The Reverse Vaccuum (RevVac) Safety Syringe, is a sterile, single use, disposable, autoretracting safety piston syringe which is intended for injection of fluid into the body, while reducing the risk of sharps injury and the potential for syringe reuse. The device is intended for use for subcutaneous and intramuscular use.

Device Description

The ReVac (Reverse Vacuum) Safety Syringe is a piston type hypodermic syringe with an automated needle retraction system. The device works like a typical syringe in that after removal of the cap, the user pulls back the syringe to feed liquid back into the barrel. Once the plunger is fully depressed, and the fluid inside is fully dispensed, a vacuum is created that is sufficient to force the retraction of the needle into the hollow chamber of the syringe. The needle is not visible and is fully inaccessible. The needle cannot be removed from the syringe without completely destroying the syringe.

The ReVac (Reverse Vacuum) Safety Syringe is a piston type hypodermic syringe with an automated needle retraction system. It is sterile, non-toxic, non-pyrogenic, retractable syringe designed to provide a safe reliable method for intramuscular and subcutaneous injection of drugs and or fluids while helping to provide protection from accidental needle sticks.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ReVac Safety Syringe, focusing on its substantial equivalence to a predicate device rather than a comprehensive study to establish specific performance acceptance criteria for a novel device. Therefore, much of the requested information regarding detailed study design, sample sizes, expert involvement, and ground truth establishment is not present in this submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Futura Safety Syringe K000860) based on similarities in intended use, design, and system performance, as well as conformity to internationally recognized standards.

Acceptance Criterion (Inferred from standards and claims)	Reported Device Performance
Intended Use Equivalence: Injection of fluid into the body, reducing sharps injury risk, preventing syringe reuse.	"Both devices are indicated for injecting fluids into the body with a permanently fixed, single lumen hypodermic needle, while helping to reduce the risk of needle sticks."
Design Equivalence (Piston Syringe): Sterile, single-use, disposable, permanently fixed needle.	"Both products are piston syringes, provided sterile, single-use and disposable."
System Performance Equivalence (Needle Retraction): Retracts contaminated needle safely inside syringe immediately after injection.	"Lastly both syringes retract the contaminated hypodermic needle safely inside syringe immediately after the completion of the patient injection."
Biocompatibility: Meets safety standards for biological interaction (ISO 10993-1:1997).	"The testing provided in the premarket notification includes biocompatibility..."
Sterility: Meets standards for sterile hypodermic syringes (ISO 7886-1:1993, ISO 7864:1993).	"The ReVac (Reverse Vacuum) Safety Syringe... is sterile, non-toxic, non-pyrogenic..."
Functionality (e.g., auto-disable, fixed dose for immunization): (ISO 7886-3:2005 - Note: This standard applies to auto-disable syringes for fixed dose immunization. While listed, the document doesn't explicitly state the ReVac is a fixed-dose syringe, so its specific applicability needs further context.)	"The ReVac (Reverse Vacuum) Safety Syringe is a piston type hypodermic syringe with an automated needle retraction system."

Study Details

Sample size used for the test set and the data provenance:
- The document mentions "Side by Side equivalence information with the Futura Safety Syringe is provided to show that the two products are equivalent in performance." However, it does not specify the sample size used for this comparative testing.
- The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The testing described appears to be primarily laboratory-based physical/mechanical testing against standards and direct comparison rather than relying on expert clinical assessment for "ground truth" in the way a diagnostic device might.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of the device (a safety syringe) and the type of testing described (biocompatibility, standard conformity, side-by-side performance), it's unlikely a clinical adjudication method like 2+1 or 3+1 would be applicable.
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:
- A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to a safety syringe device. This type of study is typically used for diagnostic imaging or AI-assisted diagnostic tools.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable to a medical device like a safety syringe. The device itself is the "standalone" component in its intended use. There is no AI algorithm being evaluated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance comparison, the "ground truth" would likely be the established performance and safety profile of the predicate device, as determined by its own regulatory clearance and adherence to relevant standards. For the ReVac syringe, conformity to the listed ISO standards and functional performance mimicking the predicate device served as the basis for equivalence.
The sample size for the training set:
- This is not applicable. This device does not use machine learning or AI models, so there is no training set.
How the ground truth for the training set was established:
- This is not applicable as there is no training set for this device.

