(15 days)
Not Found
No
The description focuses on the mechanical function and safety features of a physical device (trocar and cannula) and does not mention any computational or data-driven components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is intended for guidewire introduction during gastrointestinal procedures, not for treating a disease or condition. It facilitates a procedure but does not have a therapeutic effect itself.
No
This device is designed for guidewire introduction during gastrointestinal procedures, facilitating access rather than diagnosing a condition.
No
The device description clearly outlines a physical medical device consisting of a safety trocar and a cannula, intended for physical insertion during a procedure. It also mentions bench top testing, biocompatibility testing, and sterilization testing, which are typical for physical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Safety Trocar Cannula is a surgical instrument used to facilitate the introduction of a guidewire into the gastrointestinal tract during procedures like PEG and PEJ. It is a tool used during a procedure on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a procedural function (guidewire introduction during gastrointestinal procedures), not a diagnostic test on a biological sample.
- Device Description: The description details the physical components and how they are used for access and guidewire placement, not for analyzing a biological sample.
Therefore, the Safety Trocar Cannula falls under the category of a surgical or procedural device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Safety Trocar Cannula is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (percutaneous Endoscopic Gastrotomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.
Product codes
KNT
Device Description
The Safety Trocar Cannula is a sterile, single used for guidewire introduction during a gastrointestinal procedure. The device consists of a safety trocar with passive sharps protection and a cannula.
During a gastrointestinal procedure requiring access via a guidewire, the device is inserted into the stomach under direct visualization via an endoscope. Once inserted, the safety trocar is removed from the cannula that provides smooth surface for the needle to slide out during removal as well as a lumen to facilitate guidewire introduction. The passive safety feature of the proposed Safety Trocar Cannula is activated when the safety trocar is separated from the cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Safety Trocar Cannula was evaluated via bench top testing, biocompatibility testing, and sterilization testing.
The following tests were performed on the Safety Trocar Cannula:
- Sheath Stiffness
- Sheath Outer Diameter (OD)
- Device Functionality
- Sheath Inner Diameter (ID) Needle Compatibility
- Sheath to Sheath Hub Tensile Strength
- Cover Tube Tensile Strength
- Needle Tube to Needle Hub Bond Strength
- Sheath/Sheath Hub to Needle/Needle Hub Connection
- Needle Tip Puncture Optimization
- Sheath Inner Diameter (ID) Accessory Compatibility
- Sheath Lie Distance
- ISO 9626
- ISO 23908
The Safety Trocar Cannula met all pre-defined testing requirements. The testing performed demonstrates that the Safety Trocar Cannula meets the performance requirements and is substantially equivalent to the predicate. Modified TFX Medical Safety Needle with Introducer (K043258)
The Safety Trocar Cannula meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 23, 2021
Boston Scientific Corporation Lingling Guo Senior Regulatory Affairs Specialist 100 Boston Scientific Wav Marlborough, MA 01752
Re: K211072
Trade/Device Name: Safety Trocar Cannula Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: April 9, 2021 Received: April 12, 2021
Dear Lingling Guo:
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.
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
1
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,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211072
Device Name Safety Trocar Cannula
Indications for Use (Describe)
The Safety Trocar Cannula is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (percutaneous Endoscopic Gastrotomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.
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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K211072 Page 1of 3
SECTION 5 510(K) SUMMARY
510(k) SUMMARY
- Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Lingling Guo Senior Regulatory Affairs Specialist Tel: (508) 382-0456 Date Prepared: April 9, 2021
2. Proposed Device:
Trade Name: Safety Trocar Cannula Classification Name: Gastrointestional Tube and Accessories Regulation Number: 21CFR §876.5980 Product code: KNT Classification: Class II
3. Predicate Device:
Trade Name: Modified TFX Medical Safety Needle with Introducer Classification Name: Gastrointestional Tube and Accessories Regulation Number: 21CFR 8876.5980 Product code: KNT Classification: Class II 510(k) Clearance Number: K043258
4. Device Description:
The Safety Trocar Cannula is a sterile, single used for guidewire introduction during a gastrointestinal procedure. The device consists of a safety trocar with passive sharps protection and a cannula.
During a gastrointestinal procedure requiring access via a guidewire, the device is inserted into the stomach under direct visualization via an endoscope. Once inserted, the safety trocar is removed from the cannula that provides smooth surface for the needle to slide out during removal as well as a lumen to facilitate guidewire introduction. The passive safety feature of the proposed Safety Trocar Cannula is activated when the safety trocar is separated from the cannula.
4
5. Indications for Use:
The Safety Trocar Cannula is indicated to be used for guidewire introduction during gastrointestinal procedures such as PEG (percutaneous Endoscopic Gastrotomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.
6. Technological Characteristics:
The proposed Safety Trocar Cannula and the predicate device are both sterile, single use devices. They are identical with regard to principle of operation, materials, needle characteristics, sheath ID, sheath OD, and offer identical passive sharps protection. The proposed and predicate device both offer a non-peelable insertion sheath that fits over the needle and allows the needle to extend past the needle.
7. Substantial Equivalence
A direct comparison of key characteristics demonstrates that the proposed Safety Trocar Cannula is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance characteristics.
8. Performance Data:
The Safety Trocar Cannula was evaluated via bench top testing, biocompatibility testing, and sterilization testing.
The following tests were performed on the Safety Trocar Cannula:
- Sheath Stiffness ●
- Sheath Outer Diameter (OD) .
- Device Functionality .
- Sheath Inner Diameter (ID) Needle Compatibility .
- . Sheath to Sheath Hub Tensile Strength
- . Cover Tube Tensile Strength
- Needle Tube to Needle Hub Bond Strength
- . Sheath/Sheath Hub to Needle/Needle Hub Connection
- . Needle Tip Puncture Optimization
- Sheath Inner Diameter (ID) Accessory Compatibility .
- Sheath Lie Distance ●
- ISO 9626 ●
- . ISO 23908
The Safety Trocar Cannula met all pre-defined testing requirements. The testing performed demonstrates that the Safety Trocar Cannula meets the performance requirements and is substantially equivalent to the predicate. Modified TFX Medical Safety Needle with Introducer (K043258)
5
The Safety Trocar Cannula meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals".
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Safety Trocar Cannula sufficiently meets design requirements and is substantially equivalent to the currently cleared Modified TFX Medical Safety Needle with Introducer (K043258) and can be safely and effectively used for its proposed indication.