(142 days)
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Not Found
No
The device description and intended use clearly describe a manual, reusable surgical instrument without any mention of computational or data-driven features. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as an instrument to provide access to the patient's body for endoscopes and accessories during surgical procedures, which is a diagnostic or access function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" explicitly states that the instruments "allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures." This indicates the device is used in procedures that include diagnostic purposes.
No
The device description explicitly states it is comprised of a threaded hollow cannula with a blunt penetrating distal end, made of surgical grade stainless steel, indicating it is a physical, hardware 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 instruments are for providing access to the patient's body during surgical and diagnostic procedures. This involves direct interaction with the patient's body, not the examination of specimens in vitro (outside the body).
- Device Description: The device is described as a manual reusable surgical device, a threaded hollow cannula with a blunt penetrating distal end. This is a surgical instrument, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any other components typically associated with IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely mechanical and procedural, facilitating surgical access.
N/A
Intended Use / Indications for Use
The KSEA EndoTIP System is intended for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures.
Product codes
85 HET
Device Description
The KSEA EndoTIP System are manual reusable surgical devices provided to the end-user in a non-sterile condition. The KSEA EndoTIP System is comprised of a threaded hollow cannula with a blunt penetrating distal end. The body contact materials are surgical grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's body
Indicated Patient Age Range
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Intended User / Care Setting
qualified surgeons or physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS AUG 1 9 1998
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document 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:
Cannula |
| | Trade Name: (optional)
KSEA EndoTIP System |
Indication: The KSEA EndoTIP System is intended for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures.
Device Description: The KSEA EndoTIP System are manual reusable surgical devices provided to the end-user in a non-sterile condition. The KSEA EndoTIP System is comprised of a threaded hollow cannula with a blunt penetrating distal end. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA EndoTIP System for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures are substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences in design and dimensions between the KSEA EndoTIP System and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
ed:
Kevin Kennan
Senior Regulatory Affairs Specialist
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Image /page/1/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN..." around the left side and "...USA" on the right side. Inside the circle is a symbol consisting of three curved shapes that resemble stylized waves or ribbons. The image is in black and white and appears to be a scan or photocopy, as there are some artifacts and imperfections in the image quality.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 1998
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600
Re: K981130
EndoTIP™ System Dated: June 29, 1998 Received: June 30, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET
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 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 (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 (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 542 of the Act for 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/odrh/dsmadsmamain.html".
Sincerely yours.
Lillian Yin. Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): Not yet assigned
Device Name: EndoTIP System
Indications for Use: These instruments are intended for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures.
(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 Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981130
Prescription Use: OR Over-The-Counter Use: __
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
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