(87 days)
The Endotine Device is intended for use in browplasty surgery. The Endotine device is specifically intended for use to fixate the sub-dermis to the cranial bone in browplasty procedures.
The Endotine Device is a device fabricated from L-PLA that is intended for use in browplasty procedures. The device is molded with a post that is inserted directly into the cranial bone. A series of barbs along its face provides a feature that allows for the direct fixation the sub-dermis without the use of suture. The device is inserted into the bone with the use of an installation instrument. Additional instruments include a stepped drill and sterilization tray.
Here's an analysis of the provided text regarding the Endotine Device's acceptance criteria and studies:
The provided document is a 510(k) summary for the Coapt Systems Endotine Device, seeking substantial equivalence to a predicate device. It focuses on the device's design, intended use, and a high-level overview of performance data. This type of document typically does not contain detailed acceptance criteria or extensive study results as would be found in a full study report or clinical trial.
Based on the provided text, the following information can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for shear strength or adequacy. Instead, it relies on a comparison to the predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Bench Testing: Comparison of shear strength in-vitro to predicate device | Demonstrated "Comparison of the shear strength of the Endotine Device In-Vitro compared to the predicate device." Implies the Endotine Device met or exceeded the predicate's shear strength, or was found to be comparable. |
| Animal Testing: Adequacy for intended use | "The testing demonstrated the acceptability of the Endotine Device and confirmed that the device functions adequately to meet its intended use." |
| Tissue Interface: Comparison of device-to-tissue interface to predicate device | "Comparison of the device to tissue interface of the Endotine Device to the predicate device." Implies comparability or acceptable performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for the bench testing or animal testing.
- Data Provenance: Not explicitly stated, but "In-Vitro" implies laboratory testing, and "Animal Testing" refers to an animal model. The country of origin for the data is not mentioned. The nature of these tests (bench, animal) suggests they were prospective studies designed to evaluate the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is generally not applicable to bench or animal testing in the context of device performance directly related to mechanical properties or biological response in an animal model. Ground truth for these tests would be established through scientific measurements and observations, not expert consensus on human data.
4. Adjudication Method for the Test Set
Not applicable for bench or animal testing of mechanical properties and biological response.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done, nor would it be relevant for this type of device and the performance data presented. MRMC studies are typically used for diagnostic devices involving human interpretation of images or other data.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is a bioabsorbable fixation device, not an algorithm or AI system.
7. Type of Ground Truth Used
- Bench Testing: The ground truth would be precise engineering measurements of shear strength under defined conditions.
- Animal Testing: The ground truth would be a combination of direct observation of device function, histological analysis of tissue response, and possibly mechanical testing of the fixation in the animal model.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." The materials and design are established through engineering principles.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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AR 1 5 2002
510(K) SUMMARY
1. SUBMITTER:
Coapt Systems, Inc 261 Hamilton Avenue Suite 413 Palo Alto, CA 94301 Telephone: 650-289-1010
Contact: Jude Paganelli, Vice President Operations Date Prepared: December 10, 2001
2. DEVICE:
Endotine Device Classification Name: Bioabsorbable Fixation Device Trade Name: Coapt Systems Endotine Device
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Endotine Device was the Bionx Endobrow Screw marketed by Bionx Implants, Blue Bell, PA
4. DEVICE DESCRIPTION:
The Endotine Device is a device fabricated from L-PLA that is intended for use in browplasty procedures. The device is molded with a post that is inserted directly into the cranial bone. A series of barbs along its face provides a feature that allows for the direct fixation the sub-dermis without the use of suture. The device is inserted into the bone with the use of an installation instrument. Additional instruments include a stepped drill and sterilization tray.
5. INTENDED USE:
The Endotine Device is intended for use in browplasty surgery. The Endotine device is specifically intended for use to fixate the sub-dermis to the cranial bone in browplasty procedures.
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6. COMPARISON OF CHARACTERISTICS:
The Endotine Device is fabricated from L-PLA, while the Bionx Endobrow Screw is fabricated from L/DL-PLA. The Endotine device design provides direct fixation to the sub-dermis. The Bionx Endobrow Screw provides fixation to the device through the use of suture that is affixed to the sub-dermis.
The indications for use of the two devices are identical.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
-
- Bench Testing: Comparison of the shear strength of the Endotine Device In-Vitro compared to the predicate device.
-
- Animal Testing: The testing demonstrated the acceptability of the Endotine Device and confirmed that the device functions adequately to meet its intended use.
-
- Tissue Interface: Comparison of the device to tissue interface of the Endotine Device to the predicate device.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its head turned to the left, and the eagle's body is formed by three human profiles facing the same direction.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2002
Ms. Jude Paganelli Coapt Systems Inc. 261 Hamilton Avenue Suite 413 Palo Alto, CA 94301
Re: K014153
Trade/Device Name: Endotine Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 10, 2001 Received: December 18, 2001
Dear Ms. Paganelli:
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 for associated in the 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 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. Jude Paganelli
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
R. Mark A. Mellem
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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INDICATIONS FOR USE
The Endotine Device is intended for use in browplasty surgery. The Endotine device is specifically intended for use to fixate the sub-dermis to the cranial bone in browplasty procedures.
for Muke n Wilkerson
Division Signer
(Division Sign-ﻟﺖ Division of General Restorative and Neurological Devices K014153
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.