The Standard Trocar is intended to be used by a surgeon on a single patient during a single laparoscopic surgery under normal operating conditions. It is intended to create and maintain a port of entry into the body through tissue planes and/or potential spaces for endoscopic instruments.
Device Story
Standard Trocar is a sterile, single-use surgical instrument; consists of obturator, cannula, 5mm adapter, and introducer sheath. Used by surgeons in general and abdominal minimally invasive procedures. Operates by inserting obturator into cannula, making minor skin incision, and advancing device to access anatomical space. Provides port for 19mm outer diameter instruments; 5mm adapter allows use of smaller instruments. Upon procedure completion, device is removed and port closed via traditional methods. Benefits include establishing and maintaining access for endoscopic instruments during laparoscopic surgery.
Clinical Evidence
Bench testing only. No clinical data provided. Performance evaluation included biocompatibility (ISO 10993-1), mechanical testing, and usability testing. Device met all pre-determined acceptance criteria and demonstrated performance comparable to the predicate.
Technological Characteristics
Single-use, sterile, gamma-irradiated trocar. Materials: biocompatible medical plastics. Dimensions: 100mm length, 23mm outer diameter, 20mm inner diameter. Features: quad valve, lip seal, bladeless conical tip, suture loops/ridges for fixation. No optical channel or insufflation port. Biocompatibility per ISO 10993-1; sterilization SAL 10^-6.
Indications for Use
Indicated for use in general and abdominal minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
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.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 9, 2020
Standard Bariatrics Ms. Alison Sathe Vice President, Regulatory 4362 Glendale Milford Rd. Cincinnati, Ohio 45242
Re: K200517
Trade/Device Name: Standard Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 28, 2020 Received: March 2, 2020
Dear Ms. Sathe:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K200517
Device Name Standard Trocar
## Indications for Use (Describe)
The Standard Trocar is a sterile, single consisting of an obturator, a cannula, a 5mm adapter and introducer sheath. This system is indicated for use in general and abdominal minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
Type of Use (Select one or both, as applicable)
| <span style="font-size:10pt;">☑</span> 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 PRAStaff@fda.hhs.gov
"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}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized white "S" inside, followed by the words "STANDARD BARIATRICS" in black, sans-serif font. The "TM" symbol is present to the right of the word "BARIATRICS".
# 510(k) Summary
#### I. Submitter's Information
| Company Name: | Standard Bariatrics, Inc. |
|-----------------|----------------------------------------------------|
| Address: | 4362 Glendale Milford Road<br>Cincinnati, OH 45242 |
| Phone Number: | 513-658-0328 |
| Fax Number: | 513-436-0201 |
| Contact Person: | Alison Sathe, Vice President, Regulatory |
| Phone Number: | 513-304-7971 |
| Email Address: | alison@standardbariatrics.com |
| Date Prepared: | February 27, 2020 |
#### II. Device
| Tradename: | Standard Trocar |
|----------------------|---------------------------|
| Common Name: | Trocar |
| Classification Name: | Endoscope and Accessories |
| Classification: | Class II (21CFR876.1500) |
| Product Code: | GCJ |
#### III. Predicate Device
Applied Medical Modular Trocar, K060096, K083638, Class II (21CFR876.1500), Product Code GCJ, Applied Medical Resources Corporation
#### IV. Device Description
The Standard Trocar is a single-patient-use disposable trocar manufactured from biocompatible medical plastics. The device is comprised of a trocar cannula, obturator, 5 mm adaptor, and introducer sheath. The Standard Trocar is a sterile, single patient use surgical instrument intended to establish a port of entry for 19mm outer diameter instruments to be used during minimally invasive procedures. The 5 mm adaptor provides the means for the trocar to also be used with 5 mm diameter instruments. The trocar is compatible with commercially available laparoscopic instruments. In addition, as Standard Bariatrics develops additional laparoscopic instruments, the Standard Trocar will accommodate those devices. The Standard Trocar is sterilized using gamma irradiation and provided to the user in a Tyvek tray with peel lid.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image is a logo for Standard Bariatrics. The logo consists of a red, stylized letter "S" on the left and the words "STANDARD BARIATRICS" in black on the right. The letter "S" is made up of three curved lines that are stacked on top of each other. The words "STANDARD BARIATRICS" are in a bold, sans-serif font, and the letters are all capitalized.
#### V. Indications for Use:
The Standard Trocar is a sterile, single-use device consisting of an obturator, a cannula, a 5mm adapter and introducer sheath. This system is indicated for use in general and abdominal minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
#### VI. Intended Use:
The Standard Trocar is intended to be used by a surgeon on a single patient during a single laparoscopic surgery under normal operating conditions. It is intended to create and maintain a port of entry into the body through tissue planes and/or potential spaces for endoscopic instruments.
