(240 days)
Not Found
No
The device description and intended use focus on the material properties and function as a bone replacement scaffold, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as being placed into bony voids or gaps and being replaced by bone during the healing process, indicating a therapeutic function in aiding bone regeneration.
No
The device, OSferion, is described as a bone replacement material intended to fill bony voids or gaps. Its function is to resorb and be replaced by bone during healing, not to diagnose a condition.
No
The device description explicitly states that OSferion is a "white porous material composed of β-tricalcium phosphate" and is supplied in physical forms like "blocks, cylinders, granules and wedges." This indicates it is a physical implantable material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- OSferion's Intended Use: The intended use of OSferion is to be "gently packed or placed into bony voids or gaps of the skeletal system." This is a material that is implanted inside the body to aid in bone healing.
- Device Description: The description confirms it's a "white porous material composed of β-tricalcium phosphate" intended to "fill bony voids or gaps." This is consistent with an implantable medical device, not a diagnostic test.
Therefore, OSferion is an implantable medical device used for bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stablity of the bony structure. OSferion is used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation.
The OSferion range consists of two product types with porosities of 75% and 60%. Osferion (porosity:75%) tends to have less compression strength than Osferion (porosity:60%.) Products are supplied in blocks, cylinders, granules and wedges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bony voids or gaps of the skeletal system (i.e. the 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
KO61499
JAN 26 2007
510(k) SUMMARY
OSferion
Regulatory Affairs & Quality Assurance
Email:Laura.storms-tyler@olympus.com Establishment Registration No: 2429304
34-3 Hirai, Hinode-machi, Nishitama-gun,
Establishment Registration No: Form 2891 to be submitted to FDA upon 510(k) clearance.
Olympus Biomaterial Corporation Hinode Factory
Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058, USA
Phone: 631-844-5688 FAX: 631-844-5554
Tokyo 190-0182. Japan
January 25, 2007
1 General Information
- E Applicant: Olympus Biomaterial Corporation 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182, Japan Establishment Registration No: Form 2891 to : be submitted to FDA upon 510(k) clearance. 배 Official Correspondent: Official Correspondent: Laura Storms-Tyler Executive Director
■ Manufacturer: (Sterilization site)
2 Device Identification
- Device Trade Name:
- Common Name:
- Regulation Number:
Regulatory Class:
Classification Panel:
- Regulation Name: Resorbable calcium salt bone void filler device
OSferion
Bone void filler
21 CFR 888.3045
- ll
- Product Code: MQV
-
Orthopedic
1
3 Predicate Device Information
| Device Name: | chronOS | Vitoss |
|---|---|---|
| Common Name: | Bone void filler | Bone void filler |
| Manufacturer: | Synthes | Orthovita |
| 510(k) No. | K013072 | K994337 |
4 Device Description
OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stablity of the bony structure. OSferion is used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation.
The OSferion range consists of two product types with porosities of 75% and 60%. Osferion (porosity:75%) tends to have less compression strength than Osferion (porosity:60%.) Products are supplied in blocks, cylinders, granules and wedges.
5 Indications for Use
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Comparison of Technological Characteristics e
OSferion is basically identical to the predicate devices in the indication fir use, and is similar in specifications except for the porosity of the material.
Comparison between the subject and predicate devices is shown in Table1. The clinical literature provided in this submission supports the safety and efficacy of OSferion.
2
Table 1. Comparison of Specifications Subject Device: OSferion Predicate Device: chronOS
| Specifications | Sublect Devic | edicate Device | |
|---|---|---|---|
| Indication/Intended | |||
| use | Bone void filler, synthetic | Bone void filler, synthetic | Bone void filler, synthetic |
| Patient population | Individuals with bone voids | ||
| or gaps, caused by surgery | |||
| or trauma. | Individuals with bone | ||
| voids or gaps, caused by | |||
| surgery or trauma. | Individuals with bone voids | ||
| or gaps, caused by surgery | |||
| or trauma. | |||
| Anatomical location | Bony voids or gaps of the | ||
| skeletal system, i.e., the | |||
| extremities, spine and | |||
| pelvis | Bony voids or gaps of the | ||
| skeletal system, i.e., the | |||
| extremities, spine and | |||
| pelvis | Bony voids or gaps of the | ||
| skeletal system, i.e., the | |||
| extremities, spine and pelvis | |||
| Labeling | Same intended use, | ||
| contradictions, warnings, | |||
| precautions and adverse | |||
| events as predicate | See enclosure | See enclosure | |
| Structure of the | |||
| material | Interconnective porosity | Trabecular strucuture | |
| similar to cancellous bone | Interconnective porosity | ||
| Chemical | |||
| composition of | |||
| material | B - Tricalciumphosphate | ||
| (CaCO3) | ß - Tricalciumphosphate | ||
| (CaCO3) | ß - Tricalciumphosphate | ||
| (CaCO 3) | |||
| Porosity of material | 60%,75% | 90% | 55% |
| Sterility | