(90 days)
Not Found
No
The summary describes a mechanical gas-assisted applicator system for delivering hemostatic agents. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on mechanical and functional aspects of the device.
No.
The device is intended to assist the delivery of a powdered hemostatic agent, not to directly treat a condition or disease itself. It is an applicator system.
No
The device is described as an "Application System" intended to assist in the delivery of a powdered hemostatic agent. Its purpose is to apply a substance, not to detect, identify, or determine the nature of a disease or condition. The performance studies focus on mechanical and functional aspects of delivery, not on diagnostic accuracy.
No
The device description explicitly lists multiple hardware components including a Gas Regulator, Foot pedal, Tubing set, Adapter Handle, and FlexiTip XL-R rigid applicator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to assist the delivery of a powdered hemostatic agent to a treatment site during surgery. This is a therapeutic or procedural function, not a diagnostic one.
- Device Description: The description details a system for applying a substance to the body, not for analyzing samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information.
- Performance Studies: The performance studies focus on mechanical function, delivery of the agent, and system performance in a simulated surgical environment. These are not typical studies for an IVD, which would focus on analytical and clinical performance related to diagnosis.
- Predicate Device: The predicate device (FibriJet Air Assisted Endoscopic Applicator) is also a device for applying a substance during surgery, further supporting the non-IVD nature.
In summary, the device's purpose is to facilitate a surgical procedure by delivering a therapeutic agent, not to provide diagnostic information based on in vitro analysis.
N/A
Intended Use / Indications for Use
The device is intended to assist the delivery of a powdered hemostatic agent to the treatment site in surgical procedures including endoscopic surgeries, using a 5 mm or larger trocar.
Product codes
GCJ
Device Description
The MEDAFOR DIRECT Gas-Assisted Application System is intended to be used on patients undergoing surgery including laparoscopic procedures. The gas-assisted applicator kit and regulator are provided to assist the user in the application of powdered hemostatic agents to bleeding tissue in surgical procedures including laparoscopic/endoscopic surgeries, using a 5 mm or larger trocar.
The device system consists of the following components in the following packaging configurations:
- Regulator Kit: Packaged in a corrugated box - Components Included: Gas Regulator, Foot pedal
- Gas Assisted Applicator Kit is supplied as a sterile, single use kit packaged in a preformed PETG tray and Tyvek®¹ lid - Components Included: Tubing set, Adapter Handle, FlexiTip XL-R rigid applicator
The gas regulator and foot pedal are supplied separately as non-sterile, reusable components. The Gas-Assisted Applicator kit is provided as a sterile, disposable unit, consisting of the tubing set, applicator adapter and a single unit of FlexiTip XL-R applicator. These disposable components are kitted together in a preformed tray and Tyvek® lid and terminally sterilized by ethylene oxide.
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
The MEDAFOR DIRECT Gas-Assisted Application System underwent mechanical, performance, and biocompatibility assessments to verify that the device functions in a safe and effective manner.
The mechanical tests performed on the MEDAFOR DIRECT Gas-Assisted Application System include:
- Device Interface Compatibility: Trocar luer compatibility, Trocar 5 mm cannula compatibility, CO2 tank connector compatibility
- Device Delivery: Container content delivery of hemostatic agent in powdered form, Delivery Control (location and area), Blood clearing from site, System Leak Testing (Maintaining Pneumoperitinum)
- Device Functionality: Pressure Monitoring, Flow Control & Monitoring, System Performance Testing (Internal device component compatibility (gas tank tubing to regulator/tubing to adapter/adapter to FlexiTip XL-R ))
- System Verification Test in Swine: Performed as intended under simulated conditions to confirm output meets input
All tests met acceptance criteria. These results provide assurance that the device has been designed and evaluated to assure conformance to the requirements for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
JAN 2 4 2013
Date Prepared: January 9, 2013
Submitter Information:
| Submitter's Name/Address | Contact Person |
|---|---|
| Medafor | Melissa Young, Senior Regulatory Affairs Specialist |
| 2700 Freeway Boulevard, Suite 800. | |
| Minneapolis, MN 55430 | |
| Telephone: 763-231-8201 | |
| Fax: 763-571-1035 |
Device Information:
| Trade Name | MEDAFOR DIRECT Gas-Assisted Application System - MEDAFOR DIRECT™
Pressurized Gas Regulator and DIRECT Kit™ Gas-Assisted Applicator |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Gas Regulator and Gas-Assisted Spray Kit |
| Classification Name | Endoscope and Accessories |
| Product Code | GCJ |
| Regulation | 876.1500 |
| Panel | General and Plastic Surgery |
Performance Standards:
No performance standards applicable to this product have been developed under Section 514 of the Act.
Predicate Device:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| FibriJet Air Assisted Endoscopic Applicator | Micromedics, Inc. | K042834 |
Device Description:
The MEDAFOR DIRECT Gas-Assisted Application System is intended to be used on patients undergoing surgery including laparoscopic procedures. The gas-assisted applicator kit and regulator are provided to assist the user in the application of powdered hemostatic agents to bleeding tissue in surgical procedures including laparoscopic/endoscopic surgeries, using a 5 mm or larger trocar.
