(119 days)
Not Found
No
The 510(k) summary describes a synthetic bone void filler composed of ceramic granules and a polymeric binder. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance study is a comparison to a predicate device in an animal model, not an evaluation of an AI/ML algorithm's performance.
Yes.
The device is a bone void filler intended to promote bone growth during the healing process, falling under the definition of a therapeutic device.
No
The device is described as a bone void filler intended to be replaced by new bone growth, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a synthetic, osteoconductive and resorbable bone void filler consisting of ceramic granules and a polymeric binder, provided in physical forms (cylinders, strips, blocks). This is a physical medical device, 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 AttraX Putty is a "bone void filler" used in surgical procedures to fill gaps in bone. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details the composition of the material (ceramic granules and polymeric binder) and its physical forms (cylinders, strips, blocks). This aligns with a medical device used for implantation or filling, not for analyzing samples from the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue, etc.) to provide information about a patient's health status or disease.
- Anatomical Site: The device is applied directly to the "posterolateral spine," which is a surgical application, not a diagnostic one.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. AttraX Putty is used in vivo (inside the body) for a structural and therapeutic purpose.
N/A
Intended Use / Indications for Use
AttraX Putty is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects resulting from traumatic injury to the bone. AttraX Putty is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. AttraX Putty provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
AttraX Putty is a synthetic, osteoconductive and resorbable bone void filler device consisting of ceramic granules premixed with a polymeric binder that provides cohesion between the granules of AttraX Putty are composed of beta-tricalcium phosphate (beta-TCP > 90%) and hydroxyapatite (HA
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2015
Progentix Orthobiology B.V. Yvonne P. Bovell QA/RA Manager Professor Bronkhorstlaan 10D, Building 48 3723 MB Bilthoven The Netherlands
Re: K151584 Trade/Device Name: AttraX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 27, 2015 Received: August 31, 2015
Dear Ms. Bovell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151584
Device Name AttraX Putty
Indications for Use (Describe)
AttraX Putty is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects resulting from traumatic injury to the bone. AttraX Putty is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. AttraX Putty provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
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510(k) Summary AttraX Putty
Date: 10 June 2015
ADMINISTRATIVE INFORMATION
Classification Regulations
Product Code
Classification Panel
Reviewing Branch
| Submitter details: | |
|---|---|
| Name | Progentix Orthobiology B.V. |
| Address | Professor Bronkhorstlaan 10, building 48 |
| 3723 MB Bilthoven | |
| The Netherlands | |
| Telephone | +31-30-2297280 |
| Fax | +31-30-2297299 |
| Contact person: | |
| Name | Yvonne P. Bovell |
| Position | QA/RA Manager |
| Telephone | +31-30-2297212 |
| yvonne.bovell@progentix.com | |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/Proprietary Name | AttraX Putty |
| Common Name | Filler, bone void, calcium compound |
| Classification Name | Resorbable calcium salt bone void filler device |
MQV
21 CFR 888.3045, Class II
Restorative Devices Branch
Orthopaedic and Rehabilitation Devices Panel
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INTENDED USE
AttraX Putty is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. AttraX Putty is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. AttraX Putty provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
DEVICE DESCRIPTION
AttraX Putty is a synthetic, osteoconductive and resorbable bone void filler device consisting of ceramic granules premixed with a polymeric binder that provides cohesion between the granules of AttraX Putty are composed of beta-tricalcium phosphate (β-ΤCP > 90%) and hydroxyapatite (HA