K123325 · Medafor, Inc. · GCJ · Jan 24, 2013 · Gastroenterology, Urology
Device Facts
Record ID
K123325
Device Name
Medafor Direct Gas-Assisted Application System
Applicant
Medafor, Inc.
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Jan 24, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
System delivers powdered hemostatic agents to bleeding tissue during surgery, including laparoscopic/endoscopic procedures. Components include a reusable gas regulator and foot pedal, and a sterile, single-use applicator kit (tubing, adapter, rigid applicator tip). Operates by connecting to a CO2 gas source; user-controlled via foot pedal to create a gas stream that fluidizes and sprays the powder onto the treatment site. Used in OR settings by surgeons. Output is a controlled spray of hemostatic powder, assisting in blood clearing and hemostasis at the surgical site. Benefits include precise, localized delivery of hemostatic agents in minimally invasive environments.
Clinical Evidence
Bench and animal testing only. Mechanical testing verified trocar compatibility, delivery control, blood clearing, system leak testing, and pressure/flow monitoring. System verification testing performed in swine confirmed output meets input requirements under simulated conditions. No human clinical data presented.
Technological Characteristics
Materials: stainless steel and biosafe polymers. Energy source: external CO2 gas supply. Form factor: regulator, foot pedal, and disposable tubing/applicator kit. Connectivity: luer lock gas connections. Sterilization: ethylene oxide (disposable components).
Indications for Use
Indicated for patients undergoing surgical procedures, including endoscopic/laparoscopic surgeries, requiring the application of a powdered hemostatic agent via a 5 mm or larger trocar.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
FibriJet Air Assisted Endoscopic Applicator (K042834)
Submission Summary (Full Text)
{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™<br>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:
Page lot 3
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| 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<br>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<br>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<br>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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1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
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Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
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Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
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At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
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Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
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Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
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With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
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Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
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Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
