The ADAPt™ Universal Laparoscopic 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

The ADAPt™ Universal Laparoscopic Port consists of an obturator and cannula set which will accommodate instruments in the 5-10mm range with a cannula length of 100mm and the 5-10-12mm range with cannula lengths of 100mm and 125mm. The device utilizes a set of three seals. The first seal is the Floating Top Seal which accommodates instruments ranging from 10mm to 12mm. The second seal is the Floating Caged Seal which accommodates instruments in the 5mm range. The third seal is the Duck Bill Seal used to maintain insufflation, if no instruments are placed in the port during surgery.

AI/ML Overview

The ADAPt™ Universal Laparoscopic Port is considered substantially equivalent to its predicate device (The ADAPT™ Laparoscopic Port and Accessory, K010007). The evaluation of this device is based on determining its substantial equivalence to the predicate device rather than fulfilling specific, independent acceptance criteria.

Here's a breakdown of the information based on your request, understanding that the context is substantial equivalence for a medical device rather than a diagnostic AI system:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence determination for a medical device (a surgical trocar), the "acceptance criteria" are not reported as quantitative performance metrics in the same way they would be for an AI diagnostic algorithm. Instead, the acceptance is based on demonstrating that the device performs as intended and is equivalent to a predicate device, thereby not raising new questions of safety or effectiveness.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance
Basic Design and Function	Identical to the predicate device (K010007).
Material Compatibility (Patient Contact)	All materials (except for Valox core overmolded with CLS 8110 Silicone Parylene N Cating 1.0-1.8 uM thick) were cleared in the predicate device. New material was tested in accordance with ISO 10993-1.
Performance Characteristics	Equivalent to marketed predicate devices.
Safety and Effectiveness	Changes do not introduce any new issues of safety and effectiveness.
Intended Use	Aligns with the predicate device for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

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

The document states that "bench testing has been performed." However, it does not specify the sample size for this bench testing or the provenance of any data used (e.g., country of origin, retrospective/prospective).

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

This information is not provided. The study relies on bench testing comparisons to a predicate device, not on expert-adjudicated ground truth as would be typical for a diagnostic AI.

4. Adjudication method for the test set

This information is not applicable and not provided. The evaluation is based on bench testing of the device's physical and functional characteristics.

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 such study was done. This is a medical device, not an AI-assisted diagnostic tool.

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

No such study was done. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the performance and safety established for the predicate device (K010007) and the bench testing results demonstrating that the modified ADAPt™ Universal Laparoscopic Port performs equivalently and safely. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for an AI diagnostic.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI system that requires a "training set."

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

Not applicable.

Summary

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Section 8 - Summary of Safety and Effectiveness

SEP 1 0 2008

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

K082156

The ADAPt™ Universal Laparoscopic Port

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

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-4904 919-433-4996 Fax:

B. Contact Person

Special 510(k)

Angela Bouse Regulatory Affairs Specialis

C. Date Prepared

July 29, 2008

D. Device Name

Trade Name: The ADAPt™ Universal Laparoscopic Port

Common Name: Surgical Trocar

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

E. Device Description

Teleflex Medical, Inc.

CONFIDENTIAL

Page 8.1

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F. Indications for Use

The ADAPE™ Universal Laparoscopic 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.

G. Contraindications

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

H. Substantial Equivalence

The proposed ADAPt™ Universal Laparoscopic Port is substantially equivalent to the predicate device:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
The ADAPT™ LaparoscopicPort and Accessory	Teleflex Medical, Inc. /Taut, Inc.	K010007	02/22/2001

I. Comparison To Predicate Device

The basic design and function of the proposed ADAPt™ Universal Laparoscopic Port is identical to the predicate device, except that the ADAPt™ Universal Laparoscopic Port has the following changes:

Includes a Floating Caged Seal which is composed of two rigid halves made . of valox providing the structural integrity of the seal, the valox core is overmolded all around the outer edges with the silicone which provides sealing capability of the seal. The two halves are held in place with an elastic hinge on one side and secured by a pair of magnets on the other side;
. A Rotary Valve Chamber was created to accommodate the Floating Caged Seal;
The shaft of the obturator is lengthened to accommodate the extended height . of the Rotary Valve Chamber.

J. Materials

All materials that have patient contact, for exception of Valox core overmolded with CLS 8110 Silicone Parylene N Cating 1.0-1.8 uM thick, have been cleared in predicate device under 510(k) K010007. New material was tested in accordance with ISO 10993-1.

Teleflex Medical, Inc.

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K. Technological Characteristics

A comparison of the technological characteristics of the proposed ADAPtTM Universal Laparoscopic Port and the predicate device has been performed. The results of this comparison demonstrate that the ADAPt™ Universal Laparoscopic 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 Laparoscopic Port is substantially equivalent to the predicate device, and that the ADAPt™ Universal Laparoscopic Port will perform as intended.

M. Conclusion

Based upon the comparative test results, the proposed ADAPt™ Universal Laparoscopic Port is substantially equivalent in performance to the predicate device cleared to market via 510(k) K010007. The changes made to the proposed ADAPt™ Universal Laparoscopic Port do not introduce any new issues of safety and effectiveness.

Teleflex Medical, Inc.

CONFIDENTIAL

Page 8.3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

SEP 1 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Teleflex Medical % Ms. Angela Bouse Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709

Re: K082156

Trade/Device Name: ADAPt™ Universal Laparoscopic Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 25, 2008 Received: August 26, 2008

Dear Ms. Bouse:

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. Iisting 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 (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.

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Page 2 - Ms. Angela Bouse

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 the reporting 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 M. Millman

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 Statement

Page 1 of 1

510(k) Number:

K082156

Device Name:

ADAPtTM Universal Laparoscopic Port

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D)

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)

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

510(k) Number L682152

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.