(28 days)
Not Found
No
The summary describes a physical implant and insertion tool for surgical fixation, with no mention of software, data processing, or AI/ML terms.
Yes
The device is used in surgery to fixate the cheek subdermis in an elevated position, which is a therapeutic intervention.
No
The device is described as a "soft tissue fixation platform" for use in surgery to elevate the cheek subdermis, which is a therapeutic rather than a diagnostic function.
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 is for "subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is an "implant pre-loaded on an insertion tool" used for "soft tissue fixation." This is a surgical implant and delivery system, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the ENDOTINE Ribbon™ is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ENDOTINE Ribbon™ is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
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
midface
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
Not Found
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
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:
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 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.
2
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.
3
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
4
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)
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