The LevaLap Laparoscopic Access Device is intended for use in the peri-umbilical region of the abdominal wall prior to the establishment of a pneumoperitoneum to aid in the insertion of a Veress needle during gynecologic (pelvic) and general surgical (intra-abdominal) laparoscopic procedures.

Device Description

The LevaLap Laparoscopic Access Device is a sterile single-use device, consisting of a clear hemisphere-shaped housing containing a port for connection to a standard operating room (OR) vacuum system and a septum for introduction of a Veress needle. The LevaLap Laparoscopic Access Device is intended to raise the abdominal wall above critical organs and vessels by means of negative pressure, thus creating an initial space prior to insufflation in preparation for laparoscopic access. The device includes a vacuum bypass plug positioned in the vacuum intake port.

AI/ML Overview

The provided text describes the LevaLap Laparoscopic Access Device, but it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving device performance as it would typically be described for an AI medical device.

The product described is a laparoscopic access device, which is a physical instrument, not an AI algorithm. Therefore, many of your questions, such as those related to AI assistance, human readers, ground truth establishment for AI, and training sets, are not applicable in this context.

However, I can extract the available information related to the device's performance through non-clinical testing.

Here's a breakdown of what can be derived from the text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Performance Specification)	Reported Device Performance
Device maintains consistent negative pressure at -0.8 Bar for a minimum of 1 minute, with a 14G needle inserted in the septum (under simulated use conditions).	Testing successfully demonstrated that these specifications are met (non-clinical bench tests for vacuum draw and vacuum hold).

2. Sample size used for the test set and the data provenance

The text mentions "representative functional testing against specified requirements for vacuum draw and vacuum hold at T=0 and after accelerated aging simulating 2 years." However, it does not specify the sample size for these tests or the data provenance beyond "simulated use conditions." Given it's a physical device's mechanical performance, "data provenance" in the sense of patient data is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The device is a mechanical instrument, and its performance criteria are based on physical measurements (negative pressure maintenance) rather than expert interpretation of medical images or other data that would require "ground truth" established by experts.

4. Adjudication method for the test set

This question is not applicable, as there's no expert interpretation or consensus-building process described for evaluating the device's mechanical performance.

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

This question is not applicable. This is a physical medical device, not an AI algorithm that assists human readers.

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

This question is not applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance appears to be physical measurements of vacuum pressure and hold time under simulated conditions, compared against defined performance specifications.

8. The sample size for the training set

This question is not applicable. The device is a physical instrument, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable.

Summary of Relevant Information:

Acceptance Criteria: Maintains consistent negative pressure at -0.8 Bar for a minimum of 1 minute with a 14G needle in the septum.
Study Proving Performance: Non-clinical bench tests were performed successfully for vacuum draw and vacuum hold, and also after accelerated aging simulating 2 years.
Sample Size/Provenance: Not specified beyond "representative functional testing" under "simulated use conditions."
Ground Truth Type: Physical measurements against defined performance specifications.
Biocompatibility: Also tested successfully in accordance with ISO 10993-1.
Additional Testing: Sterilization, packaging integrity, and shelf-life testing were also performed.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

February 23, 2022

Core Access Surgical Technologies, Inc. Marianne D. Jacklyn Director of Regulatory Affairs 3495 Piedmont Road, NE Building 11, Suite 905 Atlanta. GA 30305

Re: K212786 Trade/Device Name: LevaLap Laparoscopic Access Device Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: January 5, 2022 Received: January 10, 2022

Dear Marianne D. Jacklyn:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{1}------------------------------------------------

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212786

Device Name LevaLap Laparoscopic Access Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92

General Information 1

Submitter Core Access Surgical Technologies, Inc. 3495 Piedmont Road, Building 11, Suite 905 Atlanta, GA 30305 USA

Contact Person Marianne D. Jacklyn, Director of Regulatory Affairs mjacklyn@castlap.com +1 (503) 729-9633

Date prepared 2

February 17, 2022

Device Information ന

Trade Name	LevaLap Laparoscopic Access Device
Common Name	Laparoscopic insufflator
Classification Number	21 CFR 884.1730
Classification Name	Laparoscopic insufflator
Product Code	HIF
Product Code Name	Insufflator, Laparoscopic
Regulatory Class	II

Predicate Device র্ব

Predicate Device Aragon Surgical LapCap (K073452)

The predicate device has not been subject to a design related recall.

