(11 days)
Not Found
No
The 510(k) summary describes a purely mechanical device made of stainless steel for elevating the abdominal wall. There is no mention of software, image processing, AI, ML, or any data-driven components.
No
The device is used to elevate/retract the abdominal wall for low pressure laparoscopic procedures, which is a supportive function during a medical procedure, not a direct therapeutic treatment for a disease or condition.
No
The device description states its use is to "elevate/retract the abdominal wall for low pressure laparoscopic procedures," which is a surgical/interventional function, not a diagnostic one. There is no mention of it being used to detect, identify, or monitor any medical conditions.
No
The device description explicitly states it is manufactured entirely from stainless steel, indicating it is a physical hardware device.
Based on the provided information, the Maher Abdominal Wall Elevator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "elevate/retract the abdominal wall for low pressure laparoscopic procedures." This is a surgical tool used during a procedure on a patient's body.
- Device Description: The description reinforces its use as a surgical instrument made of stainless steel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The Maher Abdominal Wall Elevator is a surgical instrument used to facilitate a surgical procedure.
N/A
Intended Use / Indications for Use
The Maher Abdominal Wall Elevator is used to elevate/retract the abdominal wall for low pressure laparoscopic The device is intended to be used after the establishment of a pneumoperitoneum.
Product codes
79 GCJ
Device Description
The Maher Abdominal Wall Elevator is used to elevate/retract the abdominal wall for low pressure laparoscopic The device is intended to be used after the establishment of a pneumoperitoneum. The device is manufactured entirely from stainless steel is widely used in the medical field and biocompatibility is assured
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
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)
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) Premarket Notification Maher Abdominal Wall Elevator Cook Urological, Incorporated and COOK OB/GYN®
160878
J. 510(k) Summary of Safety and Effectiveness
Submitted By:
Rick Lykins Cook Urological, Incorporated and COOK OB/GYN® 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 March 1, 1996
MAR 1 5 1996
Device:
Trade Name: Maher Abdominal Wall Elevator Proposed Classification Name: Laparoscope, General and Plastic Surgery 79 GCJ
Predicate Devices:
The Maher Abdoninal Wall Elevator is substantially equivalent to predicate abdominal wall elevators in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Mediflex® Bookler® A.W.E.L.™ Abdominal Wall Elevator (K943614) manufactured by Mediflex, 250 Gibbs Road, Islandia, NY 11722.
Device Description:
The Maher Abdominal Wall Elevator is used to elevate/retract the abdominal wall for low pressure laparoscopic The device is intended to be used after the establishment of a pneumoperitoneum. The device is procedures. manufactured entirely from stainless steel is widely used in the medical field and biocompatibility is assured
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Urological, Incorporated and COOK OB/GYN®. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.