#### VII. Technological Characteristics
The Standard Trocar and its predicate have been evaluated to determine substantial equivalence technological characteristics are provided in Table 1.
| | Standard Trocar | Predicate Device |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Standard Trocar | Modular Trocar System |
| 510(k) Holder | Standard Bariatrics | Applied Medical |
| 510(k) Number | TBD | K060096, K083638 |
| Product Code | GCJ | GCJ |
| Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Classification | Laparoscope, General & Plastic Surgery<br>II | Laparoscope, General & Plastic Surgery<br>II |
| Intended Use | To be used by a surgeon on a single patient<br>during a single laparoscopic surgery under<br>normal operating conditions. It is intended<br>to create and maintain a port of entry into<br>the body through tissue planes and/or<br>potential spaces for endoscopic instruments. | To be used by a surgeon on a single patient<br>during a single laparoscopic surgery under<br>normal operating conditions. It is intended to<br>create and maintain a port of entry into the<br>body through tissue planes and/or potential<br>spaces for endoscopic instruments. |
| Indications for Use | The Standard Trocar is a sterile, single-use<br>device consisting of an obturator, a cannula,<br>a 5mm adapter and introducer sheath. This<br>system is indicated for use in general and<br>abdominal minimally invasive surgical<br>procedures to establish a path of entry or to<br>gain access through tissue planes and/or<br>potential spaces for endoscopic instruments. | Applied Medical Modular Trocar Systems are<br>sterile, single-use devices consisting of an<br>obturator, a cannula and seal. These systems<br>are indicated for use in general, abdominal,<br>gynecological and thoracic minimally invasive<br>surgical procedures to establish a path of entry<br>or to gain access through tissue planes and/or<br>potential spaces for endoscopic instruments. |
| How Supplied | Single use, sterile | Single use, sterile |
| Principle of operation | Obturator is inserted into canula, minor skin<br>incision is made, device is advanced<br>through incision to access desired<br>anatomical space. Laparoscopic instruments<br>are passed through the device. Upon<br>completion, device is removed and port is<br>closed utilizing traditional closure methods. | Obturator is inserted into canula, minor skin<br>incision is made, device is advanced through<br>incision to access desired anatomical space.<br>Laparoscopic instruments are passed through<br>the device. Upon completion, device is<br>removed and port is closed utilizing traditional<br>closure methods. |
| Components | Obturator, cannula | Obturator, cannula |
| Optional Accessory | 5 mm adaptor<br>Introducer sheath | None |
## Table 1: Overview of technological characteristics
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image is a logo for Standard Bariatrics. The logo consists of a red, stylized letter "S" on the left and the words "STANDARD BARIATRICS" in black on the right. The "S" is made up of three parallel lines that curve around to form the shape of the letter. The word "STANDARD" is above the word "BARIATRICS", and there is a trademark symbol after the word "BARIATRICS".
K200517
| | Standard Trocar | Predicate Device |
|--------------------------|-------------------------------------------|-------------------------------------------|
| Length1 | 100 mm | 100 mm |
| Shaft Outer<br>Diameter3 | 23 mm | 19 mm |
| Shaft Inner Diameter3 | 20 mm | 16 mm |
| Valve | Quad valve | Quad valve |
| Seal Shape | Lip seal | Multi-leaflet seal |
| Method of affixing | Suture loops and ridges/ threads on shaft | Suture loops and ridges/ threads on shaft |
| Tip shape | Bladeless conical tip | Bladeless conical tip |
| Optical Channel | No | Yes |
| Insufflation Port | No | Yes |
| Shelf Life | 1 year | 2 years |
| Biocompatibility | Biocompatible per ISO 10993-1 | Biocompatible per ISO 10993-1 |
| Sterilization | Provided sterile via gamma | Provided sterile via gamma |
| SAL | 10-6 SAL | 10-6 SAL |
#### VIII. Performance Testing
Performance Testing was conducted to evaluate and compare the technological and performance characteristics. Pre-determined performance specifications were tested and verification and validation activities were conducted to demonstrate that the Standard Trocar met the defined criteria. Testing on the subject device included biocompatibility, mechanical testing, and usability.
Performance evaluation of the Standard Trocar during the design validation and verification was completed by applying methods of internationally recognized standards such as, EN ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and Testing within a risk management process, EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices, and Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process, among others.
The Standard Trocar met acceptance criteria and demonstrated comparable performance to the predicate device for the equivalent indications for use.
#### IX. Conclusions
The results from the nonclinical testing demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device. The design/technological differences do not raise any new types of questions and the performance data provide reasonable assurance of safety and effectiveness to demonstrate substantial equivalence. The subject and predicate devices are therefore substantially equivalent.
<sup>1</sup> Per the 510(k) summary, the device is available in lengths ranging from 50-150mm. The device Standard Bariatrics obtained for comparison is the model AM15 which is reflected in this table.
