(192 days)
Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.
Bond Bone™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.
The provided text describes a 510(k) premarket notification for a medical device called Bond Bone™, a synthetic bone grafting material. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with acceptance criteria for device performance in human subjects.
Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this 510(k) submission as no such studies were conducted or reported for this device to prove its performance against acceptance criteria in the traditional sense of a clinical trial. The device's performance is demonstrated through its equivalence to the predicate device.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission demonstrating substantial equivalence to a predicate device, there are no explicit "acceptance criteria" for clinical performance that the device had to meet. Instead, the acceptance criteria are implicitly that the new device's chemical and physical characteristics must be equivalent to those of the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Bond Bone™) |
|---|---|
| Equivalent Chemical Composition | Equivalent to predicate device |
| Equivalent Phase Composition | Equivalent to predicate device |
| Equivalent Trace of Impurities | Equivalent to predicate device |
| Equivalent Density and Porosity | Equivalent to predicate device |
| Equivalent Particle Size | Equivalent to predicate device |
| Equivalent Morphology | Equivalent to predicate device |
| Equivalent Setting Time and Reaction Temperature | Equivalent to predicate device |
| Equivalent Compressive Strength and Elastic Modulus | Equivalent to predicate device |
| Equivalent pH Analysis | Equivalent to predicate device |
| Equivalent Dissolution Rate | Equivalent to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The submission focuses on physical and chemical testing, not clinical performance with a "test set" of patient data.
- Data Provenance: Not applicable for clinical data. The tests were likely conducted in a laboratory setting, presumably by the manufacturer (MIS Implants Technologies Ltd. or its contracted labs). The country of origin of the company is Israel.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" established by human experts for a clinical test set in this type of submission. The performance assessment was based on objective physical and chemical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or human adjudication was performed.
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 an AI/software device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a bone grafting material, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" for this submission refers to the measured physical and chemical properties of the device, compared to those of the predicate. These are objective laboratory measurements, not ground truth derived from clinical observations.
8. The sample size for the training set
Not applicable. There's no training set for an algorithm as this is a physical medical device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" in this context is a series of chemical and physical performance tests conducted on the Bond Bone™ device. The goal of these tests was to demonstrate that the new Bond Bone™ product is substantially equivalent to its predicate device, Bond Bone™ from Augma Biomaterials Ltd. (K083858).
The text states:
"Bond Bone™ has been tested for a number of chemical and physical characteristics: chemical composition, phase composition, trace of impurities, density and porosity, particle size, morphology, setting time and reaction temperature, compressive strength and elastic modulus, pH analysis and dissolution rate. All these characteristics are equivalent to those of the predicate device."
This series of laboratory tests, comparing the new device's properties to those of the predicate, serves as the evidence that the device meets the (implicit) acceptance criteria for substantial equivalence. The "acceptance criteria" here are that the new device's properties fall within a range considered equivalent to the predicate device's established properties. The study concludes that based on these tests, the device has the "same performance characteristics" as the predicate device.
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Implants Technologies Ltd.
510(k) Summary:
Bond Bone™
Company Name: MIS Implants Technologies Ltd. P.O.Box 7 Bar Lev Industrial Park 20156, ISRAEL Telephone: +972-4-901-6800 Fax: +972-4-991-8623
Establishment Registration Number: 3004203816
- Contact Name: Iman Khorshid VP Quality & Regulatory Affairs Telephone: +972-4-901-6800 Fax: +972-4-991-8623 E-mail: iman@mis-implants.com
US Agent: Motti Weisman - VP Marketing MIS Implants Technologies Inc. 14-25 Plaza Rd. Suite S-3-5 Fair Lawn New Jersey; 07410 Phone: (201) 797-9144 (201) 797-9145 Fax: E-mail: service@misimplants.com
Date prepared: July 30, 2010
Trade Name: Bond Bone™
Classification name: Bone Grafting Materials
Common/usual name: Bone Grafting Materials, Synthetic
Product Code: LYC
Regulation No.: 872.3930
Class: II
Classification Panel: Dental Products Panel
510 (k) Bond Bone™ Section E - Page 1 of 12
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Implants Technologies Ltd.
Predicate Device:
Bond Bone™ from Augma Biomaterials Ltd., Usishkin 8, Netanya 42273, Israel cleared under 510(k) No. K083858.
Description of the device:
Bond Bone™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.
Indications for Use:
Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.
Substantial Equivalence:
Bond Bone™ has the same intended use as Bond Bone™ from Augma Biomaterials Ltd., Usishkin 8, Netanya 42273, Israel cleared under 510(k) No. K083858, and has same performance characteristics. Bond Bone™ is therefore substantially equivalent to the predicate device.
Performance testing:
Bond Bone™ has been tested for a number of chemical and physical characteristics: chemical composition, phase composition, trace of impurities, density and porosity, particle size, morphology, setting time and reaction temperature, compressive strength and elastic modulus, pH analysis and dissolution rate.
All these characteristics are equivalent to those of the predicate device.
510 (k) Bond Bone™ Section E - Page 2 of 13
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Implants Technologies Ltd.
Conclusion:
The evaluation of Bond Bone™ does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.
510 (k) Bond Bone™
Section E – Page 3 of 13
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Iman Khorshid Vice President Quality & Regulatory Affairs MIS Implants Technologies Limited P.O. Box 7 Bar Lev Industrial Park Israel 20156
OCT 2 1 2010
Re: K101014
Trade/Device Name: Bond Bone™ Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: September 7, 2010 Received: September 9, 2010
Dear Ms. Khorshid:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2- Ms. Khorshid
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. ' Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor Y.ou/Industry/default.htm.
Sincerely vours.
Rh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized font, with the "I" being taller than the other letters. To the right of the logo is the text "Implants Technologies Ltd." in a smaller font. The text is right-aligned with the "S" in the logo.
OCT 2 1 2010
| 510(k) Number (if known): | K101014 |
|---|---|
| --------------------------- | --------- |
| INDICATIONS FOR USE |
|---|
| --------------------- |
Bond Bone™ Device Name:
Indications for Use: Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.
Prescription Use X OR (Part 21 CFR 801 Subpart D)
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division Control, Dental Devices
510(k) Number:
510 (k) UNO Narrow Implant Section D- Page 1 of 1
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.