(184 days)
No
The summary describes a mechanical trocar and cannula system for creating surgical ports, with no mention of software, data processing, or AI/ML terms.
No
The device is described as creating and maintaining a port of entry for endoscopic procedures, which is an access function, not a therapeutic intervention.
No
The device is described as creating and maintaining a port of entry for endoscopic procedures, which is a surgical function, not a diagnostic one.
No
The device description explicitly states it is a "two piece device which consists of a reusable sleeve and a disposable plastic housing with seal adapter," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for creating and maintaining a port of entry during endoscopic procedures. This is a surgical/procedural function, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a cannula and trocar, which are instruments used for accessing body cavities during surgery. This aligns with the procedural intended use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural.
N/A
Intended Use / Indications for Use
Both the Auto Suture* Cannula** and the Auto Suture* Modified Versaport* Trocar (K954108) are intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Auto Suture* Cannula** is a two piece device which consists of a reusable sleeve and a disposable plastic housing with seal adapter. While the Auto Suture* Modified Versaport* Trocar (K954108) is a totally disposable trocar with cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Auto Suture* Modified Versaport* Trocar (K954108)
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
KAPSIIS
510(k) SUMMARY OF INFORMATION:
FEB 1 3 1997 United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000
- CONTACT PERSON: Janet G. Johnson
- August 9, 1996 DATE PREPARED:
CLASSIFICATION NAME: Manual Surgical Instrument for general use
-
COMMON NAME: Trocar Cannula
PROPRIETARY NAME: Trademark name not yet determined. -
PREDICATE DEVICE: Auto Suture* Modified Versaport* Trocar (K954108)
DEVICE DESCRIPTION: The Auto Suture* Cannula** is a two piece device which consists of a reusable sleeve and a disposable plastic housing with seal adapter. While the Auto Suture* Modified Versaport* Trocar (K954108) is a totally disposable trocar with cannula. -
INTENDED USE: Both the Auto Suture* Cannula** and the Auto Suture* Modified Versaport* Trocar (K954108) are intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry
-
MATERIALS: All component materials of the Auto Suture* Cannula** are comprised of materials which are in accordance with ISO Standard #10993-1.