(169 days)
Not Found
No
The device description and intended use describe a mechanical trocar system, and there is no mention of AI, ML, or image processing.
No.
The device is a surgical instrument used for creating a puncture, not for treating a disease or condition. Its intended use is for "first puncture technique according to Hasson in laparoscopic applications," which is a procedural step rather than a therapeutic intervention.
No
The device, a Trocar System, is described as being used for a "first puncture technique" in laparoscopic applications, which is a surgical procedure, not a diagnostic one.
No
The device description clearly identifies it as a "Trocar System according to Hasson," which is a physical surgical instrument used in laparoscopic procedures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical technique (first puncture according to Hasson in laparoscopic applications). This is a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a "Trocar System," which is a surgical instrument used to create an opening into a body cavity.
- Lack of IVD characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of samples
- Reagents or test kits
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This trocar system is a surgical tool used during a procedure.
N/A
Intended Use / Indications for Use
The Olympus ,,Trocar System according to Hasson" has been designed for first puncture technique according to Hasson in laparoscopic application.
The Olympus "Trocar System according to Hasson" has been designed for first puncture technique according to Hasson in laparoscopic applications.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
July 1 2 1999
Image /page/0/Picture/1 description: The image shows the logo and contact information for Olympus Winter & IBE. The business address is Kuehnstr. 61, D-22045 Hamburg, and the mailing address is Postfach 70 17 09, D-22017 Hamburg. The telephone number is (040) 6 69 66-0, and the telefax number is (040) 6 68 15 91.
510(k) SUMMERY
OLYMPUS TROCAR SYSTEM ACC. TO HASSON
This summery of 510(k) safety and effectivness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Device Name: | Trocar System according to Hasson. | ||
|---|---|---|---|
| Common/Usual Name: | Trocar, blunt and cone for laparoscopic application. | ||
| Classification Name: | and | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | |
| LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | |||
| Classification: | and | CFR 876.1500 Class II | |
| CFR 884.1720 Class II |
Predicate Devices:
"
| Manufacturer | Description | 510(k) | |
|---|---|---|---|
| Olympus | A5676 | 11 mm Trocar Tube, 125 mm | K923982 |
| Olympus | A5673 | 11 mm Trocar, 225 mm, Conical tip | K923982 |
| Olympus | 05203 | Trocar 11 mm, with valve and conical tip | K790071 |
| Karl Storz | 30103 GO | Trocar, size 11 mm, consisting of: | Unknown |
| Karl Storz | 30103 O | Trocar only, with blunt tip | |
| Karl Storz | 30103 G | Cannula, 2 flanges for fixation with | |
| sutures, adjustable conical sleeve, | |||
| insufflation stopcock, | |||
| for 10 mm laparoscopes, length 13 cm | |||
| Karl Storz | 30160 C1 | Cone for trocars size 6 mm, black | Unknown |
| Karl Storz | 30101 C1 | Cone for trocars size 7 mm, black | |
| Karl Storz | 30103 C1 | Cone for trocars size 11 mm, black | |
| Karl Storz | 30101 C1 | Cone for trocars size 13 mm, black |
1
| Prepared & Submitted by: | Mrs. Laura Storms-Tyler |
|---|---|
| (Contact Person) | Olympus America Inc. |
| Endoscope Division | |
| Two Corporate Center Drive | |
| Melville, NY 11747-3157 | |
| Phone: 516-844-5688 | |
| FAX: 516-844-5416 |
November 30, 1998 Summery Preparation Date:
Statement of Intended Use:
The Olympus ,,Trocar System according to Hasson" has been designed for first puncture technique according to Hasson in laparoscopic application.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1:2 1999
Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747
Re: K990237
Trade Name: Trocar System According to Hasson Regulatory Class: II Product Code: GCJ Dated: April 8, 1999 Received: April 21, 1999
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 -- Ms. Laura Storms-Tyler
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Page 1 of 1
990237
510(k) Number (if known):
Device Name:
ﻤﻴﺘﺴﻴ
Trocar System according to Hasson
Indications for Use:
The Olympus "Trocar System according to Hasson" has been designed for first puncture technique according to Hasson in laparoscopic applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (per 21CFR 801.109) | ✓ | OR | Over-the Counter Use |
|---|---|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K990237 |