(49 days)
Not Found
Not Found
No
The device description explicitly states it is a "manually operated surgical device" and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML technologies in the summary.
No
The device is described as a surgical instrument for making incisions to allow insertion of other devices, not for treating a condition or disease.
No
The device is described as a manually operated surgical device intended for making incisions and allowing the insertion of endoscopes/accessories during surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it is a manually operated surgical device composed of physical materials (stainless steel and PEEK), indicating it is a hardware device, not software-only.
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 KSEA Plastic Trocars are for making incisions into the patient's body to allow insertion of endoscopes and accessories during surgical procedures. This is a direct surgical intervention on the patient.
- Device Description: The device is described as a manually operated surgical device composed of surgical grade materials.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not for direct surgical intervention.
N/A
Intended Use / Indications for Use
The KSEA Plastic Trocars are intended for use by qualified surgeons during general endoscopic and laparoscopic procedures.
These instruments are manually operated surgical devices intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laperoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Karl Storz Plastic Trocars are manually operated surgical devices. The body contact portions of the KSEA Plastic Trocars are composed of surgical grade stainless steel and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.
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
qualified surgeons
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.
Not Found
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
O
K974366
Jan. 8, 1998
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance This Sammal y of 910(x) bare) and sicel Devices Act (SMDA) of 1990 and 21 CFR 807.92. All with the requirent is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Trocar and Cannula
Trade Name: (optional)
Karl Storz Plastic Trocar |
Indication: The KSEA Plastic Trocars are intended for use by qualified surgeons during general endoscopic and laparoscopic procedures.
Device Description: The Karl Storz Plastic Trocars are manually operated surgical devices. The body contact portions of the KSEA Plastic Trocars are composed of surgical grade stainless steel and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.
Substantial Equivalence: The Karl Storz Plastic Trocars are substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Plastic Trocars and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
:
Kevin Kennan
Senior Regulatory Affairs Specialist
Image /page/0/Picture/10 description: The image shows a close-up of some text and numbers. The text appears to be somewhat faded or distorted, making it difficult to read clearly. The numbers "60" are visible at the top of the image, and the numbers "161" are visible at the bottom of the image.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy 600 Corporate Pointe Culver City, California 90230-7600
JAN - 8 1998
K974366 Re: Trade Name: KSEA Plastic Trocars Regulatory Class: II Product Code: GCJ Dated: November 19, 1997 Received: November 20, 1997
Dear Mr. Kennan:
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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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
2
Page 2 - Mr. Kennan
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 your 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,
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
5100k) Number (if known): K974366
ﺍﻟﻤﺪﺍﺭﺱ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺎﺯﻟﺔ ﺍﻟﻤﺘﺎﺯﻟﺔ ﺍﻟﻤﺘﺎﺯﻟﺔ ﺍﻟﻤﺘﺎﺯﻳﻊ ﺍﻟﻤﺘﺎﺯﻳﻊ ﺍﻟﻤﺘﺎﺯﻳﻊ ﺍﻟﻤﺘﺎﺯﻳﻊ ﺍﻟﻤﺘﺎﺯﻟﺔ ﺍﻟﻤﺘﺎﺯﻳﻊ ﺍﻟﻤﺘﺎﺯﻳﻊ ﺍﻟﻤﺘﺎﺯﻳﻊ ﺍﻟﻤﺘﺎﺯﻳﻊ ﺍﻟﻤﺘﺎﺯﻳﻊ ﺍﻟﻤﺘﺎﺯﻟﺔ ﺍﻟﻤﺘﺎﺯﻳﻊ ﺍﻟﻤﺘﺎﺯﻟﺔ ﺍﻟﻤ
Read of the more the more of the most of the may of
יו י יוני יורד
Device Name: KSEA Plastic Trocars
Indications for Use: These instruments are manually operated surgical devices intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laperoscopic procedures.
=XEC LEGAL REG 410-5519
913014803002
TO
Station Section ... Section Section Section in the
P.07
-पर
.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | K974366 |
| 510(k) Number | |
|---|---|
| Prescription Use: | |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use: |
| (Optional Format 1-2-96) |