(75 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of a surgical implant (button and suture) for tendon/ligament fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for fixation of anatomical structures, not for treating a disease or condition or affecting the structure or function of the body.
No
Explanation: The device is described as being used for "fixation of tendons and ligaments during orthopedic reconstruction procedures," indicating it is a surgical implant rather than a diagnostic tool. Its function involves providing structural support, not identifying a medical condition.
No
The device description clearly outlines physical components made of titanium and polyester suture, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of tendons and ligaments during orthopedic reconstruction procedures." This describes a surgical implant used in vivo (within the body) to physically support and stabilize tissues.
- Device Description: The description details a physical implant made of titanium and polyester suture. It does not describe any components or processes related to testing samples in vitro (outside the body) to diagnose or monitor a condition.
- Lack of IVD Characteristics: The document 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
The device is clearly a surgical implant used directly in a patient's body during a procedure.
N/A
Intended Use / Indications for Use
The EndoButton Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Product codes
GAT, MBI
Device Description
The EndoButton Continuous Loop consists of two components. The first is the EndoButton which is made of Titanium 6AL 4V ELI allov (ASTM F136). Its length is from 12 to 18 mm and its width is from 4 to 6 mm. It is oblong in shape with four holes through which suture is threaded.
The second component is the polvester suture which is preattached to the center holes. The loop soan lengths range from 10 to 80 mm and is approximately 5 mm in diameter. The suture portion of the EndoButton Continuous Loop is made of polyester. Poly(ethylene terepthalate). The suture is prepared from fibers of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. The suture meets the applicable requirements established by the United States Pharmacopeia (U.S.P.) for non-absorbable surgical suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tendons and ligaments
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)
The EndoButton Continuous Loop was tested against the EndoButton with EndoButton Tape to determine if it was equivalent in strength. Tensile strength, Stiffness, Cyclic Fatigue Testing and Residual Tensile Strength were examined. After the testing was completed, it was determined that the EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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
APR - 1998
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
5980155 The assigned 510(k) number is :
This summary was prepared on January 15, 1998
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048
B. Company Contact
Demetrios Tsakonas Clinical/Regulatory Specialist
். Device Name
EndoButton Continuous Loop Trade Name:
Common Name: · · Suture Retention Device; Surgical Button; Retention Bridge
- Polyester Surgical Suture .
Classification Name: · Button, Surgical · Non absorbable surgical suture (Poly[ethylene terephthalate])
D. Predicate/Legally Marketed Devices
EndoButton & EndoButton Tape Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048
1
E. Device Description
The EndoButton Continuous Loop consists of two components. The first is the EndoButton which is made of Titanium 6AL 4V ELI allov (ASTM F136). Its length is from 12 to 18 mm and its width is from 4 to 6 mm. It is oblong in shape with four holes through which suture is threaded.
The second component is the polvester suture which is preattached to the center holes. The loop soan lengths range from 10 to 80 mm and is approximately 5 mm in diameter. The suture portion of the EndoButton Continuous Loop is made of polyester. Poly(ethylene terepthalate). The suture is prepared from fibers of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. The suture meets the applicable requirements established by the United States Pharmacopeia (U.S.P.) for non-absorbable surgical suture.
F. Performance
The EndoButton Continuous Loop was tested against the EndoButton with EndoButton Tape to determine if it was equivalent in strength. Tensile strength, Stiffness, Cyclic Fatigue Testing and Residual Tensile Strength were examined. After the testing was completed, it was determined that the EndoButton Continuous Loop is as strong as the currently marketed EndoButton with EndoButton Tape.
G. Intended Use
The EndoButton Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction ..
H. Substantial Equivalence
The EndoButton Continuous Loop and the EndoButton & EndoButton Tape have similar designs. Both are used in fixating soft tissue ligaments. The EndoButton components are the same. The suture lengths are similar. The EndoButton tape comes in only one total length 60 cm. where as the suture portion of the EndoButton Continuous Loop will come in a variety of lengths ranging from 10 to 80 mm.
Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations.
2
A summary comparison of the characteristics of the EndoButton Continuous Loop and the substantially equivalent devices is presented in the table below.
| Attribute | Current Product | Substantially Equivalent Product | Substantially Equivalent Product |
|---|---|---|---|
| Indication | EndoButton Continuous | ||
| Loop | |||
| Fixation of tendons and | |||
| ligaments during | |||
| orthopedic reconstruction | |||
| procedures such as | |||
| Anterior Cruciate | |||
| Ligament (ACL) | |||
| Reconstruction. | EndoButton | ||
| K922559 | EndoButton Tape | ||
| K952535 | |||
| Dimensions | EndoButton: | ||
| width: 4 - 6 mm | |||
| length: 12 - 18 mm | |||
| Suture loop span length: | |||
| 10 - 80 mm | EndoButton: | ||
| width: 4 - 6 mm | |||
| length: 12 - 18 mm | EndoButton Tape | ||
| Total Suture length: | |||
| 60 cm | |||
| Material | EndoButton: Titanium | ||
| Suture: Polyester | Titanium | Polyester | |
| Sterilization | gamma irradiation | gamma irradiation | ethylene oxide |
| Labeling | Sterile, Single Use Only | Sterile, Single Use | |
| Only | Sterile, Single Use Only |
Applicant Demetrice Jackson
Date 1/15/98
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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 features a stylized eagle with three lines representing the head, body, and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 1998
Mr. Demetrios Tsakonas Clinical/Regulatory Specialist Endoscopy Division Smith & Nephew, Incorporated 130 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K980155 Trade Name: EndoButton Continuous Loop Regulatory Class: II Product Code: GAT and MBI Dated: January 15, 1998 Received: January 16, 1998
Dear Mr. Tsakonas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set .... forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 – Mr. Tsakonas
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
b
Hia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (If Known): (c 980) 55
Device Name: EndoButton Continuous Loop
Indications for Use: The EndoButton Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ligament (ACL) Reconstruction. : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Division of General 510(k) Numbe
Prescription Use
(Per 21 CFR 801.109)
or Over-The-Counter Use _