(115 days)
Not Found
No
The device description and intended use focus on the mechanical application of fluids. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The document describes the device as an applicator for fluids, not as a device that directly provides therapy itself. Its intended use is to deliver fluids to a treatment site, which aligns with an accessory function rather than a therapeutic one. The predicate device, "Fibrijet Aerosol Applicator," also suggests a delivery mechanism rather than a therapeutic agent.
No
The device is described as an applicator for delivering fluids to a treatment site, not for diagnosing a condition. Its function is to apply substances, not to provide diagnostic information.
No
The device description explicitly lists physical components such as needles, syringe holder, double piston stopper, nozzle, and syringes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply fluids or liquids to a "treatment site." This indicates application to a living organism (in vivo) rather than testing samples outside the body (in vitro).
- Device Description: The components listed (needles, syringe holder, nozzle, syringes) are consistent with a device used for delivering substances to a patient, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device's function is purely for delivery.
Therefore, the Regen Spray Applicator is a device for applying substances to a treatment site, which falls outside the definition of an In Vitro Diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
treatment site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
Technological Characteristics
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.
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.
2
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.
3
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
4
Enclosure
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5
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