A sterile, single-use hypodermic syringe, incorporating a safety mechanism designed to withdraw the needle back into the safety shield after use and lock it in this position. To be used for injecting medications or fluid into the patient by attached cannula or via IV therapy or to draw samples or fluids by the same means.

Device Description

The Smartlock™ safety syringe is a sterile, single use hypodermic syringe incorporating an innovative safety mechanism. It is designed to withdraw the needle into the safety shield after use and to lock it in this position. The syringe consists of three parts: a safety shield, a barrel and a plunger. There is no rubber piston. The syringe is packaged fully assembled and no set-up action or pre-use motion is necessary. Needles are attached in the standard luerslip method and can be changed during a procedure, if necessary. The materials used in production are medical grade polypropylene and polyethylene. As the last of the medication is delivered, the plunger rim will disengage the safety clips from the shoulder. As the plunger is retracted (as if to refill), the needle will also retract. The plunger must be retracted fully until a "click" sound is heard and no movement is possible. Disposal is then simple and safe. The functioning of the 3ml, 5ml and 10ml Smartlock ™ Safety Syringes are identical in all respects, save the amount of fluid which can be aspirated.

AI/ML Overview

The provided text describes the "Smartlock™ Safety Syringe" and presents information from a 510(k) submission, including a comparison to predicate devices and results from a clinical trial and a simulated use study. However, the document does not explicitly state acceptance criteria for the device. Instead, it aims to demonstrate substantial equivalence to existing predicate devices.

Therefore, the response below will focus on explaining how the studies demonstrate substantial equivalence, rather than directly fulfilling a "reported device performance" against "acceptance criteria" table as the document does not provide such a table.

1. Table of Acceptance Criteria and Reported Device Performance

As the provided document is a 510(k) summary, it focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and reporting performance against them. The "acceptance criteria" for a 510(k) would generally be the performance of the predicate device, which the new device aims to match or be non-inferior to.

The studies aim to show that the Smartlock™ safety syringe performs comparably to or better than the predicate devices in relevant aspects. The key performance metrics evaluated were:

Acceptance Criteria (Implied by Predicate Device Performance)	Reported Device Performance (Smartlock™ Safety Syringe)
Clinical Performance (Syringe Functionality)	Substantially equivalent to Becton Dickinson Plastipak™ standard syringe in respect of comparable characteristics. Nurses ranked both types of syringes similarly and positively. Successful functioning of syringes confirmed by monitors and an independent auditor.
Safety Mechanism Usage / Effectiveness	Substantially equivalent to Becton Dickinson Safety-Lok™ safety syringe with respect to the rates of correct usage. The success rates in correctly using the Smartlock™ safety syringe did not significantly differ from the Safety-Lok™. "In-service" training sessions enhance the rate of correct usage for both safety syringes, with the Safety-Lok™ scoring slightly higher with this added training. The intention of the safety mechanism (needle retraction and locking) is fulfilled, rendering the syringe unusable after activation.
Physical and Operational Characteristics	Generally comparable in intended use, syringe size (5ml), type (single-use), and the principle of operation for 3ml, 5ml, and 10ml versions. Key differences exist in the number of parts (3 vs 6), materials (polypropylene/polyethylene vs silicone rubber in predicate), connection type (luerslip vs luerlock), scaling (read in reverse off plunger vs forward off barrel), and aspiration method. The safety feature operates by needle retraction and locking in one operation, activated manually after medication dispensing, similar in intent to the Safety-Lok™ pulling a shield over the needle. The Smartlock™ cannot be re-used, similar to the Safety-Lok™. Sterilization via EO gas (vs. Gamma radiation for Safety-Lok™ and EO gas for Plastipak™).

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

Clinical Trial: The clinical trial involved nurses in three South African hospitals. The exact number of nurses or syringes evaluated is not specified.
Simulated Use Study: The simulated use study was conducted at three separate American hospitals. The exact number of participants or simulated uses is not specified.

Both studies appear to be prospective in nature, as they involve monitoring and evaluations during actual or simulated use.

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

Clinical Trial:
- Monitors: "Experienced personnel" monitored the actual use of syringes by nurses. No further specific qualifications or number of monitors are given.
- Auditor: An "independent auditor" evaluated the number of syringes which functioned successfully. No specific qualifications (e.g., medical background, experience years) or number of auditors are given.
Simulated Use Study: No specific experts are mentioned for establishing ground truth, as the study focused on comparing correct usage rates between the two safety syringes among nurses who received instruction.

4. Adjudication Method for the Test Set

Clinical Trial: There isn't an explicit "adjudication method" described in the sense of resolving disagreements between multiple expert reads. However, "experienced personnel" monitored use, and an "independent auditor" evaluated successful function, suggesting a form of review process.
Simulated Use Study: The study assessed "success rates in correctly using" the syringes. The method of determining "correct usage" is not detailed, so no specific adjudication method is mentioned.

