(74 days)
The Banyan Medical Disposable Secondary Cannula and Trocar for Laparoscopic Use is indicated for applications in abdominal and gynecologic minimally invasive laparoscopic surgical procedures to establish a port of entry for endoscopic and laparoscopic instruments. The trocar is used with visualization for secondary insertions.
The Banyan Medical line of Disposable Secondary Cannula and Trocars for Laparoscopic Use consists of a trocar, cannula sleeve and a silicone seal. The design has two possible trocars, a sharp faceted tip and a conical tip. An insufflation adapter, when supplied, is compatible with standard luer lock fittings and provides for insufflation of the abdominal cavity. The Cannula and Trocar will be sold in 5mm, 8mm, 10mm and 12mm sizes.
The provided document describes the 510(k) summary for the "Banyan Medical Disposable Secondary Cannula and Trocar for Laparoscopic Use." This device is a medical instrument, not an AI/ML powered device, and therefore the provided Input does not contain the information required to populate most of the sections of this response.
Here's a breakdown of the available information and how it relates to your request:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Performance Data | |
| Compression testing of the cannula | Demonstrated performance as intended |
| Tensile testing of the knob to shaft of trocar | Demonstrated performance as intended |
| Puncture testing of the trocar tip | Demonstrated performance as intended |
| Shelf life testing | Demonstrated performance as intended |
| Accelerated age testing | Demonstrated performance as intended |
| Ship testing | Demonstrated performance as intended |
| Luer testing (gauging, liquid leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking per ISO 594-1 and 594-2) | Demonstrated performance as intended |
| Sterilization Validation | |
| Sterilization according to ISO 11135:2007 (Part 1) and ISO 10993-7:2008 (Ethylene Oxide sterilization residuals) | Achieved a sterility assurance level (SAL) of ≥ 10⁻⁶ |
| Sterilization data meets requirements of draft documents: "Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labeled as Sterile" | Met requirements |
| Package and Product Integrity | |
| Testing according to ISO 11607-1:2006 and ASTM-F-1980-07(2011) | Demonstrated integrity |
| Biocompatibility | |
| Determined by guidelines in ISO 10993-1:2009 | Materials determined to be biocompatible |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document specifies "Non-Clinical Performance Data" and "bench testing." It does not provide specific sample sizes for these tests, nor does it mention data provenance in terms of country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a physical medical instrument (trocar and cannula), not an AI/ML-based diagnostic or imaging device that would require expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable due to the nature of the device (physical medical instrument).
5. 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 information is not applicable. The device is a physical medical instrument, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an AI/ML algorithm. The performance evaluation focuses on the physical and material characteristics of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance and bench testing, the "ground truth" or acceptance criteria were based on established engineering and materials standards (e.g., ISO, ASTM) and the device's ability to perform its intended mechanical functions (e.g., compression strength, tensile strength, sterility level).
8. The sample size for the training set
This information is not applicable. The device is a physical medical instrument; there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for this type of device.
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510(k) SUMMARY: 1.0
. ·
510(k) SUMMARY
| Submitter: | Banyan Medical, LLC.89 Bellows StreetWarwick, RI 02888 |
|---|---|
| Contact Person: | Tammy Healey, Quality Manager |
| Telephone: | 401-383-9336 |
| Fax: | 401-228-7397 |
| Establishment Registration#: | 3009770724 |
| 510(k) Number: | K133375 |
| Date 510(k) Prepared: | October 30, 2013 |
| Proprietary Name: | Banyan Medical Disposable SecondaryCannula and Trocar for Laparoscopic Use |
| Common Name: | Cannula and Trocar |
| Classification: | 876.1500 |
| Product Code: | GCJ |
| Classification Name: | Laparoscope, General & Plastic Surgery |
| Substantial EquivalenceClaimed To: | K911462; Apple Medical Surgical Trocar |
| Substantial EquivalenceClaimed To: | K112358; Unimax Secondary Trocar |
510(k) Summary Page 1 of 3
Page 19 of 410
.
