(131 days)
The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The Reprocessed Stability Sleeve has application in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Reprocessed Bladeless Trocar: The Reprocessed Bladeless Trocar, is a sterile single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator contains a clear, tapered optical element. The 5 mm obturator accommodates an appropriately sized 0° endoscope and provides visibility of individual tissue layers during insertion. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Reprocessed Dilating Tip (Bladed) Trocar: The Reprocessed Dilating Tip Trocar is a sterile, single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator has a sharp, flat-bladed tip and spring-loaded shield is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Reprocessed Stability (Universal) Sleeve (Cannula): The Reprocessed Stability Sleeve is a sterile, single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
The document provided describes the reprocessing of surgical trocars and sleeves, and the performance data focuses on demonstrating that the reprocessed devices are as safe and effective as new (predicate) devices. This is not the type of medical device for which the requested acceptance criteria and study information (AI/radiology performance metrics, expert adjudication, etc.) would typically apply.
The device is a reprocessed medical instrument, not an AI or diagnostic imaging device. Therefore, the performance evaluation centers on its physical integrity, sterility, and functionality after reprocessing, rather than diagnostic accuracy or human-AI interaction.
Here's an analysis based on the provided text, highlighting why most of your requested points are not applicable in this context:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria for each test and reported pass/fail results. Instead, it lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Tested and performs as originally intended. |
| Validation of Reprocessing | Tested and performs as originally intended. |
| Sterilization Validation | Tested and performs as originally intended. |
| Function Test(s) | Each individual device is tested for appropriate function of its components prior to packaging. Tested and performs as originally intended. |
| Packaging Validation | Tested and performs as originally intended. |
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 does not specify the sample sizes for the performance tests (biocompatibility, reprocessing validation, sterilization, function, packaging). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (bench and laboratory), these details are less critical than for clinical trials.
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 question is not applicable. The "ground truth" for a reprocessed medical instrument involves objective measurements of sterility, material integrity, and mechanical function, not diagnostic interpretations by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials, particularly in image interpretation, to resolve discrepancies between readers. This device undergoes bench and laboratory testing.
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 question is not applicable. An MRMC study is relevant for diagnostic devices (e.g., AI in radiology). This submission is for reprocessed surgical instruments. Human "improvement" or AI assistance is not a relevant metric here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the "ground truth" for this device relates to objective physical and biological properties. It includes:
- Sterility: Absence of viable microorganisms (validated through sterilization methods).
- Biocompatibility: Absence of adverse biological reactions (tested with accepted standards).
- Functional Performance: Mechanical integrity and operation of components (e.g., seals, bladed tip, stopcock valve, resistance to leakage, insertion force).
- Cleaning Efficacy: Absence of residual soil after reprocessing.
- Packaging Integrity: Maintenance of sterility barrier.
These are established through standardized laboratory methods and specifications, not expert consensus or pathology in the diagnostic sense.
