(51 days)
Not Found
No
The 510(k) summary describes a mechanical, bioabsorbable implant and insertion tools for surgical fixation. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on similarity to predicate devices, cadaver modeling, and surgeon feedback, not algorithmic performance.
Yes
The device is used for subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position, addressing a physiological or anatomical condition.
No
The device is described as an implant used for midface suspension surgery to fixate the cheek subdermis, indicating a therapeutic or surgical purpose rather than a diagnostic one.
No
The device description explicitly states that the device consists of "insertion tools and bioabsorbable implants," which are physical hardware components, not software.
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 is 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 consists of "insertion tools and bioabsorbable implants" used for surgical fixation. This aligns with a surgical device, not a diagnostic test.
- 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. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The ENDOTINE Midface™-ST 4.5 is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
Product codes
GAM, IIWC
Device Description
The ENDOTINE Midface™-ST 4.5 consists of insertion tools and bioabsorbable implants. The device implant consist of two components: (1) a fixation platform attached to an anchoring leash, and (2) an anchoring tack. This device along with its institution 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
midface, cheek subdermis, bone and tissue (of the 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
The ENDOTINE Midface-ST 4.5 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 Midface™-ST 4.5 performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications.
Key Metrics
Not Found
Predicate Device(s)
K023992/K014153, N18331, K974309
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
10/23/03
Image /page/0/Picture/1 description: The image shows a logo for "Coapt". The logo consists of a stylized graphic above the word "Coapt". The graphic features a series of curved lines that intersect in the center, creating a symmetrical design. The word "Coapt" is written in a simple, sans-serif font.
11 510(k) SUMMARY
11.0 510(k) Summary
Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE Midface™-ST 4.5 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 Mirchelles of 21
- 81000 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
Lori DonDiego Director, Regulatory Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, CA Telephone: (650) 461-7647 Facsimile: (650) 213-9336 Email: Idondiego@coaptsystems.com
DATE OF PREPARATION OF 510(K) SUMMARY
August 29, 2003
DEVICE TRADE OR PROPRIETARY NAME
ENDOTINE Midface™-ST 4.5 Device
DEVICE COMMON OR CLASSIFICATION NAME
Classification Name: Absorbable Poly (glycolide/L-lactide) Surgical Suture Regulation Number: 878.4493 Class: П Product Code: GAM
- 0 3 3
Coapt Systems, Inc.
1820 Embarcadero Boad Palo Alto, CA 94303
650.331.7670 Mair 650.213.9377 Fax
82
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 Forehead™ | ||
| Device | Coapt Systems, Inc | K023992/K014153 |
| PDS II Suture | Ethicon, Inc. | N18331 |
| Lactosorb® Panels | Walter Lorenz Surgical | K974309 |
DEVICE DESCRIPTION
The ENDOTINE Midface™-ST 4.5 consists of insertion tools and bioabsorbable implants. The device implant consist of two components: (1) a fixation platform attached to an anchoring leash, and (2) an anchoring tack. This device along with its institution tools are supplied sterile for single use only.
INTENDED USE STATEMENT
The ENDOTINE Midface™-ST 4.5 is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
SUBSTANTIAL EQUIVLANCE COMPARISON
1. Indications Summary
The "Indication Statement" for the ENDOTINE Midface™-ST 4.5 is substantiated by the results of the performance evaluations and comparison testing to the PDS II Suture predicate device. The intended use statement for the ENDOTINE Midface™ ST 4.5 is more specific than that of the predicate device, but both devices are approved for use in soft tissue. In addition, the selected predicate device is routinely used in the midface lift procedure. The differences between the ENDOTINE Midface™-ST 4.5 and the predicate device do not affect the safety and effectiveness of the ENDOTINE Midface™S Sp 4.5. An appropriate and complete testing program supports the ENDOTINE Midface™ ST 4.5 is suitable to perform and operate as clinically intended.
2. Technological Characteristics Summary
The ENDOTINE Midface™ ST 4.5 is substantially equivalent in design, materials and fundamental scientific technology to the ENDOTINE Forehead and Lactosorb Panel predicate devices. Further, the technological characteristics of the ENDOTINE Midface-ST 4.5 are similar to many absorbable, implantable general, orthopedic and plastic surgery devices legally distributed by other manufacturers. Any differences between the ENDOTINE Midface™-ST 4.5 and the predicate devices are minor and do not raise issues regarding safety or effectiveness. This statement is substantiated by a history of
... 659
83
2
clinical use with the ENDOTINE Forehead device, and an established safety profile of the device material in the midface (bone and tissue).
3. Performance Summary
The ENDOTINE Midface-ST 4.5 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 Midface™-ST 4.5 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 Sysems believes the ENDOTINE Midface™-ST 4.5 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 Midface™-ST 4.5 Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.
. 6 6 () 84
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
OCT 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lori DonDiego Director, Regulatory Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, California 94303
Re: K032698
Trade/Device Name: ENDOTINE Midface™-ST 4.5 Regulation Number: 21 CFR 878.4493, 888.3040 Regulation Name: Absorbable suture, Bone fixation screw Regulatory Class: II Product Code: GAM, IIWC Dated: August 29, 2003 Received: September 2, 2003
Dear Ms. DonDicgo:
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. 17rug. 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 complics 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 (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.
4
Page 2 - Ms. Lori DonDiego ・
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 (301) 594-4659. 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.
Sincerely yours,
/ Mark N. Mulhern
Cclia 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
5
Coapi Systems, Inc.
510(k) Premarket Notification ENDOTINE Midface™SST 4.5
STATEMENT OF INDICATIONS FOR USE 4
| 510(k) Number: | Not yet assigned |
|---|---|
| Device Name: | ENDOTINE Midface TM-ST 4.5 |
| Indications for Use: | The ENDOTINE MidfaceTM-ST 4.5 is indicated for use in |
| subperiosteal midface suspension surgery to fixate the | |
| cheek subdermis in an elevated position. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
or
Over-the-Counter
Per 21 CFR 801.109
Optional Format 1-2-96
ivision Sign-Off) Division of General. Restorative and Neurological Devices
510(k) Number K032698
3 . . UZZ