(29 days)
No
The summary describes a mechanical implant and insertion tools, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty and fixation of the subdermis to the frontal bone, which are surgical procedures, not therapeutic treatments for a disease.
No
The device is described as an implant and tools used for fixation in subperiosteal browplasty, which is a surgical procedure, not a diagnostic one.
No
The device description explicitly states that the device consists of a bioabsorbable implant, an insertion tool, and a stainless steel drill bit, which are all hardware components.
Based on the provided information, the ENDOTINE TransBleph™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "subperiosteal browplasty" and "to fixate the subdermis to the frontal bone." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device consists of an implant, insertion tool, and drill bit. These are tools and materials used in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The ENDOTINE TransBleph™ does not perform this function.
Therefore, the ENDOTINE TransBleph™ is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty surgery. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the cranial bone in browplasty.
Product codes
HWC
Device Description
The ENDOTINE TransBleph™ 3.0/3.5 Device consists of a bioabsorbable implant, an insertion tool, and stainless steel drill bit. The device implant is a soft tissue fixation platform that is anchored in the cranial bone. The insertion tool and the drill bit are sterilized together with the implant device in a plastic tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bone, brow, frontal bone
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)
K040740, K014153, K023992, K033524
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
10.0 510(k) SUMMARY NOV - 5 2004
Coapt Systems is providing a summary of the safety and effectiveness information Coapt Systems is proPriams a canesBleph™ 3.0/3.5 Device. This 510(k) summary of available for the LADO FINE Frances is submitted in accordance with the requirements of salery and encest vehicless mission 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990.
SPONSOR/APPLICANT NAME AND ADDRESS
Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7600 Facsimile: (650) 213-9336
CONTACT INFORMATION
Bankim Mehta Vice President, Operations, QA and RA Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7640 Facsimile: (650) 213-9336 Email: bmehta@coaptsystems.com
DATE OF PREPARATION OF 510(K) SUMMARY
October 8, 2004
DEVICE TRADE OR PROPRIETARY NAME
ENDOTINE TransBleph™ 3.0/3.5 Device
DEVICE COMMON OR CLASSIFICATION NAME
Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 888.3040 II Class: HWC Product Code:
1
IDENTIFICATION OF THE LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS BEING CLAIMED
| Name of Predicate
Device | Name of Manufacturer | 510(k) or
PMA
Number |
|--------------------------------|----------------------|----------------------------|
| ENDOTINE
TransBleph™ Device | Coapt Systems, Inc | K040740 |
| ENDOTINE Forehead™
Devices | Coapt Systems, Inc. | K014153
K023992 |
| ENDOTINE Chin™
Devices | Coapt Systems, Inc. | K033524 |
DEVICE DESCRIPTION
The ENDOTINE TransBleph™ 3.0/3.5 Device consists of a bioabsorbable implant, an insertion tool, and stainless steel drill bit. The device implant is a soft tissue fixation platform that is anchored in the cranial bone. The insertion tool and the drill bit are sterilized together with the implant device in a plastic tray.
INTENDED USE STATEMENT
The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty surgery. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the cranial bone in browplasty.
SUBSTANTIAL EQUIVALENCE
In review of the device description, predicate comparison and design control activities incorporated in this submission, no significant new issues of safety or effectiveness have been raised for the Modified TransBleph™ 3.0/3.5 Device. The Modified Device meets all internal functional performance requirements.
Based on the design, materials, fundamental technology, intended use, and performance evaluations, Coapt Systems believes the proposed ENDOTINE TransBleph™ 3.0/3.5 Device is substantially equivalent to the unmodified predicate device, the ENDOTINE TransBleph™ Device, currently marketed under the Federal Food, Drug and Cosmetic Act. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2004
Mr. Bankim Mahta Vice President, Operations, QA and RA Coapt Systems, Inc. 1820 Embarcadero Road Palo Atlo, California 94566
Re: K042796
Trade/Device Name: ENDOTINE TransBleph™ 3.0/3.5 Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: October 6, 2004 Received: October 7, 2004
Dear Mr. Mahta:
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 (OS) 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 - Mr. Bankim Mahta
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 (240) 276-0115. 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,
Miriam 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
4
Coapt Systems, Inc.
Image /page/4/Picture/1 description: The image shows the text "Special 510(k) Premarket Notification ENDOTINE TransBleph™ 3.0/3.5". Above the text is a handwritten number, K042796. The text appears to be part of a document or label, possibly related to medical devices or regulatory submissions. The "510(k)" likely refers to a premarket submission to the U.S. Food and Drug Administration (FDA).
STATEMENT OF INDICATIONS FOR USE
| 510(k) Number (if known): | Not yet assigned |
|---|---|
| Device Name: | ENDOTINE TransBleph™ 3.0/3.5 Device |
| Indications For Use: | The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the frontal bone. |
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Meriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of _ |
510(k) Number K042776