The ADAPt™ Universal Balloon Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

Device Description

ADAPt™ Universal Balloon Open Access Port is used to establish a port of entry into the abdominal cavity, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The port is positioned into the peritoneum during minimally invasive surgical procedures, in order to provide a pathway for the insertion and removal of various sized surgical devices. ADAPTM Universal Balloon Open Access Port is intended to be used by trained physicians.

AI/ML Overview

The ADAPT™ Universal Balloon Open Access Port (K112456) is a surgical trocar device. The submission is a Special 510(k), indicating a modification to an already cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not include a specific table of quantitative acceptance criteria or detailed reported device performance in terms of numerical metrics for the ADAPT™ Universal Balloon Open Access Port. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through comparative bench testing.

The acceptance criterion, by its nature as a Special 510(k), is that the modified device (ADAPt™ Universal Balloon Open Access Port) is substantially equivalent in performance, safety, and effectiveness to its predicate devices (ADAPT™ Balloon Open Access Port Model 41244, K023261, and ADAPt™ Universal Laparoscopic Port, K082156).

The reported device performance, therefore, is a statement of this equivalency based on bench testing.

Acceptance Criteria	Reported Device Performance
Overall Performance Equivalency: The ADAPt™ Universal Balloon Open Access Port is substantially equivalent in performance to the predicate devices and performs as intended.	"The results of this comparison demonstrate that the ADAPI™ Universal Balloon Open Access Port is equivalent to the marketed predicate devices in performance characteristics.""Based upon the comparative test results, the proposed ADAPT™ Universal Balloon Open Access Port is substantially equivalent in performance to the predicate devices cleared to market via 510(k) K023261 and K082156."
Safety and Effectiveness: The modifications do not introduce any new issues of safety and effectiveness.	"No new Indications for Use, patient contacting materials, manufacturing processes, or risks have been introduced with these proposed modifications.""The modifications made to the proposed ADAPT™ Universal Balloon Open Access Port do not introduce any new issues of safety and effectiveness."
Biocompatibility: Patient contacting materials comply with ISO 10993-1.	"All patient contacting materials are in compliance with ISO 10993-1."

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

The document states that "bench testing has been performed." However, it does not specify the sample size used for this bench testing.

The data provenance is from internal bench testing, conducted by Teleflex Medical, Inc. The data is retrospective in the sense that it relies on comparisons to previously cleared predicate devices and their known performance characteristics. No details are provided regarding the country of origin of the specific test data, but it would presumably be from the manufacturer's own R&D or testing facilities.

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

This information is not applicable and not provided in the document. The study involves bench testing of a medical device (a surgical trocar) for physical and functional equivalence to predicate devices, not for diagnostic accuracy or human interpretation. Therefore, there is no "ground truth" in the traditional sense established by experts for a test set of data points (e.g., medical images).

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As the study is based on bench testing for substantial equivalence, there is no need for expert adjudication of test results in the way there would be for a diagnostic AI study. The comparison is against established performance characteristics of predicate devices.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, typically in imaging or clinical decision support. The ADAPT™ Universal Balloon Open Access Port is a physical surgical device, and its evaluation focuses on its mechanical and functional equivalence, not on human interpretive performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study, as typically understood for an algorithm or AI without human intervention, was not done. The "standalone" performance here relates to the device's physical function. The bench testing performed can be considered an evaluation of the device's standalone performance in a controlled environment, demonstrating that "the ADAPIt™ Universal Balloon Open Access Port will perform as intended."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for diagnostic or AI studies is not directly applicable here. For this device, the "ground truth" for comparison is the established performance characteristics and safety profile of the predicate devices. The new device's performance is measured against these known attributes through engineering and functional bench tests to determine if it meets the same standards.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable and not provided. As there is no AI algorithm or training set, the concept of establishing ground truth for a training set does not apply.

