(14 days)
K/DEN: Not Found
Not Found
No
The device description and performance studies focus on mechanical delivery of a prosthetic, with no mention of AI/ML terms or functionalities.
No.
The device facilitates the delivery of a prosthetic; it does not directly treat a disease or condition itself.
No
This device is designed to deliver a soft tissue prosthetic for repair, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (rolling tines/plunger assembly, hollow plastic delivery tube, "T" handle, optional switching stick) and describes a mechanical process for delivering a soft tissue prosthetic. There is no mention of software as a component or function of the device.
Based on the provided information, the Davol Delivery System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair)." This describes a surgical tool used in vivo (within the body) to deliver a medical device.
- Device Description: The description details a mechanical device for rolling and delivering a prosthetic. It does not mention any components or functions related to testing samples of human origin in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Davol Delivery System does not fit this description.
N/A
Intended Use / 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).
Product codes
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preliminary bench testing was performed using several different large soft tissue prosthetics. Testing consisted of rolling the soft tissue prosthetic, inserting the 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 conditions. "Thibited damage after use. Further, the trials prosmetics not the proposed des demonstrated that wetting the prosthetic facilitates ease of delivery.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Davol Surgical Mesh Delivery System, MedChem Surgical Delivery System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
Page 1 of (3
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
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.
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
Page 2 of '
2
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping lines or waves, often interpreted as representing the department's mission related to health and well-being.
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.
4
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
5
INDICATIONS FOR USE
510(k) Number (if known):
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