(128 days)
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.
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.
This document describes the 510(k) submission for Stryker Endoscopy's "Passport® Trocars and Accessories" (K130826). The submission focuses on expanding the pediatric indication for the existing Passport® Trocars and introducing two new accessory devices: the Robotic Reducer Cap and the Stopcock with Rotating Male Luer.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria or detailed device performance metrics in a readily quantifiable format for the Passport® Trocars and Accessories.
Instead, it broadly states:
| Criterion Area | Description / Reported Performance |
|---|---|
| New Pediatric Indication for Passport® Trocars | This is the only change to the Passport® Trocars portion of the submission. The document explicitly states: "Therefore this submission does not contain any performance data for the previously cleared Passport® Trocars (K08161)." The basis for substantial equivalence for this expansion appears to rely on the existing predicate device's characteristics and the assumption that the fundamental design is safe and effective for the broadened age range. There are no new performance tests mentioned specifically for the pediatric indication. |
| Accessories (Robotic Reducer Cap & Stopcock with Rotating Male Luer) | Performance Testing: "The accessories were tested for performance in accordance with design specifications and applicable performance standards." "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." |
| Biocompatibility | "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 | "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." |
| Technological Comparison | "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 devices. The differences in the technological characteristics do not impact safety or effectiveness (See Section 12 - Substantial Equivalence)." |
In summary, the specific quantitative acceptance criteria and their corresponding results are not provided in this excerpt. The document relies on general statements about meeting "design specifications," "applicable performance standards," and compliance with ISO standards.
The remaining questions delve into specific study details that are not present in the provided text. The document is a 510(k) summary, which typically provides a high-level overview rather than detailed study protocols or results.
Here's what cannot be answered from the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not mentioned. The document only states that "bench performance testing" was performed for the accessories. It does not provide details on sample sizes for these tests, nor does it refer to any clinical "test set" in the context of human or animal data.
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)
- Not applicable/Not mentioned. This information is typically relevant for studies involving human interpretation or subjective assessment (e.g., medical imaging devices evaluating disease presence). The device in question is a surgical tool and accessories, and the performance testing mentioned is "bench performance testing," which would not involve experts establishing "ground truth" in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. Similar to point 3, adjudication methods are for resolving discrepancies in human interpretation, which is not described as part of the performance testing for this device.
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
- No. This device is a surgical instrument and accessories, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study or AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not mentioned for a clinical context. For the bench testing of accessories, the "ground truth" would be related to engineering specifications and measurements (e.g., force, flow rate, seal integrity). The document does not provide details on these specific measurements or the "ground truth" against which they were compared, other than generally stating compliance with "design specifications and applicable performance standards."
8. The sample size for the training set
- Not applicable. This device does not involve an AI algorithm, and therefore there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
Conclusion based on provided text:
The submission for the Passport® Trocars and Accessories relies on:
- Substantial equivalence to a predicate device (K080161) for the main trocar component, especially for the pediatric indication expansion, indicating that no new performance data was generated for the trocars themselves for this part of the submission.
- Bench performance testing for the new accessories, ensuring they meet "design specifications" and "applicable performance standards."
- Compliance with ISO standards for biocompatibility (ISO 10993-1) and sterilization (ISO 11135-1).
The document is a high-level summary and does not contain the detailed quantitative acceptance criteria or granular study data typically found in a full study report. It focuses on establishing that the device "raises no new questions of safety and effectiveness" due to its similarity to predicate devices and adherence to general performance and safety standards.
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Section 5. 510(k) Summary
PER 21 CFR 807.92
| 510(k) Owner/Sponsor:Address: | Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138 | AUG1 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, ShieldedTrocar, 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.
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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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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
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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
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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
§ 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.