The following table describes the MEDAFOR DIRECT Gas-Assisted Application System that is intended to be commercially marketed. The device system consists of the following components in the following packaging configurations:
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1
| MEDAFOR DIRECT Configurations and Components | ||
|---|---|---|
| No. | Packaging Configuration | Components Included |
| 1. | Regulator Kit: Packaged in a corrugated box | Gas Regulator |
| Foot pedal | ||
| 2. | Gas Assisted Applicator Kit is supplied as a sterile, single use kit packaged in a preformed PETG tray and Tyvek®¹ lid | Tubing set |
| Adapter Handle | ||
| FlexiTip XL-R rigid applicator |
The gas regulator and foot pedal are supplied separately as non-sterile, reusable components. The Gas-Assisted Applicator kit is provided as a sterile, disposable unit, consisting of the tubing set, applicator adapter and a single unit of FlexiTip XL-R applicator. These disposable components are kitted together in a preformed tray and Tyvek® lid and terminally sterilized by ethylene oxide.
Intended Use/Indications for Use:
The device is intended to assist the delivery of a powdered hemostatic agent to the treatment site in surgical procedures including endoscopic surgeries, using a 5 mm or larger trocar.
Summary of Non-Clinical Testing:
The MEDAFOR DIRECT Gas-Assisted Application System underwent mechanical, performance, and biocompatibility assessments to verify that the device functions in a safe and effective manner.
The mechanical tests performed on the MEDAFOR DIRECT Gas-Assisted Application System include:
| Critical Parameter | Mechanical Test |
|---|---|
| Device Interface | |
| Compatibility | Trocar luer compatibility |
| Trocar 5 mm cannula compatibility | |
| CO2 tank connector compatibility | |
| Device Delivery | Container content delivery of hemostatic agent in powdered form |
| Delivery Control (location and area) | |
| Blood clearing from site | |
| System Leak Testing (Maintaining Pneumoperitinum) | |
| Device Functionality | Pressure Monitoring |
| Flow Control & Monitoring | |
| System Performance Testing (Internal device component compatibility (gas tank | |
| tubing to regulator/tubing to adapter/adapter to FlexiTip XL-R ) |
1 Tyvek® is a registered trademark of DuPont
2
| Critical Parameter | Mechanical Test |
|---|---|
| System Verification Test in Swine: Performed as intended under simulated conditions | |
| to confirm output meets input |
All tests met acceptance criteria. These results provide assurance that the device has been designed and evaluated to assure conformance to the requirements for its intended use.
Substantial Equivalence Comparison
The MEDAFOR DIRECT Gas Assisted Application System is substantially equivalent to the predicate device based on a comparison of the indications for use and the technological The technological characteristics include design configuration, materials, characteristics. method of sterilization, compatibility with the same ancillary devices (such as a standard 5 mm trocar) and method of operation.
While the subject and predicate device are intended to deliver materials to the patient during endoscopic surgery, they differ in the types of material to be delivered. The predicate device is intended to apply two nonhomogeneous liquids, while the subject device delivers a powder hemostat to the treatment site. However, when both devices are activated, the compressed gas fluidizes the liquid and powdered hemostat in the same manner, forcing them into an air stream in the form of a spray when exiting the applicator system.
Both subject and predicate devices are made of stainless steel and biosafe polymer materials and are terminally sterilized by ethylene oxide.
Both systems include components consistent with that used in endoscopic gas-assisted systems (regulator, footswitch, applicator/tubing set), however the applicator tubing set design and connections differ. The predicate applicator is designed as a dual path system that allows connection of two syringes by luer lock at the distal end. At the proximal end, the applicator is attached by threaded connection to the Replaceable tips. In contrast, the subject applicator has a simpler single path design that connects to a hemostatic powder container by friction fit at the distal end and does not require any attachment at the proximal end. Both device tubing sets attach to the gas supply by luer lock connections. The testing performed confirms that the MEDAFOR DIRECT Gas- Assisted Application System does will perform as intended, safely and effectively.
Conclusion
Based on the results from the bench and animal testing performed and the substantial equivalence comparison, the MEDAFOR DIRECT Gas-Assisted Application System does not raise new questions of safety and effectiveness when compared to the legally marketed predicate device and is, therefore, substantially equivalent.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird-like figure. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medafor, Incorporated % Ms. Melissa Young Senior Regulatory Affairs Specialist 2700 Freeway Boulevard, Suite 800 Minneapolis, Minnesota 55430
January 24, 2013
Re: K123325
Trade/Device Name: MEDAFOR DIRECT Gas-Assisted Application System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 09, 2013 Received: January 10, 2013
Dear Ms. Young:
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.
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 or any I vith 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.
4
Page 2 -- Ms. Melissa Young
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 other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K123325_____________________________________________________________________________________________________________________________________
MEDAFOR DIRECT Gas-Assisted Application System Device Name:
Indications for Use:
The device is intended to assist the delivery of a powdered hemostatic agent to the treatment site in surgical procedures including endoscopic surgeries, using a 5 mm or larger trocar.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR :
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Neil R Ogden 2013.01.18 14:06:00 -05'00'
(Division Sign-Off) Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
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