(17 days)
Fortoss® Vital is intended for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.
Fortoss® Vital bone graft substitute is a calcium salt based pre-measured powder and liquid component. The two components are designed to be mixed intraoperatively to produce a homogeneous paste which can then be applied to osseous defects. The product is provided sterile for single patient use. When Fortoss® Vital is placed in direct contact with viable host bone, new bone grows in apposition to the surface of the implant, filling the pores with new bone during the healing process. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.
This document is a 510(k) summary for the Fortoss® Vital bone graft substitute. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information regarding acceptance criteria and a study to prove meeting those criteria is not present.
However, I can extract what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study for the Fortoss® Vital. Instead, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a predicate device. The primary "performance" reported is its equivalence to the predicate in key characteristics.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same technological characteristics as predicate | "modified Fortoss® Vital has the same technological characteristics as the predicate device" |
| Differences do not raise concerns regarding safety and effectiveness | "any differences do not raise any concerns regarding safety and effectiveness." |
| Resorbs and is replaced with bone during healing | "modified Fortoss® Vital provides a bone graft substitute that resorbs and is replaced with bone during the healing process." |
| Same indications as predicate | "The indications... are the same as the identified predicate device" |
| Same contraindications as predicate | "The contraindications... are the same as the identified predicate device" |
| Same risks as predicate | "The risks... are the same as the identified predicate device" |
| Same potential adverse events as predicate | "The potential adverse events are the same as the identified predicate device" |
| Legally marketed predicate device (basic features, intended uses) | "Documentation provided demonstrates that the modified Fortoss® Vital is substantially equivalent to the legally marketed predicate device in basic features and intended uses." |
| No new concerns regarding safety and effectiveness | "No new concerns have been identified regarding safety and effectiveness of the modified device." |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not provided. The document refers to "Data supplied" and "Documentation provided" but does not specify a test set size for animal or human studies. The nature of a 510(k) submission, especially for a bone graft substitute demonstrating substantial equivalence, often relies on comparing existing data or characteristics to a predicate, rather than conducting new, large-scale clinical trials.
- Data provenance: Not explicitly stated regarding specific studies. The applicant is Biocomposites Ltd, located in Keele, Staffordshire, England. This suggests the data might originate from or be compiled in the UK. The document uses terms like "Non Clinical Testing," implying laboratory or animal studies, but specifics on provenance are absent.
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 this submission is not about an AI/ML device that requires expert adjudication for ground truth establishment. It's a medical device (bone graft substitute) submission focused on substantial equivalence.
4. Adjudication method for the test set:
This information is not provided as it's not relevant 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:
This information is not provided as this device is a bone graft substitute, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided as this device is a bone graft substitute, not an AI/ML algorithm.
7. The type of ground truth used:
For a bone graft substitute, "ground truth" would typically refer to established biological and material science principles, existing clinical performance data of the predicate, and possibly pre-clinical (e.g., animal model) results. The document states "Data supplied demonstrates that the modified Fortoss® Vital is substantially equivalent to the predicate device." This implies the ground truth is derived from the known characteristics and performance of the predicate device, potentially supported by laboratory testing on the new device verifying these characteristics.
8. The sample size for the training set:
This information is not provided as this is not an AI/ML device that utilizes a training set.
9. How the ground truth for the training set was established:
This information is not provided as this is not an AI/ML device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a handwritten string of characters that appears to be a combination of letters and numbers. The characters are 'KCS2353'. The writing style is cursive, and the characters are connected. The image is in black and white.
510(k) SUMMARY
SEP - 5 2008
Fortoss® Vital
Applicant Biocomposites Ltd Keele Science Park Keele Staffordshire England ST5 ENT
Contact Person Miss Marie Whallev +44 (0) 1782 338580 Tel: Fax +44 (0) 1782 338599 Email: mw@biocomposites.com
Classification Name: Common/Usual Name: Trade/Proprietary Name Product Code
Bone grafting material, synthetic Synthetic Bone Graft Substitute Fortoss® Vital LYC
Device Description
Fortoss® Vital bone graft substitute is a calcium salt based pre-measured powder and liquid component. The two components are designed to be mixed intraoperatively to produce a homogeneous paste which can then be applied to osseous defects.
The product is provided sterile for single patient use. When Fortoss® Vital is placed in direct contact with viable host bone, new bone grows in apposition to the surface of the implant, filling the pores with new bone during the healing process. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.
{1}------------------------------------------------
Intended Use / Indications
The intended use of Fortoss® Vital is for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.
Summary of Technology
The modified Fortoss® Vital has the same technological characteristics as the predicate device and any differences do not raise any concerns regarding safety and effectiveness.
The modified Fortoss® Vital provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The indications, contraindications, risks and potential adverse events are the same as the identified predicate device and are thus substantially equivalent.
Non Clinical Testing
Data supplied demonstrates that the modified Fortoss® Vital is substantially equivalent to the predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Substantial Equivalence
Documentation provided demonstrates that the modified Fortoss® Vital is substantially equivalent to the legally marketed predicate device in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of the modified device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marie Whalley Biocomposites, Limited Keele Science Park Keele Staffordshire England ST5 5NL
SEP - 5 2008
Re: K082383
Trade/Device Name: Fortoss Vital Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 14, 2008 Received: August 19, 2008
Dear Ms. Whalley:
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.
{3}------------------------------------------------
Page 2 - Ms. Whalley
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 on use not 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 pregative 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, parmits 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 Center for Devices and Radiological Health's (CDR ('s' S) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other geaderal 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.
JKAmelia-Lend on D for 11
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Fortoss® Vital
Indications For Use:
Fortoss® Vital is intended for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.
V Prescription Use (Part 21 CFR 801 Subpart D)
OR
No Over-The-Counter use (Part 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)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K052303
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.