench testing has been performed on the Safe'n'Sound® Staked Passive Delivery System - Cone version. 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." It also mentions "Simulated clinical use testing has been performed. It confirmed that the Safe'n'Sound® Staked Passive Delivery System - Cone version could be used safely and effectively to shield needles inside the protection device after use."
Since this is a submission for a piston syringe accessory and not an AI/ML medical device for diagnosis or image analysis, many of the requested categories (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, or specific acceptance criteria for diagnostic performance) are not applicable or are not detailed in the provided text.
Based on the nature of the device (a mechanical accessory for syringes), the "acceptance criteria" would primarily revolve around functional performance, safety, and biocompatibility, rather than diagnostic accuracy metrics like sensitivity or specificity.
Therefore, I cannot populate most of the requested table and information as it pertains to AI/ML device studies. I will address what can be inferred from the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from document) | Reported Device Performance (Inferred from document) |
|---|---|---|
| Functional Performance | Device functions as intended (e.g., aids in protection from accidental needle sticks, effectively shields needles after use). | "Confirmed the product functions as intended and is substantially equivalent to the predicate device." "Confirmed that the Safe'n'Sound® Staked Passive Delivery System - Cone version could be used safely and effectively to shield needles inside the protection device after use." |
| Biocompatibility | Meets ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) requirements. | "Biocompatibility testing performed demonstrates that the product meets ISO 10993-5 and ISO 10993-10 requirements." |
| Safety | Prevents accidental needle sticks from prefilled 1 mL-long staked needle ISO Standard glass syringes for healthcare professionals, self-injecting patients, and individuals assisting them. Performs safely during simulated clinical use. | "Aids in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needle sticks." "Confirmed that the Safe'n'Sound® Staked Passive Delivery System - Cone version could be used safely and effectively..." |
| Rigidity | Plunger rod is sufficiently stiff to improve rigidity (implied comparative acceptance vs. predicate or previous material). | New polypropylene resin for the plunger rod is "slightly stiffer to improve rigidity." The changes (including material change) "have proven to be insignificant based upon design and process validations, bench testing, biocompatibility testing and simulated clinical use studies performed," implying the new rigidity meets functional requirements. |
| Insertion Force | Reduced insertion force for prefilled syringes (implied comparative acceptance vs. predicate due to sleeve design changes). | "Sleeve design changes, including syringe clips (2 of 6) are reduced in size so that insertion force of the prefilled syringe is reduced." The changes "have proven to be insignificant based upon design and process validations, bench testing, biocompatibility testing and simulated clinical use studies performed," implying the reduced force is acceptable and functional. |
| Material/Design Changes | Changes to design (body, cone, sleeve clips) and plunger rod material (new polypropylene resin) do not negatively impact safety or effectiveness and maintain substantial equivalence to the predicate device. | "These design changes have proven to be insignificant based upon design and process validations, bench testing, biocompatibility testing and simulated clinical use studies performed." "The Safe'n'Sound® Staked Passive Delivery System - Cone version raises no new issues of safety or effectiveness." |
Due to the nature of the device and the provided document, the following sections cannot be answered with specific details as they pertain primarily to diagnostic AI/ML studies and are not documented here for this mechanical device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "Bench testing" and "Simulated clinical use testing" but does not specify sample sizes for these tests or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable as the device is a mechanical accessory, not a diagnostic tool requiring expert interpretation for "ground truth".
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable for a mechanical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable as the device is a syringe accessory, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable as the device is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a mechanical device like this, "ground truth" would be established via engineering specifications, functional requirements, and safety standards (e.g., successful needle shielding, no accidental sticks, material integrity). The document does not detail the specific methodology for establishing this "ground truth" beyond stating successful testing.
8. The sample size for the training set
- This is not applicable as there is no "training set" for a mechanical device in this context.