Device Description ട്

The LevaLap Laparoscopic Access Device is a sterile single-use device, consisting of a clear hemisphereshaped housing containing a port for connection to a standard operating room (OR) vacuum system and a septum for introduction of a Veress needle. The LevaLap Laparoscopic Access Device is intended to raise the abdominal wall above critical organs and vessels by means of negative pressure, thus creating an initial space prior to insufflation in preparation for laparoscopic access.

{4}------------------------------------------------

Indications for Use റ

7 Comparison of Technological Characteristics

The subject and predicate devices have the same intended use and principle of operation, using mechanical force applied via negative pressure to lift the abdominal wall. Both devices consist of a round-shaped housing with an entry point for a Veress needle, and a vacuum intake port to connect to standard vacuum systems. Technological differences are limited to different materials of construction, septum/disc compression design, and the vacuum bypass plug component of the subject device. These differences do not raise different questions of safety and effectiveness.

The subject device has established performance specifications to support its intended use, with testing to demonstrate that these specifications are met. In addition, the finished subject device underwent biocompatibility testing for cytotoxicity, sensitization and irritation, in accordance with ISO 10993-1 and the FDA Guidance on use of this standard.

The subject device includes a vacuum bypass plug positioned in the vacuum intake port. This component is designed to prevent abdominal tissue prolapsing into the vacuum intake port.

In addition to the simulated use testing described below, validation activities for the subject device also included sterilization, packaging integrity and shelf-life testing.

Table 1. Device Comparison
Description	Subject Device	Predicate Device (K073452)
Indications foruse	The LevaLap Laparoscopic Access Deviceis intended for use in the peri-umbilicalregion of the abdominal wall prior to theestablishment of a pneumoperitoneum toaid in the insertion of a Veress needleduring gynecologic (pelvic) and generalsurgical (intra-abdominal) laparoscopicprocedures.	The Aragon Surgical LapCap is intendedfor use in the peri-umbilical region ofthe abdominal wall with a Veressneedle for the establishment of apneumoperitoneum during gynecologic(pelvic) and general surgical(intraabdominal) laparoscopicprocedures.
Description	The LevaLap Laparoscopic Access Deviceis a sterile single-use device, consisting ofa clear hemisphere-shaped housingcontaining a port for connection to astandard operating room (OR) vacuumsystem and a septum for introduction of aVeress needle. The device includes avacuum bypass plug positioned in thevacuum intake port.	The Aragon Surgical LapCap is a single-use device used during laparoscopicsurgical procedures. The device consistsof a bell-shaped polycarbonate domehousing containing a pass-through portfor introduction of a standard Veressneedle and a vacuum port forattachment to a standard hospitalvacuum line.

Please refer to Table 1 below for a detailed technological comparison.

{5}------------------------------------------------

K212786

Table 1. Device Comparison
Description	Subject Device	Predicate Device (K073452)
Principle ofoperation	Mechanical force is applied by applyingvacuum and introducing a negativepressure onto the surface of patient'sabdomen, to lift the abdominal wall.	Mechanical force is applied by applyingvacuum and introducing a negativepressure onto the surface of patient'sabdomen, to lift the abdominal wall.
Materials	Styrene-butadiene copolymers (SBC)Thermoplastic elastomer (TPE)	PolycarbonateNo other materials are known
PerformanceSpecifications	Under simulated use conditions, thedevice maintains consistent negativepressure at -0.8 Bar for a minimum of1 minute, with a 14G needle inserted inthe septum.	Unknown
Testing	The subject device underwentrepresentative functional testing againstspecified requirements for vacuum drawand vacuum hold at T=0 and afteraccelerated aging simulating 2 years.In addition, validation activities includedsterilization, package integrity, shelf lifeand biocompatibility testing.	Unknown

Non-Clinical Performance 8

Non-clinical testing was conducted to verify that the LevaLap Laparoscopic Access Device performs as intended. The following non-clinical bench tests were performed successfully on the Levalap Laparoscopic Access Device: vacuum draw and vacuum hold; biocompatibility according to ISO 10993-1 and the related FDA Guidance; shelf-life testing for package integrity, vacuum draw, and vacuum hold.

ഗ Conclusion

The subject and predicate devices have the same intended use and similar technological characteristics. The differences in technological characteristics do not raise different questions of safety or effectiveness. Performance testing conducted on the subject device demonstrate that it is as safe and effective as the predicate device to support substantial equivalence.

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.