← Product Code [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET) · K973737 # MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M (K973737) _Richard Wolf Medical Instruments Corp. · HET · Dec 12, 1997 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K973737 ## Device Facts - **Applicant:** Richard Wolf Medical Instruments Corp. - **Product Code:** [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET.md) - **Decision Date:** Dec 12, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1720 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use The trocar sleeves and trocars serve to gain access to body cavities. The dilation set is used for enlarging the access; trocar sleeves of smaller diameters can be replaced with trocar sleeves of larger diameters. For examination, diagnosis, and/or therapy when used in conjunction with endoscopic accessories in the various medical specialties such as surgery, urology and, gynecology when used by suitably trained and qualified specialists. ## Device Story Trocar sleeves and trocars provide artificial access to body cavities for endoscopic procedures. Dilation set allows sequential replacement of smaller diameter sleeves with larger ones. Used in surgery, urology, and gynecology by trained specialists. Device functions as a mechanical conduit for endoscopes and accessories (forceps, electrodes, insufflators). Benefits include smaller diameters for minimally invasive access, potentially improving cosmetic outcomes. No automated processing or software involved. ## Clinical Evidence No clinical tests performed. Bench testing confirmed that steam sterilization (fractional method) does not influence functional performance. ## Technological Characteristics Mechanical trocar and sleeve system. Materials: Biocompatible materials consistent with previous R. Wolf devices. Design: Smaller diameters for minimally invasive access; some models feature reduced sealing housing without automatic valves. Energy source: None (manual). Sterilization: Steam (fractional method). ## Regulatory 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. ## Predicate Devices - Trocar sleeve with trocar (pre-enactment) - Trocar system ([K932441](/device/K932441.md)) - Laparoscopy dilation system ([K942201](/device/K942201.md)) - Trocars and thread sleeve (Karl Storz) - Trocars/ cannulas systems (Jarit) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Vernon 1 lills, Illinois 6006 1 Phone: 847.913.1143 Fax: 847.913.1488 MEDIC # 510(k) Summary of Safety and Effectiveness DEC 12 1997 | Company / Institution name: | Richard Wolf Medical Instruments Corp. | |--------------------------------|----------------------------------------| | Division name (if applicable): | N.A. | | Street address: | 353 Corporate Woods Parkway | | City: | Vernon Hills | | State/Province: | Illinois | | Country: | USA | | ZIP/Postal Code: | 60061 | | Contact name: | Mr. Robert L. Casarsa | | Contact title: | Quality Assurance Manager | | Date of Preparation: | September 26, 1997 | |--------------------------------------|--------------------| | FDA establishment regulation number: | 14 184 79 | | Phone number (include area code): | (847) 913-1113 | | FAX number (include area code): | (847) 913-0924 | Product Information: | Trade name: | Trocar sleeves and trocars,
Dilatation sleeve and guide rod | |----------------------|----------------------------------------------------------------| | Model number: | 8930.xxx,
8756.xxx,
8309.xxx,
8903.xxx | | Common name: | Trocar sleeves and trocars | | Classification Name: | Trocar | Information on devices to which substantial equivalence is claimed: | 510(k) Number | Trade or proprietary or model name | Manufacturer | |---------------|------------------------------------|----------------| | 1 pre-enact. | 1 Trocar sleeve with trocar | 1 Richard Wolf | | 2 K932441 | 2 Trocar system | 2 Richard Wolf | | 3 K942201 | 3 Laparoscopy dilation system | 3 Richard Wolf | | 4 | 4 Trocars and thread sleeve | 4 Karl Storz | | 5 | 5 Trocars/ cannulas systems | 5 Jarit | ### 1.0 Description The trocar sleeves are part of the MICRO and MINI instrument set for laparoscopic microsurgery, particularily suitable for diagnostics, smaller interventions, outpatient, and pediatric laparoscopy. The instruments smaller diameter allows better cosmetic effects than the larger diameters because they are less invasive. べアグ {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a close-up of a symbol or character, possibly from a non-Latin alphabet or a stylized font. The symbol is dark and appears to be stamped or printed onto a lighter background. The edges of the symbol are somewhat rough, suggesting it may be part of a larger text or design. #### 2.0 Intended Use The trocar sleeves and trocars serve to provide artificial access to body cavities. Trocar sleeves of smaller diameters can be replaced with trocar sleeves of bigger diameters with the dilation set. ### Technological Characteristics 3.0 The trocar sleeves and trocars have comparable biocompatible device materials as previous R. Wolf devices. The dimensions are smaller to perform minimally invasive laparoscopy. Partly the trocar sleeves are without automatic valves as a result of minimizing the sealing housing. #### 4.0 Substantial Equivalence These devices are substantially equivalent to existing pre-enactment devices and 510(k) devices sold by Richard Wolf and 510(k) devices sold by Karl Storz and Jarit. #### 5.0 Performance Data The steam sterilization tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted devices when using the fractional method. #### 6.0 Clinical Tests No clinical tests performed. #### 7.0 Conclusions Drawn These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual. By: Robert J. Casassa Robert L. Casarsa Quality Assurance Manager Date: Sept 25, 97 8-2 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC | 2 |997 Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Re: K973737 MINI Trocar sleeve and trocars 3.5 mm; MICRO Trocar sleeve and trocars 2 mm; Dilatation sleeve and guide rod 2 - 3.5 mm Dated: September 26, 1997 Received: September 30, 1997 Regulatory class: II 21 CFR §884.1720/Product code: 85 HET 21 CFR §876.1500/Product code: 78 FDE Dear Mr. Casarsa: 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 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 requirement, as set forth in the Quality System Regulation (QS) 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. Pailure 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 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/cdrh/dsmamain.html". Sincerely yours, W.Liau Yu Lillian Yiu, Ph.D. 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 {3}------------------------------------------------ | | | | | | | | | | | | | | | | | | Comments of Children Comers of | | | | | | | | |--|--|--|--|--|--------------------------------------------------------------------------|--|--|--|--|--|--|--|--|------------------------------------|--|---|--------------------------------|--|---|--|--|---|--|--| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | - | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | : | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | . | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Compound Collection of Confinition | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | . Balland Annual Comments of the Career of Children Comments of Children | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | . | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | # Indications for Use K973737 510(k) Number (if known): Trocar sleeves, trocars and dilation sleeve ## Intended Use: Device Name: The trocar sleeves and trocars serve to gain access to body cavities. The dilation set is used for enlarging the access; trocar sleeves of smaller diameters can be replaced with trocar sleeves of larger diameters. ## Indication and Scope of Application: For examination, diagnosis, and/or therapy when used in conjunction with endoscopic accessories in the various medical specialties such as surgery, urology and, gynecology when used by suitably trained and qualified specialists. ## Contraindications: There are currently no known contraindications relating directly to the product. The physician should decide whether or not the planned application can be performed based on the of the patient's general condition. ### Combinations: The trocar sleeves and trocars are used in with insufflators, reducing sleeves, extraction sleeves, dilation sleeves, guide rods, threaded fixation sleeves, sliding cones and, endoscopes, as well as endoscopic accessories (e.g. forceps, electrodes). (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 K 4 510(k) Number . Prescription Use Per 21 CFR 801.109 OR Over-The Counter --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K973737](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K973737) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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