(168 days)
BoneMedik and BoneMedik-S are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone graft substitute that resorbs and is replaced with bone during the healing process.
BoneMedik and BoneMedik-S are coralline hydroxyapatite bone void fillers. They are similar except that BoneMedik-S contains about one percent silicon. Both are osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite. Once implanted the porous hydroxyapatite is resorbed and the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the BoneMedik and BoneMedik-S surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue growing into the space previously occupied by the implant.
This document describes the premarket notification (510(k)) for the BoneMedik and BoneMedik-S bone void fillers. It does not contain a standalone study to prove that the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics like sensitivity, specificity, AUC for an AI/diagnostic device). Instead, this is a regulatory submission for a medical device seeking clearance based on "substantial equivalence" to existing legally marketed devices, not on a new clinical performance study demonstrating efficacy with acceptance criteria and a detailed statistical analysis of a test set.
However, I can extract the information provided about the tests performed and what they aimed to achieve, which can be interpreted as demonstrating the device meets certain performance standards relevant to its safety and basic function, though not in the context of an AI/diagnostic device's performance study.
Here's a breakdown of the information based on your request, with the caveat that the prompt's structure is better suited for AI/diagnostic device studies:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/diagnostic device, there are no "acceptance criteria" in terms of classification metrics (sensitivity, specificity). Instead, the device met various standards and passed specific tests.
| Acceptance Criteria/Standard Met | Reported Device Performance |
|---|---|
| Performance Testing (Bench): | |
| Extraction material test | Met criteria (implicit pass for 510(k) clearance) |
| Heavy metal contents | Met criteria (implicit pass for 510(k) clearance) |
| Ca/P ratio | Met criteria (implicit pass for 510(k) clearance) |
| Shape | Met criteria (implicit pass for 510(k) clearance) |
| Size | Met criteria (implicit pass for 510(k) clearance) |
| Packaging | Met criteria (implicit pass for 510(k) clearance) |
| Compressive strength | Met criteria (implicit pass for 510(k) clearance) |
| Animal Testing (Implantation): | |
| Macroscopic observations of bony ingrowth | Demonstrated bony ingrowth (implicit pass for 510(k) clearance) |
| Microscopic observations of bony ingrowth | Demonstrated bony ingrowth (implicit pass for 510(k) clearance) |
| X-ray photos | Demonstrated bony ingrowth (implicit pass for 510(k) clearance) |
| X-ray diffraction patterns | Demonstrated characteristics consistent with hydroxyapatite and bony ingrowth (implicit pass for 510(k) clearance) |
| Biocompatibility (ISO 10993): | |
| Cytotoxicity | Met ISO 10993 standards |
| Sensitization | Met ISO 10993 standards |
| Irritation | Met ISO 10993 standards |
| Acute systemic toxicity | Met ISO 10993 standards |
| Sterilization (Gamma Radiation): | |
| Sterility Assurance Level (SAL) | Validated to provide a minimum SAL of 10⁻⁶ |
| General Standards: | |
| ISO 10993 (Biocompatibility) | Met |
| ISO 11137 (Sterilization) | Met |
| ISO 13409 (Sterilization validation) | Met |
| ISO 13779-1:2000 (Implants for Surgery) | Met |
| FDA Guidance Document: "Resorbable Calcium Salt Bone Void Filler Device, Guidance for Industry and FDA" | Studies designed according to applicable sections of this guidance document. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes for the "test set" in terms of number of samples for each test type (e.g., number of animals for implantation, number of samples for mechanical testing). It refers to "studies described in this document" for various tests.
- Data Provenance: Not explicitly stated, but the submitter is Meta Biomed Co., Ltd., Cheongwongun, Chungbuk, Korea. The studies were likely performed in Korea or under their supervision. They are described as "studies used to provide the data required in the guidance document." These would be considered prospective tests performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not relevant or provided for this device submission. The tests performed (e.g., chemical analysis, mechanical testing, animal implantation assessment, biocompatibility assays) do not typically rely on "experts" establishing a "ground truth" through consensus in the way an AI diagnostic algorithm's image interpretation would. The 'ground truth' comes from objective measurements, histological analysis, and adherence to established scientific and regulatory protocols.
4. Adjudication Method for the Test Set
Not relevant or provided for this type of device and study. Adjudication methods like "2+1" are used for expert review in diagnostic studies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI/diagnostic device, so an MRMC study is not applicable. The device is a bone void filler material, not an imaging interpretation tool or diagnostic algorithm that would assist human readers.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
No. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" in this context is established through:
- Established scientific methodologies: For chemical composition (Ca/P ratio, heavy metals), physical properties (shape, size, compressive strength), and biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity).
