The Davol Delivery System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

Device Description

The proposed device is designed to roll a soft tissue prosthetic in a tight uniform manner and provide a protective tube through which the rolled prosthetic can be delivered into the abdomen. The proposed device consists of four distinct parts, a rolling tines/plunger assembly which is used to roll the soft tissue prosthetic, a hollow plastic delivery tube to hold the rolled prosthetic, a "T" handle which is placed over the tines to facilitate the plunging motion to deliver the prosthetic, and an optional switching stick which can be used to maintain the tissue path created by a trocar sleeve. The proposed device will be provided as a sterile device for single patient use. It will be available in two sizes, a small size for the delivery of smaller soft tissue prosthetics and a large size for the delivery of larger prosthetics.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Davol Delivery System, a device intended to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair. The document focuses on establishing substantial equivalence to predicate devices and describes limited bench testing.

Therefore, it does not contain information about acceptance criteria or a study proving the device meets specific performance acceptance criteria in the way typically expected for an AI/ML medical device. Instead, the "study" described is limited bench testing to demonstrate functionality and address potential concerns.

Here's a breakdown of the available information based on your request, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not define specific, quantifiable acceptance criteria (e.g., accuracy thresholds, failure rates) for the device's performance, nor does it provide a formal table of results against such criteria. The "performance" described is functional operation.

Acceptance Criteria (N/A – Not specified)	Reported Device Performance
No explicit numerical or quantitative acceptance criteria are provided in the document.	Functionality: Demonstrated ability to roll soft tissue prosthetics, insert them into the delivery device, and plunge them out onto a tabletop. Integrity: Prosthetics did not exhibit damage after use. Ease of Delivery: Wetting the prosthetic facilitates ease of delivery.
No explicit numerical or quantitative acceptance criteria are provided in the document.	Safety/Effectiveness of Rounded/Slit Tip: The rounded shape facilitates entry into the incision, and the slit valve allows the prosthetic to exit. This design choice "does not affect the safety and effectiveness of the device" as it facilitates entry.
No explicit numerical or quantitative acceptance criteria are provided in the document.	Safety/Effectiveness of Adjustable Wing Component: Provides a visual gauge of insertion depth and a bracing point. This component "does not adversely affect the safety and effectiveness of the device" as it remains outside the body and provides an additional visual guide.

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

Sample Size: "Several different large soft tissue prosthetics" were used. The exact number is not specified. The number of trials performed is also stated as "Several trials were repeated." This is a very small and undefined sample.
Data Provenance: The testing was "Preliminary bench testing," indicating laboratory conditions rather than human or animal studies. No country of origin is mentioned, but it's implied to be within the Davol, Inc. R&D setting. The testing was prospective in the sense that it was conducted specifically for the 510(k) submission to demonstrate functionality.

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

Not applicable. There was no "ground truth" in the clinical or diagnostic sense with expert review. The "ground truth" was simply the observation of the device's mechanical function (rolling, delivery, lack of damage to prosthetics) during bench testing. This typically involves R&D engineers or technicians. No specific number or qualifications are mentioned.

4. Adjudication Method for the Test Set

Not applicable. There was no "adjudication" in the clinical sense. The results were likely observed and documented by the testing personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a mechanical delivery system, not an AI/ML-based diagnostic or assistive technology. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.

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

Not applicable. This device is a mechanical delivery system, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" was observational/functional. It involved direct observation of the device's ability to mechanically perform its intended function (rolling and delivering prosthetics without damage in both dry and wet conditions).

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical system, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a mechanical system, not an AI/ML algorithm that requires a training set or associated ground truth establishment.

Summary

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SECTION 6.

KO4 1641

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

A. Submitter Information

Submitter's Name: Address:

Telephone: Fax: Contact Person: Date of Preparation: Davol, Inc. Subsidiary of C. R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920 401-463-7000 ext. 2263 401-463-3845 Suzanne LaScalza May 6, 2004

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JUL 0 1 2004

Device Name B.

Trade name:	Davol Delivery System
Common/Usual name:	Soft Tissue Prosthetic Delivery System
Classification name:	Endoscope and Accessories

C. Predicate Device Names

Trade name: Davol Surgical Mesh Delivery System (Davol Inc.)

MedChem Surgical Delivery System (Davol Inc.) Trade name:

D. Device Description

E. Intended Use

The Davol Delivery System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

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F. Technological Characteristics Summary

The Davol Delivery System and the predicate Davol device have the same intended use. Both devices are indicated to facilitate the delivery of soft tissue prosthetics, such as surgical mesh to the surgical site during laparoscopic soft tissue repair procedures (e.g. hernia repair).

The proposed device is similar to the two predicate devices in principle of operation and general design. The key differences are in the details of the device design.

In order to accommodate large soft tissue prosthetics, the large proposed device was designed with an inner diameter of 20 mm and an outer diameter of approximately 21 mm. The inner and outer diameters of the proposed device are similar to the large predicate MedChem device and fall within the size range of similar currently marketed devices.

The insertion end of the predicate devices could not be used in the proposed device since the open end of the predicate Davol device would be difficult to insert directly through an incision and even the slight taper of the predicate MedChem device would prevent the prosthetic from exiting the delivery tube. Instead, the insertion end of the proposed device is covered with a thin, flexible, rounded tip which is slit into three triangular leaves to form a valve. The rounded shape facilitates the entry of the delivery tube into the incision site while the slit valve allows the rounded tip to open wide enough to permit the prosthetic to exit. The insertion end of the proposed device does not affect the safety and effectiveness of the device since the rounded tip simply facilitates entry into the incision compared to an open insertion end.

The proposed device has an adjustable wing component on the delivery tube. which is not present in either of the two predicate devices. The wing component remains outside the body and provides a visual gauge of the insertion depth, as well as a place for the surgeon to brace against while pushing the soft tissue prosthetic through the delivery tube. This component does not adversely affect the safety and effectiveness of the device since the component remains outside the body and simply provides additional visual guide.

The switching stick of the proposed device is an optional component provided to maintain the pathway from the skin incision, through the tissue layers to the abdomen. Although neither predicate device includes a switching stick component, switching sticks, or exchange rods are sometimes packaged with currently marketed laparoscopic devices and commonly used to maintain the tissue pathway.

Preliminary bench testing was performed using several different large soft tissue prosthetics. Testing consisted of rolling the soft tissue prosthetic, inserting the

MAY 17 2004

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MAY 17 2004

Page 32

rolled prosthetic into the delivery device and plunging it out of the device onto a tabletop. Several trials were repeated after soaking the prosthetic in saline solution to simulate were ropens are sults demonstrated that neither the solution to simulate were conditions. "Thibited damage after use. Further, the trials prosmetics not the proposed des demonstrated that wetting the prosthetic facilitates ease of delivery.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 01 2004

C.R. Bard, Inc. c/o Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K041641

Trade/Device Name: Davol Delivery System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 16, 2004 Received: June 17, 2004

Dear Mr. Mosenkis:

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 (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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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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. 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):

K041641

Device Name:

Davol Delivery System

Indications for Use:

The Davol Delivery System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

Prescription Use X (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)

Mìriam C. Provost

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

510(k) Number K041641

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.