(28 days)
The ENDOTINE Ribbon™ is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
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.
The provided text is a 510(k) summary for the ENDOTINE Ribbon™, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about a study proving acceptance criteria are not available in this particular document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria or specific reported device performance metrics in the way that would be found in a clinical study report. The 510(k) process for this device relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific quantitative criteria. The statement, "The Modified Device meets all internal functional performance requirements," is the closest the document comes to mentioning performance.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided 510(k) summary. The submission is a regulatory filing for market clearance based on substantial equivalence, not a report of a new clinical study with a test set of data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available in the provided 510(k) summary. Given the absence of a distinct test set and associated ground truth establishment process, this detail is not relevant to this submission.
4. Adjudication Method for the Test Set
This information is not available in the provided 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not available and is not applicable to this device. The ENDOTINE Ribbon™ is a bioabsorbable surgical implant for soft tissue fixation, not an AI-powered diagnostic or assistive tool. Therefore, a study comparing human reader performance with and without AI assistance would not be relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not available and is not applicable to this device. As mentioned, this is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
This information is not available in the provided 510(k) summary.
8. The Sample Size for the Training Set
This information is not available in the provided 510(k) summary. This device is not an AI/ML product that would require a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not available in the provided 510(k) summary. This is not an AI/ML product.
Summary of Device and Regulatory Context based on the provided text:
The ENDOTINE Ribbon™ is a bioabsorbable implant pre-loaded on an insertion tool, intended for subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
The manufacturer, Coapt Systems, Inc., sought 510(k) clearance by demonstrating substantial equivalence to their previously marketed device, the ENDOTINE Midface™ ST 4.5 Device (K032698).
The core of the submission states: "Based on the design, materials, fundamental technology, intended use, and performance specifications, Coapt Systems believes the proposed ENDOTINE Ribbon™ is substantially equivalent to the unmodified predicate device... Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale."
The FDA's letter confirms that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This means the regulatory body accepted the manufacturer's claim of equivalence, implying that the safety and effectiveness of the ENDOTINE Ribbon™ are considered comparable to a device already on the market, rather than requiring a new, independent study to establish specific acceptance criteria and performance against those criteria.
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Coapt Systems, Inc.
2002 APR 6
510(k) SUMMARY 10.0
Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Ribbon™. 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 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
March 8, 2005
DEVICE TRADE OR PROPRIETARY NAME ENDOTINE Ribbon™
DEVICE COMMON OR CLASSIFICATION NAME
Classification Name: Absorbable Surgical Suture Regulation Number: 878.4493 Class: II GAM Product Code:
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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 Midface™ST 4.5 Device | Coapt Systems, Inc | K032698 |
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 subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
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 Ribbon™. The Modified 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 unmodified predicate device, the ENDOTINE Midface™ ST 4.5 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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three horizontal lines extending from its head, representing the department's mission to protect and promote the health and well-being of Americans.
2005 APR 6
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Ruedy Director, Regulatory and Clinical Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, California 94303
Re: K050611
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 8, 2005 Received: March 10, 2005
Dear Ms. Ruedy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined 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 encroom's regions and the Medical Device Amendments, or to conimeres processified in accordance with the provisions of the Federal Food. Drug. de necs that have been require approval of a premarket approval application (PMA). and Cosmetic Act, that do movice, subject to the general controls provisions of the Act. The r our may, merere, mains of the Act include requirements for annual registration. Iisting of general controls provisions were mactice, 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 If your device is elassified (overal controls. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obac or vents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial cquivalence determination does not mean Flease of advised that I Dri 3 installed on our device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any rederal statutes and regulations sincluding, but not limited to: registration and listing (21 comply with an the Act 31equirements, n.e., good manufacturing practice requirements as set CFR Part 807), idocing (21 CFR Part 807), good manat 820); and if applicable, the clectronic (200 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Linda Ruedy
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your of substantial equivalence of your device to a legally premarket notineatem " mesults 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 If you don't specific as not any and (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 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/industry/support/index.html.
Sincerely yours,
L. Misiura, C.Petrat, Ph.D.
Miriam C. Provost, Ph.D. 42-Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kosobil Special 510(k) Premarket Notification ENDOTINE Ribbon™
STATEMENT OF INDICATIONS FOR USE
Not yet assigned 510(k) Number (if known): ENDOTINE Ribbon™ Device Name:
Indications For Use:
The ENDOTINE Ribbon™ is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
Prescription Use __
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)
5 orative
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§ 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.