(21 days)
No
The description focuses on a mechanical fixation device and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is used for fixation of prosthetic material, not for treating or diagnosing a condition.
No
Explanation: The device is intended for "fixation of prosthetic material to soft tissue," which is a surgical procedure, not a diagnostic one. It does not gather information about the patient's health status.
No
The device description clearly states it is a physical device ("sterile single use devices for the fixation of prosthetic material") constructed of a physical material ("absorbable synthetic polyester copolymer"). It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "sterile single use device for the fixation of prosthetic material such as hernia mesh to soft tissue." This further reinforces its use in a surgical setting for physical fixation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The description clearly indicates a surgical device used for physical fixation within the body, not a diagnostic tool used on in vitro samples.
N/A
Intended Use / Indications for Use
Absorbatack™ Absorbable Fixation Devices are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures such as hernia repair.
The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.
Product codes
GDW
Device Description
Absorbatack™ Absorbable Fixation Devices are sterile single use devices for the fixation of prosthetic material such as hernia mesh to soft tissue. The Tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The device is offered with of 5, 10 or 20 tacks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified labeling for the subject device is based on performance testing obtained for the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
ട്. 510(k) SUMMARY:
510(K) Summary of Safety and Effectiveness:
SUBMITTER:
CONTACT PERSON:
DATE PREPARED:
TRADE/PROPRIETARY NAME:
COMMON/USUAL NAME:
CLASSIFICATION NAME:
PREDICATE DEVICE(S):
DEVICE DESCRIPTION:
Note: There are no modifications
to the previously cleared devices.)
Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473
JUL 1 6 2009
1881
Rebecca Ronner Associate, Regulatory Affairs Phone: (203) 492-5346 Fax: (203) 492-5029
June 24, 2009
Absorbatack™ Absorbable Fixation Device
Absorbable Tack and Applicator
Implantable Staple
K071920 - Absorbatack™ Absorbable Fixation Device
Absorbatack™ Absorbable Fixation Devices are sterile single use devices for the fixation of prosthetic material such as hernia mesh to soft tissue. The Tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The device is offered with of 5, 10 or 20 tacks.
Absorbatack™ Absorbable Fixation Devices are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures such as hernia repair.
Absorbatack™ Absorbable Fixation Device is identical to the predicate device.
Absorbatack™ Absorbable Fixation Devices is comprised of materials which have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices - Part I Evaluation and Testing and is identical to the predicate device
There has been no change to the Absorbatack ™ Absorbable Fixation Device. The modified labeling for the subject device is based on performance testing obtained for the predicate device.
INTENDED USE:
TECHNOLOGICAL CHARACTERISTICS:
MATERIALS: CHARACTERISTICS:
PERFORMANCE DATA: CHARACTERISTICS:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus symbol, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the logo. The caduceus symbol is depicted with three intertwined snakes and a staff.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2009
Covidien LP % Ms. Rebecca Ronner 60 Middletown Avenue North Haven. Connecticut 06473
Re: K091900
Trade/Device Name: Absorbatack™ Absorbable Fixation Device Regulation Number: 21 CFR 878:4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 24, 2009 Received: June 25, 2009
Dear Ms. Ronner:
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 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); 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.
2
Page 2 - Ms. Rebecca Ronner
If 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/ucm115809.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.fda.gov/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Poe Dhlson
Mark N. Melen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
4. INDICATIONS FOR USE STATEMENT:
510(k) Number (if known): K091900
Device Names:
Indications For Use
Absorbatack™ Absorbable Fixation Device
The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair
Prescription Use (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)
Daind Krome for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number KD91900
Page 1 of