(41 days)
Not Found
No
The summary describes a physical implant and surgical tools, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used to fixate the subdermis to the mentum in chinplasty surgery, which is a medical treatment.
No
The device is described as an implant used in surgery (subperiosteal chinplasty surgery) to fixate the subdermis to the mentum. Its purpose is interventional, not diagnostic.
No
The device description explicitly states the device kit consists of a chin implant, insertion tool, and drill bit, which are physical 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 chinplasty surgery" and "to fixate the subdermis to the mentum in chinplasty." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "implant with insertion tool and a drill bit." This is a surgical implant and associated tools, not something used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The ENDOTINE Chin TM 3.5 is intended for use in subperiosteal chinplasty surgery. The ENDOTINE Chin TM 3.5 is specifically indicated for use to fixate the subdermis to the mentum in chinplasty.
Product codes (comma separated list FDA assigned to the subject device)
HWC, GAM
Device Description
The ENDOTINE Chin™ 3.5 Device kit consists of the chin implant with insertion tool and a drill bit. The Chin device along with its insertion tool and drill bit 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
chin / mentum
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)
Design performance studies that included cadaveric modeling and evaluation, and strength testing results that exceeded specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K033524
p/3
DEC 1 8 2003 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 Chin™ 3.5 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 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
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
November 6, 2003
DEVICE TRADE OR PROPRIETARY NAME
ENDOTINE Chin™ 3.5 Device
DEVICE COMMON OR CLASSIFICATION NAME
Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 888.3040 Class: II Product Code: HWC
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Koza 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 | K014153/K023992 |
| Lactosorb® Panels | Walter Lorenz Surgical | K974309 |
DEVICE DESCRIPTION
The ENDOTINE Chin™ 3.5 Device kit consists of the chin implant with insertion tool and a drill bit. The Chin device along with its insertion tool and drill bit are supplied sterile for single use only.
INTENDED USE STATEMENT
The ENDOTINE Chin™ 3.5 is intended for use in subperiosteal chinplasty surgery. The ENDOTINE Chin™ 3.5 is specifically indicated for use to fixate the subdermis to the mentum in chinplasty.
SUBSTANTIAL EQUIVLANCE COMPARISON
1. Indications Summary
The ENDOTINE Forehead™ Device intended use statement is nearly identical to the the new ENDOTINE Chin Device intended use. Both ENDOTINE devices (Forehead and Chin) are intended to elevate and fixate soft tissue in facial surgeries. Moreover, the anchoring methods are very similar for both devices, applying a pulling force to the skeletal system for support. Both devices are intended for soft tissue suspension using the patented multi-point technology developed by Coapt Systems.
The different anatomical sites for use between the ENDOTINE Chin™ 3.5 and ENDOTINE Forehead™ Device do not suggest new issues of safety and effectiveness when used in the chin region that could affect the substantial equivalence determination.
2. Technological Characteristics Summary
The ENDOTINE Chin™ 3.5 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 Chin 3.5 are similar to many absorbable, implantable general, orthopedic and plastic surgery devices legally distributed by device manufacturers. Any differences between the ENDOTINE Chin™ 3.5 and the predicate devices are minor and do not raise new issues regarding safety or effectiveness. This statement is substantiated by the clinical history to
2
date for the ENDOTINE Forehead Device and an established safety profile of the device material in both the forehead and chin regions.
3. Performance Summary
The ENDOTINE Chin™ 3.5 Device is safe and appropriate for the intended use due to the following:
- Its similarity to the predicate device, the ENDOTINE Forehead Device. .
- Design performance studies that included cadaveric modeling and evaluation, and . strength testing results that exceeded specifications.
- Feedback and user observation from several leading surgeons. .
The ENDOTINE Chin™ 3.5 performance data meet the applicable standards and fulfill the device requirements as defined in the design specifications.
An appropriate and complete testing program supports the ENDOTINE Chin™ 3.5 is suitable to perform and operate as clinically intended.
SUBSTANTIAL EQUIVALENCE CONCLUSION
Based on the design, materials, function, intended use, and performance evaluations discussed hercin, Coapt Systems believes the ENDOTINE Chin™ 3.5 Device is substantially equivalent to the selected predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. No new issues of safety or effectiveness were raised for the ENDOTINE Chin™ 3.5 Device. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2003
Ms. Lori DonDiego Director, Regulatory Affairs Coapt Systems, Inc. 1820 Embarcadero Road Palo Alto, California 94303
Re: K033524 Trade/Device Name: ENDOTINE Chin™ 3.5 Regulation Number: 21 CFR 888.3040; 21 CFR 878.4493 Regulation Name: Smooth or threaded metallic bone fixation fastener; Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: HWC, GAM Dated: November 6, 2003 Received: November 7, 2003
Dear Ms. DonDiego:
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 either 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 (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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,
Miriam C. Provost
for Celia 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
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STATEMENT OF INDICATIONS FOR USE 4
| 510(k) Number: | K033524 |
|---|---|
| Device Name: | ENDOTINE Chin TM 3.5 Device |
| Indications for Use: | The ENDOTINE Chin TM 3.5 is intended for use in subperiosteal chinplasty surgery. The ENDOTINE Chin TM 3.5 is specifically indicated for use to fixate the subdermis to the mentum in chinplasty. |
Prescription Use X ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
K 033524
3(k) Number