Reactor(TM) Trocar and Sleeve

K150549 · Sharp Medical Prducts, LLC · GCJ · Jun 1, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150549
• Device Name: Reactor(TM) Trocar and Sleeve
• Applicant: Sharp Medical Prducts, LLC
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sharp Medical Reactor™ Trocar and Sleeve has indications in the creation of a port of entry into the thoracic cavity and allows the user to create and maintain limited access into the chest for the intention of chest tube placement.

Device Story

Reactor™ Trocar and Sleeve; manual surgical instrument for thoracic access. Device consists of obturator with flat distal tip enclosing circular scalpel-shaped knife blade. Trigger-actuated mechanism extends blade ~1mm and immediately retracts upon compression. Accommodates instruments up to 36 Fr (12 mm). Used in hospital settings by clinicians to create/maintain port of entry for chest tube placement. Manual operation; no energy source. Benefits include controlled tissue penetration for chest tube insertion.

Clinical Evidence

Bench testing only. Comparative performance testing against predicate included dry fire test, tissue insertion test, chest tube placement test, shaft rotation test, torque test, and surgical imitation tests using TraumaMan surgical simulator. Results validate performance equivalent to predicate.

Technological Characteristics

Single-use, sterile (ISO 11137). Materials: TEXIN RXT90A (sleeve), ULTEM HU1004-8H8D264 (trocar). Biocompatible per ISO 10993. Pistol grip with squeeze-action trigger. Dimensions: up to 12 mm diameter, 100 mm length. Mechanical operation; no energy source.

Indications for Use

Indicated for patients requiring thoracic cavity access for chest tube placement.

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

• Visiport Plus (K935086)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 1, 2015

Sharp Medical Devices, LLC % Ms. Melanie Cox McFarlane Medical Incorporated 2571 Kaneville Court Geneva, Illinois 60134

Re: K150549

Trade/Device Name: Reactor™ Trocar and Sleeve Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 9, 2015 Received: April 13, 2015

Dear Ms. Cox:

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

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

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known) K150549

Device Name Reactor™ Trocar and Sleeve

Indications for Use (Describe)

The Sharp Medical Reactor™ Trocar and Sleeve has indications in the creation of a port of entry into the thoracic cavity and allows the user to create and maintain limited access into the intention of chest tube placement.

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 5.0 510(k) Summary

| Date | April 9, 2015 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner Operator | Sharp Medical Devices<br>7694 E. Rose Garden Lane<br>Scottsdale, AZ 85255 |
| Preparer/ Contract<br>Manufacture | McFarlane Medical<br>2571 Kaneville Court<br>Geneva, IL 60134<br>FDA No. 3006977040 |
| Contact | Melanie Cox, Operations<br>McFarlane Medical, Inc.<br>2571 Kaneville Court<br>Geneva, IL 60134<br>Telephone [phone], ext. 124<br>Fax [phone] |
| Predicate Device | K935086 Visiport Plus, by United States Surgical |
| Device Name | Reactor™ Trocar and Sleeve |
| Proprietary Name | Reactor™ |
| Common Name | Surgical Trocar and Accessory |
| Classification Name | Trocar and Accessories |
| Classification | The classification for the Reactor™ Trocar with Sleeve is Trocar, General & Plastic<br>Surgery, GCJ, classified in Class II, at 21 CFR 876.1500. This is a General and Plastic<br>Surgery classification. |

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

## Substantial Equivalence

The Reactor™ Trocar with Sleeve is substantially equivalent to the VISIPORT™ Plus RPF 5-12. The Reactor™ Trocar with Sleeve will have of the same intended use and the specifications are substantially equivalent to the predicate device. The Reactor™ Trocar with Sleeve poses no significant changes from the safety and efficacy of the predicate device.

| | Subject Devices | Substantially Equivalent | |
|-------------|--------------------------------------------------------------|--------------------------------------------------------------------------------|--|
| | | Devices | |
| Product | Reactor™ Trocar with | Visiport™ Plus | |
| Description | Sleeve | | |
| REF | 100-36-01 | 176674P | |
| Number | | | |
| 510(k) | K150549 | K935086 | |
| Number | | | |
| Intended | The device allows the user | Unknown | |
| Use | to create and maintain | | |
| | access for the intention of | | |
| | chest tube placement. | | |
| Indications | The Sharp Medical Reactor™ | The Visiport™ Plus optical trocar has | |
| for Use | Trocar and Sleeve has | indications in the creation of a port of | |
| | indications in the creation of a | entry into the abdominal or thoracic<br>cavities during endoscopic procedures. | |
| | port of entry into the thoracic | The device allows the user to view | |
| | cavity and allows the user to | passage of the trocar tip through the | |
| | create and maintain limited<br>access into the chest for the | tissue layers of the abdominal or thoracic | |
| | intention of chest tube | cavity wall. | |
| | placement. | | |
| Anatomical | Thoracic cavity | Thoracic cavity | |
| Sites | | | |
| Where | Hospital | Hospital | |
| Used | | | |
| Energy | N/A | N/A | |
| Used | | | |
| Human | Actuated by compressing | Actuated by compressing trigger | |
| Factors | trigger | | |
| Design | | | |
| Descriptive | Up to 12 mm | 5 mm to 12mm | |
| Size | | | |
| Length | 100 mm | | |
| Materials | | | |
| Sleeve | TEXIN RXT90A | Unknown | |
| Trocar | ULTEM HU1004-8H8D264 | Unknown | |
| | LT GRAY | | |

#### Description of Device The Reactor™ Trocar consists of an obturator with a flat tip at the distal end which encloses a circular scalpel shaped knife blade. The blade extends approximately 1mm and immediately retracts when the trigger is squeezed. The clear sleeve with printing accommodates instruments up to 36 Fr. or 12 mm.

{5}------------------------------------------------

| Intended Use | The device allows the user to create and maintain access for the intention of chest tube<br>placement. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Sharp Medical Reactor™ Trocar and Sleeve has indications in the creation of a port<br>of entry into the thoracic cavity and allows the user to create and maintain limited access<br>into the chest for the intention of chest tube placement. |
| Technological<br>Characteristics | The technological characteristics of the subject device are the same as the predicate<br>device. The device is a single use, sterile product compliant with ISO 11137 (Sterilization<br>of Healthcare Products). It features a pistol grip with a squeeze-action trigger. The<br>materials are biocompatible and comply with ISO 10993 (Biological Evaluation of<br>Medical Devices). |
| Performance Data | Comparative performance testing between the subject device and the predicate device<br>included a dry fire test, tissue insertion test, chest tube placement test, shaft rotation test,<br>torque test, and surgical imitation tests in the TraumaMan surgical simulator.<br>The bench tests confirm the performance of the Reactor™ Trocar and Sleeve is<br>substantially equivalent to the predicate device and validate the Reactor™ Trocar and<br>Sleeve perform as intended. |
| Conclusion | Based on the 510(k) summaries and the information provided herein, we conclude that the<br>subject device is substantially equivalent to the predicate device under the Federal Food,<br>Drug and Cosmetic Act. |