Summary

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ReVac Safety Syringe 510(k) Premarket-Notification Submission

510(k) Summary

1.) Submitted by: Revolutions Medical Corporation Inc. 2073 Shell Ring Circle Mount Pleasant, SC 29466 Registration: 10027335

FEB 1 3 2009

Revolutions Medical Corporation Inc. 2.) Contact: 2073 Shell Ring Circle Mount Pleasant, SC 29466 F. David Rothkopf 617-899-3449 508-231-8861 Fax DROTHK@AOL.COM

3.) Device Name: ReVac Auto Retractable Safety Syringe

4.) Classification Name: Piston Syringe (with permanently attached needle)

Class II, 21 CFR 880.5860 5.) Device Class:

Panel: 80

Product Code: FMF, MEG

6.) Predicate Devices:

Futura Safety Syringe K000860

7.) Device Description:

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K083/193
Pg 2 of 2

8.) Device Intended Use:

The Reverse Vacuum (RevVac) Safety Syringe is a sterile, single use, disposable, autoretracting safety piston syringe which is intended for injection of fluid into the body, while reducing the risk of sharps injury and the potential for syringe reuse. The device is intended for use for subcutaneous and intramuscular use.

9.) Substantial Equivalence Comparison

A. Revolutions Medical Corporation makes the claim of substantial equivalence of the ReVac Safety Syringe to the Futura Safety Syringe K000860 based on similarities in intended use, design, and system performance. Both devices are indicated for injecting fluids into the body with a permanently fixed, single lumen hypodermic needle, while helping to reduce the risk of needle sticks. Both products are piston syringes, provided sterile, singleuse and disposable. Lastly both syringes retract the contaminated hypodermic needle safely inside syringe immediately after the completion of the patient injection.

10.) Brief Description of Testing

The testing provided in the premarket notification includes biocompatibility and standard conformity. Side by Side equivalence information with the Futura Safety Syringe is provided to show that the two products are equivalent in performance. The testing supports the claimed indications for use.

The ReVac safety syringe 3cc/ml was tested to the internationally recognized standards listing in Table 1.

Standard ID	Title
ISO 7886-1:1993	Sterile Hypodermic syringe for Single Use
ISO 7886-3:2005	Sterile Hypodermic syringe for Single Use –Auto disable Syringes for Fixed Dose Immunization
ISO7864: 1993	Sterile Hypodermic Needle for Single Use-Syringes for Manual Use
ISO 10993-1:1997	Biological Evaluation of Medical Devices —Evaluation and testingTable 1

In addition, the contents of this premarket notification are provided with the consideration of the FDA's "Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes; FDA April 1993" and "Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff."

11) Conclusion

Revolutions Medical believes that the ReVac Auto Retractable Safety Syringe is substantially equivalent to the predicate device Futura Safety Syringe based on intended usage and system performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2009

Son Medical C/o Mr. Richard Theriault Acting Vice President Engineering/Manufacturing Revolutions Medical Corporation 2073 Shell Ring Circle Mount Pleasant, South Carolina 29466

Re: ' K083193

Trade/Device Name: ReVac Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMF Dated: January 16, 2009 Received: January 22, 2009

Dear Mr. Theriault:

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 Federal Register.

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Page 2 - Mr. Theriault

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 (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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D. watson for

Ginette Y. Michaud, M.D. Acting 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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ReVac Safety Syringe 510(k) Premarket-Notification Submission

Indications for Use Form

510(k) Number (if known): K083193

Device Name: ReVac Safety Syringe

Indications for Use:

Prescription Use X OR

Over-the-Counter Use 21 CFR 801.109

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

Concurrence of CDRH, Office of Device Evaluation (ODE).

St. Ole Sa

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

510(k) Number: K083193

CONFIDENTIAL Revolutions Medical Inc. 510(k) October 27, 2008

ReVac Safety Syringe

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).