(38 days)
Not Found
No
The description focuses on the mechanical components and intended use of a surgical trocar, with no mention of AI or ML capabilities.
No.
The device is described as a surgical instrument used to establish a path of entry for other instruments during minimally invasive procedures, not to provide therapy itself.
No
The device description clearly states it is a "surgical instrument intended to establish a port of entry" for endoscopic instruments, which is a tool used during surgery, not a device for diagnosing conditions.
No
The device description clearly states it is a physical, single-patient-use disposable trocar made from biocompatible medical plastics, consisting of hardware components like a cannula, obturator, adapter, and sheath.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "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." This describes a surgical tool used during a procedure on a patient's body.
- Device Description: The description details a physical instrument (trocar, cannula, adapter, sheath) used for creating access points in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device's function is purely surgical access.
N/A
Intended Use / 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.
Product codes
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
To be used by a surgeon on a single patient during a single laparoscopic surgery under normal operating conditions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ----------------------------------------------- |
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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 |
| 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 | |
| II | Laparoscope, General & Plastic Surgery | |
| II | ||
| Intended Use | 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. | 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. | ||
| 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. | Applied Medical Modular Trocar Systems are | |
| sterile, single-use devices consisting of an | ||
| obturator, a cannula and seal. These systems | ||
| are indicated for use in general, abdominal, | ||
| gynecological and thoracic minimally invasive | ||
| surgical procedures to establish a path of entry | ||
| or to gain access through tissue planes and/or | ||
| potential spaces for endoscopic instruments. | ||
| How Supplied | Single use, sterile | Single use, sterile |
| Principle of operation | Obturator is inserted into canula, minor skin | |
| incision is made, device is advanced | ||
| through incision to access desired | ||
| anatomical space. Laparoscopic instruments | ||
| are passed through the device. Upon | ||
| completion, device is removed and port is | ||
| closed utilizing traditional closure methods. | Obturator is inserted into canula, minor skin | |
| incision is made, device is advanced through | ||
| incision to access desired anatomical space. | ||
| Laparoscopic instruments are passed through | ||
| the device. Upon completion, device is | ||
| removed and port is closed utilizing traditional | ||
| closure methods. | ||
| Components | Obturator, cannula | Obturator, cannula |
| Optional Accessory | 5 mm adaptor | |
| Introducer sheath | None |
Table 1: Overview of technological characteristics
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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".
| Standard Trocar | Predicate Device | |
|---|---|---|
| Length1 | 100 mm | 100 mm |
| Shaft Outer | ||
| 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.
1 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.