(23 days)
Not Found
No
The summary describes a bioabsorbable implant and insertion tool for tissue fixation, with no mention of AI or ML capabilities.
No
The device is described as an implant used for elevation and fixation of tissues during cosmetic procedures, which is not considered a therapeutic use. Its function is primarily structural and aesthetic rather than treating a disease or condition.
No.
The "Intended Use" section states that the device is indicated for "elevation and fixation of tissues," which describes a therapeutic or cosmetic purpose, not a diagnostic one.
No
The device description explicitly states it consists of a bioabsorbable implant and an insertion tool, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "elevation and fixation of tissues... during cosmetic procedures." This describes a surgical or procedural use on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "bioabsorbable implant pre-loaded on an insertion tool" used for "soft tissue fixation." This is consistent with a surgical implant and delivery system, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ENDOTINE Ribbon™ does not fit this description.
N/A
Intended Use / Indications for Use
The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
Product codes
GAM
Device Description
The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
temporal region, midface, lower face/jowl, neck
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
Coapt Systems, Inc.
Special 510(k) Premarket Notification ENDOTINE Ribbon™
APR 1 ° 2006
K060828/2
510(k) SUMMARY 10.0
Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Ribbon™ (Subject) . This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 8807.92 and pursuant to Section 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
Linda Ruedv Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7647 Facsimile: (650) 213-9336 Email: Iruedy@coaptsystems.com
DATE OF PREPARATION OF 510(K) SUMMARY
March 22, 2006
DEVICE TRADE OR PROPRIETARY NAME
ENDOTINE Ribbon™
DEVICE COMMON OR CLASSIFICATION NAME
Classification Name: Absorbable Surgical Suture Regulation Number: 878.4493 Class: II Product Code: GAM
1
Coapt Systems, Inc.
2060828
2/2
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 Ribbon™ | Coapt Systems, Inc | K051415 |
DEVICE DESCRIPTION
The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.
INTENDED USE STATEMENT
The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
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 ENDOTINE Ribbon™ (Subject). The Subject Device meets all internal functional performance requirements.
Based on the design, materials, fundamental technology, intended use, and performance specifications, Coapt Systems believes the proposed ENDOTINE Ribbon™ is substantially equivalent to the predicate device, the ENDOTINE Ribbon™ 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 shows a circular logo with text around the perimeter and a stylized bird in the center. The text around the perimeter appears to be "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The bird in the center is composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2006
Coapt Systems, Inc. c/o Ms. Linda Ruedy Director, Regulatory and Clinical Affairs 1820 Embarcadero Road Palo Alto, California 94303
Re: K060828
Trade/Device Name: ENDOTINE Ribbon™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: March 30. 2006 Received: March 31, 2006
Dear Ms. Ruedy:
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 cither 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
3
Page 2 - Ms. Linda Ruedy
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. 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 vours.
'Qmee
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Coapt Systems, Inc.
Special 510(k) Premarket Notification ENDOTINE Ribbon™
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Not yet assigned
ENDOTINE Ribbon™
Device Name:
Indications For Use:
The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
Prescription Use × (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)
2m00
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_KCC 65 28