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

No, a formal Multi-Reader, Multi-Case (MRMC) comparative effectiveness study, as typically performed for diagnostic imaging devices, was not conducted. The studies involved nurses (users/readers) but focused on their ability to correctly use the device and their subjective experience, rather than their diagnostic accuracy across multiple cases with and without AI assistance. The device is a syringe, not a diagnostic tool requiring interpretation by multiple readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

This question is not applicable to the Smartlock™ Safety Syringe. This device is a physical medical instrument (a syringe), not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for this product.

7. The Type of Ground Truth Used

Clinical Trial: The ground truth for the clinical trial was the observed successful functioning of the syringes during actual use and the subjective experiences/ranking of nurses. This is performance and usability ground truth.
Simulated Use Study: The ground truth for the simulated use study was the rate of correct usage of the safety mechanism by nurses, and potentially their subjective feedback, which falls under usability and performance.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this device. A training set is typically relevant for machine learning algorithms. As the Smartlock™ Safety Syringe is a physical medical device, not an AI or algorithm, the concept of a training set as described here does not apply.

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

Not applicable, as there is no training set for this device.

Summary

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ATTACHMENT D

$\times$ 9 73888

3 1998 JUN

510(k) Summary

Applicant 1.

Medical Innovations Limited Exchange House Athol Street Douglas Isle of Man

Contact Persons:

Daniel Kracov USA: Patton Boggs LLP 2550 M Street, N.W. Washington, D.C. 20037 (202) 457-5623 (202) 457-6315 (fax)

South Africa: John Tyler Medical Innovations Limited c/o Design Equity (Pty) Ltd 7th Floor Norwich Life Towers 13 Fredman Drive Sandton +27 11 884 0614 +27 11 884 4163 (fax)

2. Device Details

Smartlock TM Syringe Trade Name: hypodermic syringe, safety syringe, Common Names: piston syringe with safety mechanism Classification Name: piston syringe ll Class:

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Predicate Devices 3.

The Smartlock™ safety syringe is substantially equivalent to the Becton Dickinson Plastipak™ standard syringe in use.

The Smartlock™ safety syringe is also substantially equivalent to the Becton Dickinson Safety-Lok™ safety syringe

Product Description 4.

Image /page/1/Figure/5 description: The image shows a black and white drawing of a syringe. The syringe has a needle on the left side and a plunger on the right side. The barrel of the syringe has markings that indicate the volume of fluid inside. The plunger is partially depressed, indicating that some fluid has already been expelled from the syringe.

Smartlock™ Safety Syringe - 5ml

The Smartlock™ safety syringe is a slight departure from standard syringes in that whilst it consists of three parts i.e. a safety shield, a barrel and a plunger, there are differences in their design. There is no rubber piston. The syringe is packaged fully assembled and no set-up action or pre-use motion is necessary. Needles are attached in the standard luerslip method and can be changed during a procedure, if necessary. The materials used in production are medical grade polypropylene and polyethylene.

As the last of the medication is delivered, the plunger rim will disengage the safety clips from the shoulder. As the plunger is retracted (as if to refill), the needle will also retract. The plunger must be retracted fully until a "click" sound is heard and no movement is possible. Disposal is then simple and safe. The functioning of the 3ml, 5ml and 10ml Smartlock ™ Safety Syringes are identical in all respects, save the amount of fluid which can be aspirated.

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5. Intended Use

The Smartlock™ safety syringe is intended as a sterile, single use, disposable syringe to be used for injecting medications or fluids into the patient by attached cannula or via intravenous therapy, or to draw samples or fluids by the same means. Only once the medication has been administered or the sample taken, should the safety mechanism be activated.

The intention of the safety mechanism is, after use of the syringe, to bring the needle within the safety shield in one motion and to lock it in that position. rendering the syringe unusable. The safety mechanism has no effect on the efficacy of the syringe in regard to its performing the function of a standard syringe. The 3ml, 5ml and 10ml Smartlock™ syringes all function using the same principle and all have the same intended use.

The Smartlock™ syringes are not intended to be used with syringe pumps. The appropriate warnings are printed on the syringe labeling.

