(109 days)
Incisive Surgical, INSORB® Absorbable Staple, Ethicon Inc., Vicryl® Suture
Not Found
No
The summary describes a manual surgical stapler and resorbable staples, with no mention of AI or ML capabilities.
No.
The device is described as a surgical stapler that delivers implantable septal staples to connect internal tissues and aid healing, which is a surgical tool rather than a therapeutic device in itself.
No
The device, a septal stapler, is used to connect tissues for healing and approximation during surgery. It does not identify or detect medical conditions.
No
The device description clearly states it consists of resorbable fixation devices delivered via a manual surgical stapler delivery system, indicating a physical hardware component.
Based on the provided information, the ENTact™ Septal Stapler is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- ENTact™ Function: The ENTact™ Septal Stapler is a surgical device used during surgery to physically connect tissues within the nasal septum. It is an implantable device used in vivo (within the body) to aid healing and tissue approximation.
The description clearly indicates a surgical tool for internal tissue repair, not a device for testing biological samples.
N/A
Intended Use / Indications for Use
The ENTact™ Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.
Product codes
OLL
Device Description
The ENTact™ Septal Stapler consists of resorbable fixation devices, which are delivered via an manual surgical stapler delivery system. The ENTact™ implantable septal staples, composed of an absorbable copolymer, may be used during nasal surgery to approximate the mucoperichondrial flaps of the nasal septum and at the completion of surgery. The staples are provided preloaded in a single-use, disposable stapler.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal septum
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Incisive Surgical, INSORB® Absorbable Staple, Ethicon Inc., Vicryl® Suture
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
JAN - 6 2009
510(k) Number K082750
510(k) SUMMARY
Trade Name:
Sponsor:
ENTact™ Septal Stapler
ENTrigue Surgical, Inc. 12672 Silicon Drive, Suite 150 San Antonio, Texas 78249 Telephone: (210) 298-6336 Fax: (210) 298-6399 Contact Person: Gabriele G. Niederauer, Ph.D.
Date Prepared:
January 5, 2009
Product Code and Device Classification Name:
Classification:
Predicate Devices:
Device Description:
Indications for Use:
OLL
Implantable Staple (21 C.F.R. § 878.4750)
Class II
Incisive Surgical, INSORB® Absorbable Staple Ethicon Inc., Vicry|® Suture
The ENTact™ Septal Stapler consists of resorbable fixation devices, which are delivered via an manual surgical stapler delivery system. The ENTact™ implantable septal staples, composed of an absorbable copolymer, may be used during nasal surgery to approximate the mucoperichondrial flaps of the nasal septum and at the completion of surgery. The staples are provided preloaded in a single-use, disposable stapler.
The ENTact™ Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ENTrigue Surgical, Inc. c/o Gabriele G. Niederauer, Ph.D. Vice-President, Research & Development 12672 Silicon Drive, Suite 150 San Antonio, TX 78249
Re: K082750
Trade/Device Name: ENTact Septal Stapler System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: OLL Dated: December 19, 2008 Received: December 22, 2008
Dear Dr. Niederauer:
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 I ou may ontrols provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
JAN - 6 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 or mry 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.
2
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,
M. B. Egerlins, m.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
1082750
Indications for Use Statement
510(k) Number (if known): KOOQ750
Device Name: ENTact™ Septal Stapler
Indications for Use:
The ENTact™ Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.
Prescription Use 区
AND/OR
Over-The-Counter Use O
(Part 21 C.F.R. 801 Subpart D)
(21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Cennon
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number KD82750
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