(128 days)
Not Found
No
The device description and performance studies focus on mechanical components and sterilization, with no mention of AI or ML.
No.
The devices are described as access devices that create and maintain a passageway for laparoscopic instruments, which are tools used during surgical procedures, rather than being therapeutic themselves.
No
The device description clearly states its purpose is to create and maintain a passageway for laparoscopic instruments, which is an access function during surgery, not a diagnostic one.
No
The device description clearly states that the device is a family of single-use physical devices (trocars and accessories) and mentions sterilization and physical testing, indicating it is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Passport® Trocars are used as access devices during laparoscopic procedures to create and maintain a passageway for surgical instruments. This is a surgical tool used directly on the patient during a procedure.
- Device Description: The description reinforces that these are single-use devices serving as an access port for laparoscopic instruments during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not as surgical tools used directly on the body during a procedure.
N/A
Intended Use / Indications for Use
Passport® Trocars are indicated for use as access devices that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures, in adult and adolescent (12 to 21 years of age) populations.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Passport® Trocars with pediatric indication and Accessories (herein referred to as 'proposed devices') are a family of single-use devices that serve as an access port for laparoscopic instruments during laparoscopic surgery. The two accessory devices included in the submission are the Robotic Reducer Cap and Stopcock with Rotating Male Luer. These devices are to be used with the Passport® Trocars previously cleared in K080161 (herein referred to as 'predicate devices'). The Robotic Reducer Cap can be attached to the 8.5 mm and 12 mm robotic Passport® Trocars to reduce the seal size to accommodate smaller instruments. The Stopcock with Rotating Male Luer can be attached to 3 and 5 mm Passport® Trocars that do not have built-in stopcocks in order to control flow of CO2. The proposed devices are sterilized by ethylene oxide.
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
adult and adolescent (12 to 21 years of age)
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 pediatric indication expansion is the only change to the Passport® Trocars portion of the submission. Therefore this submission does not contain any performance data for the previously cleared Passport® Trocars (K08161). The accessories were tested for performance in accordance with design specifications and applicable performance standards. Biocompatibility was verified per ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and related collateral standards for patient contacting materials. Sterilization was verified per ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Bench performance testing performed on the accessories verifies the safety and effectiveness of the devices per design specifications and acceptance criteria. Test results obtained indicate that the accessories comply with applicable performance standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Section 5. 510(k) Summary
PER 21 CFR 807.92
| 510(k) Owner/Sponsor:
Address: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 | AUG
1 2013 |
|-----------------------------------|--------------------------------------------------------------------------------------------|---------------|
| Establishment Number: | 2936485 | |
| Telephone Number: | (408) 855-6377 | |
| Contact Person: | Rebecca Goldberg; Regulatory Affairs Analyst | |
| Email Address: | rebecca.goldberg@stryker.com | |
| Proposed Device: | Passport® Trocars and Accessories | |
| Common/Usual Name: | Disposable Surgical Trocar/Cannula Accessory | |
| Product Code: | GCJ | |
| FDA Regulation Number: | 21 CFR 876.1500 - Endoscope and accessories | |
| Device Classification: | Class II | |
| Predicate Device: | Passport Optical Trocar, Vortex Seal, Blunt Tip Trocar, Shielded
Trocar, Cannula Anchor | |
| Common/Usual Name: | Disposable Surgical Trocar/Cannula and Accessories | |
| Product Code: | GCJ | |
| FDA Regulation Number: | 21 CFR 876.1500 - Endoscope and accessories | |
| Device Classification: | Class II | |
| Premarket Notification: | K080161 | |
Device Description
The Passport® Trocars with pediatric indication and Accessories (herein referred to as 'proposed devices') are a family of single-use devices that serve as an access port for laparoscopic instruments during laparoscopic surgery. The two accessory devices included in the submission are the Robotic Reducer Cap and Stopcock with Rotating Male Luer. These devices are to be used with the Passport® Trocars previously cleared in K080161 (herein referred to as 'predicate devices'). The Robotic Reducer Cap can be attached to the 8.5 mm and 12 mm robotic Passport® Trocars to reduce the seal size to accommodate smaller instruments. The Stopcock with Rotating Male Luer can be attached to 3 and 5 mm Passport® Trocars that do not have built-in stopcocks in order to control flow of CO2. The proposed devices are sterilized by ethylene oxide.
Intended Use/Indications for Use
Passport® Trocars are indicated for use as access devices that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures in adult and adolescent (12 to 21 years of age) populations.
1
Technological Comparison
マ
Passport® Trocars with pediatric indications employ the same technological characteristics as the predicate devices (K080161). The Robotic Reducer Cap and Stopcock with Rotating Male Luer employ many of the same technological characteristics as the predicate The differences in the technological characteristics do not impact safety or devices. effectiveness (See Section 12 - Substantial Equivalence).
Performance Testing
The pediatric indication expansion is the only change to the Passport® Trocars portion of the submission. Therefore this submission does not contain any performance data for the previously cleared Passport® Trocars (K08161). The accessories were tested for performance in accordance with design specifications and applicable performance standards. Biocompatibility was verified per ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and related collateral standards for patient contacting materials. Sterilization was verified per ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Bench performance testing performed on the accessories verifies the safety and effectiveness of the devices per design specifications and acceptance criteria. Test results obtained indicate that the accessories comply with applicable performance standards.
Conclusion
The submitted information in this premarket notification is complete, and based on the indications for use, technological characteristics, performance testing and comparison to the intended use for predicate devices, Passport® Trocars and Accessories raise no new questions of safety and effectiveness and can be considered to be substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2013
Stryker Endoscopy % Ms. Rebecca Goldberg Regulatory Affairs Analyst 5900 Optical Court San Jose, California 95138
Re: K130826
Trade/Device Name: Passport® Trocars and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 27, 2013 Received: July 1, 2013
Dear Ms. Goldberg:
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 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
3
Page 2 - Ms. Rebecca Goldberg
forth in the quality systems (OS) 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/MedicalDevices/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.
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
Device Name: Passport® Trocars and Accessories
510(k) Number if known: K130826
Indications for Use:
Passport® Trocars are indicated for use as access devices that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures, in adult and adolescent (12 to 21 years of age) populations.
Over-The-Counter Use Prescription Use __ X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nipper -S
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130826
Stryker Passport® Trocars and Accessories 510(k) Submission K130826-S005