PROCEDUR SF SAFETY SYRINGE DEVICE by AVANCA MEDICAL DEVICES, INC.

The Procedur-SF device is used to inject fluids into, or withdraw fluids from, the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Device Description

The Procedur-SF device is a piston safety syringe. The Procedur-SF device utilizes two syringes assembled in a plastic holder. The syringe plungers are connected by a pulley.

AI/ML Overview

This looks like a 510(k) summary for a medical device called "Procedur-SF," which is a piston safety syringe. This document primarily focuses on the regulatory clearance process, specifically demonstrating "substantial equivalence" to predicate devices, rather than detailed performance study results with acceptance criteria.

Therefore, much of the requested information (like specific acceptance criteria, sample sizes for test sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and detailed training set information) is not present in the provided document. This is typical for a 510(k) summary, which generally doesn't include the granular details of performance testing unless it's a novel technology requiring extensive de novo clinical data.

However, I can extract what is available and indicate what is missing:

Here's an analysis of the provided 510(k) summary regarding the Procedur-SF safety syringe:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from document)	Reported Device Performance (from document)
Not explicitly stated in terms of quantitative criteria or benchmarks. The filing focuses on demonstrating substantial equivalence to predicate devices.	The device is deemed "substantially equivalent" to predicate devices (Becton Dickinson Single Use Hypodermic Syringes K980987 and Retractable Technologies, Inc. VanishPoint Safety Syringe K980069) for its intended use. This implies its performance characteristics, particularly regarding safety to reduce sharps injuries and prevent reuse, are comparable to these legally marketed devices.

Missing Information: Typical acceptance criteria for a safety syringe might include:

Force required for activation of the safety mechanism.
Reliability of the safety mechanism (e.g., successful activation rate).
Prevention of accidental needle sticks post-use.
Prevention of syringe re-use.
Fluid delivery/withdrawal accuracy.
Compatibility with different needle gauges.
Biocompatibility.
Sterility assurance.
Shelf life.

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

Sample Size (Test Set): Not specified in the provided document.
Data Provenance: Not specified. Based on the 510(k) process, this would typically involve in-vitro (bench) testing, and potentially some limited human factors or simulated use testing, but the document does not detail the specifics of such studies.

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

Number of Experts: Not applicable/not specified. The device is a physical medical device (syringe), not an AI/diagnostic tool requiring expert-established ground truth for image interpretation or diagnosis. Performance would be assessed through objective engineering and biological tests.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Performance testing for a syringe would involve objective measurements and observations rather than expert adjudication in the context of diagnostic interpretation.

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

MRMC Study: No, this type of study is not relevant for a safety syringe. MRMC studies are typically performed for diagnostic imaging devices or algorithms where human readers interpret cases.

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

Standalone Performance: Not applicable. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly detailed. For a device like a safety syringe, "ground truth" would be established through:
- Engineering specifications and test standards: Conformance to established design parameters, material properties, and performance benchmarks (e.g., ASTM standards for medical devices).
- Bench testing: Objective measurements of mechanical properties, fluid dynamics, and safety mechanism functionality.
- Biocompatibility testing: Compliance with ISO 10993 standards.
- Sterility testing: Assurance of sterilization methods.
- Simulated use testing: To evaluate the safety mechanism's effectiveness in preventing sharps injuries and reuse under controlled conditions.
  The document states the device "utilizes two syringes assembled in a plastic holder. The syringe plungers are connected by a pulley," implying a mechanical design to achieve the safety features.

8. The Sample Size for the Training Set

Sample Size (Training Set): Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set." Device design and development typically involve iterative prototyping and testing, rather than a formal "training set" in the AI sense.

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

Ground Truth (Training Set): Not applicable.

Summary of What the Document Provides:

The provided 510(k) summary for the Procedur-SF safety syringe is a regulatory notification document. Its primary purpose is to demonstrate substantial equivalence to existing, legally marketed predicate devices (Becton Dickinson Single Use Hypodermic Syringes K980987 and Ret retractable Technologies, Inc. VanishPoint Safety Syringe K980069).

This means the applicant asserted that their device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The FDA's clearance (letter dated JAN 21 2005) indicates agreement with this assertion.

Therefore, the "study that proves the device meets the acceptance criteria" is implicitly the set of engineering, safety, and performance tests (not detailed in this summary but required for 510(k) submission) that allowed the FDA to determine substantial equivalence to devices that have already met safety and effectiveness standards. The specific quantitative results and acceptance criteria from those underlying tests are not included in this high-level summary.

Summary

{0}------------------------------------------------

K042487

JAN 2 1 2005

510(K) SUMMARY

Sponsor:	Avanca Medical Devices, Inc.800 Bradbury SEAlbuquerque, NM 87106
Submitted By:	Ferguson MedicalConsultant to Avanca Medical Devices, Inc.
Contact Information:	Phone: 505.272.7000FAX: 505.272.7000
Classification Name:	Piston syringe, antistick
Common/Usual Name:	Syringe, safety syringe, injection syringe,aspiration syringe and others
Proprietary Name:	Procedur-SF
Classification Number:	21 CFR 880.5860/Procode ${90}$ FMF/ ${90}$ MEG
Substantial Equivalence:	Becton Dickinson Single Use HypodermicSyringes (K980987) and RetractableTechnologies, Inc. VanishPoint Safety Syringe(K980069)
Device Description:	The Procedur-SF device is a piston safetysyringe
Intended Use:	The Procedur-SF device is intended to be usedto inject fluids into, or withdraw fluids from,the body, while reducing the risk of sharpsinjuries and potential for syringe reuse
Technological Characteristics:	The Procedur-SF device utilizes two syringesassembled in a plastic holder. The syringeplungers are connected by a pulley

{1}------------------------------------------------

Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines that appear to be emanating from a central point.

JAN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Avanca Medical Devices, Incorporated C/O Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road, NE #931 Albuquerque, New Mexico 87111

Re: K042487

Trade/Device Name: Procedur SF Safety Syringe Device Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 12, 2004 Received: December 27, 2004

Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined the device is substantially equivalent (for the referenced above and have acternines re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate comments, or to that have been reclassified in accordance with the provisions of Amendinens, of to devroes mar na ris of the that do not require approval of a premarket the rederal I ood, Drug, and Ocenimay, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the First - 1110 Jisting of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is clubstired (200 as a dditional controls. Existing major regulations affecting (PMA), it may of subject to Sach adatof Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 - Mr. Ferguson

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualles of a base your device complies with other requirements mean that IDA has muce a doceminations administered by other Federal agencies. of the Act of ally I ederal statutes and rightenents, including, but not limited to: registration You must comply with an the Here Progations (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality sion 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) This letter will anon your be began mading of substantial equivalence of your device to a premarket notification. - The PDF mailis 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), If you desire specific at 110 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 may obtain 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 yours,

Ching-Lin Liu, Ph.D.

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

{3}------------------------------------------------

Indications For Use

510(k) Number (If known): K042487

Device Name: Procedur-SF

Indications For Use:

The Procedur-SF device is used to inject fluids into, or withdraw fluids from, the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Prescription Use __ ర్ల (Part 21 CFR 801 Subpart D) And/Or

Over-The- Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE

from link

്സ്ision Sign-Off) (വിടിനെ ടിറ്റ്റ്-Off)
Division of Anesthesiology, General Hospital.
Division of Anesthesiology, General Devices Division of Antonion Control, Dental Devices

:10(k) Number:________________________________________________________________________________________________________________________________________________________________ Page 1 of 1

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).