(193 days)
Synthes chronOS Composite is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS Composite is indicated for use in the treatment of bony defects created surgically or through traumatic injury. Synthes chronOS Composite, combined with autogenous blood and/or bone marrow or autograft, is intended to be used in spine for posterolateral fusion. Following placement into the bony void, chronOS Composite resorbs and is replaced with bone during the healing process.
Synthes chronOS Composite is a synthetic, porous, osteoconductive, resorbable bone void filler made from chronOS ß-TCP granules imbedded in a matrix of poly (lactide-co-ε-caprolactone). The composite is flexible and may be molded by the surgeon or used directly as supplied. The flexible chronOS Composite provides contourability and malleability of the device to the bony implant site.
The provided text is a 510(k) summary for the Synthes chronOS Composite device, which is a resorbable calcium salt bone void filler. This document primarily focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC) or standalone studies cannot be found in the provided text.
Based on the information given, here's what can be extracted and what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not available | Not available |
Explanation: The document does not specify quantitative acceptance criteria (e.g., minimum tensile strength, degradation rate, osteoconductive properties, clinical success rates). The general "acceptance" in this context is the FDA's determination of "substantial equivalence" to predicate devices, meaning it is considered safe and effective for its intended use based on comparison rather than new performance data against specific, pre-defined metrics.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This document is a 510(k) summary for substantial equivalence, not a report of a new clinical or performance study with a distinct "test set" in the context of AI/device performance.
- Data Provenance: Not applicable. No specific test data from a study is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No test set requiring ground truth established by experts is mentioned.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set requiring adjudication is mentioned.
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
- MRMC Study: No. This is a medical device (bone void filler), not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is a medical device (bone void filler), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable. There is no specific "ground truth" mentioned in the context of a performance study for this device. The basis for approval is substantial equivalence to legally marketed predicate devices, meaning the already accepted performance and safety profile of the predicate devices serves as the benchmark.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. This is not an AI/machine learning device.
Summary of Study (as per the 510(k) in the provided text):
The document states: "Documentation is provided which demonstrates that Synthes chronOS Composite is substantially equivalent to other legally marketed Synthes devices."
This indicates that the "study" conducted for K071046 was a substantial equivalence comparison study. This type of study does not involve new clinical trials or performance tests to establish novel performance metrics against predefined acceptance criteria. Instead, it involves comparing the new device (Synthes chronOS Composite) to predicate devices (Synthes (USA) chronOS™ (K043045) and chronOS TCP (K013072)) based on:
- Intended Use: Identical or very similar.
- Technological Characteristics: Similar materials, design, mechanism of action. The chronOS Composite differs by adding poly (lactide-co-ε-caprolactone) to chronOS ß-TCP granules, making it flexible and moldable.
- Performance Data: Often includes bench testing (e.g., mechanical properties, degradation), biocompatibility testing, and potentially some in-vivo animal data for safety, all demonstrating that the new device performs as safely and effectively as the predicate devices. The document does not detail these tests or their results, only that they were provided to demonstrate substantial equivalence.
The FDA's review concluded that the device is substantially equivalent to the predicate devices for the stated indications for use. This means the device met the regulatory acceptance criterion for market access under the 510(k) pathway by demonstrating it is as safe and effective as existing legally marketed devices.
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0CT 2 3 2007
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| 510(k) Summary | OCT 23 | |
|---|---|---|
| Submitter: | Synthes Biomaterials1230 Wilson DriveWest Chester, PA 19380 | |
| Company Contact: | Jeffrey L. Dow, JDDirector, Clinical & Regulatory AffairsSynthes Biomaterials484 356 9720dow.jeff@synthes.com | |
| Name of Device: | Synthes chronOS Composite | |
| Device Classification: | Class II, 21 CFR § 888.3045 | |
| Product Code: | MQV | |
| Common Name: | Resorbable Calcium Salt Bone Void Filler | |
| Predicate Devices: | Synthes (USA) chronOS™ (K043045)chronOS TCP (K013072) | |
| Intended Use: | Synthes chronOS Composite is indicated for bonyvoids or gaps that are not intrinsic to the stability ofthe bony structure. Synthes chronOS Composite isindicated for use in the treatment of bony defectscreated surgically or through traumatic injury.Synthes chronOS Composite, combined withautogenous blood and/or bone marrow or autograft, isintended to be used in spine for posterolateral fusion.Following placement into the bony void, chronOSComposite resorbs and is replaced with bone duringthe healing process. | |
| Device Description: | Synthes chronOS Composite is a synthetic, porous,osteoconductive, resorbable bone void filler madefrom chronOS ß-TCP granules imbedded in a matrixof poly (lactide-co-ε-caprolactone). The compositeis flexible and may be molded by the surgeon orused directly as supplied. The flexible chronOSComposite provides contourability and malleabilityof the device to the bony implant site. |
:
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Substantial Equivalency:
Documentation is provided which demonstrates that Synthes chronOS Composite is substantially equivalent to other legally marketed Synthes devices.
' The term "substantial equivalence" as used in the 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended, and as applied under 21 CFR Part 807, Subpart E, under which a devices an be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an adminission against interest under the US patent laws or their application by the courts
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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 consists of a stylized representation of a human figure with three faces in profile, stacked on top of each other. The faces are depicted in a flowing, abstract manner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUI 2 3 2007
Synthes Biomaterials % Jeffrey L. Dow, JD 1230 Wilson Drive West Chester, PA 19380
Re: K071046
Trade/Device Name: Synthes chronOSTM B-TCP Composite Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: October 18, 2007 Received: October 22, 2007
Dear Mr. Dow:
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 - Jeffrey L. Dow, JD
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 Biometric'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 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 yours,
Mark A. Mulkern
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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2. Indications for Use
510(k) Number (if known): K 0 7 104 6
Device Name: Synthes chronOS™ Composite Indications: Synthes chronOS Composite is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS Composite is indicated for use in the treatment of bony defects created surgically or through traumatic injury. Synthes chronOS Composite , combined with autogenous blood and/or bone marrow or autograft, is intended to be used in spine for posterolateral fusion. Following placement into the bony void, chronOS Composite resorbs and is replaced with bone during the healing process. Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millman
KO71046
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
Synthes (USA) Premarket Notification 510(k) chronOS Composite
CONFIDENTIAL
§ 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.