(98 days)
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.
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.
The provided text is a 510(k) summary for SterilMed, Inc.'s reprocessed endoscopic trocars. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove device performance in the context of an AI/ML device.
Therefore, the information required for the requested output (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, etc.) is not present in the provided document. The document describes a traditional medical device reprocessing and its approval process, not an AI/ML device study.
Here's a breakdown of what is available vs. what is not:
What is present:
- Device Description: Reprocessed endoscopic trocar, consisting of a sleeve and obturator.
- Intended Use: To provide a pathway for entry of minimally invasive instruments to a body organ or cavity during various surgical procedures.
- Functional and Safety Testing mentioned: Cleaning validation, sterilization validation (ISO 11135, USP <71>), biocompatibility testing (ISO 10993), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), shelf life validation (ASTM 1980-07), and functional performance validated using bench and laboratory testing.
- Conclusion: Substantial equivalence to predicate devices based on similarities in functional design, materials, indications for use, and methods of construction.
What is NOT present (and is required for your requested output, indicating this is not an AI/ML study report):
- Specific Acceptance Criteria (quantitative metrics like sensitivity, specificity, AUC, etc. for an AI model). The document mentions "appropriate functional characteristics" but doesn't quantify them.
- Reported Device Performance against specific quantitative criteria.
- Sample Size for a test set (in terms of cases/images for an AI model). The document mentions "representative samples" for functional testing but not a quantified test set for AI evaluation.
- Data Provenance (country of origin, retrospective/prospective for AI data).
- Number of experts and their qualifications for establishing ground truth. This typically applies to AI model evaluation where human experts label data.
- Adjudication method (2+1, 3+1, none) for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect size. This is specific to human-AI collaboration studies.
- Standalone (algorithm-only) performance data.
- Type of ground truth used (expert consensus, pathology, outcomes data). While "functional performance was validated" and "cleaning validation," etc., are mentioned, these are for a reprocessing procedure, not for establishing ground truth for an AI model's output.
- Sample size for the training set (for an AI model).
- How the ground truth for the training set was established (for an AI model).
In summary, the provided text describes the regulatory approval of a reprocessed physical medical device (endoscopic trocar) through a 510(k) submission, not the evaluation of an AI/ML medical device. Therefore, it does not contain the information requested in your bullet points, which are tailored for AI/ML device studies.
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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 |
| PredicateDevices: | The reprocessed endoscopic trocars are substantially equivalent to the Applied Medical trocars(510(k)s K072674, K060096, K041795, K032889, K012884, & K012968). |
|---|---|
| DeviceDescription: | The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturatorthat is available in varying lengths and diameters. The obturator may be blunt, bladed, orshielded-bladed (blade covered by a retractable shield). Reprocessed endoscopic trocars aredevices that provide a pathway for entry of minimally invasive instruments to a body organ orcavity during abdominal, thoracic or gynecologic surgical procedures. |
| Indications forUse: | The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimallyinvasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologicor other minimally invasive surgical procedures. |
| Functional andSafety Testing: | Representative samples of reprocessed endoscopic trocars were tested to demonstrateappropriate functional characteristics. Process validation testing was performed to validate thecleaning and sterilization procedures as well as device packaging. In addition, themanufacturing process includes visual and validated functional testing of all products produced. |
| Summary ofNon-clinicalTestsConducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO11135, USP <71>), biocompatibility testing (ISO 10993), ethylene oxide residual testing (ISO10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and shelf lifevalidation (ASTM 1980-07). In addition, functional performance was validated using benchand laboratory testing. The results of these tests prove substantial equivalence between thesubject 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 ofoperation), 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
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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
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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
Page 1 of 1
§ 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.