(22 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and bioabsorbable nature of the implant, with no mention of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The document describes a device used for tissue elevation and fixation during cosmetic procedures, not a device for treating a disease or condition.
No
Explanation: The Endotine Ribbon™ is described as an implantable device used for elevation and fixation of tissues during cosmetic procedures, which is a therapeutic function, not a diagnostic one. It does not mention any ability to detect, identify, or monitor medical conditions or diseases.
No
The device description explicitly states it consists of an insertion tool/cover and a bioabsorbable implant, 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 describes a surgical procedure for tissue elevation and fixation during cosmetic procedures. This is a direct intervention on the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The device is an implantable bioabsorbable material with fixation tines and an anchoring leash, used with an insertion tool. This is a surgical device, not a diagnostic reagent or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ENDOTINE Ribbon™ is used in vivo (inside the body) for a surgical procedure.
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 an insertion tool/cover and a bioabsorbable implant. The device implant consists of fixation tines attached to an anchoring leash. This device along with its insertion tools are supplied sterile for single use only.
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
The ENDOTINE Ribbon™ Device is safe and appropriate for the intended use due to the following:
- Its similarity to the predicate devices.
- A design pathway that included extensive cadaver modeling and evaluations which exceeded user specifications and USP Standards for absorbable surgical sutures.
- Feedback and user observation from several leading surgeons.
The ENDOTINE Ribbon™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications.
Key Metrics
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
JUN 2 3 2005
KOSI415,1/3
510(k) Premarket Notification ENDOTINE Ribbon™
11 510(k) SUMMARY
510(k) Summary 11.0
Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Ribbon™ Device. This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 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 Ruedy 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
May 31, 2005
DEVICE TRADE OR PROPRIETARY NAME
ENDOTINE Ribbon™ Device
DEVICE COMMON OR CLASSIFICATION NAME
Classification Name: Absorbable Poly (glycolide/L-lactide) Surgical Suture Regulation Number: 878.4493 Class: II Product Code: GAM
1
KOS/4/5$_{2/3}$
Coapt Systems, Inc.
510(k) Premarket Notification ENDOTINE Ribbon™
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™ | ||
| Device | Coapt Systems, Inc | K050611 |
| PDS II Suture | Ethicon, Inc. | N18331 |
| Contour Necklift Threads | Surgical Specialties | K050247 |
DEVICE DESCRIPTION
The ENDOTINE Ribbon™ consists of an insertion tool/cover and a bioabsorbable implant. The device implant consists of fixation tines attached to an anchoring leash. This device along with its insertion tools are supplied sterile for single use only.
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 EQUIVLANCE COMPARISON
1. Indications Summary
The "Indication Statement" for the ENDOTINE Ribbon™ is substantiated by the results of the performance evaluations and comparison testing to the predicate devices. The intended use statement for the ENDOTINE Ribbon™ is more specific than that of the PDS II Suture, but both devices are approved for use in soft tissue. In addition, the selected predicate device is routinely used in face lift procedures. The differences between the ENDOTINE Ribbon™ and the predicate devices do not affect the safety and effectiveness of the ENDOTINE Ribbon™. The Contour Necklift Thread is intended to be used in a neck lift procedure.
2. Technological Characteristics Summary
The ENDOTINE Ribbon™ is substantially equivalent in design, materials and fundamental scientific technology to the ENDOTINE Ribbon™. Further, the technological characteristics of the ENDOTINE Ribbon™ are similar to many absorbable, implantable general, orthopedic and plastic surgery devices legally distributed by other manufacturers. Any differences between the ENDOTINE Ribbon™ and the predicate devices are minor and do not raise issues regarding safety or effectiveness.
2
3. Performance Summary
The ENDOTINE Ribbon™ Device is safe and appropriate for the intended use due to the following:
- Its similarity to the predicate devices. .
- A design pathway that included extensive cadaver modeling and evaluations . which exceeded user specifications and USP Standards for absorbable surgical sutures.
- Feedback and user observation from several leading surgeons. .
The ENDOTINE Ribbon™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications.
SUBSTANTIAL EQUIVALENCE CONCLUSION
Based on the design, materials, function, intended use, and performance evaluations discussed herein, Coapt Systems believes the ENDOTINE Ribbon™ is substantially equivalent to the predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. No new issues of safety or effectiveness were raised for the ENDOTINE Ribbon™ Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.
3
Image /page/3/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three horizontal lines forming its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2005
Ms. Linda Ruedy Director, Regulatory and Clinical Affairs Coapt Systems Incorporated 1820 Embarcadero Road Palo Alto, California 94303
Re: K051415
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: May 31, 2005 Received: June 1, 2005
Dear Ms. Ruedy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) 75 the enactment date of the Medical Device Amendments, or to comments province to may 20, 1978, are excordance with the provisions of the Federal Food, Drug, devices that have boon recuire approval of a premarket approval application (PMA). and Cosmetic Act (110-) that to nevice, subject to the general controls provisions of the Act. The r our may, therefore, manner of the Act include requirements for annual registration, listing of general controls provisions or ractice, 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 your device is classified dditional controls. Existing major regulations affecting your device it may be subject to saan additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oodo cements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I Drivisation that your device complies with other requirements of the Act that I Drimas made a and regulations administered by other Federal agencies. You must or any 1 catal statutes and equirements, including, but not limited to: registration and listing (21 comply with an the 11th of 11th Part 801); good manufacturing practice requirements as set OFF in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty bytvelles (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Linda Ruedy
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will and w yourse of substantial equivalence of your device to a legally premation nouried.com "Te 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 11 you desire specific acrepliance 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 other general mionmantial 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/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K0514/5
Coapt Systems, Inc.
510(k) Premarket Notification ENDOTINE Ribbon™
STATEMENT OF INDICATIONS FOR USE 4
| 510(k) Number: | Not yet assigned |
|---|---|
| Device Name: | ENDOTINE Ribbon™ |
| 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)
Division of General Restorative
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KOSITIS