(206 days)
The Oscera7™ Synthetic Absorbable Bone Wax is indicated in the control of bleeding from cut or damaged bones by acting as a pressure tamponade, or mechanical barrier .
The Oscera7™ Synthetic Absorbable Bone Wax is a kneadable, biocompatible, synthetic absorbable material indicated for control of bleeding from bone surfaces. Hemostasis is accomplished by the physical mechanism of tamponade as it is pressed into the pores of the cut or damaged bone surface.
Post-application, the component materials, which include a fatty acid salt, isopropyl hexadecanoate, an alkylene oxide copolymer and ß-tricalcium phosphate, are dispersed and absorbed within the body.
The provided text describes a 510(k) submission for the Oscera7TM Synthetic Absorbable Bone Wax. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and studies in the format requested for AI/software devices.
Therefore, many of the requested fields cannot be directly extracted or are not applicable to this type of medical device submission. However, I can infer some information based on the context of a 510(k) and the provided text.
Here's a breakdown of the available and inferred information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Hemostatic Capability | Effective control of bleeding from cut or damaged bones by acting as a pressure tamponade/mechanical barrier. | Demonstrated in bench and animal testing. |
| Bioresorbability | Component materials (fatty acid salt, isopropyl hexadecanoate, alkylene oxide copolymer, ß-tricalcium phosphate) are dispersed and absorbed within the body post-application. | Demonstrated in bench and animal testing. |
| Biocompatibility | No adverse biological reactions. | Demonstrated in bench and animal testing. |
| Functionality | Device performs its intended purpose. | Demonstrated in verification testing. |
| Safety | No unacceptable risks to the patient. | Demonstrated in verification testing. |
| Effectiveness | Achieves the desired clinical outcome (hemostasis). | Demonstrated in verification testing. |
| Substantial Equivalence | Same intended use as predicate devices, absorbable, and uses materials found individually in predicate products. | Confirmed by FDA based on the submission. |
Explanation of Inference:
- Acceptance Criteria: These are inferred from the "Intended Use," "Device Description," and "Design Verification" sections. For a 510(k), compliance with these functional requirements and demonstrating substantial equivalence to legally marketed predicate devices are the primary "acceptance criteria."
- Reported Device Performance: The document states that "Verification testing of Oscera7™ included both bench and animal testing. The testing demonstrated the hemostatic capability, bioresorbability, and biocompatibility, thereby establishing compliance to the functional requirements of the device." It also concludes that "the cumulative test results demonstrated the functionality, safety and effectiveness of Oscera7™, as well as its substantial equivalence to the predicate devices."
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the document. The text only mentions "bench and animal testing" but does not specify sample sizes or data provenance (e.g., country, retrospective/prospective). This level of detail is typically not included in a 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided and is not applicable to a non-AI/software medical device like bone wax. "Ground truth" in this context would likely refer to direct measurements or observations from animal models or bench tests, not expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation, especially for diagnostic or screening devices.
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
This is not applicable as the Oscera7TM Synthetic Absorbable Bone Wax is a physical medical device, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the Oscera7TM Synthetic Absorbable Bone Wax is a physical medical device, not an AI or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Based on the type of device and testing mentioned ("bench and animal testing"), the "ground truth" would likely be established through:
- Direct measurement/observation in bench tests: For properties like mechanical integrity, absorption rates, or material composition.
- Histopathology or physiological measurements in animal models: To assess hemostasis, bioresorption, and biocompatibility (e.g., inflammation, tissue integration, presence/absence of material).
- Clinical observation in animal models: For immediate hemostatic effect.
The document does not explicitly state the specific ground truth methods but implies these through the types of tests mentioned.
8. The Sample Size for the Training Set
This information is not provided and is not applicable to this type of device. "Training set" is a term used in machine learning; this device undergoes traditional design verification and validation testing.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable to this type of device for the same reasons as #8.
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K060987 page 1/2
Image /page/0/Picture/1 description: The image shows the logo for CP Medical. The text "CP Medical" is displayed in a bold, outlined font. Below the company name, it says "Portland, OR USA" in a smaller font.
NOV - 2 2006
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
Device Name: Oscera7TM Synthetic Absorbable Bone Wax
Device Model Number: Classification Name:
Device Classification:
Predicate Devices:
Bone Wax (MTJ)
Unclassified
CP Medical 803 NE 25th Ave.
OS31
CP Medical Bone Wax, K024372 Ethicon Bone Wax, (Pre-amendment) Orthostat Bone Putty, K043260 Autosuture Bone Wax, K971680
Manufacturer:
Establishment Registration Number:
Official Contact:
3032563 Betsy Cortelloni Regulatory Affairs Manager Theragenics Corporation® 5203 Bristol Industrial Way
Portland, OR 97232 USA
Buford, GA 30518 Phone: 770-271-0233 Fax: 770-831-4369
Intended Use: The Oscera7™ Synthetic Absorbable Bone Wax is indicated in the control of bleeding from cut or damaged bones by acting as a pressure tamponade, or mechanical barrier .
Device Description: The Oscera7™ Synthetic Absorbable Bone Wax is a kneadable, biocompatible, synthetic absorbable material indicated for control of bleeding from bone surfaces. Hemostasis is accomplished by the physical mechanism of tamponade as it is pressed into the pores of the cut or damaged bone surface.
Post-application, the component materials, which include a fatty acid salt, isopropyl hexadecanoate, an alkylene oxide copolymer and ß-tricalcium phosphate, are dispersed and absorbed within the body.
Substantial Equivalence Comparison: Oscera7™ has the same intended use control of bleeding - as each of the predicates listed. Oscera7™ is absorbable, as
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are the Orthostat and Autosuture bone waxes. All of the materials used in the Oscera7™ formulation have been used individually in the predicate products.
Design Verification: Verification testing of Oscera7™ included both bench and animal testing. The testing demonstrated the hemostatic capability, bioresorbability, and biocompatibility, thereby establishing compliance to the functional requirements of the device.
Conclusion: The results of verification testing confirmed that design inputs were achieved and the cumulative test results demonstrated the functionality, safety and effectiveness of Oscera7™, as well as its substantial equivalence to the predicate devices.
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Image /page/2/Picture/1 description: The image shows a circular logo. The logo contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged in a circular fashion around an emblem. The emblem is a stylized depiction of an eagle or bird-like figure, with three curved lines representing the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CP Medical % Theragenics Corporation Ms. Betsy Cortelloni Regulatory Affairs Manager 5203 Bristol Industrial Way Buford. Georgia 30518
NOV - 2 2006
Re: K060987
Trade/Device Name: Oscera7" Synthetic Absorbable Bone Wax Product Code: MTJ Dated: September 20, 2006 Received: September 21, 2006
Dear Ms. Cortelloni:
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 becn 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 (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.
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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Page 2 - Ms. Betsy Cortelloni
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) 276-0115. 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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INDICATIONS FOR USE FORM
Page 1 of
510(K) number (if known): K060987
Device Name: Oscera7™ Synthetic Absorbable Bone Wax
Indications for Use:
The Oscera7™ Synthetic Absorbable Bone Wax is indicated in the control of bleeding from cut or damaged bones by acting as a pressure tamponade, or mechanical barrier .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Division of General. Restorative, and Neurological
N/A