(64 days)
Synthes chronOS™ is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS™ is indicated for use in the treatment of bony defects created surgically or through traumatic injury.
Synthes chronOS™ is intended to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement into the bony void, chronOS™ resorbs and is replaced with bone during the healing process.
Synthes chronOS™ is a porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate (TCP). Synthes chronOS™ is resorbed and replaced by new bone during the healing process. The pore structure of chronOS™ provides a matrix for the ingrowth of bone. chronOS™ is provided sterile in a double sterile pack. It is available in various forms including granules, blocks, wedges and cylinders.
Synthes chronOS™ may be packaged with a perfusion syringe that is used to mix the bone void filler with the patient's blood components and/or bone marrow.
This document is a 510(k) summary for the Synthes chronOS™ bone void filler. It describes the device, its intended use, and its substantial equivalence to a predicate device.
Crucially, this document does not contain information on acceptance criteria or a study proving device performance against such criteria.
The 510(k) process is a premarket notification to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that these do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate.
Therefore, the requested information cannot be extracted from the provided text.
Here's why and what might be found in a different type of submission or document:
- Acceptance Criteria and Reported Device Performance: These are typically established during device development and verified through design validation studies, which could include clinical trials, animal studies, or bench testing. A 510(k) summary generally refers to these studies if they were used to demonstrate substantial equivalence, but it doesn't usually present the raw data, acceptance criteria, or detailed results in this format. The 510(k) focuses on comparison to a predicate, not necessarily detailed performance metrics against predefined criteria in the same way a PMA (Premarket Approval) might.
- Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): These are all elements of a detailed study report. While studies would have been conducted to support the safety and effectiveness claims, the 510(k) summary is a high-level overview for regulatory purposes.
- Training Set Sample Size and Ground Truth: This information would be relevant for machine learning-based devices, which this particular product (a bone void filler) is not.
To find the requested information, one would typically need to consult:
- Clinical Study Reports: If clinical studies were conducted to support the 510(k) (which is less common for "substantially equivalent" devices unless significant new technological characteristics are present), these reports would contain the details.
- Design Validation Documentation: Internal company documents detailing the testing and validation performed.
- PMA Submissions: Devices requiring a PMA go through a more rigorous review process, and their submissions contain extensive data on safety and effectiveness, including detailed acceptance criteria and study results.
- Summary of Safety and Effectiveness Data (SSED): For PMA-approved devices, the FDA publishes these summaries, which detail the studies and findings.
In summary, the provided text does not contain the information requested about acceptance criteria and detailed study performance.
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JAN - 7 2005
3.0 510(k) Summary
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Device Name: | Synthes (USA) chronOS™ |
| Classification: | Class II, 21 CFR §888.3045Filler, Calcium Sulfate Performed Pellets |
| Class II, 21 CFR §880.5860Piston Syringe | |
| Predicate Device: | Synthes chronOS™Orthovita, Inc. Vitoss® Scaffold Synthetic Cancellous Bone VoidFiller and Imbibe II Syringe |
| Device Description: | Synthes chronOS™ is a porous, osteoconductive, resorbable bonevoid filler made from β-Tricalcium Phosphate (TCP). SyntheschronOS™ is resorbed and replaced by new bone during thehealing process. The pore structure of chronOS™ provides a matrixfor the ingrowth of bone. chronOS™ is provided sterile in a doublesterile pack. It is available in various forms including granules,blocks, wedges and cylinders. |
| Synthes chronOS™ may be packaged with a perfusion syringe thatis used to mix the bone void filler with the patient's bloodcomponents and/or bone marrow. | |
| Intended Use: | Synthes chronOS™ is indicated for use in bony voids or gaps thatare not intrinsic to the stability of the bony structure. chronOS™is indicated for use in the treatment of bony defects createdsurgically or through traumatic injury. |
| Synthes chronOS™ is intended to be gently packed or placed intobony voids or gaps of the skeletal system (i.e. the extremities,spine, and pelvis) and may be combined with autogenous bloodand/or bone marrow. Following placement into the bony void,chronOS™ resorbs and is replaced with bone during the healingprocess. | |
| SubstantialEquivalence: | Documentation is provided which demonstrates that SyntheschronOS™ is substantially equivalent* to other legally marketedSynthes devices. |
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*The term "substantial equivalence" as used in the 510(k) notification is limited to the definition of substantial equivalence found in the Food, Drug and Cosmetic Act, as amended and as applied under 21 CRF 807, Subpart F, under which a device can 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 admission 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2005
Ms. Kathy Anderson Regulatory Manager Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K043045
Trade/Device Name: Synthes (USA) Chronos with Perfusion Syringe Regulation Number: 21 CFR 888.3045, 21 CFR 880.5860 Regulation Name: Resorbable calcium salt bone void filler, Piston Syringe Regulatory Class: II Product Code: MQV, FMF Dated: January 3, 2005 Received: January 4, 2005
Dear Ms. Anderson:
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. Kathy Anderson
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) 594-4659. 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 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 yours,
Willy Otto
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) chronOSTM
Indications:
Synthes chronOS™ is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS™ is indicated for use in the treatment of bony defects created surgically or through traumatic injury.
Synthes chronOS™ is intended to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement into the bony void, chronOS™ resorbs and is replaced with bone during the healing process.
Prescription Use (Per 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)
Division Sign-Off
Division of General, Restorative, and Neurological Devices
510(k) Number K043045
0004
§ 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.