MALLEABLE TIP ENDOSCOPIC APPLICATOR

K123847 · Micromedics, Inc. · GCJ · Jan 8, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K123847
• Device Name: MALLEABLE TIP ENDOSCOPIC APPLICATOR
• Applicant: Micromedics, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 8, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Malleable Tip Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.

Device Story

Sterile, single-use, disposable endoscopic applicator; delivers hemostatic agents to bleeding surgical sites. Device features malleable distal tip for directional placement of agents; inserted through 5 mm or larger trocar. Operated by surgeons in clinical/surgical settings. Mechanical design allows precise agent application to control bleeding; benefits patient by facilitating effective hemostasis during endoscopic surgery.

Clinical Evidence

Bench testing only. Included leak, particulate, volume, tissue compliance, hemostatic agent multi-use, shelf life, kink, pinch, bounce back, flexible tip strength, and sterilization validation tests. Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Sterile, single-use, disposable endoscopic applicator. Features malleable distal tip for directional control. Cannula and stylet construction. Sterilized via ethylene oxide. Packaged in double sterile barrier tray.

Indications for Use

Indicated for delivery of hemostatic agents to bleeding surgical sites in patients requiring endoscopic procedures via 5 mm or larger trocars.

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.

Predicate Devices

• Endoscopic Applicator (K120608)
• 360° Gas Assisted Endoscopic Applicator (K122526)

Submission Summary (Full Text)

{0}------------------------------------------------

K123847

#### Micromedics, Inc.

Special 510(k) Premarket Notification Malleable Tip Endoscopic Applicator

# 510(K) SUMMARY

#### JAN 8 2013

#### Date Prepared: December 5, 2012

| 510(k) Submitter | Contact for Official Correspondence | |
|----------------------------|-----------------------------------------|--|
| Micromedics, Inc. | Jodi L. Raus, MBA, RAC | |
| 1270 Eagan Industrial Road | Tel: [phone]; Fax: [phone] | |
| St. Paul. MN 55121-1385 | Email: [e-mail] | |

| General Information | | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------|
| Trade Name | Malleable Tip Endoscopic<br>Applicator | Common Name | Endoscopic Applicator |
| Classification<br>Information | Endoscope and accessories<br>per 21 CFR 876.1500 (Class II) | Product Code | GCJ |
| | | Panel | General & Plastic Surgery |
| Predicate<br>Devices | Endoscopic Applicator, K120608 cleared on March 15, 2012<br>360° Gas Assisted Endoscopic Applicator, K122526, cleared on November 16, 2012 | | |

#### Device Description

The Malleable Tip Endoscopic Applicator is a sterile, single-use, disposable device intended for delivering a hemostatic agent to bleeding sites. The Malleable Tip Endoscopic Applicator is the identical to predicate with the addition of a malleable tip at the distal end which allows directional placement of hemostatic agents.

The Malleable Tip Endoscopic Applicator cannula and stylet are packaged in a double sterile barrier tray configuration and sterilized using ethylene oxide. Six individually sterile packaged applicators are contained in a shelf carton along with instructions for use. This is the identical packaging configuration as the previously cleared device.

# Intended Use / Indications

The Malleable Tip Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar

## Substantial Equivalence Comparison

The endoscopic applicator subject to this special 510(k) incorporates a flexible tube at the distal end of the applicator which allows for directional positioning of the tip.

{1}------------------------------------------------

# Summary of Non-Clinical Performance Data

The Malleable Tip 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.

- Leak Testing .
- Particulate Testing .
- . Volume Test
- . Cannula Tissue Compliance
- Hemostatic Agent Multi-Use .
- Shelf life Evaluation ●
- . Kink Test
- Pinch Test .
- Bounce Back Test .
- Flexible Tip Strength .
- Sterilization Validation .

## Substantial Equivalence Conclusion

The Malleable Tip Endoscopic Applicator does not raise new questions of safety or effectiveness when compared to the predicate device and is, therefore, substantially equivalent.

- The remainder of this page intentionally left blank .-

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wave-like shapes below it.

#### 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

Micromedics, Incorporated % Ms. Jodi L. Raus Director of Regulatory, Clinical and Quality Affairs 1270 Eagan Industrial Road, Suite 120 Saint Paul, Minnesota 55121

#### January 8, 2013

#### Re: K123847

Trade/Device Name: Malleable Tip Endoscopic Applicator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: December 14, 2012 Received: December 14, 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 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

{3}------------------------------------------------

Page 2 - Ms. Jodi L. Raus

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/ucm115809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

{4}------------------------------------------------

Micromedics, Inc.

Special 510(k) Premarket Notification Malleable Tip Endoscopic Applicator

# Indications for Use

510(k) Number (if known): ___K123847

Malleable Tip Endoscopic Applicator Device Name:

Indications for Use:

The Malleable Tip Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwight Yen 2013.01.08 14:01:50 -05'00'

(Division Sign-off) Division of Surgical Devices 510(k) Number K123847