(144 days)
Not Found
No
The device description and intended use describe a mechanical surgical retractor and port, with no mention of computational analysis, image processing, or AI/ML terms.
No
The device is described as surgical instruments (retractor and port) used to create and maintain access and retract tissue during laparoscopic procedures, not to treat a disease or condition.
No
The device description clearly states its purpose as a surgical instrument for creating and maintaining an operative cavity, retracting tissue, and creating a port of entry during laparoscopic procedures. These are all interventional functions, not diagnostic ones.
No
The device description clearly states that the A-Lap™ set is composed of physical components: a retractor made of polyester mesh and stainless steel wires, and a laparoscopic port including a trocar and flexible cannula. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for creating and maintaining operative cavities and retracting tissue during surgical procedures (gynecologic, general, urologic, and thoracic). This is a surgical device used in vivo (within the body).
- Device Description: The device is described as a laparoscopic surgical device consisting of a retractor and a port. These are instruments used directly in surgery.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly a surgical instrument used during a procedure, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The A-Lap™ set has application for use in the creation and maintenance of an operative cavity such as the gynecologic, general, urologic and thoracic procedures. The set may be used in procedures to create and maintain a port of entry and for temporary retracting of tissue.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The A Lap™ set is laparoscopic surgical device compose of two components:
A-Lap™ Retractor - a surgical retraction instrument used to move, retain or hold back internal organs in the operative region during laparoscopic surgery. The device purposes is to widen the access area to the treatment site (the surgical field), to grasp and retract the surrounding tissues, to maintain the resultant size of the access area and to secure the retracted tissue or organs by holding it away from the surgical site. The retraction is achieved by a 12 cm X 12 cm polyester mesh connected to stainless steel wires.
EZaxess - a laparoscopic port included a 170 mm long and 10mm in diameter bladeless trocar and flexible cannula (10cm long and 10mm in diameter). The device is used to create and maintain a port of entry during laparoscopic surgery. The A Lap™ set is intended to be use for various laparoscopic surgical procedures, such as gynecologic, general, urologic and thoracic procedures. It is fully disposable and is intended for single use only.
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)
Biocompatibility of the A-Lap™ Set, the A-Lap™ Retractor and EZaxess materials has been verified in accordance with ISO 10993-1. Biological evaluation of Medical Devices - Part 1. Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (
§ 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
082291
erge (1) of (3)
510(k) Summary A-Lap TM Set, the A-LapTM Retractor, and the EZaxess
Date: December 16, 2008
Submitter Information:
JAN - 2 2009
EZsurgical New Industrial Park, P.O. Box 620 Yogneam, Israel Tel: (972)-4-9090000 Fax: (972)-4-9090055
Contact Person:
Liat Diamant - Porat Duet Medical Consulting Ltd. 22 Haarava St. P.O. Box 536 Zur-Moshe 42810, Israel Tel: (972) -52-8337207 liat@duet-medical.com
Device Identification
A-Lap™ Retractor Trade Name: Device Classification Name: Retractor General & Plastic Surgery Review Panel: Product Code: GCJ 876.1500 Regulation Number: . Device Class: II
EZaxess Trade Name: Device Classification Name: Laparoscope, general & plastic surgery Review Panel: General & Plastic Surgery Product Code: GCJ 876.1500 Regulation Number: Device Class: II
A-Lap™ Set Trade Name: Device Classification Name: Laparoscope, general & plastic surgery General & Plastic Surgery Review Panel: GCJ Product Code: Regulation Number: 876.1500 Device Class: II
Predicate devices:
1
The A-Lap™ Set, the A-Lap™ Retractor and EZaxess are substantially equivalent to the following predicate devices:
- endoscopic Fan (United States Surgical Autosuture retractor corporation); cleared under K914190.
- Autosuture Endo paddle retractor (Autosuture); 510(k) exempt.
- Autosuture Versaport Plus Bladeless Trocar (Tyco Healthcare Group); cleared under K081169.
Device Description:
The A Lap™ set is laparoscopic surgical device compose of two components:
A-Lap™ Retractor - a surgical retraction instrument used to move, retain or hold back internal organs in the operative region during laparoscopic surgery. The device purposes is to widen the access area to the treatment site (the surgical field), to grasp and retract the surrounding tissues, to maintain the resultant size of the access area and to secure the retracted tissue or organs by holding it away from the surgical site. The retraction is achieved by a 12 cm X 12 cm polyester mesh connected to stainless steel wires.
EZaxess - a laparoscopic port included a 170 mm long and 10mm in diameter bladeless trocar and flexible cannula (10cm long and 10mm in diameter). The device is used to create and maintain a port of entry during laparoscopic surgery. The A Lap™ set is intended to be use for various laparoscopic surgical procedures, such as gynecologic, general, urologic and thoracic procedures. It is fully disposable and is intended for single use only.
Intended Use
The A-Lap™ Set, the A-Lap™ Retractor and EZaxess will be both distributed together as a set and distributed separately.
-
- A-Lap™ set:
The A-Lap™ set has application for use in the creation and maintenance of an operative cavity such as the gynecologic, general, urologic and thoracic procedures. The set may be used in procedures to create and maintain a port of entry and for temporary retracting of tissue.
- A-Lap™ set:
-
- A-LapTM retractor:
The A-Lap™ retractor has application for use in the creation and maintenance of an operative cavity such as the gynecologic, general, urologic and thoracic procedures. The device may be used in procedures requiring temporary retracting of tissue.
- A-LapTM retractor:
-
- EZaxess :
The EZaxess is intended for use in creating and maintaining a port of entry in gynecologic, general, urologic and thoracic procedures.
- EZaxess :
Technological Characteristics
The components of the A-Lap™ Set, the A-Lap™ Retractor and EZaxess are similar in basic materials, design, construction and performance to the predicate devices.
2
KU8229| page 3 of 3
Safety and Performance Testing
Biocompatibility of the A-Lap™ Set, the A-Lap™ Retractor and EZaxess materials has been verified in accordance with ISO 10993-1. Biological evaluation of Medical Devices - Part 1. Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (