Who is the manufacturer of PORTLAND TROCARS?

Surgical Innovations Plc filed the 510(k) submission for PORTLAND TROCARS (K962193).

What is the FDA product code for PORTLAND TROCARS?

GCJ. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for PORTLAND TROCARS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PORTLAND TROCARS?

Mikroland trocar (contract manufactured for Surgical Innovations).

Who can help prepare an FDA 510(k) submission like PORTLAND TROCARS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PORTLAND TROCARS

K962193 · Surgical Innovations Plc · GCJ · Aug 28, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K962193
Device Name	PORTLAND TROCARS
Applicant	Surgical Innovations Plc
Product Code	GCJ · Gastroenterology, Urology
Decision Date	Aug 28, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Portland Trocars is very similar to all other trocar devices previously found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976.

Device Story

Reusable trocar for laparoscopic surgery; features replaceable tip design; provides economic benefits of reusable instruments with convenience of disposable tips. Used by surgeons in clinical/OR settings. Device facilitates minimally invasive access; identical materials and sterilization methods (autoclaving) to existing market predicates; no increased patient risk.

Clinical Evidence

No clinical data; substantial equivalence based on design, material, and sterilization similarity to existing predicate devices.

Technological Characteristics

Reusable trocar; replaceable tip mechanism; materials identical to predicate surgical instruments; sterilization via autoclaving.

Indications for Use

Indicated for use in laparoscopic procedures as a reusable surgical instrument with a replaceable tip.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

Mikroland trocar (contract manufactured for Surgical Innovations)

Related Devices

K012644 — REPROCESSED TROCARS AND CANNULAS · Surgical Instruments Service and Savings, Inc. · Jul 29, 2002
K140101 — ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS · Ab Medica Sas · Jul 10, 2014
K043592 — REPROCESSED ENDOSCOPIC TROCAR · Sterilmed, Inc. · May 23, 2005
K070059 — REPROCESSED TROCARS · Ascent Healthcare Solutions · Oct 2, 2007
K121240 — REPROCESSED ENDOSCOPIC TROCARS · Sterilmed, Inc. · Jun 11, 2012

Submission Summary (Full Text)

{0} AUG 28 1976 510(k) Notification - Portland Trocars K962193 Summary of Safety and Effectiveness The Portland Trocars is very similar to all other trocar devices previously found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976. Due to the increased demand for minimally invasive surgery, trocars have become an essential part of laparoscopic procedures. By providing the surgeon with a fully reusable instrument with replaceable tip such as the Portland Trocars, SI have optimized the economy of a reusable instrument, with the advantages of the disposable instrument, in the provision of the replaceable tip concept. The materials used in the construction of the Portland Trocars are commonly found in other surgical instruments and are identical with that used in the product manufactured by Mikroland. Also, the means of sterilization (autoclaving) has long been used by hospitals for the sterilization of surgical instruments. Surgical Innovations believes this instrument is substantially equivalent to that manufactured by Mikroland which was produced under contract for Surgical Innovations, to Surgical Innovations specifications. Also, this instrument is as effective as other competitive product and does not increase the risk to the patient.