(48 days)
Not Found
No
The summary describes a reprocessed mechanical surgical instrument (trocar) and its performance testing, with no mention of AI or ML capabilities.
No
This device is a surgical instrument used to create a pathway for other instruments; it does not directly treat a condition or perform therapy.
No
Explanation: The device, an endoscopic trocar, is used to create a pathway for surgical instruments during minimally invasive procedures. Its purpose is to facilitate access and manipulation of tissues and organs for treatment, not to diagnose conditions.
No
The device description clearly states it is a "sterile instrument consisting of a sleeve and obturator," which are physical hardware components. The performance studies also focus on validation of cleaning, sterilization, packaging, and functional performance through bench testing, all related to a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is used to "provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures." This describes a surgical tool used in vivo (within the body) for accessing and manipulating tissues.
- Device Description: The description of the device as a "sterile instrument consisting of a sleeve and obturator" further reinforces its role as a surgical access tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases, monitor conditions, or screen for health issues. This device's function is purely procedural and surgical.
N/A
Intended Use / Indications for Use
The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs.
Product codes
NLM
Device Description
The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturator that is available in varying lengths and diameters. The obturator may be bladeless or dilating tip. Reprocessed trocars are devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic, or other minimally invasive surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Minimally invasive surgical procedures
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
Functional and Safety Testing: Representative samples of reprocessed endoscopic trocars were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging, In addition, the manufacturing process includes visual and validated functional testing of all products produced.
Summary of Non-clinical Tests Conducted: Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP ), biocompatibility testing (ISO 10993), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing, Performance testing shows the reprocessed endoscopic trocar to perform as originally intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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JUN 1 1 2012
), biocompatibility testing (ISO 10993), ethylene oxide residual testing (ISO 10993-7), packaging
validation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM 1980-07). In
addition, validation of functional performance (bench testing) was performed through simulated use, visual
inspection, fatigue testing, and function testing, Performance testing shows the reprocessed endoscopic trocar
to perform as originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed endoscopic trocars are safe, effective, and substantially equivalent to
the predicate devices, Ethicon Endo-Surgery ENDOPATH® XCEL™ With OPTIVIEW® Technology Trocars
(K032676), as described in this premarket notification submission. |
r
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 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, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 1 2022
Sterilmed. Incorporated % Mr. Jason Skramsted, RAC 11400 73td Avenue, North Maple Grove, Minnesota 55369
Re: K121240
Trade/Device Name: Reprocessed Endoscopic Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NLM Dated: April 23, 2012 Received: April 24, 2012
Dear Mr. Skramsted:
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
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Page 2 - Mr. Jason Skramsted
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.
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,
Madle Al millum
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "STERILMED" in a simple, sans-serif font. To the left of the word is a circular graphic with a stylized design. The text and graphic appear to be part of a logo or brand identity.
510(K) PREMARKET NOTIFICATION SUBMISSION 23 APRIL 2012
For Reprocessed Endoscopic Trocars
Indications for Use
510(k) Number (if known):
Device Name: Reprocessed Endoscopic Trocars
Indications for Use:
The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs.
Prescription Use X (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)
Neil R.P. Ogden for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121240
CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.
4
K121240-List of device models included in this submission.
and the control of the country of the county of
| Manufacturer | Model # | Device Description |
|---|---|---|
| Ethicon Endo- | ||
| Surgery | 2B5ST | Bladeless Trocars (D 5mm, L 75mm, Stability |
| Sleeve) | ||
| 2B5LT | Bladeless Trocars (D 5mm, L 100mm, Stability | |
| Sleeve) | ||
| 2D5ST | Dilating Tip Trocars (D 5mm, L 75mm, Stability | |
| Sleeve) | ||
| 2D5LT | Dilating Tip Trocars (D 5mm, L 100mm, Stability | |
| Sleeve) | ||
| 2CB5ST | Universal Sleeves (D 5mm, L 75mm, Stability | |
| Sleeve) | ||
| 2CB5LT | Universal Sleeves (D 5mm, L 100mm, Stability | |
| Sleeve) |
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