PROCEDUR-10 by AVANCA MEDICAL DEVICES, INC.

A crucial takeaway is that this submission relies on "substantial equivalence" to a predicate device (Avanca Medical Devices Procedur-10 device, K042486) rather than presenting a novel clinical study with explicit acceptance criteria and corresponding performance metrics. The FDA's letter states: "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..."

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not applicable or explicitly stated in this type of submission focused on substantial equivalence for a Class II medical device like a piston syringe. Such devices typically have well-established performance standards and a known safety profile, and substantial equivalence evaluations primarily involve demonstrating that the new device's technological characteristics, materials, and intended use are similar enough to a legally marketed predicate that it raises no new questions of safety or effectiveness.

Despite the lack of a dedicated performance study described in these documents, I will address each point based on what can be inferred or explicitly stated.

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for a Piston Syringe for Substantial Equivalence)	Reported Device Performance (Implied by Substantial Equivalence)
Functionality: Ability to inject and withdraw fluids.	Device performs as intended, similar to predicate syringe.
Material Compatibility: Biocompatible materials.	Materials are appropriate for contact with body fluids.
Dimension & Fit: Compatible with medical connectors (e.g., Luer).	Standard dimensions and fit.
Sterility (if applicable): Maintain sterility for intended use.	Device designed to be sterile or sterilized appropriately.
Leakage/Integrity: No leaks during use.	Device maintains integrity during injection/withdrawal.
Ease of Use: Plunger movement, grip, visual clarity (if transparent).	User-friendly operation.
Safety: No new safety concerns compared to predicate.	Considered safe for its intended use.
Effectiveness: Achieve intended purpose of fluid transfer.	Effectively performs fluid transfer.

Note: These are implied criteria for a piston syringe, not explicitly stated acceptance criteria from a performance study for this specific 510(k) submission. The "reported device performance" is essentially that it functions equivalently to the predicate.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A). The provided documents do not describe a dedicated performance study with a test set, sample size, or data provenance. The submission relies on substantial equivalence to a predicate device already on the market.

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)
- N/A. As no dedicated performance study with a test set is described, there's no mention of experts establishing a ground truth for such a study.

Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set or adjudication method is described within these documents for a performance study.

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
- N/A. This device is a piston syringe, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.

If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a mechanical piston syringe. There is no algorithm or AI component involved, so a standalone algorithm performance study is not applicable.

The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- N/A. Given the reliance on substantial equivalence for a simple mechanical device, the "ground truth" implicitly refers to the well-established performance and safety profile of the predicate device and the general understanding of how piston syringes function. No specific ground truth type for a novel study is mentioned.

The sample size for the training set
- N/A. No training set is applicable or described for this type of submission for a mechanical device.

How the ground truth for the training set was established
- N/A. No training set is applicable or described.

Summary

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NOV - 9 2005

K052075

510(K) SUMMARY

Sponsor:	Avanca Medical Devices, Inc.801 University Blvd SE - Suite 307Albuquerque, NM 87106
Submitted By:	Frank FergusonVice President
Contact Information:	Phone: 505.243.4600FAX: 505.243.4601
Classification Name:	Piston Syringe
Common/Usual Name:	Syringe, injection syringe, aspiration syringeand others
Proprietary Name:	Procedur-10
Classification Number:	21 CFR 880.5860/Procode 80 FMF
Substantial Equivalence:	Avanca Medical Devices Procedur-10 device(K042486)
Device Description:	The Procedur-10 device is a piston syringe
Intended Use:	The Procedur-10 device is intended to be usedto inject fluids into, or withdraw fluids from,the body
Technological Characteristics:	The Procedur-10 device utilizes two syringecomponents assembled in a plastic holder.The syringe plungers are connected by apulley.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2005

Mr. Frank Ferguson Vice President Avanca Medical Devices, Incorporated 801 University Boulevard SE, Suite 307 Albuquerque, New Mexico 87106

Re: K052075

Trade/Device Name: Procedur-10 Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 28, 2005 Received: October 31, 2005

Dear Mr. Ferguson:

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. Ferguson

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 (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.

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 Office of 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 Division 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,

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

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Indications For Use

510(k) Number (If known): หุ บรว 2075

Device Name: Procedur-10

Indications For Use:

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.

Prescription Use __ XX (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)

Apten D.m

Con Sinn-Off) is on ot Anesthesiology, General Hospital, Intection Control, Dental Devices

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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).