Summary

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ADAPT™ Universal Balloon Open Access Port

Section 8 - Summary of Safety and Effectiveness

Page 1.83

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

ADAPT™ Universal Balloon Open Access Port

OCT - 4 2011

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8049 Fax: 919-433-4996

B. Contact Person

Special 510(k)

Natalie Smith Regulatory Affairs Specialist

C. Date Prepared

August 23, 2011

D. Device Name

Trade Name: ADAPt™ Universal Balloon Open Access Port

Common Name: Surgical Trocar

Classification Name: Endoscope and Accessories (21 CFR 876.1500, Product Code GCJ)

E. Device Description

F. Indications for Use

The Universal Balloon Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

Teleflex Medical, Inc.

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ADAPt™ Universal Balloon Open Access Port Special 510(k) Section 8 - Summary of Safety and Effectiveness

G. Contraindications

Where minimally invasive techniques are contraindicated, other methods and instrumentation should be employed.

H. Substantial Equivalence

The proposed Universal Balloon Open Access Port is substantially equivalent to the predicate devices:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
ADAPT™ Balloon Open AccessPort Model 41244	Teleflex Medical, Inc. /Taut, Inc.	K023261	12/13/02
ADAPT™ UniversalLaparoscopic Port	Teleflex Medical, Inc. /Taut, Inc.	K082156	09/10/2008

I. Comparison To Predicate Devices

The essence of this change is the selection of previously approved key features from K023261; ADAPt™ Balloon Open Access Port Model 41244 and K082156; ADAPr™ Universal Laparoscopic Port, to produce a new consolidated design. No new Indications for Use, patient contacting materials, manufacturing processes, or risks have been introduced with these proposed modifications.

The new consolidated design of the ADAPt™ Universal Balloon Open Access features the Balloon from K023261 with the additional features of the Universal and Duckbill Seals arising from K082156. A polypropylene Ring Clamp (non-patient contacting) has replaced an acrylic cannula clamp (aka H clamp) from the previous design and the definition of the cannula working length has been clarified. In doing so, the actual working length of the Access Port has been lengthened to 125mm which is a length previously cleared for port access under K023261. All other proven attributes of the ADAPtTM Balloon Open Access Port remain the same.

J. Materials

All patient contacting materials are in compliance with ISO 10993-1.

K. Technological Characteristics

A comparison of the technological characteristics of the proposed ADAPITM Universal Balloon Open Access Port and the predicate has been performed. The results of this comparison demonstrate that the ADAPI™ Universal Balloon Open

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ADAPt™ Universal Balloon Open Access Port Special 510(k) Section 8 - Summary of Safety and Effectiveness

Access Port is equivalent to the marketed predicate devices in performance characteristics.

L. Performance Data

The bench testing has been performed to verify that the performance of the proposed ADAPt™ Universal Balloon Open Access Port is substantially equivalent to the predicate device, and that the ADAPITM Universal Balloon Open Access Port will perform as intended.

L. Conclusion

Based upon the comparative test results, the proposed ADAPT™ Universal Balloon Open Access Port is substantially equivalent in performance to the predicate devices cleared to market via 510(k) K023261 and K082156. The modifications made to the proposed ADAPT™ Universal Balloon Open Access Port do not introduce any new issues of safety and effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Teleflex Medical, Inc. % Ms. Natalie Smith Regulatory Affairs Specialist 2917 Week Drive Research Triangle Park. North Carolina 27709

OCT - 4 2011

Re: K112456

Trade/Device Name: Universal Balloon Open Access Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class H Product Code: GCJ Dated: September 13, 2011 Received: September 23, 2011

Dear Ms. Smith:

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. Please note: CDRH does not evaluate information related to contraction and warranties. We remind you; however, that device labeling must be truthful and not misleading.

ff 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 not the Act

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Page 2 - Ms. Natalie Smith

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm1 | 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.lda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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K11 2456

Indications for Use

Page 1 of 1

510(k) Number:

Device Name:

Universal Balloon Open Access Port

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter use ・ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel R. Jale Eur nxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112456

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.