(49 days)
The ENDOTINE TransBlephTM Device is intended for use in subperiosteal browplasty fixation. The ENDOTINE TransBlephTM is specifically indicated for use to fixate the sub-dermis to the frontal bone.
The ENDOTINE TransBleph™ Device kit consists of the brow implant with inscrtion tool and a drill bit. The TransBleph device along with its insertion tool and drill bit are supplied sterile for single use only.
The provided 510(k) summary for the ENDOTINE TransBleph™ Device does not contain the typical information associated with studies that establish acceptance criteria and prove a device meets them through clinical or performance evaluations in the way a diagnostic algorithm or a complex interventional device would.
This document describes a fastener (an implantable device) and focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, intended use, and performance evaluations. The "performance summary" refers primarily to mechanical testing and anecdotal feedback rather than a formal clinical study with quantifiable acceptance criteria.
Here's an analysis of the provided text in relation to your request, highlighting what's missing and what can be inferred:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided document in the format of specific, measurable acceptance criteria with corresponding performance results.
The "Performance Summary" section (K04 0748, page 3) states:
- "Design performance studies that included cadaveric evaluation, and strength and compression testing results that exceeded specifications."
- "Feedback and user observation from several leading surgeons."
- "The ENDOTINE TransBleph™ performance data meet the applicable standards and fulfill the device requirements as defined in the design specifications."
While it mentions "exceeded specifications" and "meet applicable standards and fulfill device requirements," the specific numerical specifications, acceptance criteria, and the exact results are not detailed. For example, it doesn't state "tensile strength X N, acceptance criteria > Y N, device achieved Z N."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document mentions "cadaveric evaluation" and "feedback and user observation from several leading surgeons." This suggests a small, unspecified number of cadavers and surgeons were involved.
- Data Provenance: Not specified. "Cadaveric evaluation" implies laboratory-based testing, not human clinical trial data. The "feedback and user observation" would likely be from surgeons practicing where the company operates or sponsored evaluations, but no country or specific setting is mentioned.
- Retrospective/Prospective: Not applicable in a formal sense, as no clinical trial is described. Mechanical testing of cadavers would be a prospective experiment. Surgeon feedback would be descriptive observation, not a structured clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This concept of "ground truth" as it applies to diagnostic algorithms or complex outcome measures is not relevant or described for this type of device submission. The device is a bone fixation fastener. The "experts" mentioned are "several leading surgeons" who provided "feedback and user observation." Their number and specific qualifications beyond being "leading surgeons" are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not mentioned. There was no formal adjudication process described, as there was no study producing ambiguous results requiring expert consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for diagnostic AI devices, not for a bone fixation fastener.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As noted in point 3, the concept of "ground truth" in the context of diagnostic performance is not applicable. The "ground truth" for this device's performance would be its mechanical integrity (strength, compression) and its ability to achieve its intended surgical function (fixate subdermis to frontal bone) in a cadaveric setting. This is evaluated by mechanical testing results "exceeding specifications" and "user observation," not through pathology or outcomes data from a clinical trial.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of developing this physical medical device. The device design is based on engineering principles, materials science, and presumably iterative design and testing.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study (as described in the 510(k)) and its Basis for Clearance:
The clearance for the ENDOTINE TransBleph™ Device was based on the following, rather than a formal clinical study with detailed acceptance criteria:
- Substantial Equivalence: The primary strategy was to demonstrate that the device is substantially equivalent in design, materials, function, and intended use to already legally marketed predicate devices (ENDOTINE Forehead™, Lactosorb® Panels, ENDOTINE Chin™ 3.5 Device).
- Performance Testing (Non-Clinical):
- Cadaveric evaluation: This involved testing the device's function in cadaver models. Although details are scant, this would assess its ability to be implanted and secure tissue as intended.
- Strength and compression testing: Mechanical tests to ensure the device can withstand the forces it will encounter in vivo. The document states these "exceeded specifications," implying internal design requirements were met.
- User Observation/Feedback: Input from "several leading surgeons" regarding their experience or observations.
- Material Safety: Reliance on the established safety profile of the device materials (likely the bioabsorbable material used in the predicate devices) in both the forehead and other craniofacial sites.
Conclusion:
The provided 510(k) summary does not describe a clinical study in the format typically used for diagnostic or more complex interventional devices, where quantitative acceptance criteria and detailed study designs (sample sizes, ground truth establishment, expert adjudication, MRMC studies) are paramount. Instead, the clearance was sought through a demonstration of substantial equivalence supported by non-clinical performance testing (mechanical and cadaveric) and anecdotal expert feedback. The acceptance criteria were implied to be the fulfillment of "design specifications" and "applicable standards" regarding mechanical performance, rather than clinical efficacy metrics.