- Histopathology and imaging: For animal implantation tests (macroscopic and microscopic observations of bony ingrowth, X-ray photos and diffraction patterns).
- Validation protocols: For sterility assurance levels.
8. The Sample Size for the Training Set
Not applicable. This device is a material, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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510 (k) SUMMARY
SEP 17 2007
Submitter: Mr. T. H. Kim, BioQM Manager, Meta Biomed Co., Ltd., Cheongwongun, Chungbuk, Korea. Tel: 82-43-218-1983.
Classification Names and Numbers: Resorbable Calcium Salt Bone Void Filler I. Device, 21 CFR 888.3045, product code MQV.
II. Common/Usual Name: Bone void filler, bone filler, bone graft material
III. Proprietary Names: BoneMedik, and BoneMedik-S
IV. Establishment Registration Number: 9681254
V. Performance Standard: None established under section 514. However, the material meets ISO 10993 for biocompatibility, ISO 11137 Sterilization of health care products, and ISO 13409 for Sterilization validation and ISO 13779-1:2000, Implants for Surgery. Hydroxyapatite, Ceramic Hydroxyapatite.
VI. Device Description: BoneMedik and BoneMedik-S are coralline hydroxyapatite bone void fillers. They are similar except that BoneMedik-S contains about one percent silicon. Both are osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite. Once implanted the porous hydroxyapatite is resorbed and the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the BoneMedik and BoneMedik-S surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue growing into the space previously occupied by the implant.
VII. Special Controls Guidance Document: Applicable sections of the guidance document. "Resorbable Calcium Salt Bone Void Filler Device, Guidance for Industry and FDA were used to design the studies described in this document. The studies used to provide the data required in the guidance document included: A. Performance Testing, Bench: Extraction material test, heavy metal contents, Ca/P ratio, shape, size, packaging and compressive strength; B. Animal Testing: Implantation tests including macroscopic and microscopic observations of bony ingrowth including x-ray photos and x-ray diffraction patterns. (C ) Biocompatibility: The biocompatibility of BoneMedic and BoneMedic-S were studied in accordance with ISO 10993, cytotoxicity, sensitization and irritation, and acute stystemic toxicity. (D) Sterility:BoneMedik and BoneMedik-S are sterilized with gamma radiation. The sterilization cycles were validated to provide a minimum sterilility assurance level of 10°
VIII. Labels and Labeling: Draft labels of BioMedik and BioMedik-S and instructions for use are provided.
XI.
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IX. Indications for Use: BoneMedik and BoneMedik-S are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone graft substitute that resorbs and is replaced with bone during the healing process.
X. Substantial Equivalence: BoneMedik and BoneMedik-S are substantially equivalent to the device classified in 21 CFR 888.3045, "Resorbable calcium salt bone void filler device," product code MQV. They are also substantially equivalent to several devices currently on the market cleared by the 510(k) process. They are substantially equivalent (and nearly identical) to the Interpore, Intl. product, "Pro Osteon Implant 500 products originally cleared under the Premarket Approval system as P860005 and after reclassification cleared under 510(k)s K990131, K980817 and others. Like Pro Osteon 500, BoneMedik and BoneMedik-S are based on natural product that provides the unique structure. BoneMedik and BoneMedik-S are also substantially equivalent to the Kensey-Nash Bone Void Filler, cleared by the Kensey Nash Corp. in K060917 and K033679, and several others.
The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
-
- These products have the same intended use, to fill bony voids and gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or those created from traumatic injury to the bone.
-
- The technological characteristics for this product are similar to those of the predicate devices and those currently on the market and have the same starting material as the closest predicate.. In addition, the technological differences are well understood in the dental industry,
-
- Descriptive information provided shows that the materials from which these devices are made are well known to industry and government professionals and similar to those classified and currently used in marketed devices.
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- The FDA "Decision-Making Process" chart was used and appears in Appendix VIII.
[End of Summary]
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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 features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2007
Meta Biomed Co., Ltd % Mr. Tae-Hoon Kim 414-12 Mo Choong Dong Chong Ju City Choong Chong Buk Do, Republic of Korea.
Re:
K070897 Trade/Device Name: BoneMedik and BoneMedik-S Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 14, 2007 Received: August 20, 2007
Dear Mr. Tae-Hoon Kim:
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 - Mr. Tae-Hoon Kim
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Bucher
Mark N. Melkerspr Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 5 -
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ- Division D.O.
:
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices and Radiological Devices | 240-276-0120 |
:
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IX. Indications for Use: [Separate Page]
510(k) Number: NA
Device Name: BoneMedik and BoneMedik-S
Indications for use:
BoneMedik and BoneMedik-S'are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone graft substitute that resorbs and is replaced with bone during the healing process.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
H, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number_ 407089 7
N/A