(110 days)
ATLANTIK™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ATLANTIK™ is a bone void filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
ATLANTIK™ is a synthetic and osteoconductive bone void filler. It is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 70% hydroxyapatite (FIA) and 30% beta-tricalcium phosphate (TCP). Its porosity is interconnected and opened with a total volume ratio of 70%.
ATLANTIK™ is available in the form of irregular-shaped vial-packed granules of different sizes and blocks with various shapes and sizes.
ATLANTIK TM is provided sterile for single use.
The provided text describes a 510(k) Summary for the ATLANTIK™ Bone Void Filler but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in the context of performance metrics like sensitivity, specificity, or reader improvement with AI assistance.
The document focuses on demonstrating substantial equivalence to predicate devices through bench testing for material properties. Therefore, many of the requested categories about AI performance studies, sample sizes for test/training sets, and expert adjudication cannot be extracted from this text.
Here's a breakdown of what can be extracted and what cannot, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be provided as requested. The document doesn't list specific performance metrics (like sensitivity, specificity, AUC) or corresponding acceptance criteria. Instead, it discusses the substantial equivalence of material properties.
| Acceptance Criteria (e.g., specific thresholds for performance metrics) | Reported Device Performance (e.g., actual values for performance metrics) |
|---|---|
| Not specified from a clinical performance or AI perspective. | Not specified from a clinical performance or AI perspective. |
| Material Properties (Bench Testing): | Bench Testing Results (Demonstrating Substantial Equivalence): |
| Similarity in Phase Composition (XRD) | ATLANTIK™'s phase composition investigated by XRD. |
| Similarity in Chemical Composition (ICP) | ATLANTIK™'s chemical composition investigated by ICP. |
| Similarity in Porosity (Mercury intrusion porosimetry, SEM, density measurements) | ATLANTIK™'s porosity investigated by these methods. |
| Similarity in Dissolution Rate and pH (Buffered solution at pH 7.3) | ATLANTIK™'s dissolution rate and pH compared to predicate devices in a buffered solution at pH 7.3. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document describes bench testing of material properties, not a clinical study involving a "test set" of patient data for evaluating a diagnostic device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. See point 2. Ground truth in this context refers to the material standards and measurements for comparing physical and chemical properties.
4. Adjudication Method for the Test Set
Not applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. This is not a multi-reader multi-case study for evaluating diagnostic performance. The device is a bone void filler.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical bone void filler, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the material properties testing, the "ground truth" was established by standard analytical methods for characterizing materials, such as:
- X-ray diffraction (XRD) for phase composition.
- Induced coupled plasma spectrometry (ICP) for chemical composition.
- Mercury intrusion porosimetry, scanning electron microscopy (SEM), and density measurements for porosity.
- Buffered solution testing for dissolution rate and pH.
The comparison was made against predicate devices using these same analytical methods to demonstrate similarity.
8. The Sample Size for the Training Set
Not applicable. This isn't an AI/machine learning device with a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
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MEDICAL BIOMAT, INC. 3595 Piedmont Road Bldg 11 - Suite 710 Phone : 404 233 8623 Fax : 404 202 5925
JUL 1 0 2007
Section 5
510(k) Summary for ATLANTIK™ Bone Void Filler
OWNER:
MEDICAL BIOMAT, INC. 3595 Piedmont Road Bldg 11 - Suite 710 Phone : 404 233 8623 Fax : 404 202 5925
CONTACT:
Aurélien BIGNON, PhD MEDICAL GROUP 5, chemin du Catupolan 69120 Vaulx-en-Velin, France Phone: 00 33 4 72 81 48 33 Fax: 00 33 4 72 81 22 72 e-mail: a.bignon@medicalgroup.fr
SUMMARY PREPARATION DATE: May 23, 2007
DEVICE:
A
ア
| and the count of the been the first of the first of the first and the first and | ||||||
|---|---|---|---|---|---|---|
| > > PROPRIETARY NAME: | ATLANTIKTM |
- 公 USUAL NAME:
Bone Void Filler
Resorbable calcium salt bone void filler device (21 CFR
- A CLASSIFICATION NAME:
- DEVICE PANEL:
PRODUCT CODE:
888.3045) Orthopedic MQV
PREDICATE DEVICES:
| > Biomatlante | MBCPTM | Bone Void Filler | (K051774) |
|---|---|---|---|
| > IsoTis NV | OsSaturaTM BCP | Bone Void Filler | (K030131) |
DEVICES DESCRIPTION:
ATLANTIK™ is a synthetic and osteoconductive bone void filler. It is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 70% hydroxyapatite (FIA) and 30% beta-tricalcium phosphate (TCP). Its porosity is interconnected and opened with a total volume ratio of 70%.
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ATLANTIK™ is available in the form of irregular-shaped vial-packed granules of different sizes and blocks with various shapes and sizes.
ATLANTIK TM is provided sterile for single use.
INTENDED USE:
ATLANTIK™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ATLANTIK ''s a bone void filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
SUBSTANTIAL EQUIVALENCE INFORMATION:
ATLANTIK™ and the predicate devices are similar in design, materials, chemical composition and function. ATLANTIK™ and the predicate devices are made of hydroxyapatite and beta-tricalcium phosphate with similar weight ratios. They have similar porous structures in terms of porosity volume ratio, porosity size distribution and interconnectivity. ATLANTIK™ and the predicate devices are osteoconductive and have similar dissolution rates. ATLANTIK™ and the predicate devices are provided sterile and non-pyrogenic for single patient use.
TESTING:
Extensive bench testing comparing ATLANTIKTM and the predicate devices have been performed to support substantial equivalence. Phase composition has been investigated by X-ray diffraction (XRD). Chemical composition was investigated by induced coupled plasma spectrometry (ICP). Porosity was investigated by mercury intrusion porosimetry, scanning electron microscopy (SEM) and density measurements. Dissolution rate and pH of ATLANTIK™ and the predicate devices were compared in a buffered solution at pH 7.3.
CONCLUSION:
Hydroxyapatite and beta-tricalcium phosphate have been used in clinical practice for more than 25 years with no remarkable safety issues. The devices to which ATLANTIK™ claims substantial equivalence have been used safely for many years in clinical environment. Testing results demonstrate that ATLANTIK is as safe and as effective as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. 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
MEDICAL BIOMAT, INC. % Aurelien Bignon, Ph.D. 5. Chemin Du Catupolan Vaulx-En-Velin. France 69120
JUL 1 0 2007
Re: K070794
Trade Name: ATLANTIK™M Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void device Regulatory Class: Class II Product Code: MQV Dated: June 12, 2007 Received: June 14, 2007
Dear Dr. Bignon,
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 (OS) 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
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Aurelien Bignon, Ph.D.
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours.
Vaubare Buehn
Mark N.Melkerson Director Division of General, Restorative and Neurological Devices, Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Aurelien Bignon, Ph.D.
cc: HFZ-401 DMC HFZ-404 510(k) Staff
HFZ- Division D.O.
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices andRadiological Devices | 240-276-0120 |
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Section 4 Indications for use
510(k) Number (if known): K070794
ATLANTIK™ Device Name:
Indications for use:
ATLANTIK™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ATLANTIK™ is a bone void filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR
NO Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sarba Queen
Division Sign Off
(Division Sign
Division
N.
510(k) Number K070744
SECTION 4
§ 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.