8. The sample size for the training set
This question is not applicable. This device is a physical instrument, not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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K132629
SECTION 5: 510(k) SUMMARY
Submitter:
t
Stryker Sustainability Solutions 1810 W Drake Drive Tempe, Arizona 85283
Contact:
Amanda Babcock Regulatory Affairs Lead (480) 763-5300 (o) (863) 904-2312 (f) amanda.babcock@stryker.com
Date of preparation: August 20, 2013
Trade/Proprietary Name: Reprocessed Trocars and Stability Name of device: Sleeve
Classification Name: Laparoscope, General & Plastic Surgery, Reprocessed
| ClassificationInformation: | Class: | II |
|---|---|---|
| Panel: | Gastroenterology/Urology | |
| Product Code: | NLM | |
| Citation: | 21 CFR §876.1500 |
| PredicateDevice | 510(k) Title | Manufacturer |
|---|---|---|
| K062497 | Reprocessed Trocars | Stryker Sustainability Solutions |
| K070059 | Reprocessed Xcel Bladed Trocars | Stryker Sustainability Solutions |
| K122511 | ENDOPATH XCEL BLADELESSTROCAR WITH OPTIVIEWTECHNOLOGY ENDOPATH XCELBLUNT TIP TROCAR WITHOPTIVIEW TECHNOLOGY | Ethicon Endo-Surgery |
Device Description:
Reprocessed Bladeless Trocar:
The Reprocessed Bladeless Trocar, is a sterile single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator contains a clear, tapered optical element. The 5 mm obturator accommodates an appropriately sized 0° endoscope and provides visibility of individual tissue layers during insertion. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Stryker Sustainability Solutions Reprocessed Trocars and Stability Sieeve Traditional 510(k)
Page 1
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Reprocessed Dilating Tip (Bladed) Trocar:
The Reprocessed Dilating Tip Trocar is a sterile, single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator has a sharp, flat-bladed tip and spring-loaded shield is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Reprocessed Stability (Universal) Sleeve (Cannula):
The Reprocessed Stability Sleeve is a sterile, single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Indications for Use:
Reprocessed Bladeless Trocar:
The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Reprocessed Dilating Tip Trocar:
The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Reprocessed Stability Sleeve:
The Reprocessed Stability Sleeve has application in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Technological Characteristics:
The design, materials, and intended use of Reprocessed Bladeless Trocar, Reprocessed Dilating Tip Trocar, and Reprocessed Stability Sleeves are identical to the predicate devices. The mechanism of action of Reprocessed Bladeless Trocar. Reprocessed Dilating Tip Trocar, and Reprocessed Stability Sleeves are identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of Bladeless Trocars. Dilating Tip Trocars, and Stability Sleeves includes removal of adherent visible soil and decontamination. Each individual Bladeless Trocar. Dilating Tip Trocar and Stability Sleeve is tested for appropriate function of its components prior to packaging and labeling operations.
Stryker Sustainability Solutions Reprocessed Trocars and Stability Sleeve Traditional 510(k)
Page 2
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Performance data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Bladeless Trocar, Reprocessed Dilating Tip Trocar, and Reprocessed Stability Sleeves. This included the following tests:
- . Biocompatibility
- Validation of reprocessing .
- Sterilization Validation .
- 0 Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed Bladeless Trocar, Reprocessed Dilating Tip Trocar, and Reprocessed Stability Sleeves perform as originally intended.
Conclusion:
Stryker Sustainability Solutions concludes that the reprocessed devices are as safe and effective to the predicate devices as described herein.
Stryker Sustainability Solutions Reprocessed Trocars and Stability Sleeve Traditional 510(k)
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized human figure with three lines representing the body, arms, and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written in bold, uppercase letters to the right of the figure. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66 Silver Spring, MD 20993-0002
December 31, 2013
Stryker Sustainability Solutions % Ms. Amanda Babcock Regulatory Affairs Lead 1810 West Drake Drive Tempe, Arizona 85283
Re: K132629
Trade/Device Name: Reprocessed Dilating Tip Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NLM Dated: September 9, 2013 Received: September 23, 2013
Dear Ms. Babcock:
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): Jabeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the
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Page 2 - Ms. Amanda Babcock
..............................................................................................................................................................................
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/ResourcesforYowIndustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR 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,
Binita S. Ashar : S. 2013.12.31 11:34:41 -05'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K132629
Device Name: Reprocessed ENDOPATH® XCEL™ Bladeless Trocar with OPTIVIEW® Technology
Indications For Use: The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Device Name: Reprocessed ENDOPATH® XCEL™ Dilating Tip Trocar with OPTIVIEW® Technology
Indications For Use: The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Device Name: Reprocessed ENDOPATH® XCEL™ Universal Trocar Stability Sleeve
Indications For Use: The Reprocessed Stability Sleeve has application in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132629
Stryker Sustainability Solutions Reprocessed Trocars and Stability Sleeve Traditional 510(k)
Page 20
§ 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.