(114 days)
The Weck Reusable Obturator is indicated for use with appropriate disposable Weck Vista cannulas in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
The Weck® Reusable Obturator is used to establish penetration into the abdominal cavity during laparoscopic surgical procedures. When used with the appropriate corresponding disposable cannula, the system creates a port of entry into the patient, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The obturator is positioned into the peritoneum as a guide to the corresponding cannula during minimally invasive surgical procedures, and then is removed in order to provide a pathway for the insertion and removal of various sized surgical devices. The Weck® Reusable Obturator is intended to be used by trained physicians.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate obturators for performance | Achieved; comparative test results demonstrate substantial equivalence. |
| Seamless interchangeability with predicate obturators | Achieved; comparative test results demonstrate seamless interchangeability. |
| Compliance with ISO 10993-1 for patient-contacting materials | Achieved; all patient-contacting materials are in compliance. |
| Appropriate cleaning and sterilization instructions for reusable devices | IFU updates integrated according to ISO 17664:2004 to ensure appropriate cleaning and sterilization. |
| Introduction of no new issues of safety and effectiveness | Achieved; modifications do not introduce any new issues. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the traditional sense of a clinical or observational study with human subjects or a defined dataset. Instead, the evaluation was based on bench testing.
- Sample Size: Not explicitly stated as a number of devices or data points, but rather refers to "bench testing" which implies a series of tests conducted on the device.
- Data Provenance: The data originates from internal "bench testing" performed by Teleflex Medical, Inc. The document does not specify country of origin for the data or if it was retrospective or prospective, though bench testing is inherently prospective in its execution for the purpose of verifying performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The testing performed was bench testing to verify performance characteristics and substantial equivalence, not a clinical study requiring expert assessment for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Bench testing does not typically involve an adjudication method as would be used in clinical trials with multiple expert readers. The evaluation was based on objective measurements and comparisons against predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The study described is a bench test comparison of a reusable device against disposable predicate devices to demonstrate substantial equivalence, not a study involving human readers or comparative effectiveness in a clinical setting.
6. Standalone Performance Study
Yes, a standalone performance evaluation was conducted in the form of "bench testing." This testing was performed on the device itself to verify its performance characteristics and compare them to predicate devices, without human intervention as part of the primary performance measurement.
7. Type of Ground Truth Used
The "ground truth" for this device evaluation was established through objective performance metrics and specifications derived from the predicate devices, as determined through their own clearance processes. The Weck® Reusable Obturator was tested to verify that its performance was "substantially equivalent" and "seamlessly interchangeable" with these established predicate devices.
8. Sample Size for the Training Set
This information is not applicable and not provided. The device being evaluated is a physical medical device (an obturator), not an AI algorithm or software. Therefore, there is no "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical medical device.
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Traditional 510(k) Section 8 - Summary of Safety and Effectiveness
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
OCT 11 1 2012
Reusable Obturator
Weck® Reusable Obturator
A. Name, Address, Phone, and Fax Number of Applicant
Teleflex Medical. Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-4918 919-433-4996 Fax:
B. Contact Person
Holly Kornegay Regulatory Affairs Associate
C. Date Prepared
June 14, 2012
D. Device Name
Trade Name: Common Name: Regulatory Classification: Classification Name: Regulation Number: Regulation Name: Product Code:
Weck® Reusable Obturator Surgical Trocar . Class II . Endoscope and Accessories 21 CFR 876.1500 Arthroscope and Accessories GCJ
E. Device Description
The Weck® Reusable Obturator is used to establish penetration into the abdominal cavity during laparoscopic surgical procedures. When used with the appropriate corresponding disposable cannula, the system creates a port of entry into the patient, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The obturator is positioned into the peritoneum as a guide to the corresponding cannula during minimally invasive surgical procedures, and then is removed in order to provide a pathway for the insertion and removal of various sized surgical devices. The Weck® Reusable Obturator is intended to be used by trained physicians.
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F. Indications for Use
The Weck Reusable Obturator is indicated for use with appropriate disposable Weck Vista cannulas in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
G. Contraindications
Where minimally invasive techniques are contraindicated, other methods and instrumentation should be employed.
H. Substantial Equivalence
The proposed Weck® Reusable Obturator is substantially equivalent to the predicate disposable obturator used with the following devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| ADAPT TM Laparoscopic Portand Accessory | Teleflex Medical, Inc. /Taut, Inc. | K010007 | 02/22/01 |
| ADAPTTM UniversalLaparoscopic Port | Teleflex Medical, Inc. | K082156 | 09/10/2008 |
I. Comparison to Predicate Devices
This proposed product line extension to K010007, ADAPTM Laparoscopic Port and Accessory, and K082156, ADAP1M Universal Laparascopic Port, affords a new product code for a reusable stainless steci obturator. .
The incorporation of the stainless steel material will allow trained physicians the ability to reuse the obturator, without any modification to material or dimensions of the compatible systems noted above.
J. Materials
All patient contacting materials are in compliance with ISO 10993-1.
K. Technological Characteristics
A comparison of the technological characteristics of the proposed Weck® Reusable Obturator and the predicates has been performed. The results of this comparison demonstrate that the Weck® Reusable Obturator is compatible with the cannulas of the systems noted above and additionally offers the feature of "reusability".
Teleflex Medical, Inc.
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L. Performance Data
The bench testing has been performed to verify that the performance of the proposed Weck® Resuable Obturator is substantially equivalent to the predicate obturators and that the Weck® Reusable Obturator is seamlessly interchangeable with the predicate obturator.
L. Conclusion
Based upon the comparative test results, the proposed Weck® Reusable Obturator is substantially equivalent in performance to the predicate devices cleared to market via 510(k) K010007 and K082156. The modifications made to the Weck® Reusable Obturator do not introduce any new issues of safety and effectiveness. IFU updates have been integrated according to ISO 17664:2004, Sterilization of Medical Devices, to ensure appropriate cleaning and sterilization instructions for reusable devices, by the end user.
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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Teleflex Medical, Incorporated % Ms. Holly Kornegay Regulatory Affairs Associate 2917 Weck Drive Research Triangle Park, North Carolina 27709
Re: K121796
Trade/Device Name: Weck® Reusable Obturator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 1, 2012 Received: September 17, 2012
DEC - 4 2012
Dear Ms. Kornegay:
This letter corrects our substantially equivalent letter of October 11, 2012.
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 (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.
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 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.
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Page 2- Ms. Holly Komegay
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure: New Indication For Use
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Indications for Use
Page I of I
510(k) Number:
Device Name: Weck® Reusable Obturator
Indications for Use:
The Weck Reusable Obturator is indicated for use with appropriate disposable Weck Vista cannulas in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Miller
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
-10(k) Number K-121796
Teleflex Medical, Inc.
§ 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.