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.

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.

The EZaxess is intended for use in creating and for maintaining a port of entry in gynecologic, general, urologic and thoracic procedures.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the A-Lap™ Set, A-Lap™ Retractor, and EZaxess devices, focusing on acceptance criteria and the study that proves the devices meet them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance metrics. Instead, it refers to general compliance with standards and equivalence to predicate devices. The "performance" is primarily assessed through design analysis, in vitro, and in vivo data to confirm safety and effectiveness, and substantial equivalence.

Based on the text, the implicit acceptance criteria and reported performance relate to:

Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Verified: Materials confirmed biocompatible according to ISO 10993-1 for external communicating, blood contact, short duration (<24 hours) device use.
Safety and Effectiveness	Confirmed: Design analysis, in vitro, and in vivo data confirm safety and effectiveness.
Substantial Equivalence to Predicate Devices	Met: The devices are substantially equivalent in basic materials, design, construction, performance, indications for use, and principles of operation to the predicate devices (endoscopic Fan, Autosuture Endo paddle retractor, Autosuture Versaport Plus Bladeless Trocar). Specifically, device evaluation included flexibility & mechanical strength tests and mesh compliance, aligning with the expected performance of similar commercially available retractors/trocars.
Minimum Requirements for Intended Use (General Functional Characteristics)	Met: Based on the above, the devices meet the minimum requirements considered adequate for their intended use.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify the sample sizes used for the in vitro or in vivo tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The term "in vivo data" suggests that some studies were conducted on living subjects, but details are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The filing does not describe a process involving experts establishing ground truth for performance metrics, as it is a device intended for surgical retraction/access and not an diagnostic AI device.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable in the context of this type of device submission. Adjudication methods are typically relevant for diagnostic studies where expert consensus is needed to establish a definitive diagnosis.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument (retractor and trocar), not an AI-assisted diagnostic tool or a device that impacts "human reader" performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not performed. This is a physical surgical device, not an algorithm or AI.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic AI devices (e.g., pathology, outcomes data) is not directly applicable here. For this surgical device, the "ground truth" for proving safety and effectiveness would be established through a combination of:

Compliance with Biocompatibility Standards: ISO 10993-1.
Engineering Design Analysis: Demonstrating the device's adherence to design specifications and mechanical integrity.
In vitro testing: Likely bench testing for flexibility, mechanical strength, and mesh compliance to ensure the device performs as intended in a simulated environment.
In vivo data: This would typically involve animal studies or potentially human clinical data (though not explicitly detailed here) to demonstrate safe and effective organ retraction and port creation without adverse events.
Substantial Equivalence: Comparison to the known safe and effective performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/algorithm-based device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as this is not an AI/algorithm-based device and does not have a training set or associated ground truth in that context.

Summary

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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:

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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:

Intended Use

The A-Lap™ Set, the A-Lap™ Retractor and EZaxess will be both distributed together as a set and distributed separately.

1. 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.
1. 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.
1. EZaxess :
  The EZaxess is intended for use in creating and maintaining a port of entry in gynecologic, general, urologic and thoracic procedures.

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.

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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 (<24 hours) device.

Design analysis, in vitro and in vivo data confirm the safety and effectiveness of the device and that the basic functional characteristics are substantially equivalent to the predicate devices cited. Device evaluation included flexibility & mechanical strength tests and mesh compliance.

Summary of Substantial Equivalence

Based on the indications for use, technological characteristics, and safety and performance testing, A-Lap™ Set, the A-Lap™ Retractor and EZaxess meets the minimum requirements that are considered adequate for intended use and is substantially equivalent in design, materials, principles of operation and indications for use to current commercially available retractors/trocar predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black-and-white design, and the text is in a sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EZsurgical. % Duet Medical Consulting Ltd. Ms. Liat Diamant - Porat 22 Haarava Street P.O. Box 536 Zur-Moshe 42810 Israel

JAN - 2 2009

Re: K082291

Trade/Device Name: A-LapTM Set, A-Lap™ Retractor, EZaxess Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: December 18, 2008 Received: December 24, 2008

Dear Ms. Diamant - Porat:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulheran

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

k08229

Device Name:

A-Lap M Set

Indications for Use:

Prescription Use (Per 21 CFR 801.109 subpart D)

Over the Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices ·

510(k) Number K062291

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

A-Lap™ Retractor

Indications for Use:

Prescription Use (Per 21 CFR 801.109 subpart D)

Over the Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peth

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K68229 510(k) Number

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INDICATIONS FOR US

510(k) Number (if known):

K.082291

Device Name:

EZaxess

Indications Use:

The EZaxess is intended for use in creating and for maintaining a port of entry in gynecologic, general, urologic and thoracic procedures.

Prescription Use X (Per 21 CFR 801.109 subpart D)

OR . Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign.Off) Division of General, Restorative, and Neurological Devices

510(k) Number K022051

Regulation Number and Section

§ 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.