(39 days)
Not Found
No
The device description and performance studies focus on the material properties and biological function of a synthetic bone void filler, with no mention of AI or ML.
Yes
The device is described as "filling bony voids or gaps of the skeletal system" and being "gradually resorbed and replaced with bone during the healing process," indicating a direct action on the body for a medical purpose.
No
The device description and intended use clearly state that OSSAPLAST ORTHO is a synthetic implantable material used to fill bony voids, gradually becoming resorbed and replaced with bone. It does not perform any diagnostic function.
No
The device description clearly states it is a synthetic, implantable, resorbable ceramic in granulate form, which is a physical material, 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 OSSAPLAST ORTHO is for filling bony voids or gaps in the skeletal system. This is a therapeutic and structural application within the body.
- Device Description: The description details a synthetic, implantable, resorbable ceramic material. This is a physical implant, not a reagent or instrument used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. OSSAPLAST ORTHO does not fit this description.
N/A
Intended Use / Indications for Use
OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illium, and/or extremities) 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 or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
OSSAPLAST ORTHO (1000 – 2000 µm) is a synthetic, implantable, resorbable, radiopaque β-tricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of pure-phase β-ΤСР [Саз(РОд)չ] and is osteoconductive, with high interconnecting porosity. OSSAPLAST ORTHO (1000 – 2000 µm) is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (e.g., the spine, pelvis, illium, and/or extremities)
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)
Performance testing was conducted in conformance with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA (FDA/ODE, 6/2/2003). All data demonstrated that OSSAPLAST ORTHO (1000 – 2000 µm) is suitable for use as a bone void filler. It has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K05 0416
MAR 2 9 2005
Image /page/0/Picture/2 description: The image shows the word "OSSACUR" in a bold, sans-serif font. A thick, black circle partially surrounds the word, with the top and bottom portions of the circle missing. The word is centered within the circle, creating a logo-like appearance.
510(K) Summary
A. Submitter Information
| Submitter's Name: | OSSACUR® AG |
|---|---|
| Address: | Benzstrasse 2 |
| D-71720 | |
| Oberstenfeld, Germany | |
| Phone Number: | (+49) 7062 9404-0 |
| Fax Number: | (+49) 7062 9404-20 |
| Contact Person: | Arne Briest |
| Date of Preparation: | February 16, 2005 |
B. Device Name
| Trade Name: | OSSAPLAST ™ ORTHO (1000 – 2000 μm) |
|---|---|
| Common/Usual Name: | Bone Void Filler |
| Classification Name: | Resorbable calcium salt bone void filler device |
| §888.3045 (Product Code: MOV) |
C. Predicate Devices
| Trade Name: | Cerasorb® ORTHO (K014156) |
|---|---|
| Trade Name: | Cerasorb® M ORTHO (K040216) |
| Trade Name: | OSSAPLAST™ ORTHO (K042305) |
D. Device Description
OSSAPLAST ORTHO (1000 – 2000 µm) is a synthetic, implantable, resorbable, radiopaque β-tricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of pure-phase β-ΤСР [Саз(РОд)չ] and is osteoconductive, with high interconnecting porosity.
000061
1
Image /page/1/Picture/1 description: The image shows the number "2/2" in the upper left corner. To the right of the numbers is the logo for "OSSACUR". The logo has the text "OSSACUR" with a partial circle above and below the text.
OSSAPLAST ORTHO (1000 – 2000 µm) is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
E. Intended Use
OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illium, and/or extremities) 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 or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process. OSSAPLAST ORTHO is substantially equivalent in intended use to the predicate devices.
F. Technological Characteristics Summary
OSSAPLAST ORTHO (1000 -- 2000 µm) does not incorporate any new technological characteristics as compared to the predicate devices. OSSAPLAST ORTHO (1000 - 2000 um) and the predicate devices are made from the same material (pure-phase β-TCP) and conform to the standard specifications of ASTM F1088-04 for a medical grade ß-TCP to be used in surgical implant applications. OSSAPLAST ORTHO (1000 - 2000 µm) is substantially equivalent to the predicate devices in regard to structure, porosity, form, packaging, sterility, and biocompatibility.
G. Performance Data
Performance testing was conducted in conformance with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA (FDA/ODE, 6/2/2003). All data demonstrated that OSSAPLAST ORTHO (1000 – 2000 µm) is suitable for use as a bone void filler. It has been designed and manufactured to perform in a manner substantially equivalent to that of 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized waves or lines, often interpreted as representing the department's mission related to health and well-being.
Public Health Service
MAR 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristi M. Kistner, RAC President OSSACUR AG C/o Pacific Otter Works, Inc. 975 Veronica Springs Road Santa Barbara, California 93105
Re: K050416
K050410
Trade/Device Name: OSSAPLAST™ ORTHO (1000 TO 2000 microns) Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 16, 2005 Received: February 18, 2005
Dear Ms. Kistner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered phor to may 20, 2017 () in accordance with the provisions of the Federal Food, Drug, de Mees that have been that do not require approval of a premarket approval application (PMA). and Cosmotion For (110) and the device, subject to the general controls provisions of the Act. The r ou may, ateres, anians of the Act include requirements for annual registration, listing of general controls profice, 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 that I Dr Has Intactions and regulations administered by other Federal agencies. You must or any I 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant) of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Ms. Kristi M. Kistner
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the success of a lot sticket to the legice of your device to a le This letter will allow you to begin makemity of substantial equivalence of your device to a legally premarket notification. THE FDA Inding of substantal equive 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 if you desire specific advice for your device of a Also, please note the regulation entitled, contact the Office of Comphanes at (210) 216-78 Part 807.97). You may obtain " Misbranding by reference to premainers within and r the Act from the Division of Small other general information on your responses Assistance at its toll-free number (800) 638-2041 or and index html Manufacturers, International and Oolisanters http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hypt Rhodes
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION I-E.
Statement of Indications for Use
510(k) Number (if known): _ |