(63 days)
Kasios TCP
Not Found
No
The 510(k) summary describes a synthetic bone graft substitute material and its physical properties and intended use. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on biocompatibility, not algorithmic performance.
Yes
The device is described as a bone graft substitute that is indicated for filling bone voids or defects and promotes bone regeneration, functioning as a therapeutic intervention for skeletal injuries.
No
Explanation: The device is described as a bone graft substitute used for filling bone voids, indicating a therapeutic or reconstructive purpose rather than diagnosing a condition.
No
The device description clearly states that PolyBone® Granule & Block is a physical material (synthetic resorbable calcium phosphate bone void filler) available in various shapes and sizes, intended for implantation into bone voids. This is a hardware device, 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 PolyBone® Granule & Block is for "filling bone voids or defects" and is a "bone graft substitute." This describes a device used in vivo (within the body) for a therapeutic purpose (bone regeneration).
- Device Description: The description details the material composition and physical properties of the bone void filler, again focusing on its function within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on biological samples to gain information about a person's health. PolyBone® Granule & Block is implanted inside the body to facilitate bone healing.
N/A
Intended Use / Indications for Use
PolyBone® Granule & Block is indicated only for filling bone voids or defects that are not intrinsic to the stability of the bony structure. PolyBone® Granule & Block is to be gently packed into bony voids or gaps of the skeletal system (such as extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PolyBone® Granule & Block is a bone graft substitute that resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
PolyBone® Granule & Block is a synthetic resorbable calcium phosphate bone void filler consisted of 99.99% beta-tricalcium phosphate, and 0.01% polyphosphate. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 7585% with a 200500 um pore size.
Mechanism of PolyBone® Granule & Block's bone regeneration works by bone cells resorbing polyphosphate, which is a bone regenerating palpation material. Indication for use of PolyBone® Granule & Block is a filler of bone void regions.
The device is available in a variety of shape and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (such as extremities, spine and the 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)
Biocompatibility: The biocompatibility of PolyBone® Granule & Block has been performed by ISO10993-1:2003; cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity and implantation. The testing results show PolyBone® Granule & Block to be biologically safe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kasios TCP, Vitoss Scaffold.
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.
0
K082338 (pg 1 of 2)
(yungwon Medical Co., Ltd.
Confidential
510(k) Summary
OCT 1 6 2008
Date: 8-11-2008
-
- Company making the submission
| Submitter | |
|---|---|
| Name | Kyungwon Medical Co.,Ltd |
| Address | Suite 601 World Meridian Venture Center, 60-24 |
| Gasan-Dong, Geumcheon-Gu, Seoul, Korea 153-801 | |
| Phone | +82-2-2113-8693~8 |
| Fax | +82-2-2113-8699 |
| Contact | Shim, JaeBum Ph.D. Technical Director |
| Website | http://www.kyungwonmedical.co.kr |
-
- Device:
Trade Name: PolyBone® Granule & Block Common Name: Bone Void Filler Classification Name: Resorbable Calcium Salt Bone Void Filler
- Device:
-
- Predicate Device: Kasios TCP, Vitoss Scaffold.
4. Description:
PolyBone® Granule & Block is a synthetic resorbable calcium phosphate bone void filler consisted of 99.99% beta-tricalcium phosphate, and 0.01% polyphosphate. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 7585% with a 200500 um pore size.
Mechanism of PolyBone® Granule & Block's bone regeneration works by bone cells resorbing polyphosphate, which is a bone regenerating palpation material. Indication for use of PolyBone® Granule & Block is a filler of bone void regions.
The device is available in a variety of shape and sizes.
1
KO82338
Kyungwon Medical Co., Ltd.
Confidential
-
- Indication for use:
PolyBone® Granule & Block is indicated only for filling bone voids or defects that are not intrinsic to the stability of the bony structure. PolyBone® Granule & Block is to be gently packed into bony voids or gaps of the skeletal system (such as extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PolyBone® Granule & Block is a bone graft substitute that resorbs and is replaced with bone during the healing process.
- Indication for use:
6. Review:
PolyBone® Granule & Block has the similar technological characteristics to the predicate device; components, indication for use, chemical and performance properties.
Components Similarities All devices are packed with a container
Indication for Use Similarities All devices have the same indication for use
Chemical Similarities All devices are made up from ß-Tricalcium phosphate family
Performance Properties Similarities
All devices are for filling bone voids or defects that are not intrinsic to the stability of the bony structure.
Biocompatibility
The biocompatibility of PolyBone® Granule & Block has been performed by ISO10993-1:2003; cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity and implantation. The testing results show PolyBone® Granule & Block to be biologically safe.
7. Conclusion
Based on the information provided in this premarket notification Kyungwon Medical Co.,Ltd. Concludes that PolyBone® Granule & Block is safe and effective and substantially equivalent to predicate device as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
OCT 1 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kyungwon Medical Co., Limited % Kodent, Inc. Jung Bae Bang US Agent 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670
Re: K082338
Trade/Device Name: PolyBone® Granule & Block Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 11, 2008 Received: August 15, 2008
Dear Jung Bae Bang:
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.
3
Page 2 – Jung Bae Bang
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 vours.
Mark N. Millison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
6082338 510(k) Number (if known)
Device Name: PolyBone® Granule & Block
Indications for Use:
PolyBone® Granule & Block is indicated for filling bone voids or defects that are not intrinsic to the stability of the bony structure. PolyBone® Granule & Block is to be packed into bony voids or gaps of the skeletal system (such as extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PolyBone® Granule & Block is a bone graft substitute that resorbs and it replaced with bone during the healing process.
Prescription Use X (21CRF 801 Subpart D)
Over-The-Counter Use AND/OR (21CRF 801 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 | 14082338 |
|---|---|
| --------------- | ---------- |