(142 days)
Not Found
No
The device description and intended use focus on mechanical components for surgical access and wound retraction. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device facilitates surgical procedures by providing access and retraction but does not directly treat a disease or condition.
No
Explanation: The device is an abdominal access system and wound retractor used during surgical procedures to facilitate hand entry, extract specimens, maintain pneumoperitoneum, and provide wound protection. Its function is interventional, not diagnostic.
No
The device description clearly outlines physical components (Seal Cap Assembly, Fixed-Length Access Retractor, accessories like marking pen, ruler, and forearm wrap) and their mechanical functions. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures to facilitate hand access, specimen extraction, and wound retraction. It is used on the patient's body to aid in the surgical process.
- Device Description: The description details a physical device designed to create and maintain access to the abdominal cavity. It is a surgical tool.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens in vitro (outside the body) to obtain diagnostic information about a patient's health. IVDs are used to test samples like blood, urine, or tissue to diagnose diseases or conditions.
This device falls under the category of a surgical instrument or access device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories and Fixed-Length Access Retractors are indicated for use in procedures where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The device has application in colorectal, urological, gynecologic, and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.
The ENDOPATH DEXTRUS Seal Cap Assembly with Accessories, when used in conjunction with the ENDOPATH DEXTRUS Fixed-Length Access Retractor, is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during minimally invasive surgery.
The Fixed-Length Access Retractor, when used independently, is also intended to provide wound retraction and protection against wound contamination during minimally invasive and open surgery.
Product codes
GCJ
Device Description
The device is a sterile, single patient use abdominal access system comprised of two separately packaged components:
- Seal Cap Assembly with Accessories
- Fixed-Length Access Retractor
The ENDOPATH DEXTRUS Seal Cap Assembly consists of stationary and rotating rings interconnected by means of an elastomeric material that functions as an irris valve seal with an adjustable aperture. The seal cap assembly is designed to connect with the fixed-length access retractor. The assembled device can maintain peritoneal gas pressure while allowing for insertion of the surgeon's hand or surgical instruments into the abdominal cavity.
The Fixed-Length Access Retractor is available in three sizes to accommodate a wide range of abdominal wall thicknesses. The retractor consists of a top rigid ring and a bottom flexible ring interconnected by means of an elastomeric material. The top rigid ring provides for circumferential wound retraction and is also the connection ring to the seal cap assembly. The bottom flexible ring is inserted into the abdomen for device fixation.
Accessories provided with the ENDOPATH DEXTRUS Seal Cap Assembly include a marking pen, ruler, and forearm wrap. The ruler and marking pen help measure and represent incision length, depending on surgeon glove size. The forearm wrap can be wrapped over the surgeon's glove and gown from the wrist to the upper forearm to facilitate the transition of the surgeon's gown through the iris valve during an extended reach within the abdominal cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030824, K020307, K010870, K020435
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
- Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, Puerto Rico 00969
Contact Wendy L. Turner, RAC
Director, Regulatory Affairs
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, OH 45242
Telephone: (513) 337-8807
Fax: (513) 337-2807
Email: wturner@eesus.jnj.com
Page 1 of 2
UN 1 3 2007
Date Prepared January 19 , 2007
Trade Name: Endopath® Dextrus™ Seal Cap Assembly with Accessories Device Name and Endopath® Dextrus™ Fixed-Length Access Retractors
Common or Usual Names: Extended Laparoscopy Device; Access Retractors
Classification Names:
Laparoscope, General & Plastic Surgery [21 CFR 876.1500 (GCJ)] Drape, Surgical, General & Plastic Surgery [21 CFR 878.4370 (KKX)]
Predicate Devices LAP DISC Hand Access Device (Hakko Medical Division of Hakko Shoji, Co. Ltd.), cleared under K030824 on June 4, 2003, K020307 on April 26, 2002, and K010870 on June 18, 2001
Alexis™ Wound Retractors (Applied Medical Resources Corp.), cleared under K020435 on April 15, 2002
Device Description The device is a sterile, single patient use abdominal access system comprised of two separately packaged components:
-
Seal Cap Assembly with Accessories
-
Fixed-Length Access Retractor
The ENDOPATH DEXTRUS Seal Cap Assembly consists of stationary and rotating rings interconnected by means of an elastomeric material that functions as an irris valve seal with an adjustable aperture. The seal cap assembly is designed to connect with the fixed-length access retractor. The assembled device can maintain peritoneal gas pressure while allowing for insertion of the surgeon's hand or surgical instruments into the abdominal cavity.
The Fixed-Length Access Retractor is available in three sizes to accommodate a wide range of abdominal wall thicknesses. The retractor consists of a top rigid ring and a bottom flexible ring interconnected by means of an elastomeric material. The top rigid ring provides for
1