(82 days)
Not Found
Not Found
No
The device description focuses on the mechanical aspects of a surgical trocar and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Not Found" entries for AI/ML mentions, image processing, training/test sets, and performance studies further support this conclusion.
No
The device, PortLand Trocars, is described as a surgical instrument used in laparoscopic procedures to assist the surgeon, not to provide therapy or treatment to a patient.
No
The device description clearly states its use in surgical procedures (trocars for laparoscopic procedures) and does not mention any function related to diagnosing a condition or disease.
No
The device description clearly describes a physical, reusable surgical instrument (trocar) with replaceable tips, made of materials commonly found in other surgical instruments and intended for sterilization via autoclaving. This indicates a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section, which is crucial for identifying an IVD, is "Not Found". IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description clearly states the device is a "trocar" used in "minimally invasive surgery" and "laparoscopic procedures". Trocars are surgical instruments used to create an opening into a body cavity. This is a surgical tool, not a device for analyzing biological samples.
- No mention of biological samples or analysis: The description focuses on the physical characteristics of the device, its reusability, materials, and sterilization method. There is no mention of collecting or analyzing biological specimens.
Therefore, the PortLand Trocars, as described, is a surgical instrument and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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 re-usable 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
AUG 2 8 1000
510/k)Notification---PortLand_Irocars
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 re-usable 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.