(53 days)
Straumann Granules are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
Straumann Granules are a synthetic resorbable bone graft material made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite. Straumann Granules provide a bone void filler that is resorbed and replaced with bone during the healing process.
The provided text is a 510(k) summary for the Straumann Granules, a synthetic bone graft substitute. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with detailed metrics.
Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" cannot be directly filled from this type of regulatory submission. The primary method of demonstrating acceptance for this device is based on substantial equivalence to already legally marketed devices.
Here's an analysis based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly present in the 510(k) summary. For devices like bone graft substitutes seeking clearance via the 510(k) pathway, the "acceptance criteria" are generally met by demonstrating that the device is substantially equivalent to predicate devices in terms of intended use, materials, and technological characteristics. Performance is inferred from the established safety and effectiveness of the predicates.
| Criteria Category | Acceptance Criteria | Reported Device Performance (from text) |
|---|---|---|
| Material Composition | Similar to predicate devices | "Straumann Granules are a synthetic resorbable bone graft material made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite." This is implicitly deemed similar enough to the materials of listed predicate devices (e.g., "Biphasic Calcium Phosphate," "Bio-Oss® Anorganic Bovine Bone," "Bii-GRAFT™ (Bioresorbable Calcium Phosphate)"). The basis for equivalence states "similar material characteristics." |
| Intended Use | Identical to predicate devices | "Straumann Granules are indicated for intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting." The basis for equivalence states "the same intended use." This intended use is implicitly deemed similar to or covered by the indications of the predicate devices. |
| Technological Characteristics | Similar to predicate devices | While not explicitly detailed, the statement "The Straumann Granules are substantially equivalent based on similar material characteristics and the same intended use" implies that any relevant technological characteristics (e.g., resorbability, bone void filling capability, healing process integration) are also considered similar to the predicates. |
| Safety and Effectiveness | Demonstrated by predicates | Not directly reported for the Straumann Granules in this summary, but inferred from the established safety and effectiveness of the legally marketed predicate devices to which it claims substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. This 510(k) summary does not describe a clinical test set in the way one would for a diagnostic or therapeutic device requiring a standalone performance study. The equivalence is based on existing knowledge and data related to the predicate devices.
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/Not provided. There is no "test set" and thus no ground truth established by experts in the context of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No test set requiring expert adjudication is described.
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/Not provided. This is a bone graft substitute, not a diagnostic imaging device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. No specific "ground truth" for this device's performance is established in this summary. The ground for clearance is substantial equivalence to predicates, implying their historical safety and effectiveness serve as the basis.
8. The sample size for the training set
Not applicable/Not provided. No "training set" in the context of an algorithm or a clinical trial is described.
9. How the ground truth for the training set was established
Not applicable/Not provided. No "training set" is described.
Summary of Device Acceptance Approach:
The Straumann Granules received 510(k) clearance based on demonstrating substantial equivalence to several legally marketed predicate devices. The "study" proving the device met "acceptance criteria" (which are implicitly suitability for its intended use based on similarity to predicates) was the submission and review of documentation confirming:
- Similar Material Characteristics: Made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite, which are common components in existing bone graft substitutes.
- Identical Intended Use: Indicated for intraoral/maxillofacial osseous defects, including periodontal, furcation, alveolar ridge augmentation, extraction sites, and sinus elevation grafting, aligning with the indications of the predicate devices.
- Technological Characteristics: By extension, the device is considered to function similarly to the predicate devices in terms of being a resorbable bone void filler replaced by bone during healing.
The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates that the regulatory acceptance criteria were met through the established 510(k) pathway of proving equivalence rather than through a direct performance study against a predefined set of quantitative numerical criteria specific to this new device.
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MAY - 3 2004
ATTACHMENT 1 - 510(k) Summary
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.
Applicant's Name and Address 1.
| Straumann USA (on behalf of Institut Straumann AG) | |
|---|---|
| Reservoir Place | |
| 1601 Trapelo Road | |
| Waltham, MA 02451 | |
| Telephone Number: | 781-890-0001 |
| Fax Number: | 781-890-6464 |
| Contact Person: | Linda Jalbert |
| Director, Regulatory Affairs |
Name of the Device 2.
| Proposed Trade Name: | Straumann Granules |
|---|---|
| Common Name: | Synthetic Bone Graft Substitute |
| Classification Name: | LYC |
| Bone Grafting Material, Synthetic |
Legally Marketed Devices to which Equivalence is Claimed (Predicate ന് Devices)
| Manufacturer | Device | 510(k) | DateCleared |
|---|---|---|---|
| Interpore CrossInternational | Pro-Osteon® 500R ResorbableBone Graft Filler | K990131 | 3/2/1999 |
| Medtronic | Biphasic Calcium Phosphate | K010701 | 6/5/2001 |
| Sofamor Danek | Bone Void Filler | ||
| Geistlich-Pharma | Bio-Oss® Anorganic BovineBone | K970321 | 9/15/1998 |
| Bio-Interfaces,Inc. | Bii-GRAFT™ (BioresorbableCalcium Phosphate) | K960164 | 4/10/1996 |
| Biomatlante | MBCP | K032268 | 12/11/2003 |
| IsoTiss NV | OsSatura BCP Bone Void Filler | K030131 | 05/20/2003 |
4. Description of the Device and Intended Use
Straumann Granules are a synthetic resorbable bone graft material made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite. filling and/or augmenting Straumann Granules are indicated for intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting. Straumann Granules
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provide a bone void filler that is resorbed and replaced with bone during the healing process.
5. Basis for Substantial Equivalence
:
The Straumann Granules are substantially equivalent based on similar material characteristics and the same intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or a caduceus-like design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 3 2004
Institut Straumann AG C/O Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
Re: K040646
Trade/Device Name: Straumann Granules Regulation Number: Unclassified Regulation Name: Nonc Regulatory Class: None Product Code: LYC Dated: March 10, 2004 Received: March 11, 2004
Dear Ms. Jalbert:
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 prodicate 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.
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Page 2 - Ms. Jalbert
:
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 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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilitics under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Chris Lins, Ph.D.
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number (if known):
Device Name: Straumann Granules
Indications For Use:
Straumann Granules are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
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)
Ques
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K040646
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§ 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.