(136 days)
Not Found
No
The description focuses on a mechanical fastener system and its physical properties and performance, with no mention of AI or ML.
No.
The device is used for approximating soft tissue and fixing surgical mesh, which are mechanical actions during surgery, not for treating a disease or condition.
No
The device is described as a system for approximating soft tissue and fixing surgical mesh, and its purpose is to deliver absorbable fasteners during surgical procedures. There is no mention of it being used to diagnose conditions or processes.
No
The device description clearly outlines a physical system with an ergonomic handle, trigger, shaft, penetrating tip, and absorbable fasteners. This is a hardware device, not software only.
Based on the provided information, the Davol Absorbable Fastener System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures. This describes a device used in vivo (within the body) for surgical intervention.
- Device Description: The description details a surgical instrument designed to deliver fasteners into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly perform surgical procedures within the body.
N/A
Intended Use / Indications for Use
The Davol Absorbable Fastener System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
Product codes
GDW
Device Description
The Davol Absorbable Fastener System is designed to deliver an absorbable fastener into I ho Da vir reberration ing general surgery procedures such as hernia repair. The fastener system consists of an ergonomic handle with trigger, shaft and penetrating tip. The shaft is available in either a 36 cm length for laparoscopic use or an 18 cm length for open surgical procedures. The device is preloaded with 5, 15, or 30 absorbable fasteners. Each absorbable fastener contains threads for mesh and tissue delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Biocompatibility testing on the Davol Absorbable Fastener System fastener has been completed. The biocompatibility test results show that the material used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use.
The Davol Absorbable fasteners were tested in vitro in a hernia repair model and in vivo in an animal model to confirm the mechanical strength of the repair over time as compared to the predicate device.
Additional in vitro laboratory tests were conducted to characterize material degradation over time.
All test results demonstrate that the material chosen, the manufacturing process, and the design utilized for the Davol Absorbable Fastemer System met the established specifications necessary for consistent performance during its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Page ① of ②
(082396
JAN - 2 2009
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 7.0
Submitter Information A.
Submitter's Name: Address:
- Telephone: Fax: Contact Person: Date of Preparation:
Davol Inc. Subsidiary of C. R. Bard, Inc. 100 Crossing Boulevard Warwick, RI 02886 (401) 825-8588 (401) 825-8765 Stephanie Baker August 18, 2008
Davol Absorbable Fastener System Staple, Implantable . Staple, Implantable
C. Predicate Device Name
Common/Usual Name:
Classification Name:
Trade name:
Device Name
Trade Name:
B.
Permasorb Disposable Fixation Device (K060494)
D. Device Description
The Davol Absorbable Fastener System is designed to deliver an absorbable fastener into I ho Da vir reberration ing general surgery procedures such as hernia repair. The fastener system consists of an ergonomic handle with trigger, shaft and penetrating tip. The shaft is available in either a 36 cm length for laparoscopic use or an 18 cm length for open surgical procedures. The device is preloaded with 5, 15, or 30 absorbable fasteners. Each absorbable fastener contains threads for mesh and tissue delivery.
E. Intended Use
5
The Davol Absorbable Fastener System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
PREMARKET NOTIFICATION FOR THE DAVOL ABSORBABLE FASTENER SYSTEM
1
F Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The Davol Absorbable Fastener System and the currently marketed Permasorb Disposable Fixation Device are both indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
In addition, both products are similar in technological characteristics and performance. Both devices have the same basic components including a handle and shaft designed to deliver a fastener. Both devices use similar fixation technology to deliver the fasteners by compressing a trigger. The fasteners are manufactured from the same polymer material, poly (D, L) lactide.
The proposed device and the predicate device differ in the details of the device design. The proposed device has a gun shaped handle and fasteners that are screw-like while the predicate device has a T-shaped handle and fasteners that are tack-like.
Performance Data G.
Biocompatibility testing on the Davol Absorbable Fastener System fastener has been completed. The biocompatibility test results show that the material used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use.
The Davol Absorbable fasteners were tested in vitro in a hernia repair model and in vivo in an animal model to confirm the mechanical strength of the repair over time as compared to the predicate device.
Additional in vitro laboratory tests were conducted to characterize material degradation over time.
All test results demonstrate that the material chosen, the manufacturing process, and the design utilized for the Davol Absorbable Fastemer System met the established specifications necessary for consistent performance during its intended use.
PREMARKET NOTIFICATION FOR THE DAVOL ABSORBABLE FASTENER SYSTEM
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with "DEPARTMENT OF HEALTH" at the bottom left and "USA" at the top right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Davol Inc. % C.R. Bard Inc. Ms. Stephanie Baker Senior Regulatory Affairs Associate 100 Crossing Boulevard Warwick, Rhode Island
Re: K082396
Trade/Device Name: Davol Absorbable Fastener System Regulation Number: 21 CFR 878.4750 Device Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: December 16, 2008 Received: December 17, 2008
Dear Ms. Baker:
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.
JAN - 2 2009
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.
3
Page 2 - Ms. Stephanie Baker
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 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
4
Page ① of ①
Indications for Use Statement
510(k) Number (if known):
Device Name:
Indications for Use:
782396
procedures, such as hernia repair.
Davol Absorbable Fastener System
The Davol Absorbable Fastener System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M. MELKERSON
Division of General, Restorative, and Neurological Devices
510(k) Number K082396