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
Indications for 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.
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.
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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
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
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## 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)
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# 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 (630) 208-8404, ext. 124<br>Fax (630) 232-8005 |
| 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. |
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## 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.
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| 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. |
