(177 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the physical components (thread, needle, pellets, disc). There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for surgical repair of Achilles tendon ruptures, which is a therapeutic intervention.
No
The device description and intended use clearly state that it is for surgical repair of Achilles tendon ruptures, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly outlines physical components such as a thread, harpoon, needle, lead pellets, and a disc, indicating it is a hardware-based medical device.
Based on the provided information, the Tenolig® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "surgical repair of Achilles tendon ruptures by percutaneous approach." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of surgical components like a thread, harpoon, needle, lead pellets, and a disc. These are tools used for physical repair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. The Tenolig® is a surgical implant/device used for physical repair within the body.
N/A
Intended Use / Indications for Use
TENOLIG is indicated for recent ruptures of the Achilles tendon.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
Tenolig® consists of:
- a thread in polyester (poly(ethylene terephthalate)) with a diameter of 0.85mm and -360mm length, crimped at its proximal end, onto which is mounted a 7mm-wide harpoon, and crimped at its distal end by a triangular-tipped needle, 150mm long, slightly curved at delivery and which can be adjusted during surgery according to a curve suitable for the type of rupture treated;
- two perforated lead pellets for tightening;
- an UHMW polyethylene disc, with a convex surface offering support that does not excessively compress the skin and a flat surface.
A complete kit required for normal percutaneous tenosynthesis includes two Tenolig®.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Achilles tendon
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)
Performance testing was performed in accordance with the recommendations set up in the FDA Guidance document: « Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA ». Tensile tests were performed to characterize in tension the strength of the crimping of the braid with the needle and of the braid with the spear. All results demonstrate that the Tenolig® is safe and effective.
Biocompatibility testing were conducted according to the NF S 94167 French standard. The results correspond to the requirements of the ISO-10993 standard, which requires to conduct testing in appropriate body contact and duration.
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
§ 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
Image /page/0/Picture/0 description: The image is a logo with the letters FH in a bold, sans-serif font. The letters are placed inside of a gear-like shape. Above the gear shape, the word "GROUPE" is written in a smaller, sans-serif font. Below the gear shape, the words "FOURNITURES HOSPITALIERES" are written in a similar font.
6, rue Nobel Z.I. DE KERNÉVEZ 29000 QUIMPER
Tél : 02 98 55 68 95
Fax : 02 98 53 42 13
FRANCE
Image /page/0/Picture/1 description: The image shows the text "FHI industrie" in a bold, sans-serif font. The letters "F," "H," and "I" are capitalized and larger than the rest of the text. A horizontal line underlines the entire word. The dot on the "i" is a solid circle.
510 (K) SUMMARY - TENOLIG®
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
SUBMITTER:
Fournitures Hospitalières Industrie 6 Rue Nobel, Z.I. de Kernevez 29000 QUIMPER, France Phone number: 33.2.98.55.68.95 Fax number: 33.2.98.53.42.13
AUG - 9 2006
payer (2
COMPANY CONTACT:
Christine Quendez Regulatory Affairs Manager Phone number: 33.2.98.55.68.95 Fax number: 33.2.98.53.42.13
DATE PREPARED: Junuary 30th 2006
Image /page/0/Picture/23 description: The image shows a logo with the letters "AFAQ" stacked on top of each other. The letters are in a bold, sans-serif font and are arranged in a square. Below the letters, the text "ISO 9001" is visible. The logo appears to be a certification mark, possibly related to quality management standards.
DEVICE NAME:
Trade Name: TENOLIG® Common name: Nonabsorbable Polyester Surgical Suture Classification name: Non-absorbable poly(ethylene terephthalate) surgical suture 21 C.F.R. Section 888.5000
PREDICATE DEVICES:
Name Manufacturer: 510(K) number:
POLY-TAPES® Xiros Pic. K002172
Name Modified coated VICRYL® Manufacturer: Ethicon Inc. 510(K) number: K022269
DEVICE DESCRIPTION :
Tenolig® consists of:
- a thread in polyester (poly(ethylene terephthalate)) with a diameter of 0.85mm and -360mm length, crimped at its proximal end, onto which is mounted a 7mm-wide harpoon, and crimped at its distal end by a triangular-tipped needle, 150mm long, slightly curved at delivery and which can be adjusted during surgery according to a curve suitable for the type of rupture treated;
- two perforated lead pellets for tightening; l
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