(223 days)
Not Found
No
The summary describes a synthetic bone void filler and does not mention any AI or ML components or functionalities.
Yes
The device is intended as a bone void filler to aid in the healing process of bone defects, which is a therapeutic function.
No
Explanation: KAINOS®+ is described as a bone void filler used for treatment (filling gaps in the skeletal system), not for identifying or diagnosing a medical condition.
No
The device description clearly states KAINOS®+ is a synthetic, resorbable calcium phosphate bone void filler available in granule or block-shaped forms, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that KAINOS®+ is a "bone void filler for bony voids or gaps of the skeletal system". This describes a device that is implanted or applied directly to the body to aid in bone healing.
- Device Description: The description details a "synthetic, resorbable calcium phosphate bone void filler with a trabecular structure". This is a material designed to interact with the body's tissues, not to analyze samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on in vitro testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. KAINOS®+ is a therapeutic device used to fill bone voids.
N/A
Intended Use / Indications for Use
KAINOS®+ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. KAINOS®+ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, KAINOS®+ gradually resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
KAINOS®+ is a synthetic, resorbable calcium phosphate bone void filler with a trabecular structure. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. KAINOS+ is available in granule or block-shaped forms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (extremities, spine and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020986, K032268, K080511, K0994337, K081439
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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SEP 2 8 2009
:
| 510(k) Summary | |
|---|---|
| Sponsor: | SIGNUS Medizintechnik GmbH |
| Carl-Zeiss-Strasse 2 | |
| D-63755 Alzenau, GERMANY | |
| Tel. + 49 (0) 6023 9166-136 | |
| Fax + 49 (0) 6023 9166-161 | |
| Url: http://www.signus-med.de | |
| Contact Person: | Jörg Degen, Regulatory Affairs, QM |
| Proposed Trade Name: | KAINOS®+ |
| Device Classification | Class II |
| Classification Name: | Bone void filler, calcium compound |
| Regulation: | 888.3045 |
| Device Product Code: | MQV |
| Device Description: | KAINOS®+ is a synthetic, resorbable calcium phosphate bone void filler |
| with a trabecular structure. It is an osteoconductive material which provides | |
| a porous scaffold upon which bone formation can occur. KAINOS+ is | |
| available in granule or block-shaped forms. | |
| Intended Use: | KAINOS®+ is intended for use as a bone void filler for bony voids or gaps |
| of the skeletal system (extremities, spine and pelvis) that are not intrinsic to | |
| the stability of the bony structure. These defects may be surgically created | |
| osseous defects or osseous defects created from traumatic injury to the | |
| bone. KAINOS®+ is a bone filler without initial mechanical properties. | |
| Therefore rigid fixation techniques may often be recommended. When | |
| packed into a bony site, KAINOS®+ gradually resorbs and is replaced with | |
| bone during the healing process. | |
| Materials: | KAINOS®+ is manufactured from hydroxyapatite and tricalcium phosphate |
| according to ASTM F1088 and F1185. | |
| Substantial | |
| Equivalence: | Documentation was provided which demonstrated the KAINOS®+ to be |
| substantially equivalent to previously cleared devices. These include: | |
| MasterGraft™ (Medtronic Sofamor Danek USA - K020986), MCBP™ (Biomatlante - K032268), PLEXUR P (Osteotech, Inc. - K080511) and | |
| Vitoss™ (Orthovita, Inc. - K0994337 and K081439). The substantial | |
| equivalence is based upon equivalence in material, basic design/size, | |
| intended use, indications, anatomic sites and performance. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
SFP 2 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SIGNUS Medizintechnik GmbH % Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chseterland, Ohio 44026
Re: K090387
Trade/Device Name: KAINOS® + Regulation Number: 21 CFF. 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 26, 2009 Received: August 26, 2009
Dear Dr. Warden:
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 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); 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.
2
Page 2 - Karen E. Warden, Ph.D.
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/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/ReportalProblem/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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark M. Millhurn
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number: Koqu367
Device Name: KAINOS®+
Indications for Use:
KAINOS®+ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injurv to the bone. KAINOS®+ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, KAINOS®+ gradually resorbs and is replaced with bone during the healing process.
Prescription Use X (Per 21 CFR 801.109) OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M.MELKERSON
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090387
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