(39 days)
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 (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.
The provided text is a 510(k) summary for the OSSAPLAST™ ORTHO bone void filler. It describes the device and claims substantial equivalence to predicate devices. However, this document does not contain a study explicitly designed to prove device performance against acceptance criteria in the manner requested.
Specifically, the document states: "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."
This statement indicates that performance testing was performed, and the results were found acceptable, but it does not provide the details of the acceptance criteria, the specific study design, the reported performance data, or the specific information requested in your numbered points. The 510(k) process relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical trial with explicit acceptance criteria for a novel device.
Therefore, many of your requested points cannot be answered from the provided text.
Here's an attempt to answer what can be inferred or directly stated from the document, with extensive notes about missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance (Inferred/General) |
|---|---|
| Conformance to Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device | "All data demonstrated that OSSAPLAST ORTHO (1000 – 2000 µm) is suitable for use as a bone void filler." |
| Substantial equivalence to predicate devices (Cerasorb® ORTHO, Cerasorb® M ORTHO, OSSAPLAST™ ORTHO) regarding structure, porosity, form, packaging, sterility, biocompatibility, and intended use. | "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." |
| Device is gradually resorbed and replaced with bone during the healing process. | This is part of the intended use, and substantial equivalence implies this characteristic. No specific performance data provided in the summary. |
Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., "resorption should be X% at Y months") or specific numerical results for these criteria. The approval is based on "suitability" and "substantial equivalence."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. It likely involved preclinical testing (e.g., in vitro, animal studies) as part of the "Performance testing" and "biocompatibility" assessments, but no details are given. The context of a 510(k) for a device like this usually indicates laboratory and possibly animal testing rather than large human clinical trials, unless specifically stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of information is not relevant to the "performance testing" described in this 510(k) summary, which focuses on material properties and biological response (biocompatibility, resorption), not interpretation of medical images or diagnoses.
4. Adjudication method for the test set
- Not applicable as this is not a diagnostic device or a study involving human reader interpretation.
5. 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. This is not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
- For material properties: ASTM F1088-04 standard specifications for medical grade ß-TCP as a "ground truth" for material composition and characteristics.
- For biocompatibility: Standardized biocompatibility testing parameters (e.g., ISO 10993 series) would serve as the "ground truth" to determine if the device elicits an acceptable biological response. The document states "biocompatibility" was assessed.
- For osteoconductivity/resorption: Likely histological analysis in animal models or in vitro studies. The document states it is "osteoconductive" and "gradually resorbed and replaced with bone."
8. The sample size for the training set
- Not applicable in the context of device performance testing for a bone void filler as described in this 510(k) summary. "Training set" is a concept typically associated with machine learning or AI models, which this device is not.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as point 8.
In summary: The provided document is a 510(k) summary for a medical device (bone void filler) and primarily demonstrates substantial equivalence to predicate devices and adherence to relevant standards and guidance documents. It does not outline a specific study with detailed acceptance criteria and performance metrics in the way one might expect for a novel diagnostic device or AI application. The "performance data" mentioned generally refers to compliance with established material and biological safety standards rather than a formal clinical trial with quantitative endpoints.
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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
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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.
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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 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.
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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
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SECTION I-E.
Statement of Indications for Use
510(k) Number (if known): _ |<o5o416
Device Name: OSSAPLAST™ ORTHO (1000 to 2000 um) Bone Void Filler
Indications for Use:
mateations for Coo.
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 immolo to the other or osseous defects resulting from traumatic injury to the broated observerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atwell Rhodes
Division of General, Restorative, and Neurological Devices
Page 1 of 1
OSSACUR® AG
KOSTAL B 510(k) Number-
¹¹
000016
§ 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.