(74 days)
The KSEA Plastic Trocars are intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic procedures.
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.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for two medical devices:
These summaries focus on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for 510(k) notifications. They describe the device's indications for use, device description, and state that the device is substantially equivalent to a predicate device, implying that no new issues of safety or effectiveness are raised. They do not include specific performance metrics, acceptance criteria, or detailed study results that would typically be required to fill out the requested table and answer the study-related questions.
Therefore, I cannot provide the requested information based on the given input.
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Image /page/0/Picture/0 description: The image shows the logo for STORZ, a company specializing in endoscopy. The logo features the word "STORZ" in a bold, sans-serif font, with the "O" represented by concentric circles. Below the main logo, the words "Karl Storz Endoscopy" are printed in a smaller, simpler font. The overall design is clean and professional, reflecting the company's focus on medical technology.
1998 MAY
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, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Kevin KennanSenior 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 making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during Ob/Gyn 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
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Image /page/1/Picture/0 description: The image shows a logo that appears to be rotated counter-clockwise. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The word "DEPARTM" is vertically oriented and runs along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 8 1698
Dear Mr. Kennan:
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600
Re: K980694 Plastic Trocars with Silicone Leaflet Valve Dated: February 20, 1998 Received: February 23, 1998 Regulatory Class: II
21 CFR 884.1720/Procode: 85 HET
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 (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 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 yitze 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/cdrh/dsmaldsmam.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: 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 Ob/Gyn laparoscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Sattler/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K980694
Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)
(Optional Format 1-2-96)
000003
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Image /page/3/Picture/0 description: The image shows a black and white logo of the U.S. Department of Health & Human Services. The logo features a stylized depiction of an abstract human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN" is partially visible, curving around the left side of the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Patrick Janin General Manager Future Medical Systems, Inc. 504 McCormick Drive, Suite T Glen Burnie, MD 21061
Re: K980808
ENDO FMS® UROLOGY (Fluid Management System) Dated: March 30, 1998 Received: April 1, 1998 Unclassified/Procode: 78 LJE Regulatory Class: II 21 CFR $876.1500/Procode: 78 FDC
Dear Mr. Janin:
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 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 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 (21 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/cdrb/dsmaldsmamain.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):
ENDO FMS®UROLOGY
Indications For Use:
Device Name:
The ENDO FMS® UROLOGY is a fluid management system used to maintain adequate irrigation pressure and flow in used to maintain adoques, including all endoscopic endosoople Grology procedures in the Kidney, Urethra , Bladder and Prostate.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Ratliff/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1980808 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.