(505 days)
The KSEA C.C.L. Vaginal Extractor and accessories are intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery. The C.C.L. Vaginal Extractor is indicated for women undergoing laparoscopic surgery and intended for vaginal extraction of tissue masses as large as 6-7 cm from the peritoneal cavity, following an intra-abdominal peritoneal culdotomy at the posterior vaginal fornix.
The KSEA C.C.L. Vaginal Extractor are manual reusable surgical devices (used with the KSEA Extraction Bag and KSEA Take-apart® Rotating Claw Forceps). The KSEA C.C.L. Vaginal Extractor is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery. The body contact materials are surgical grade stainless steel, HPDE, PTFE, Ultem® and polyurethane film. The non-body contact materials of the C.C.L. Vaginal Extractor are surgical grade stainless steel.
The provided 510(k) summary is for a manual surgical device (KSEA C.C.L. Vaginal Extractor), not an AI/ML-driven device. As such, the information typically required for describing the acceptance criteria and the study proving an AI/ML device meets them (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable to this submission.
The 510(k) process for a device like the KSEA C.C.L. Vaginal Extractor focuses on demonstrating substantial equivalence to a predicate device based on its intended use, design, materials, and technological characteristics, rather than performance metrics derived from AI/ML algorithms.
The summary clearly states:
- Substantial Equivalence: "The KSEA C.C.L. Vaginal Extractor for tissue extraction procedures during laparoscopic surgery are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA C.C.L. Vaginal Extractor 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."
Therefore, the study proving the device meets its acceptance criteria would typically involve:
- Bench testing: To ensure mechanical integrity, material compatibility, and functional performance (e.g., ability to grasp, extract tissue) meeting engineering specifications.
- Biocompatibility testing: To demonstrate that the materials are safe for body contact.
- Sterilization validation: To ensure the device can be effectively sterilized for repeated use.
- Usability testing: To confirm ease of use by qualified surgeons.
These types of studies are generally documented internally by the manufacturer and summarized for the FDA to support the substantial equivalence claim, but they do not involve the statistical performance metrics and expert review processes characteristic of AI/ML device validation.
None of the requested information regarding acceptance criteria for AI/ML performance, study methodology for AI, or ground truth establishment for AI models is present in the provided documents because it is not relevant to this type of device submission.
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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The logo is simple and modern, and it is likely used to represent the company's brand.
510(k) SUMMARY OF SAFETY AND EFFECTIVENE
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, Inc600 Corporate Pointe DriveCulver City, CA 90230(310) 558-1500 | DEC 19 1997 |
|---|---|---|
| Contact: | Kevin KennanRegulatory Affairs Specialist | |
| Device Identification: | Common Name:Tissue ExtractorTrade Name: (optional)KSEA C.C.L. Vaginal Extractor |
Indication: The KSEA C.C.L. Vaginal Extractor and accessories are intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery
Device Description: The KSEA C.C.L. Vaginal Extractor are manual reusable surgical devices (used with the KSEA Extraction Bag and KSEA Take-apart® Rotating Claw Forceps). The KSEA C.C.L. Vaginal Extractor is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery. The body contact materials are surgical grade stainless steel, HPDE, PTFE, Ultem® and polyurethane film. The non-body contact materials of the C.C.L. Vaginal Extractor are surgical grade stainless steel.
Substantial Equivalence: The KSEA C.C.L. Vaginal Extractor for tissue extraction procedures during laparoscopic surgery are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA C.C.L. Vaginal Extractor 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:
Kevin Kenner
Kevin Kennan Regulatory Affairs Specialist
00087
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 19 1997
Re: K962985
C. C. L. Vaginal Extractor and Accessories Dated: November 4, 1997 Received: November 6, 1997 Regulatory class: II 21 CFR §884.1720/Product codes: 85 HET
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600
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, 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 misbrantion.
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 requirement, 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 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 prodicate 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 vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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,
William Yu
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
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510(k) Number (if known): K962985
Device Name: C.C.L. Vaginal Extractor and Accessories
Indications for Use: The C.C.L. Vaginal Extractor is indicated for women undergoing laparoscopic surgery and intended for vaginal extraction of tissue masses as large as 6-7 cm from the peritoneal cavity, following an intra-abdominal peritoneal culdotomy at the posterior vaginal fornix ..
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Robert D. Ratliff |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K962985 |
| Prescription Use:(Per 21 CFR 801.109) | ✓ |
|---|---|
| OR Over-The-Counter Use: |
§ 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.