(142 days)
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.
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.
This 510(k) summary is for a Class II medical device, the KSEA EndoTIP System, which is a manual, reusable surgical cannula. Given the nature of this device (a blunt-tipped cannula), the submission focuses on substantial equivalence to existing predicate devices rather than an AI-driven or diagnostic performance study.
Therefore, many of the requested criteria related to AI performance, such as acceptance criteria based on metrics, training/test sets, expert adjudication, MRMC studies, and standalone performance, are not applicable (N/A) to this specific submission.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Device provides access to the patient's body and allows insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures. | Substantially Equivalent: The KSEA EndoTIP System is stated to be "substantially equivalent to the predicate devices since the basic features and intended uses are similar." The summary explicitly states: "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." |
| Safety and Effectiveness: No new issues of safety and effectiveness raised compared to predicates. | Demonstrated through substantial equivalence argument. No specific performance metrics (e.g., insertion force, tissue damage) are provided in this summary, as the argument relies on the known safety and performance of similar predicate devices. |
| Material Composition: Body contact materials are surgical grade stainless steel. | The device description explicitly states: "The body contact materials are surgical grade stainless steel." |
| Sterility: Provided in a non-sterile condition. | The device description explicitly states: "manual reusable surgical devices provided to the end-user in a non-sterile condition." |
2. Sample Size Used for the Test Set and Data Provenance
N/A. This submission is based on a substantial equivalence argument, comparing the design and intended use of the KSEA EndoTIP System to predicate devices. It does not involve a "test set" of clinical data in the sense of a clinical performance study with patient samples. The "data provenance" would refer to the characteristics and performance of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
N/A. As no clinical "test set" was used to establish performance metrics, there was no need for experts to establish ground truth in this context. The substantial equivalence argument implicitly relies on the FDA's and the manufacturer's understanding of the safety and effectiveness of the predicate devices, which would have been established through prior regulatory reviews and clinical experience.
4. Adjudication Method for the Test Set
N/A. There was no "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance Study
N/A. This device does not incorporate an algorithm or AI component.
7. Type of Ground Truth Used
The "ground truth" for this submission is the established safety and effectiveness of the predicate devices on which the substantial equivalence argument is based. The FDA's acceptance of the substantial equivalence relies on the regulatory history and known performance of those similar devices in the market.
8. Sample Size for the Training Set
N/A. This submission does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. There was no training set for this device.
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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 DriveCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Kevin KennanSenior 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
000067
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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
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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)
00003
§ 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.