(145 days)
Not Found
No
The description focuses on the mechanical function of a reprocessed surgical instrument and does not mention any computational or analytical capabilities, let alone AI/ML.
No.
The device facilitates surgical procedures by providing access but does not directly treat a disease or condition itself.
No
Explanation: The device description states its purpose is to "provide a pathway for entry of minimally invasive instruments" for surgical procedures like "observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs." This indicates a surgical tool, not a device used to identify or diagnose a condition.
No
The device description clearly states it is a "reprocessed endoscopic trocar," which is a physical surgical instrument, not software. The summary describes bench testing and process validation for 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 instrument used in vivo (within the body) for surgical access.
- Device Description: The description further elaborates on its use in surgical procedures like "observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs." These are all surgical actions performed directly on the patient.
- 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, tissue samples, etc., to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed for testing biological samples outside the body. 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
NLM
Device Description
Reprocessed endoscopic 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 such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs. Reprocessed endoscopic trocars are of varying lengths and diameters, and may have either a blunt or bladed obturator tip.
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
Representative samples of reprocessed endoscopic trocars underwent bench testing to demonstrate appropriate functional characteristics and biocompatibility testing to demonstrate compatibility of the device materials. Process validation testing was done 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
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.
0
KO43592 ( Cop ) of 2 SUMMARY AND CERTIFICATION SECTION 2.
2.A. 510(k) Summary
MAY 2 3 2005
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dr. Bruce R. Lester |
| SterilMed, Inc. | |
| 11400 73rd Avenue North | |
| Minneapolis, MN 55369 | |
| Ph: 763-488-3400 | |
| Fax: 763-488-3350 | |
| Date Prepared: | December 28, 2004 |
| Trade Name: | Reprocessed Endoscopic Trocar |
| Classification Name: | |
| and Number: | Laparoscope, General and Plastic Surgery |
| Class II 21CFR 876.1500 | |
| Product Code: | NLM |
| Predicate Device(s): | The reprocessed endoscopic trocar is substantially |
| equivalent to the Endopath EP Disposable Surgical Trocar | |
| (K922608), manufactured by Ethicon and AutoSuture | |
| Surgiport® Endoscopic Trocar (K925860) manufactured | |
| by US Surgical. | |
| Device Description: | Reprocessed endoscopic 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 such as observation, dissecting, cutting, | |
| repairing, and removal or manipulation of internal tissues | |
| and/or organs. Reprocessed endoscopic trocars are of | |
| varying lengths and diameters, and may have either a blunt | |
| or bladed obturator tip. |
1
K043592 (pg 2 of 2)
| 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 characteristics and biocompatibility testing to demonstrate compatibility of the device materials. Process validation testing was done 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 trocars are substantially equivalent to the Endopath EP Disposable Surgical Trocar (K922608), manufactured by Ethicon and the AutoSuture Surgiport® Endoscopic Trocar (K925860), manufactured by US Surgical. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2005
Dr. Bruce R. Lester Vice President, Research and Development SterilMed, Inc. 11400 73td Ave. North Minneapolis, Minnesota 55369
Re: K043592
Trade/Device Name: Reprocessed Laparoscope, General and Plastic Surgery (See enclosed list) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: NLM Dated: April 14, 2005 Received: April 18, 2005
Dear Dr. Lester:
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 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.
3
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/industry/support/index.html.
Sincerely yours,
-Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 – Dr. Bruce R. Lester
Reprocessed Laparoscope, General and Plastic Surgery (Trocar) Models found to be Substantially Equivalent:
-
- Ethicon, 350L
-
- Ethicon, 350S
-
- Ethicon, 35NST
-
- Ethicon, 35NLT
-
- Ethicon, 5110
-
- Ethicon, 511NT
-
- Ethicon, 512ON
-
- Ethicon, 512NT
-
- Ethicon, 355NA
-
- Ethicon, 35LNA
-
- Ethicon, 511NA
-
- Ethicon, 512NA
-
- Ethicon, 512B
-
- Ethicon, 512HA
-
- Ethicon, 355SD
-
- Ethicon, 355LD
-
- Ethicon, 578SD
-
- Ethicon, 355SM
-
- Ethicon, 355LM
-
- Ethicon, 511SM
-
- Ethicon, 512SM
-
- Ethicon, 511SD
-
- Ethicon, 512SD
-
- Ethicon, 512XD
-
- Ethicon, 355DA
-
- Ethicon, 35LDA 27. Ethicon, 511DA
-
- Ethicon, 355S
-
- Ethicon, 355L
-
- Ethicon, 511S
-
- Ethicon, 512S
-
- Ethicon, 512X
-
- Ethicon, 355ST
-
- Ethicon, 35LST
-
- Ethicon, 511ST
-
- Ethicon, 512ST
-
- Ethicon, 355SL
-
- Ethicon, 35LSL
-
- Ethicon, 511SL
-
- Ethicon, 512SL
5
Page 4 – Dr. Bruce R. Lester
Reprocessed Laparoscope, General and Plastic Surgery (Trocar) Models found to be Substantially Equivalent contd.:
- Ethicon, 355HR 42. Ethicon, 511HR 43. Ethicon, 512HR 44. AutoSuture, 179776 45. AutoSuture,179777 46. AutoSuture,179770 47. AutoSuture,179771 48. AutoSuture,179074 49. AutoSuture,179076 50. AutoSuture,179077 51. AutoSuture,179070 52. AutoSuture,179071 53. AutoSuture,179078 54. AutoSuture,179070P 55. AutoSuture,179071P 56. AutoSuture,179074P 57. AutoSuture,179076P 58. AutoSuture,179077P 59. AutoSuture,179078P 60. AutoSuture,179770P 61. AutoSuture,179771P 62. AutoSuture,179776P 63. AutoSuture,179777P 64. AutoSuture,179775 65. AutoSuture,179075 66. AutoSuture,176626 67. AutoSuture,179075P 68. AutoSuture,176626P 69. AutoSuture,179775P
6
Indications for Use Page
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.
ﺒ
ri
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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K043592 510(k) Number _
Original 510(k) Premarket Submission - Reprocessed Endoscopic Trocars CONFIDENTIAL SterilMed, Inc