(98 days)
Not Found
No
The summary describes a reprocessed mechanical surgical instrument and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is designed to create a pathway for surgical instruments, not to directly treat or diagnose a medical condition.
No.
The device description clearly states that reprocessed endoscopic trocars "provide a pathway for entry of minimally invasive instruments to a body organ or cavity during abdominal, thoracic or gynecologic surgical procedures," which is a surgical tool function, not a diagnostic one.
No
The device description clearly states it is a "sterile instrument consisting of a sleeve and obturator," which are physical hardware components. The summary also details performance studies related to cleaning, sterilization, packaging, and functional testing of these physical components.
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 device is designed to provide a pathway for surgical instruments to enter a body organ or cavity during surgical procedures. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description of the device as a sterile instrument consisting of a sleeve and obturator used for creating a pathway during surgery aligns with a surgical tool, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.), detect markers, or provide diagnostic information about a patient's condition.
- Focus on Surgical Function: The performance studies described focus on the functional characteristics of the device as a surgical tool (cleaning, sterilization, biocompatibility, packaging, shelf life, functional performance). These are relevant to a surgical device, not an IVD.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) as a surgical tool.
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.
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 blunt, bladed, or shielded-bladed (blade covered by a retractable shield). Reprocessed endoscopic trocars are devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during abdominal, thoracic or gynecologic 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
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)
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.
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 D4169, ASTM F88, ASTM F2096), and shelf life validation (ASTM 1980-07). In addition, functional performance was validated using bench and laboratory testing. The results of these tests prove substantial equivalence between the subject and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072674, K060096, K041795, K032889, K012884, K012968
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.
0
STERILMED, INC.
Medical Device Reprocessing
Small Equipment & Instrument Repair
FOR REPROCESSED ENDOSCOPIC TROCARS
II. SUMMARY AND CERTIFICATION
510(k) Summary A.
Submitter:
KIII 002 SterilMed, Inc.
Contact Person:
Garrett Ahlborg 11400 73rd Avenue North Maple Grove, MN 55369 Ph: 763-488-3483 Fax: 763-488-2051
| Date Prepared: | April 8, 2011 |
|---|---|
| Trade Name: | Reprocessed Endoscopic Trocars |
| Classification Name: | Endoscope and accessories |
| Classification Number: | Class II, 21 CFR 876.1500 |
| Product Code: | NLM |
| Predicate
Devices: | The reprocessed endoscopic trocars are substantially equivalent to the Applied Medical trocars
(510(k)s K072674, K060096, K041795, K032889, K012884, & K012968). |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 blunt, bladed, or
shielded-bladed (blade covered by a retractable shield). Reprocessed endoscopic trocars are
devices that provide a pathway for entry of minimally invasive instruments to a body organ or
cavity during abdominal, thoracic or gynecologic surgical procedures. |
| 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. |
| 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 D4169, ASTM F88, ASTM F2096), and shelf life
validation (ASTM 1980-07). In addition, functional performance was validated using bench
and laboratory testing. The results of these tests prove substantial equivalence between the
subject and predicate devices. |
| Conclusion: | The reprocessed endoscopic trocars are substantially equivalent to the Applied Medical trocars. |
| | This conclusion is based upon the devices' similarities in functional design (principle of
operation), materials, indications for use, and methods of construction. |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 8 2011
SterilMed, Inc. % Mr. Garrett Ahlborg 11400 7310 Avenue North Maple Grove, Minnesota 55369
Re: K111002
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: July 06, 2011 Received: July 07, 2011
Dear Mr. Ahlborg:
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
2
Page 2 - Mr. Garrett Ahlborg
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 (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 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.
erely yours,
For Peter R
Rum
"m"
"m"
Accunt D.e
Mark N. Melker Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for SterilMed, INC. The logo is in a bold, sans-serif font, with the words "SterilMed" in large letters and "INC." in smaller letters. Below the company name is the text "Medical Device Reprocessing" and "Small Equipment & Instrument Repair". The logo is simple and professional, and it conveys the company's focus on medical device reprocessing and repair.
FOR REPROCESSED ENDOSCOPIC TROCARS
KIII 002
Indications for Use
Device Name: Reprocessed Endoscopic Trocar
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.
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)
Nil RPogden for mxm
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111002
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