(90 days)
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.
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.
This document describes a 510(k) premarket notification for a medical device called the "Reactor™ Trocar and Sleeve". This is a regulatory submission for a device to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to establish acceptance criteria and prove performance against them in the traditional sense of a clinical or analytical validation study for an AI/ML device.
Therefore, the specific information requested in the prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets) is not applicable to this type of document, which focuses on demonstrating equivalence to an existing device through comparison of features and performance testing.
However, I can extract the information that is present concerning performance.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a quantitative table with corresponding reported performance metrics as one might see in a clinical trial report for a novel medical device. Instead, the "Performance Data" section describes the types of tests conducted to demonstrate equivalence to the predicate device. The implied "acceptance criteria" for these tests would be that the Reactor™ Trocar and Sleeve performs at least as well as, or comparably to, the predicate device in the specified tests to establish substantial equivalence.
| Performance Test Type | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dry Fire Test | Comparable performance to predicate device | Bench tests confirm the performance of the Reactor™ Trocar and Sleeve is substantially equivalent to the predicate device. |
| Tissue Insertion Test | Comparable performance to predicate device | Bench tests confirm the performance of the Reactor™ Trocar and Sleeve is substantially equivalent to the predicate device and validate the Reactor™ Trocar and Sleeve perform as intended. |
| Chest Tube Placement Test | Success in chest tube placement comparable to predicate device | Bench tests confirm the performance of the Reactor™ Trocar and Sleeve is substantially equivalent to the predicate device and validate the Reactor™ Trocar and Sleeve perform as intended. Success in chest tube placement was demonstrated in the TraumaMan surgical simulator. |
| Shaft Rotation Test | Comparable performance to predicate device | Bench tests confirm the performance of the Reactor™ Trocar and Sleeve is substantially equivalent to the predicate device. |
| Torque Test | Comparable performance to predicate device | Bench tests confirm the performance of the Reactor™ Trocar and Sleeve is substantially equivalent to the predicate device. |
| Surgical Imitation Tests (TraumaMan simulator) | Successful and intended operation within the simulated surgical environment, comparable to predicate device | These tests demonstrate the device performs as intended in a simulated surgical environment for chest tube placement. "Bench tests confirm the performance... is substantially equivalent... and validate the Reactor™ Trocar and Sleeve perform as intended." |
| Biocompatibility (ISO 10993) | Compliance with ISO 10993 (Biological Evaluation of Medical Devices) | The materials are biocompatible and comply with ISO 10993 (Biological Evaluation of Medical Devices). |
| Sterilization (ISO 11137) | Compliance with ISO 11137 (Sterilization of Healthcare Products) | The device is a single use, sterile product compliant with ISO 11137 (Sterilization of Healthcare Products). |
Note: The phrase "substantially equivalent" is the overarching "acceptance criterion" for a 510(k) submission, meaning the new device is as safe and effective as a legally marketed device. The performance tests are conducted to support this claim.
The following information is not present in the provided document:
- Sample size used for the test set and the data provenance: The document mentions "bench tests" and "surgical imitation tests in the TraumaMan surgical simulator." It does not specify the number of devices tested, the number of simulated cases, or any details about the origin of the test "data" (e.g., retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. The device is a mechanical surgical instrument, not an AI/ML diagnostic tool requiring expert ground truth for interpretation. Performance is assessed by direct physical testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of bench testing described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable as the device is a surgical instrument, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical devices like this, the "ground truth" for performance is typically objective physical measurements or successful completion of a task, not expert interpretation or pathological findings. In this case, successful performance in the described tests (e.g., successful tissue insertion, chest tube placement in a simulator) serves as the basis for performance evaluation.
- The sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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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 Devices7694 E. Rose Garden LaneScottsdale, AZ 85255 |
| Preparer/ ContractManufacture | McFarlane Medical2571 Kaneville CourtGeneva, IL 60134FDA No. 3006977040 |
| Contact | Melanie Cox, OperationsMcFarlane Medical, Inc.2571 Kaneville CourtGeneva, IL 60134Telephone (630) 208-8404, ext. 124Fax (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 & PlasticSurgery, GCJ, classified in Class II, at 21 CFR 876.1500. This is a General and PlasticSurgery 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 thoraciccavities 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 limitedaccess 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 tubeplacement. |
|---|---|
| Indication for Use | The Sharp Medical Reactor™ Trocar and Sleeve has indications in the creation of a portof entry into the thoracic cavity and allows the user to create and maintain limited accessinto the chest for the intention of chest tube placement. |
| TechnologicalCharacteristics | The technological characteristics of the subject device are the same as the predicatedevice. The device is a single use, sterile product compliant with ISO 11137 (Sterilizationof Healthcare Products). It features a pistol grip with a squeeze-action trigger. Thematerials are biocompatible and comply with ISO 10993 (Biological Evaluation ofMedical Devices). |
| Performance Data | Comparative performance testing between the subject device and the predicate deviceincluded a dry fire test, tissue insertion test, chest tube placement test, shaft rotation test,torque test, and surgical imitation tests in the TraumaMan surgical simulator.The bench tests confirm the performance of the Reactor™ Trocar and Sleeve issubstantially equivalent to the predicate device and validate the Reactor™ Trocar andSleeve perform as intended. |
| Conclusion | Based on the 510(k) summaries and the information provided herein, we conclude that thesubject device is substantially equivalent to the predicate device under the Federal Food,Drug and Cosmetic Act. |
§ 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.