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MAY 1 0 2004 11 510(k) SUMMARY
K040740
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11.0 510(k) Summary
Coapt Systems is providing a summary of the safety and effectiveness information available for the ENDOTINE TransBleph™ 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 Telephonc: (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 Fmail: Idondiego@@coaptsystems.com
DATE OF PREPARATION OF 510(K) SUMMARY March 15, 2003
DEVICE TRADE OR PROPRIETARY NAME
ENDOTINE TransBleph™ Device
DEVICE COMMON OR CLASSIFICATION NAME
Classification Name: Smooth or threaded metallic bone fixation fastencr Regulation Number: 888.3040 Class: II Product Code: HWC
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Coapt Systems, Inc.
Ki04 o 748
IDENTIFICATION OF THE LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS BEING CLAIMED
z/j
| Name of Predicate Device | Name of Manufacturer | 510(k) or PMANumber |
|---|---|---|
| ENDOTINE Forehead™Device | Coapt Systems, Inc. | K014153/K023992 |
| Lactosorb® Panels | Walter Lorenz Surgical | K974309 |
| ENDOTINE Chin™ 3.5Device | Coapt Systems, Inc. | K033524 |
DEVICE DESCRIPTION
The ENDOTINE TransBleph™ Device kit consists of the brow implant with inscrtion tool and a drill bit. The TransBleph device along with its insertion tool and drill bit are supplied sterile for single use only.
INTENDED USE STATEMENT
The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty surgery. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the frontal bone.
SUBSTANTIAL EQUIVLANCE COMPARISON
1. Indications Summary
The ENDOTINE Forehead™ Device intended use statement is nearly identical to the new ENDOTINE TransBleph Device intended use. Both ENDOTINE devices (Forehead and TransBleph) are intended to elevate and fixate soft tissue in facial browlift 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 similar anatomical sites for use between the ENDOTINE TtransBleph™ and ENDOTINE Forchead™ Device suggest no new issues of safety and effectiveness that could affect the substantial equivalence determination.
2. Technological Characteristics Summary
The ENDOTINE TRansBleph™ is substantially cquivalent in design, materials and fundamental scientific technology to the ENDOTINE Forehead, Lactosorto Panel and ENDOTINE Chin predicate devices. The technological characteristics of the F.NDOTINE TransBleph are similar to many absorbable, implantable general, orthopedic
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Coapt Systems, Inc.
K04 0748
and plastic surgery devices legally distributed by device manufacturers. Any differences between the ENDOTINE TransBleph™ and the predicate devices are inconsequential and do not raise new issues regarding safety or effectiveness. This statement is substantiated by the mechanical performance data for TransBleph. clinical history to date for the ENDOTINE Forchead/Chin Device and an established safety profile of the device material in both the forehead and other craniofacial sites.
3. Performance Summary
The ENDOTINE TransBleph™ 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 evaluation, and strength and . compression testing results that exceeded specifications,
- . Feedback and user observation from several leading surgeons.
The ENDOTINE TransBleph™ 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 TransBleebh™ is suitable to perform and operate as clinically intended.
SUBSTANTIAL EQUIVALENCE CONCLUSION
Based on the design, materials, function, intended use, and performance evaluations discussed herein, Coapt Systems believes the ENDOTINE TransBleph™ 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 TransBleph™ 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 & 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 symbol featuring three horizontal bars that curve downwards, resembling a human form. The logo is rendered in black and white.
MAY 1 0 2004
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
Rc: K040740
Trade/Device Name: ENDOTINE TransBleph™ Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 19, 2004 Received: March 22, 2004
Dear Ms. DonDiego:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your so 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). and Ocometie for ( 10) 2017 - 10:10 pm ( 10 the general controls provisions of the Act. The r ou mays atores provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practicc, 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 complies 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.
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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 premits to modicate 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
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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Coapt Systems, Inc.
STATEMENT OF INDICATIONS FOR USE 4
| 510(k) Number: | K 040746 (not yet assigned) |
|---|---|
| Device Name: | ENDOTINE TransBlephTM Device |
| Indications for Use: | The ENDOTINE TransBlephTM Device is intended for usein subperiosteal browplasty fixation. The ENDOTINETransBlephTM is specifically indicated for use to fixate thesub-dermis to the frontal bone. |
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)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.