(272 days)
Not Found
No
The 510(k) summary describes a reprocessed mechanical surgical instrument (trocar) and its reprocessing process. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on functional performance, cleaning, sterilization, and manufacturing processes, not algorithmic performance.
No
The device provides a pathway for surgical instruments but does not itself treat or cure a disease or condition.
No
The device is described as providing a pathway for entry of surgical instruments during minimally invasive procedures. Its function is to facilitate surgery, not to diagnose a condition or disease.
No
The device description explicitly states it is a "sterile instrument consisting of a radiolucent sleeve and obturator," which are physical hardware components. The summary also details bench testing and process validation for cleaning, sterilization, and packaging, 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: The intended use clearly states that the device is 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." This describes a surgical instrument used in vivo (within the body) for access during surgery.
- Device Description: The description reinforces this by describing a "sterile instrument consisting of a radiolucent sleeve and obturator" used for creating a pathway during surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health, diagnose a condition, or monitor treatment.
IVD devices are specifically designed for testing biological samples outside the body to obtain diagnostic information. This device is a surgical tool used directly on the patient during a procedure.
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 (comma separated list FDA assigned to the subject device)
NLM
Device Description
The Reprocessed Endoscopic Trocar is a sterile instrument consisting of a radiolucent sleeve and obturator in sizes ranging from 75 to 150 mm in length and 5 to 12 mm in diameter. 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 underwent bench testing to demonstrate appropriate functional performance. Process validation testing was performed to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KOS2299
ਾ ਜ਼
2.0 510(K) SUMMARY FOK REPROCESSED ENDOSCOPIC TROCARS
| Submitter: | SterilMed, Inc.
MAY 2 3 2006 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas A. Dold MBA, RAC
Director of Regulatory Affairs
SterilMed, Inc.
11400 73rd Avenue North
Minneapolis, MN 55369
Phone: 763-488-3410
Fax: 763-488-3350
E-mail: tdold@sterilmed.com |
| Date Prepared: | August 22, 2005 |
| Trade Name: | Reprocessed Endoscopic Trocar |
| Classification Name: | Laparoscope, General and Plastic Surgery |
| Classification Number: | Class II 21CFR 876.1500 |
| Product Code: | NLM |
| Predicate Device(s): | The Reprocessed Endoscopic Trocar is substantially
equivalent to the SterilMed, Inc. Reprocessed endoscopic
trocars (K043592 cleared on May 23, 2005) as well as the
Endopath® XCEL™ Bladeless Trocar (K032676 cleared
October 30, 2003) manufactured by Ethicon. |
| Device Description: | The Reprocessed Endoscopic Trocar is a sterile instrument
consisting of a radiolucent sleeve and obturator in sizes
ranging from 75 to 150 mm in length and 5 to 12 mm in
diameter. 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. |
1
Intended 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 underwent bench testing to demonstrate appropriate functional performance. Process validation testing was performed to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Conclusion:
The Reprocessed Endoscopic Trocar is substantially equivalent to the SterilMed, Inc. Reprocessed Endoscopic Trocars (K043592 cleared on May 23, 2005) as well as the Endopath® XCEL™ Bladeless Trocar (K032676 cleared October 30, 2003) manufactured by Ethicon. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2006
SterilMed, Inc. % Mr. Dennis J. Toussaint Director of Regulatory Affairs 11400 73td Avenue North Minneapolis, Minnesota 55369
Re: K052299
Trade/Device Name: Reprocessed Endoscopic Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: March 17. 2006 Received: March 20, 2006
Dear Mr. Toussaint: -
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Dennis J. Toussaint
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 – Mr. Dennis J. Toussaint
Reprocessed Endopath XCEL Bladeless Trocars found to be substantially equivalent:
: 上一篇:
ﻬ
MODEL DESCRIPTION
| B5LP | Smooth sleeve, 5mm diameter, 100mm length |
|---|---|
| B5LT | Stability sleeve, 5mm diameter, 100mm length |
| B5SP | Smooth sleeve, 5mm diameter, 75mm length |
| B5ST | Stability sleeve, 5mm diameter, 75mm length |
| B11LP | Smooth sleeve, 11mm diameter, 100mm length |
| B11LT | Stability sleeve, 11mm diameter, 100mm length |
| B12LP | Smooth sleeve, 12mm diameter, 100mm length |
| B12LT | Stability sleeve, 12mm diameter, 100mm length |
| B12SRT | Stability sleeve, 12mm diameter, 75mm length |
| H12LP | Stability sleeve, 12mm diameter, 100mm length |
5
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.
يج
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)
.m.dll.
(Division Sign-Division of General, Restorati and Neurological Devices
K052299 510(k) Number_