9. How the ground truth for the training set was established
- This is not applicable as there is no "training set" for a mechanical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2014
Nemera Ms. Beatrice Grand Demars Regulatory Scientist 600 Deerfield Parkway Buffalo Grove, IL 60089
Re: K141664
Trade/Device Name: Safe'n'Sound® Staked Passive Delivery System - Cone Version Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Accessory Regulatory Class: II Product Code: MEG Dated: September 1, 2014 Received: September 5, 2014
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.
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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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runner DDS, MA
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
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Indications for Use
510(k) Number (if known) K141664
Device Name
Safe'n'Sound® Staked Passive Delivery System - Cone version
Indications for Use (Describe)
Single use device that is 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 patiental needle sticks. The devices can be used on a wide range of patients including children and adults.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5 - Page 1 of 2
| Assigned 510(k) number: | K141664 |
|---|---|
| Company: | Nemera600 Deerfield ParkwayBuffalo Grove, IL 60089Phone: (800) 537-0178Fax: (847) 325-3795 |
| Contact: | Beatrice GRAND DEMARS |
| Date Prepared: | September 11, 2014 |
| Trade/Proprietary Name: | Safe'n'Sound® Staked Passive Delivery System -Cone version |
| Classification Name: | Antistick piston syringe accessory |
| Classification/Product Code: | 21 CFR 880.5860, Class II, Product Code MEG |
| Predicate Device: | K101233 Safe'n'Sound® Passive Delivery Systemby Rexam Healthcare |
| Device Description: | This submission is provided for modifications to thepredicate device, which includes design changesand a plunger rod raw material change. For details,please refer to Attachment 1 for DesignModifications Rationale. The Safe'n'Sound®Staked Passive Delivery System – Cone Version is asingle use anti-needle stick accessory for use withsterile 1 mL-long staked needle prefilled ISOStandard glass syringes. It fits with 1 mL-longstaked syringes with a maximum needle length of1/2" and consists of a subassembly (body, cone,sleeve, and spring) and a loose plunger rod. |
| Intended Use: | Single use device that is indicated for use as anaccessory with sterile 1 mL-long staked needleprefilled ISO Standard glass syringes to aid in theprotection of healthcare professionals, patients whoself-inject doctor prescribed medications, andindividuals that assist self-injecting patients, fromaccidental needle sticks. The devices can be used ona wide range of patients including children and |
| Technological CharacteristicComparison Summary toPredicate Device: | The Safe'n'Sound® Staked Passive Delivery System– Cone version is similar to the predicate device ingeneral technological features and principle ofoperation. Both are molded plastic subassembliesand plunger rod. Both have a spring that activatesupon injection completion to fully contain theneedle. However, the Safe'n'Sound® Staked PassiveDelivery System - Cone version body part is splitinto two (2) components (Body and Cone). Theproximal end of the body is slightly redesigned.These changes enable an enhanced view of the unitof measure. Sleeve design changes, includingsyringe clips (2 of 6) are reduced in size so thatinsertion force of the prefilled syringe is reduced.Change to a new polypropylene resin for theplunger rod, which is slightly stiffer to improverigidity. These design changes have proven to beinsignificant based upon design and processvalidations, bench testing, biocompatibility testingand simulated clinical use studies performed. |
| Performance Testing: | Bench testing has been performed on theSafe'n'Sound® Staked Passive Delivery System -Cone version. It confirmed the product functions asintended and is substantially equivalent to thepredicate device. Biocompatibility testingperformed demonstrates that the product meets ISO10993-5 and ISO 10993-10 requirements. |
| Simulated Clinical Testing: | Simulated clinical use testing has been performed. Itconfirmed that the Safe'n'Sound® Staked PassiveDelivery System - Cone version could be usedsafely and effectively to shield needles inside theprotection device after use. |
| Conclusion: | Based upon the design, technology, performance,functional testing, and intended use, theSafe'n'Sound® Staked Passive Delivery System -Cone version is substantially equivalent to predicatedevices currently marketed under the Federal Food,Drug and Cosmetic Act. The Safe'n'Sound® StakedPassive Delivery System - Cone version raises nonew issues of safety or effectiveness. |
adults.
Section 5: 510(k) Summary
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§ 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).