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510(k) SUMMARY (continued)
510(k) Number: K133375
Device Description:
The Banyan Medical line of Disposable Secondary Cannula and Trocars for Laparoscopic Use consists of a trocar, cannula sleeve and a silicone seal. The design has two possible trocars, a sharp faceted tip and a conical tip. An insufflation adapter, when supplied, is compatible with standard luer lock fittings and provides for insufflation of the abdominal cavity. The Cannula and Trocar will be sold in 5mm, 8mm, 10mm and 12mm sizes.
Intended Use:
The Banyan Medical Disposable Secondary Cannula and Trocar for Laparoscopic Use is indicated for applications in abdominal and gynecologic minimally invasive laparoscopic surgical procedures to establish a port of entry for endoscopic and laparoscopic instruments. The trocar is used with visualization for secondary insertions.
Summary of Technological Characteristics:
The trocar consists of a threaded or press fit medical grade stainless steel tip attached to an anodized aluminum shaft that is insert molded or attached to a polycarbonate knob. The cannula is an Acetal copolymer molded component with integral thread design to improve retention to the abdominal wall. The cannula is assembled with a silicone seal to prevent loss of insufflation gas. All of the technological characteristics of the new device are the same as those of the predicate device.
Performance Data:
Non-Clinical Performance Data: The Banyan Medical Disposable Secondary Cannula and Trocar performance characteristics have been evaluated through non-clinical performance and bench testing (includes compression testing of the cannula, tensile testing of the knob to shaft of trocar, puncture testing of the trocar tip, shelf life testing and accelerated age testing, ship testing, and luer testing, which includes gauging, liquid leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding and stress cracking per ISO 594-1 and 594-2). The testing has demonstrated that the device performs as intended when used according to the instructions for use. The sterilization validation was performed according to the guidelines set forth in the standard ISO 11135:2007, Sterilization of health care products -- Ethylene
510(k) Summary Page 2 of 3
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510(k) SUMMARY (continued)
510(k) Number: K133375
oxide -- Part 1; Requirements for development, validation and routing control of a sterilization process for medical devices and ISO 10993-7:2008, Biological Evaluation for Medical Devices - Part 7: Ethylene Oxide sterilization residuals. A sterility assurance level (SAL) of ≥ 10t has been achieved.
The sterilization data submitted in this document meets the requirement set forth in the draft documents: Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labeled as Sterile.
Package and product integrity were tested in accordance with ISO 11607-1.2006, Packaging for Terminally Sterilized Medical Devices and ASTM-F-1980-07(2011), Standard Guide for Accelerated Aging of Sterile Medical Device Packages.
The biocompatibility of the chosen materials was determined by the guidelines defined in ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process.
Clinical Performance Data: No clinical data is submitted.
Conclusions Drawn from Tests and Analysis:
The intended use and major performance parameters of the Banyan Medical Disposable Secondary Cannula and Trocar are similar or equivalent to the characteristics of the Apple Medical Disposable Trocar (K911462) and Unimax Secondary Trocar (K112358) as determined in section 12.0 of this Premarket Notification Traditional 510(k) submission.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion 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
January 17, 2014
Banyan Medical LLC Ms. Tammy Healey Quality Manager 89 Bellows Street Warwick, Rhode Island 02888
Re: K133375
Trade/Device Name: Banyan medical disposable secondary cannula and trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 25, 2013 Received: November 27, 2013
Dear Ms. Healey:
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 or any I 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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Page 2 - Ms. Tammy Healey
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDeyices/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 Small Manufacturers. International and Consumer Assistance 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,
Joshua GEMopper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional Banyan Medical Premarket Notification 510(K) - Establishment Number 3009770724
INDICATION FOR USE: 1.0
_
INDICATION FOR USE
510(k) Number (if known): K133375
Device Name: Banyan Medical Disposable Secondary Cannula and Trocar for Laparoscopic Use
Indications for Use:
The Banyan Medical Disposable Secondary Cannula and Trocar for Laparoscopic Use is indicated for applications in abdominal and gynecologic minimally invasive laparoscopic surgical procedures to establish a port of entry for endoscopic and laparoscopic instruments. The trocar is used with visualization for secondary insertions.
× Prescription Use AND/OR -Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Long H. Chen -A
for BSA
(Division Sign-Off) Division of Surgical Devices
510(k) Number: K133375
§ 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.