(67 days)
Cementek® LV is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® LV is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be injected into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gaps, Cementek® LV resorbs and is replaced with bone during the healing process.
As an injectable bone substitute, Cementek® LV is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced with a syringe into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in an apatitic calcium phosphate cement. Cementek® LV is marketed in a 16cc dosage.
The provided text is a 510(k) summary for the Cementek® LV bone substitute, a medical device. It does not describe acceptance criteria or a study proving that a device meets such criteria for an AI/ML-based medical device. Instead, it details the device description, intended use, and a summary of technological characteristics compared to a predicate device for a physical medical device (bone void filler).
Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, device performance, study details for AI/ML devices, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided document.
The document discusses substantial equivalence for a physical product based on comparing its characteristics to a predicate device, not the performance of an algorithm or an AI system.
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DEC 27 2004
Cementek® LV 510(k) Summarv October 18, 2004
- 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 Trade Name: Cementek® LV Common name: Bone void filler Classification name: Class II per 21 CFR section 888.3045 Product Code: MQV Equivalent Device: Cementek ® (K040669)
Device Description
As an injectable bone substitute, Cementek® LV is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced with a synnye into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in an apatitic calcium phosphate cement. Cementek® LV is marketed in a 16cc dosage.
Intended Use
Cementek® LV is intended for use only as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® LV is indicated for use in the treatment of surgically created osseous defects or osseous defects created from tranmatic injury The putty can be injected into the bony voids or gaps in the skeletal system (i.e. to bone. 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,
Summary of Technological Characteristics Compared to Predicate Device
Cementek® LV is equivalent to Cementek® in terms of physical form, how supplied, compressive strength, porosity, average pore size, composition of final product and indications.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 27 2004
Teknimed, S.A. c/o Mr. J.D. Webb The Orthomedix Group, Inc. 1001 Oakwood Blvd. Round Rock, TX 78681
Re: K042911
Trade Name: Cementek LV Bone Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 6, 2004 Received: December 8, 2004
Dear Mr. Webb:
We have reviewed your Section 510(k) premarket notification of intent to market the device we flave reviewed your becareer benefice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the ensible of the enactment date of the Medical Device Interstate conments, or to thay 20, 10 reclassified in accordance with the provisions of Amendinents, or to devroes that have o Act (Act) that do not require approval of a premarket the rederal I ood, Drug, and Ocement , therefore, market the device, subject to the general approval appreation (1 MIT). I The general controls provisions of the Act include controls provisions of the Fiel. "Into gisting 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 If your device is classined (see as additional controls. Existing major regulations affecting (I MA), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that 1 Da determination that your device complies with other requirements mean that + DA may Federal statutes and regulations administered by other Federal agencies. of the Act of any I outhal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good
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Page 2 - Mr. J.D. Webb
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.
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 (240) 276-0120. 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,
Mark A. Matheron
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
510(k) Number (if known): _ | 042911
Device Name: Cementek® LV
Indications for Use:
Cementek® LV is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® LV is indicated for use in the treatment of surgically created osseous defects or osseous defects created from tass in the injury to bone. The putty can be injected into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or golds or got Cementek® LV resorbs and is replaced with bone during the healing process.
Prescription Use X (Part 21 CFR 801 Subpart D)
510(k)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milhem
(Division Sign-Off)
Division of General, estorative,
ond Neurological D. ned
§ 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.