← Product Code [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET) · K964450 # SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT (K964450) _Pilling Weck Group · HET · Jan 10, 1997 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K964450 ## Device Facts - **Applicant:** Pilling Weck Group - **Product Code:** [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET.md) - **Decision Date:** Jan 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1720 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry. ## Device Story Manual surgical instrument; used in endoscopic abdominal and thoracic surgery. Device consists of secondary trocar with stainless steel pyramidal tip, polymer handle/shaft, and threaded polymer sleeve with insufflation port. Cap assembly includes universal adapter seal and reducer to minimize pneumoperitoneum leakage. Physician inserts trocar through abdominal/thoracic wall to create access port; trocar removed; sleeve remains in place. Sleeve serves as conduit for endoscopic instruments, laparoscopes, and probes. Device facilitates minimally invasive surgical access; maintains pneumoperitoneum during procedure. ## Clinical Evidence Bench testing only; no clinical data provided. Equivalence established through comparison of technological characteristics and intended use with predicate devices. ## Technological Characteristics Materials: stainless steel (tip), polymer (handle, shaft, sleeve). Components: pyramidal trocar, threaded sleeve with insufflation port, cap assembly with universal adapter seal and reducer. Manual operation; no energy source. Dimensions: proportionally sized. ## 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 - Core Dynamics Entree II - Access Surgical Access Single Use Trocar and Sleeve - United States Surgical Acute Suture Surgiport Disposable Surgical Trocar and Cannula with Insufflation Port - Karl Stortz Trocars and Cannula with Insufflation Ports ## 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} K964450 P192 # Pilling Weck 510(k) Summary ## 1. Submitter Name, Address, and Date of Submission: Miss Karenann J. Brozowski Group Regulatory Affairs Director Pilling Weck Group Tall Pines Park Jaffrey, NH 03452 JAN 10 1997 Telephone: (603)532-7706 Contact: Same as above. ## 2. Names of the Device, Common, Proprietary(if Known), and Classification. Classification Name: Secondary Trocar with Sleeve Common Name: Secondary Trocar and Sleeve with Insufflation Port ## 3. Identification of the legally marketed device to which the submitter claims equivalence. The Pilling Weck Secondary Trocar and Sleeve with Insufflation Port are substantially equivalent to the Core Dynamics Entree II, Access Surgical Access Single Use Trocar and Sleeve, United States Surgical Acute Suture Surgiport™ Disposable Surgical Trocar and Cannula with Insufflation Port, and Karl Stortz Trocars and Cannula with Insufflation Ports. ## 4. Description of the Device: The device consists of a Secondary Trocar and Sleeve with Insufflation Port with mounted cap. The cap consists of a universal adapter seal with reducer, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum. The Secondary Trocar is constructed with a stainless steel tip and is available in pyramidal style and has a polymer handle and upper shaft. A Teleflex Company One Weck Drive, P.O. Box 12600 Research Triangle Park, North Carolina 27709 (919) 544-8000 {1} K964450 p292 Page 2 The Sleeve, proportionally sized, is made of polymer, threaded and contains an insufflation port. There is a mounted cap assembly, which has a universal adapter seal with guiding port and reducer. ## 5. Intended Use of the Device: The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry. The usage of this product is identical to previous devices, which have the same technological characteristics. ## 6. Summary of Technological Characteristics: The following technological characteristics are the same or equivalent as predicate devices: The Trocar, consisting of a hub with a stainless steel tip are equivalent to the predicates. The sleeve with insufflation port and cap assembly, which has the port of entry for the surgical instrument and has a threaded shaft, is used with the Trocar, which is equivalent to the predicates. The Cap Assembly is contains the seal, which is used to minimize the leakage from the pneumoperitoneum, which is equivalent to the predicates. sum11mm --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K964450](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K964450) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com