Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is designed for use in applying two non-homogeneous fluids or liquids to a treatment site as deemed necessary by the clinical use requirements.

Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is for single use only.

Device Description

The Regen Spray Applicator (models R-A/NAC) & R-A/NAC3) is a self-contained disposable kit aiding to simultaneous delivery of two non-homogeneous fluids or liguids to a treatment site-as deemed necessary by the clinical use requirements.

The Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is comprised of sterile disposable needles, syringe holder, double piston stopper, nozzle, and syringes.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Regen Spray Applicator." It describes the device, its intended use, technological characteristics, and sterilization method, and states that it functions as intended. However, this document does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria through empirical data analysis.

Here's why the requested information cannot be extracted from the given text:

No Acceptance Criteria or Reported Device Performance Table: The document explicitly states: "No performance standards have been developed for this type of device." and then generally mentions, "In all instances, the Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) functioned as intended and the performance based on fluids dispensed from the applicator when the syringe plungers are depressing was as expected." This is a qualitative statement, not a quantitative table with specific criteria and results.
No Sample Size or Data Provenance for Test Set: Since no formal performance study with a test set is described, this information is absent.
No Information on Experts for Ground Truth: As there's no diagnostic or analytical study requiring ground truth establishment by experts, this detail is not present.
No Adjudication Method: Related to point 3, no adjudication method is mentioned.
No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The device is a "Spray Applicator," which is a delivery mechanism for fluids, not an imaging or diagnostic device that would typically involve human readers for interpretation, hence no MRMC study.
No Standalone Performance Study: While it states the device "functioned as intended," it does not provide details of a standalone, algorithm-only performance study with a specific methodology or metrics. The device is a physical tool, not an algorithm.
No Type of Ground Truth Used: Not applicable, as there's no diagnostic claim requiring a ground truth.
No Sample Size for Training Set: The device is a hardware device; thus, there is no "training set" in the context of an AI/ML algorithm.
No Ground Truth Establishment for Training Set: Not applicable for the same reason as point 8.

In summary, the provided document is a 510(k) Pre-Market Notification summary focused on establishing substantial equivalence to a predicate device rather than presenting a detailed performance study with quantitative acceptance criteria and empirical results for the new device's functionality.

Summary

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Image /page/0/Picture/0 description: The image shows the word "regentlab" in a stylized font. The first four letters, "rege," are in a bold, solid black font. The letters "ntlab" are outlined with a thin black line and filled with a gray pattern. To the right of the word is a circular design made up of a central cluster of dots surrounded by two concentric rings of smaller dots.

K 122122

510(k) SUMMARY

Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3)

NOV 9 .. .

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

RegenLab America 3428 Avenue Marcil Montreal (Quebec) H4A 2Z3 Canada

Phone: (514) 817-6704 Facsimile: (514) 484-6704

Contact Person: Guy Fortier, Ph.D.

Date Prepared: 4th July, 2012

Name of Device and Name/Address of Sponsor

Name of Device: Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3)

Sponsor: Regen Lab SA En Budron B2 Le Mont-sur-Lausanne, Vaud, CH-1052 Switzerland

Classification Name	Piston, Syringe (21 CFR 880.5860)
Classification	Class II
Product Code	FMF
Predicate Devices	Fibrijet Aerosol Applicator (K012868) from Micromedics;

Intended Use / Indications for Use

The Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is designed for use in applying two non-homogeneous fluids or liquids to a treatment site as deemed necessary by the clinical use requirements.

Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is for single use only.

510(k) Premarket Notification --Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) Page 22

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Technological Characteristics

The Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is comprised of sterile disposable needles, syringe holder, double piston stopper, nozzle, and syringes.

Sterilization

The Regen Sprav Applicator (models R-A/NAC1 & R-A/NAC3) is terminally sterilized by gamma irradiation (minimal dose: 25 kGv). Full cycle sterilization is designed to provide a minimum Sterility Assurance Level (SAL) of 100.

Safety and Performance Data

Biocompatibility data have been provided to support the safety of Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3). No performance standards have been developed for this type of device.

In all instances, the Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) functioned as intended and the performance based on fluids dispensed from the applicator when the syringe plungers are depressing was as expected.

Substantial Equivalence

The Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is as safe and effective as the predicate device. The Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between Regen Sprav Applicator (models R-A/NAC1 & R-A/NAC3) and its predicate device raise no new issues of safety or effectiveness. Thus, Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is substantially equivalent.

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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 consists of a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 9, 2012

Regen Lab SA C/O Guy Fortier, Ph.D. RegenLab America 3428 Avenue Marcil Montreal, Quebec H4A 2Z3 CANADA

Re: K122122

Trade/Device Name: Regen Spray Applicator (models R-A/NAC1 and R-A/NAC3) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 4, 2012 Received: July 7, 2012

Dear Dr. Fortier:

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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Page 2 - Dr. Fortier

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucml 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou People, cn=Anthony D.
Watson,
0.9.2342.19200300.100.1.1-1300092402
Date: 2012.11.09 13:59:57-05'00'

Anthony D. Watson, B.S., M.S., M.B.A. 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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Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3)

Indications for Use:

Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is designed for use in applying two non-homogeneous fluids or liquids to a treatment site as deemed necessary by the clinical use requirements.

Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is for single use only.

Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

filM for RZC Nov 9, 2012

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

KI22122 510(k) Number:

Page 1_of

510(k) Premarket Notification -Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) Page 20

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).