(88 days)
Not Found
No
The description focuses on the mechanical and fluid delivery aspects of the device, with no mention of AI or ML capabilities.
No
The device is described as an applicator for two non-homogeneous fluids, meaning it delivers substances, but it doesn't indicate that the device itself provides any therapeutic effect. Its function is to facilitate the application of fluids, not to treat.
No.
The device description states its purpose is for the "application of two non-homogeneous fluids," and it is designed for dispensing rather than for diagnosing conditions or diseases.
No
The device description clearly outlines a physical, sterile, single-use, disposable device with luer connectors, a gas source connector, and packaging, 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 for the "application of two non-homogenous fluids." This describes a process of delivering substances, not a test performed on a sample taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description details a device for connecting syringes and a gas source to apply liquids. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Reagents or test kits
The device appears to be a tool for delivering substances during an endoscopic procedure, which falls under the category of a surgical or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 360° Gas Assisted Endoscopic Applicator is intended for the application of two non-homogenous fluids.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The 360° Gas Assisted Endoscopic Applicator is a sterile, single-use, disposable device intended for the application of two non-homogeneous liquids. The 360° Gas Assisted Endoscopic Applicator is designed with two luer connectors at the proximal end, which is used for connection to two syringes containing the non-homogeneous liquids. There is also a connector at the proximal end to be attached to a tubing set which is connected to a compressed air/inert gas power source. The 360° Gas Assisted Endoscopic Applicator is packaged with an air line with filter in a PETG tray/Tyvek lid configuration and sterilized using ethylene oxide. Five individually sterile packaged applicators are contained in a shelf carton along with the instructions for use.
The endoscopic applicator subject to this special 510(k) incorporates a flexible Pebax tube at the distal end of the applicator which allows for directional positioning of the tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The 360° Gas Assisted Endoscopic Applicator was evaluated through design verification and biocompatibility testing. Biocompatibility testing performed in accordance with ISO 10993 - Biological evaluation of medical devices, Part 1 – Evaluation and tests (2009) show the device is considered safe for use for its intended biocontact. Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use over the labeled shelf life.
- Pull (Torque) Testing .
- Leak Testing .
- . Spray Testing
- Mixing Test .
- . Sterilization Validation
- Shelf life Evaluation .
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Special 510(k) Premarket Notification 360° Gas Assisted Endoscopic Applicator
Image /page/0/Picture/2 description: The image shows the text "K122526" in a handwritten style. The text is written in black ink on a white background. The numbers are slightly stylized, with the "2" having a curved shape.
510(K) Summary
NOV 1 6 2012
Date Prepared: October 12, 2012
| 510(k) Submitter | Contact for Official Correspondence |
|---|---|
| Micromedics, Inc. | |
| 1270 Eagan Industrial Road, Suite 120 | |
| St. Paul, MN 55121-1385 | Jodi L. Raus, MBA, RAC |
| Tel: 651-452-1977; Fax: 651-452-1787 | |
| Email: jodi.raus@nordsonmicromedics.com |
| General Information | |||
|---|---|---|---|
| Trade Name | 360° Gas Assisted Endoscopic | ||
| Applicator | Common Name | Endoscopic Applicator | |
| Classification | |||
| Information | Endoscope and accessories | ||
| per 21 CFR 876.1500 (Class II) | Product Code | GCJ | |
| Panel | General & Plastic Surgery | ||
| Predicate | |||
| Devices | Air Assisted Endoscopic Applicator, K042834 cleared on February 11, 2005 |
Device Description
The 360° Gas Assisted Endoscopic Applicator is a sterile, single-use, disposable device intended for the application of two non-homogeneous liquids. The 360° Gas Assisted Endoscopic Applicator is designed with two luer connectors at the proximal end, which is used for connection to two syringes containing the non-homogeneous liquids. There is also a connector at the proximal end to be attached to a tubing set which is connected to a compressed air/inert gas power source. The 360° Gas Assisted Endoscopic Applicator is packaged with an air line with filter in a PETG tray/Tyvek lid configuration and sterilized using ethylene oxide. Five individually sterile packaged applicators are contained in a shelf carton along with the instructions for use.
Intended Use / Indications
The 360° Gas Assisted Endoscopic Applicator is intended for the application of two non-homogenous fluids.
Substantial Equivalence Comparison
The endoscopic applicator subject to this special 510(k) incorporates a flexible Pebax tube at the distal end of the applicator which allows for directional positioning of the tip.
Summary of Non-Clinical Performance Data
The 360° Gas Assisted Endoscopic Applicator was evaluated through design verification and biocompatibility testing. Biocompatibility testing performed in accordance with ISO 10993 - Biological evaluation of medical devices, Part 1 – Evaluation and tests (2009) show the device is considered safe for use for its intended biocontact. Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use over the labeled shelf life.
- Pull (Torque) Testing .
- Leak Testing .
- . Spray Testing
- Mixing Test .
- . Sterilization Validation
- Shelf life Evaluation .
1
Special 510(k) Premarket Notification 360° Gas Assisted Endoscopic Applicator
Substantial Equivalence Conclusion
Substantial Equivalence Collection
The 360° Gas Assisted Endoscopic Applicator does not raise new questions of safety or effectiveness when compared to the predicate devices and is, therefore, substantially equivalent.
- The remainder of this page intentionally left blank.-
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 16, 2012
Micromedics, Incorporated % Ms. Jodi Raus MBA, RAC Director of Regulatory, Clinical and Quality Affairs 1270 Eagan Industrial Road, Suite 120 Saint Paul, Minnesota 55121
Re: K122526
Trade/Device Name: 360° Gas Assisted Endoscopic Applicator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 17, 2012 Received: October 18, 2012
Dear Ms. Raus:
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.
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
3
Page 2 - Ms. Jodi Raus MBA, RAC
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/ucml15809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Micromedics, Inc
Special 510(k) Premarket Notification 360° Gas Assisted Endoscopic Applicator
Attachment 2
Indications for Use Statement
Continued of the commend of the comments of the comments of the production of the comments of
510(k) Number:
360° Gas Assisted Endoscopic Applicator Device Name
The 360° Gas Assisted Endoscopic Applicator is intended for the Indications application of two non-homogenous fluids. for Use
OR
Prescription Use _ X (Per 21 CFR 801. 109)
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rinut for MXM
(Division Sign-Off) Division of Surgical Devices K122526 510(k) Number_