(211 days)
The Jax-tcp granules may be used alone or can be mixed with the gel to create a cohesive mass that can be applied to the defect site. The gel is contradicted for use without the use of the granules. When used together, the granules and gel should be combined in a 1:1 ratio. JAX-tcp is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. JAX-tcp is indicated to be gently packed into bony voids or gaps of the skeletal system, (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. JAX-tcp provides a filler that is resorbed and is replaced with bone during the healing process.
JAX-tcp is a single-use bone void filler consisting of two components: surgical grade ßtricalcium phosphate granules and a hydrogel, used as a handling medium. The product is supplied sterile in quantities ranging from 1cc to 30cc.
The provided document is a 510(k) premarket notification for the JAX-tcp device, which is a bone void filler. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials proving performance against specific acceptance criteria.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Here's a breakdown of why the information is not present and what is typically found in a 510(k) for such a device:
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Table of acceptance criteria and reported device performance: This document explicitly states: "A review of the test data indicated that JAX-tcp is equivalent to other predicate calcium salt based bone void fillers currently used clinically." It does not present specific acceptance criteria or quantitative performance metrics for JAX-tcp itself. The "performance data" section is very brief and refers to equivalence, not meeting specific criteria.
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Sample size used for the test set and the data provenance: Not applicable. There is no mention of a standalone study with a test set. The submission relies on demonstrating equivalence through "materials data, and testing results" without detailing specific clinical or device performance studies in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no specific test set or clinical study with ground truth establishment described.
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Adjudication method for the test set: Not applicable.
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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. JAX-tcp is a physical bone void filler, not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as JAX-tcp is a physical bone void filler.
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The type of ground truth used: Not applicable, as there's no specific test set or clinical study with ground truth establishment described.
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The sample size for the training set: Not applicable. JAX-tcp is a physical medical device, not an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The submission focuses on establishing substantial equivalence to existing predicate devices based on:
- Intended use: Bony voids or gaps not intrinsic to stability, in extremities, spine, and pelvis.
- Base material of the granules: Beta-tricalcium phosphate.
- Use of a hydrogel: As a handling medium, mixed 1:1 with granules.
- Select performance properties: While not explicitly detailed, these would typically include material properties, handling characteristics, and demonstration of resorption and bone replacement similar to predicate devices.
The document states: "The product is adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." This implies that the full 510(k) submission contained more detailed technical and non-clinical performance data to support the equivalence claim, but this summary does not elaborate on these "testing results" or the specific criteria they met.
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JUN 1 0 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Jax-tcp
Contact Person and Address Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc., Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566
Device Description
JAX-tcp is a single-use bone void filler consisting of two components: surgical grade ßtricalcium phosphate granules and a hydrogel, used as a handling medium. The product is supplied sterile in quantities ranging from 1cc to 30cc.
Device Classification Name & Product Code Resorbable calcium salt bone void filler device (§888.3045): Orthopedics/87/MQV
Indications for Use
The Jax-tcp granules may be used alone or can be mixed with the gel to create a cohesive mass that can be applied to the defect site. The gel is contradicted for use without the use of the granules. When used together, the granules and gel should be combined in a 1:1 ratio.
JAX-tcp is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. JAX-tcp is indicated to be gently packed into bony voids or gaps of the skeletal system, (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. JAX-tcp provides a filler that is resorbed and is replaced with bone during the healing process.
Performance Data
A review of the test data indicated that JAX-tcp is equivalent to other predicate calcium salt based bone void fillers currently used clinically.
Substantial Equivalence Information
The intended use; base material of the granules; use of a hydrogel; and select performance properties of the Jax-tcp product are substantially equivalent to commercially available predicate bone void filler products. The product is adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.
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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 symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2004
Ms. Kim P. Kelly MS. Rt. Manager. Regulatory & Clinical Affairs Smith & Nephew, Inc. Orthopaedic 1450 Brooks Road Memphis, TN 38116
K033552 Re:
Trade Name: Jax-tcp Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: April 30, 2004 Reccived: May 3, 2004
Dear Ms. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(t) premaince is substantially equivalent (for the referenced above and have determined the do needicate devices marketed in
indications for use stated in the enclosure) to legally marketed in the Medical Device indications for use stated in the chelosars, to regionent date of the Medical Device interstate commence prior to May 20, 1970, and salessions with the provisions of Amendments, of to devices that have been rocastly of require approval of a prematken the Federal Food, Drug, and Cosmene Act (10) and the device, subject to the general approval application (1147). 1 our 110). 1 our 1105 provisions of the Act include controls provisions of the Act. The gentire, of devices, good manufacturing practice, requirements for anilian reading misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is crassified (see aoore) inst controls. Existing major regulations affecting (PMA), if may be subject to such additional controllar controllations, Title 21, Parts 800 to 898. In the Coderal your device can be found in the Code of Peacharting your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissuance of a substantal vice complies with other requirements mean that FDA nas made a decemination is administered by other Federal agencies.
of the Act or any Federal statutes and regulations administed to sessible of the Act of any rederal statutes and reginatents, including, but not limited to: registration You must comply with an the Ace STQ (21 CFR Part 801); good manufacturing practices and listing (21 CFR Part 607), labeling (21 CFR Part 820), and if
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Page 2 – Ms. Kim P. Kelly
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
ing the subserver and a The ED to finding of whitestial equivalence of your de This letter will allow you to begin manketing your as who aquivalence of your device and thus 510(k) prematket notification: "The 1 DA mitting or bassification 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), If you desire specific advice for your device on our lacksing of got processe note the regulation please contact the Office of Comphance ar (50) - 101 - 107 Part 807.97). You
entitled, "Misbranding by reference to premarket notification the Ast from the entitled, "Misoranding by reference to promation on your responsibilities under the Act its tall f may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Simall Manator (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milkerso
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 STATEMENT
510(k) Number (if known): K033552
Device Name:Jax-tcp
Indications for Use:
The Jax-tcp granules may be used alone or can be mixed with the gel to create a cohesive mass
of the Jax-tcp granules may be mand in and stadisted for use without the use of The Jax-tcp granules may be used alone the can be nineanian of a contraction of the use of the that can be applied to the delect one. The granules and gel should be combined in a 1:1 ratio.
In a 1:1 ratio.
granates and only for bony voids or gaps that are not intrinsic to the stability of the stablity of the JAX-tcp is indicated only for bony volus or gaps that bony voids or gaps of the bony structure. JAX-TCP is indicated to be gently portugio in these defects may be surgically skeletal system, li.e., the extremities, spiric, and point in matic injury to the bone.
created osseous defects or osseous defects created from traumatic injury the bealing created osseous delects of osseous and is replaced with bone during the healing process.
Mark A. Millhurn
Division of General, Restorative, and Neurological Devices
510(k) Number K033552
Concurrence of CDRH, Office of Device Evaluation
Prescription Use __ X_____________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.