(87 days)
The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.
The predicate device (Endoscopic Visualization and Space Maintenance Cannula ) has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery including laparoscopy and thoracoscopy.
The Multi-Port Cannula is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
The Multi-Port Cannula is a single- use device which consists of two movable working cannulas, seals, a stabilizer, two stationary cannulas, leur fitting, and an insufflation tube. The two movable working cannulas passes completely through the stationary cannulas which are casted to the stabilizer. The seals within the inner wall of the cannulas seal on surgical devices that are inserted through the cannulas. The stabilizer provides a seal against the tissue at the incision site and acts to stabilize the cannulas. Surgical access is achieved via standard incision. The Multi-Port Cannula is assembled and advanced through the incision site. The user may then advance endoscopic tools through the working cannulas or stationary cannulas to perform the procedure. The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) Summary of Safety & Effectiveness for a medical device (Multi-Port Cannula), primarily focusing on demonstrating substantial equivalence to a predicate device based on intended use, materials, and technological characteristics. It does not detail specific performance studies with acceptance criteria, sample sizes, expert involvement, or ground truth establishment.
{0}------------------------------------------------
MAR 2 0 1997
Class I
510/k) SUMMARY OF SAFETY & EFFECTIVENESS
This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.
21 CFR §807.92 a(1)
ORIGIN® Medsystems, Inc. Submitter: 135 Constitution Avenue Menlo Park, CA 94025 (415) 617-5142 contact person: Anthony Durso date prepared: December 20, 1996
21 CFR §807.92 a(2)
| Common name: | Cannula |
|---|---|
| Classification name: | Manual Surgical Instrument |
21 CFR 8807.92 a(3)
Identification of predicate(s); Substantial equivalence for the Multi-Port Cannula is based on its similarities to predicate device : the ORIGIN Endoscopic Visualization and Space Maintenance Cannula . It shares the identical material, and technological characteristics as the predicate device. The Multi-Port Cannula is also similar in intended use.
21 CFR §807.92 a(4)
Device Description-parts and function/concept: The Multi-Port Cannula is a single- use device which consists of two movable working cannulas, seals, a stabilizer, two stationary cannulas, leur fitting, and an insufflation tube. The two movable working cannulas passes completely through the stationary cannulas which are casted to the stabilizer. The seals within the inner wall of the cannulas seal on surgical devices that are inserted through the cannulas. The stabilizer provides a seal against the tissue at the incision site and acts to stabilize the cannulas. Surgical access is achieved via standard incision. The Multi-Port Cannula is assembled and advanced
{1}------------------------------------------------
K965)21 P 2 of 4
ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION Multi-Port Cannula
Class I
through the incision site. The user may then advance endoscopic tools through the working cannulas or stationary cannulas to perform the procedure. The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.
{2}------------------------------------------------
K965121 P 384
Multi-Port Cannula
Class ]
ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION
Device Description-materials/physical properties: a table of the patient contact components, with their respective materials, is provided below.
| Component Name | Patient Contact | Material | Predicate |
|---|---|---|---|
| Stabilizer | yes | Sponge | Carwild Corp.Disposable SpecialtySpongesK913302 |
| StationaryCannulas | yes | Polycarbonate | EndoscopicVisualization andSpace MaintenanceCannulaK964632 |
| WorkingCannulas | yes | Polycarbonate | EndoscopicVisualization andSpace MaintenanceCannulaK964632 |
| StationaryCannula Seals | yes | Silicone Rubber | Respoable Trocar (T5)K960936 |
| WorkingCannula Seals | no | Silicone Rubber | Respoable Trocar (T5)K960936 |
| Adhesive | no | Silicone Adhesive | Blunt Tip SurgicalTrocarK924011 |
| Leur Fitting | no | Polyurethane | Airlift™ BalloonRetraction SystemK942678 |
| InsufflationTube | yes | Polyurethane | Airlift™ BalloonRetraction SystemK942678 |
The listed parts are currently being used in existing ORIGIN products, and therefore have been cleared for biocompatibility (safety) and effectiveness.
{3}------------------------------------------------
K965121 P 4 of 4
ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION Multi-Port Cannula
Class I
21 CFR §807.92 a(5)
Intended use and relationship to predicate(s): The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.
The predicate device (Endoscopic Visualization and Space Maintenance Cannula ) has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery including laparoscopy and thoracoscopy.
The Multi-Port Cannula is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
CFR $807.92 a(6)
Technological characteristics and relationship to predicate(s) The Multi-Port Cannula is substantially equivalent to the Endoscopic Visualization and Space Maintenance Cannula previously exempted product. The Multi-Port Cannula shares the, technological characteristics and materials as the predicate device.
21 CFR §807.92 b
This submission's determination of substantial equivalence is based on similarities to the predicate devices in terms of intended uses, materials, and technological characteristics.
21 CFR §807.92 c
In accordance with the specifications of this subsection, this summary (4 pages) is its own section, and has been clearly identified as such.
§ 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.