Applied Medical's Dissecting Balloon System consists of a rigid cannula with an inflatable balloon attached at the distal end that achieves separation of tissue planes during laparoscopic surgery. The system is provided sterile. The system includes three main components: An introducer that facilitates insertion of the balloon through an abdominal incision. A dissecting cannula with attached balloon, which is compatible with a 10mm endoscope to allow for visualization during tissue separation. Two balloon configurations will be offered (oval and round). An inflation bulb that is used to manually inflate the balloon

AI/ML Overview

This document is a 510(k) Premarket Notification for the Applied Medical Resources Corp. Dissecting Balloon System. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance criteria in a clinical setting. The "performance testing" section describes bench-top functional assessments and biocompatibility, which are primarily aimed at showing that the new device functions similarly and is as safe as the predicate, not necessarily that it achieves a specific clinical outcome with a quantifiable performance metric.

Therefore, many of the requested elements regarding clinical performance studies, such as sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, are not applicable in the context of this 510(k) submission.

Here's a breakdown of the information that can be extracted or deduced from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of explicit, quantifiable acceptance criteria with corresponding device performance metrics in a clinical context. The "performance testing" section describes functional equivalence testing.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Device materials are not cytotoxic, irritating, sensitizing, or acutely systemically toxic when in contact with tissue for less than 24 hours.	All materials were found to be biocompatible for cytotoxicity, intracutaneous irritation, sensitization, and acute systemic toxicity, in accordance with ISO 10993-1.
Functional Performance (Bench-top):
Device insertion is comparable to the predicate.	Side-by-side bench-top testing demonstrated comparable device insertion to the predicate device.
Tissue separation is comparable to the predicate.	Side-by-side bench-top testing demonstrated comparable tissue separation to the predicate device.
Surgical site visualization is comparable to the predicate.	Side-by-side bench-top testing demonstrated comparable surgical site visualization to the predicate device.
Balloon deflation and device removal are comparable to the predicate.	Side-by-side bench-top testing demonstrated comparable balloon deflation and device removal to the predicate device.

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

Sample Size: Not specified for the functional performance bench testing.
Data Provenance: The document describes "side-by-side bench top testing," which implies laboratory-based, prospective testing conducted by the manufacturer. No information on country of origin for clinical data is applicable as it's not a clinical study.

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

Number of Experts: Not applicable. The "ground truth" for functional performance was likely established by engineers or technicians assessing the physical properties and operation of the devices in a bench-top setting, not clinical experts.
Qualifications of Experts: Not specified or applicable in the human reader / clinical context.

4. Adjudication Method for the Test Set:

Not applicable. The bench-top testing would have involved objective measurements or direct observation of device function, not an adjudication process by human readers or clinical experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating substantial equivalence through bench-top testing and biocompatibility, not clinical effectiveness studies involving human readers or AI.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

Not applicable. This device is a mechanical surgical tool (dissecting balloon system), not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used:

Functional Performance: The ground truth for functional performance was based on direct observation and measurement of the device's physical operation and its ability to perform its intended mechanical functions (insertion, tissue separation, visualization, deflation, removal) in a bench-top setting, compared to the predicate device. It is not clinical ground truth like pathology or outcome data.
Biocompatibility: The ground truth was established through adherence to the FDA's guidance document and international standard ISO 10993-1, with results based on laboratory tests for cytotoxicity, irritation, sensitization, and systemic toxicity.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As there's no AI model or training set, this information is not relevant.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

August 30, 2018

Applied Medical Resources Corp. Corinne Yestrepsky Regulatory Affairs Specialist II 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K182024

Trade/Device Name: Dissecting Balloon System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: July 27, 2018 Received: July 30, 2018

Dear Corinne Yestrepsky:

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/ofdocs/ofpmn.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. 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

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

devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical on-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182024

Device Name Dissecting Balloon System

Indications for Use (Describe)

The Dissecting Balloon System is indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.

Type of Use (Select one or both, as applicable)
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}------------------------------------------------

510(k) Summary

510(K) Submitter:	Applied Medical Resources Corp.22872 Avenida EmpresaRancho Santa Margarita, CA, 92688(949) 713-8000
Contact Person:	Corinne Yestrepsky, PhDRegulatory Affairs Specialist IIApplied Medical Resources Corp.corinne.yestrepsky@appliedmedical.comTel: (949) 713-8176Fax: (949) 713-8205
Date of Preparation:	July 27, 2018
Trade Name:	Dissecting Balloon System
Common Name:	Blunt Dissection Balloon
Classification:	Regulation: 21 CFR 876.1500, Endoscope & AccessoriesDevice Class: Class IIProduct Code: GCJ
Predicate Device:	Preperitoneal Distention Balloon System510(k)#: K935426Product Code: GCJ
Device Description:	Applied Medical's Dissecting Balloon System consists of a rigidcannula with an inflatable balloon attached at the distal end thatachieves separation of tissue planes during laparoscopic surgery.The system is provided sterile.The system includes three main components:An introducer that facilitates insertion of the balloon through an abdominal incision. A dissecting cannula with attached balloon, which is compatible with a 10mm endoscope to allow for visualization during tissue separation. Two balloon configurations will be offered (oval and round). An inflation bulb that is used to manually inflate the balloon

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

The Dissecting Balloon System is indicated for patients Indications for use: undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.

Comparison of Technological Characteristics with the Predicate Device

The subject and predicate device systems are both blunt dissection balloons intended to separate tissue planes in the extraperitoneal space. Both systems contain an introducer, dissecting cannula with attached balloon, and inflation bulb. The subject and predicate systems are both offered in two balloon configurations (oval and round). Furthermore, each system is compatible with a 10mm endoscope to facilitate visualization of tissue separation.

The subject device system differs from the predicate in that the subject round balloon is encased in a perforated sheath to facilitate insertion where the predicate round balloon is not. Both the predicate and subject oval balloons are encased in a sheath.

Discussion of Performance Testing

The following performance data is provided in support of the substantial equivalence determination.

Biocompatibility

The biocompatibility evaluation for Applied Medical's Dissecting Balloon System was conducted in accordance with the FDA's guidance document. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The subject device contacts tissue for a duration of less than 24 hours, so the following endpoints were considered and all materials were found to be biocompatible.

Cytotoxicity
Intracutaneous Irritation
Sensitization
Acute Systemic Toxicity

Functional Performance

Side-by-side bench top testing was performed with the subject and predicate device systems to demonstrate substantial equivalence. The bench top tests were designed to focus on the functional performance of a blunt dissection balloon device. Both subject and predicate device systems were evaluated for:

. Device insertion
Tissue separation ●
. Surgical site visualization
Balloon deflation and device removal ●

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

Conclusion

Results of testing demonstrate that the subject Dissecting Balloon System is substantially equivalent to the predicate Preperitoneal Distention Balloon System, and that the subject device performs comparably to the current marketed device for the same intended use.

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.