TRIHA + by TEKNIMED SA | FDA 510(k) Summary

TRIHA+ is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. TRIHA+ is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. TRIHA+ should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

TRIHA+ is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Device Description

TRIHA+ is an osseo-conductive macroporous implant made of synthetic béta tri calcium phosphate (_-TCP (Ca(PO).) indicated for bone void filler. It has a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. The porosity is 60-80% and the size of pores is 200-500μm. TRIHA+ implant slowly resorbs during the remodelling and bone defect repair process and is progressively replaced with bone. The progressive resorption of TRIHA+ is intended to prevent premature resorption.

AI/ML Overview

This document is a 510(k) premarket notification for the TRIHA+ bone void filler device. It is a regulatory submission to the FDA, demonstrating substantial equivalence to previously marketed devices. Such submissions typically do not contain detailed acceptance criteria or study results of the type you are asking for.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is primarily done by comparing technological characteristics and intended use, rather than by presenting extensive clinical trial data or performance metrics against pre-defined acceptance criteria, especially for Class II devices like this bone void filler.

Therefore, based on the provided text, I cannot extract the specific information you requested. The document clearly states that TRIHA+ is equivalent in material, indications, and use to two predicate devices: BIOSORB (K021763) and Vitoss™ Scaffold (K994337). The "Summary of Technological Characteristics Compared to Predicate Device" states that TRIHA+ is similar in composition, porosity, pore size, and resorption. This comparison is the basis for its clearance, not a new study demonstrating performance against acceptance criteria.

Here's why the requested information is absent:

A table of acceptance criteria and the reported device performance: Not provided. The review is based on substantial equivalence, not novel performance data against set criteria.
Sample size used for the test set and the data provenance: Not applicable, as a new test set/clinical study is not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a bone void filler, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new study data is presented.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

In summary, this document is an FDA clearance letter based on a 510(k) submission, not a scientific publication detailing a study with acceptance criteria and performance metrics. The clearance is granted because the FDA deemed the device substantially equivalent to existing, legally marketed predicate devices.

Summary

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Date November 21, 2003

K031826

Submitter Teknimed, S.A. 11 rue Apollo 31240 L'Union FRANCE

Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Common name Bone void filler

Classification name Filler, calcium sulfate, preformed pellets (per 21 CFR section 888.3045)

Equivalent Device

TRIHA+ is equivalent in material, indications and use as BIOSORB (K021763) (Sciences et Bio Materiaux, Lourdes, France) and Vitoss™ Scaffold (K994337) (Orthovita, Inc. (Malvern PA).

Device Description

Intended Use

Summary of Technological Characteristics Compared to Predicate Device

TRIHA+ is similar to the predicate devices in terms of composition, porosity, pore size, and resorption.

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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a human head and torso.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 28 2003

Teknimed SA c/o Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, TX 78681 Attn. J.D. Webb

Re: K031826

Trade Name: TRIHA+ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: September 10, 2003 Received: September 16, 2003

Dear Mr. Webb:

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 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

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Page 2 - Mr. J.D. Webb

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050

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 vours,

for Mark A. Mullann

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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510(k) number (if known):

Device Name:

Indications for Use:

TRIHA+ Indications for Use

13 182

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of General, Neurological and Restorative Devices

510(k) Number ----------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use J (per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)

for Mark N. Millman

rision vision of General, Restorative and Neurological Devices

"(':) Number_

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.