6. Comparison

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-4-COMPARISON OF SYRINGES

COMPARISON	Smartlock™ SAFETY SYRINGE	B-D SAFETY-LOK™	B-D PLASTIPAK™
Syringe Size	5ml - single use	5 ml - single use	5ml - single use
Syringe Type	Safety	Safety	Standard
Number of Parts	3	6	3
Materials	Safety shield and Plunger -PolypropyleneBarrel - PolyethyleneAll components silicone free	Plunger, Barrel, Safety shield,Locking Ring - PolypropylenePiston - Silicone Rubber	Plunger and Barrel - PolypropylenePiston - Silicone Rubber
Connection Type	Luerslip	Luerlock	Luerlock
Scales andMarkings	Graduations as per ISO 7886 with scaleintervals of 0.5ml.Blue indicator arrow at base of safetyshield.All graduations can be clearly read.Use once only.Trademark symbol	Graduations as per ISO 7886withscale intervals of 0.2ml.Green strip around safety shield.Graduations can only be read throughthe safety shield.Sterile single use.Trademark symbol.	Graduations as per ISO 7886 with scaleintervals of 0.5ml.Graduations can be clearly read.Trademark symbol.
Color	Parts - virgin material (clear)Printing - blue	Parts - virgin material (clear)- red locking ringPrinting - black and green	Parts - virgin material (clear)Printing - black
Safety Feature	Needle retracts into safety shield andlocks in one operation.Mechanism activated manually ondispensing of medication.	Safety shield is pulled over needleand locks in one operation.Mechanism activated manually ondispensing of medication.	No safety feature.
-5-
Numbering	Read in reverse off plunger.	Read forward off barrel.	Read forward off barrel.
Aspiration	Fluid fills into the plunger as the plungeris withdrawn.	Fluid fills into the barrel as theplunger is withdrawn.	Fluid fills into the barrel as the plungeris withdrawn.
VolumeDetermination	Read off the arrow indicator at the baseof the safety shield.	Read off the top edge of the blackrubber piston.	Read off the top edge of the blackrubber piston.
Warnings	Not to be autoclaved.Not suitable for blood gassing.Only to be used with needles 1½" orshorter. Not to be used with syringepumps.	Not to be autoclaved.Only to be used with needles 1½" orshorter. Not to be used with syringepumps.	Do not re-sterilise.Not to be used with paraldehyde.
Intended Use	As a single use, hypodermic syringe.Safety feature protects afteradministration.	As a single use, hypodermic syringe.Safety feature protects afteradministration.	As a single use, hypodermic syringe. Nosafety feature.
Operation	6 steps to operate :1. attach needle / remove needle cap2. draw medication3. expel air4. administer medication5. pull to lock safety mechanism6. dispose	6 steps to operate :1. attach needle / remove needlecap2. draw medication3. expel air4. administer medication5. pull to lock safety mechanism6. dispose	5 steps to operate :1. attach needle / remove needle cap2. draw medication3. expel air4. administer medication5. dispose
Re-usability	Cannot re-use	Cannot re-use	Easy to re-use
Sterilisation	EO gas (non-flammable)	Gamma radiation.	EO gas.
Labeling	1. On primary syringe packaging2. On dispensing box	1. On primary syringe packaging2. On dispensing box	1. On primary syringe packaging2. On dispensing box

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and the same

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Clinical Trial 7.

Clinical trials were held in three South African hospitals to compare the Smartlock™ safety syringe to the Becton Dickinson Plastipak™ standard syringe. The primary hypothesis was that the Smartlock™ safety syringe would be substantially equivalent to the conventional syringe in respect of comparable characteristics.

The information collected was comprehensive and extremely detailed and included both the objective and subjective experiences of the participating nurses. Monitoring of the actual use of syringes by the nurses, was by experienced personnel and evaluation of the number of svringes which functioned successfully was by an independent auditor.

The results were largely clear cut. The nurses ranked both types of syringes similarly and positively, and this was confirmed by the monitors and the auditor. The Smartlock™ safety svringe proved substantial equivalence to the Plastipak™ syringe in use.

8. Simulated Use Study

A simulated use study was conducted at three separate American hospitals. The Smartlock™ safety syringe was compared to the Becton Dickinson Safety syringe. The success rates in correctly using the Smartlock™ safety syringe did not significantly differ from the rates seen with the Becton Dickinson Safety svringe among nurses who received instruction from the package insert. When a verbal "inservice" training session was added, the Safety-Lok™ was scored at a slightly higher level,

The study documented that the Smartlock™ safety syringe is substantially equivalent to the Safety-Lok™ safety syringe with respect to the rates of correct usage. The study also documented that "in-service" training sessions prior to introducing the syringes to hospitals would enhance the rate of correct usage.

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Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 1998

Medical Innovation Limited ·C/O Mr. Daniel A. Kracov Counsel to Medical Innovations Limited Patton Boggs, L.L.P. 2550 M Street N.W. Washington, DC 20037-1350

Re : K973888 Trade Name: Smartlock Safety Syringe Regulatory Class: II Product Code: MEG Dated: March 31, 1998 Received: March 31, 1998

Dear Mr. Kracov:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Kracov

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Tim thy Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Smartlock™ Safety Syringe Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Crescenti

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K973888

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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).