(110 days)
Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram ™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, spine, or pelvis) caused by degeneration, trauma or surgery. It also can be used with autograft as a bone graft extender. Apaceram™ is resorbed and replaced with bone during the healing process.
Apaceram ™ is a hydroxyapatite osteoconductive bone void filler. It is available in four types: AX, B, G, and R, which vary in porosity, shape and sizes. Apaceram ™ is provided sterile for single patient use.
The provided text is a 510(k) Summary for the Apaceram™ Bone Graft Substitute, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It is important to note that a 510(k) summary for a bone void filler generally does not contain detailed information about a study with acceptance criteria in the context of an AI/algorithm-driven device's performance measurement. The data presented here pertains to the safety and efficacy of the physical bone graft substitute material itself, not an AI or software component.
Therefore, many of the requested points regarding sample sizes, expert adjudication, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as they are not relevant to the type of device being described.
However, I can extract the information that is present and relevant to the device's acceptance criteria and the basis for its approval.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a 510(k) device are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the new device has the same intended use and the same technological characteristics as the predicate device(s), or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness, and is as safe and effective as the predicate device(s).
For Apaceram™ Bone Graft Substitute, the "acceptance criteria" are implicitly met by demonstrating similar design, material composition, final product configurations, and function to the predicate devices.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance / Basis for Equivalence |
|---|---|
| Intended Use: Similar to predicate device(s). | Apaceram™ is intended for use as a bone void filler for bony voids, gaps, or defects (extremities, spine, or pelvis) caused by degeneration, trauma or surgery, and as a bone graft extender. This aligns with typical indications for bone void fillers. |
| Technological Characteristics: Similar design, materials, function, and performance to predicate device(s). | Apaceram™ and the predicate devices (K033722, ApaPore®; K051774, MBCP™) are similar in: - Design: Osteoconductive bone void filler. - Material Composition: Calcium salts (specifically hydroxyapatite for Apaceram™). - Final Product Configurations: Provided in various particulate and shaped sizes. - Function: Provide an interconnected, highly porous scaffold environment for new bone ingrowth; resorbed and replaced with bone during healing. |
| Safety and Biocompatibility: Does not raise new questions of safety and effectiveness. | "The safety and biocompatibility testing performed by Pentax and a long history of safe clinical use of this material support the safety and effectiveness of Apaceram™ and its equivalence to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in this context. The 510(k) summary does not describe a "test set" in the sense of a dataset used to evaluate an AI algorithm. Instead, it refers to biocompatibility testing and clinical use history of similar materials.
- Data Provenance: The document mentions "safety and biocompatibility testing performed by Pentax" (the submitter) and "a long history of safe clinical use of this material." The specific countries of origin or whether this refers to prospective or retrospective studies are not detailed in this 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 as it's not relevant to a 510(k) submission for a bone graft substitute. Ground truth establishment by experts in the context of an AI algorithm's performance is not part of this documentation.
4. Adjudication method for the test set
- Not applicable for this type of medical device submission.
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 device is a physical bone graft substitute and does not involve AI or human readers in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a traditional 510(k) bone graft substitute, "ground truth" for proving substantial equivalence primarily relies on:
- Material Characterization: Chemical composition analysis, physical properties (porosity, degradation rate).
- Biocompatibility Testing: In vitro and in vivo studies to assess biological response (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation effects).
- Functional Equivalence: Demonstrated ability to act as an osteoconductive scaffold, promote bone ingrowth, and resorb over time, often through animal studies or referencing established knowledge of the material.
- Clinical History/Outcomes Data (of the material/predicate devices): Referencing established safety and effectiveness through the long history of clinical use of similar materials and predicate devices.
8. The sample size for the training set
- Not applicable as this is not an AI/algorithm-driven device.
9. How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/1 description: The image shows the text "K071912" at the top, followed by "Apaceram TM" and "Traditional 510(k)" below it. The text appears to be part of a document or label. The numbers "510" and "12" are clearly visible in the image.
510(k) SUMMARY— Apaceram™ Bone Void Filler
| Submitter Name: | Pentax Corporation |
|---|---|
| Submitter Address: | 2-36-9 Maeno-cho |
| Itabashi-ku, Todyo 174-8639 JAPAN | |
| Contact Person: | Hiroyasu Takeuchi |
| Vice President, General Manager | |
| New Ceramics Division | |
| Phone Number: | 813-3960-1290 |
| Fax Number: | 813-3960-2681 |
| Date Prepared: | July 11, 2007 |
| Device Trade Name: | Apaceram ™ Bone Graft Substitute |
| Device Common Name: | Synthetic, porous hydroxylapatite |
| Classification Number: | 21 CFR 888.3045 |
| Classification Name: | Resorbable calcium salt bone void filler |
| Product Code: | MQV |
| Predicate Devices: | K033722, ApaPore® Bone Graft Substitute, ApaTech Ltd. |
| K051774, MBCP ™ , Biomatlante. | |
| Statement of Intended Use: | Apaceram ™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram ™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, spine, or pelvis) caused by degeneration, trauma or surgery. It also can be used with autograft as a bone graft extender. Apaceram ™ is resorbed and replaced with bone during the healing process. |
| Device Description: | Apaceram ™ is a hydroxyapatite osteoconductive bone void filler. It is available in four types: AX, B, G, and R, which vary in porosity, shape and sizes. Apaceram ™ is provided sterile for single patient use. |
| Technological Characteristics and Substantial Equivalence: | The Apaceram ™ and the predicate devices are similar in design, material composition, final product configurations, and function. They are made of calcium salts, are osteoconductive, and provide an interconnected, highly porous scaffold environment for new bone ingrowth. The safety and biocompatibility testing performed by Pentax and a long history of safe clinical use of this material support the safety and effectiveness of Apaceram ™ and its equivalence to the predicate devices. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pentax Corp. % Patsy J. Trisler, J.D., RAC Regulatory Consultant 5600 Wisconsin Avenue Suite 509 Chevy Chase, Maryland 20815
OCT 2 9 2007
Re: K071912
Trade/Device Name: Apaceram™ Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 11, 2007 Received: July 11, 2007
Dear Ms. Trisler:
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 (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.
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Page 2 - Patsy J. Trisler, J.D., RAC
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 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 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 A. Melhusen
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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510(k) Number (if known):
Device Name:
Apaceram™ Bone Graft Substitute
Indications for Use:
Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram ™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, spine, or pelvis) caused by degeneration, trauma or surgery. It also can be used with autograft as a bone graft extender. Apaceram™ is 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)
(Posted November 13, 2003)
Mark A. Millman
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number
§ 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.