(110 days)
No
The 510(k) summary describes a synthetic bone void filler material and its physical and chemical properties. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is described as a "bone void filler" used for "bony voids or gaps of the skeletal system," which directly implies a therapeutic use to aid in bone repair or regeneration.
No
Explanation: The device is described as a bone void filler used for surgical or traumatic bone defects, not for diagnosing medical conditions.
No
The device description clearly states it is a synthetic and osteoconductive bone void filler in the form of granules and blocks, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ATLANTIK™ is a "bone void filler for bony voids or gaps of the skeletal system". This describes a device that is implanted or used directly on the patient's body to fill a physical space.
- Device Description: The description details a "synthetic and osteoconductive bone void filler" made of calcium phosphate ceramic, available as granules and blocks. This is consistent with a material used for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while ATLANTIK™ is a material used to physically fill a void within the body.
N/A
Intended Use / 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.
Product codes
MQV
Device 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%.
ATLANTIK™ is available in the form of irregular-shaped vial-packed granules of different sizes and blocks with various shapes and sizes.
ATLANTIK™ is provided sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (e.g. extremities and pelvis)
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)
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.
Testing results demonstrate that ATLANTIK is as safe and as effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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%.
1
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.
2
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
3
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
4
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 and
Radiological Devices | 240-276-
0120 |
5
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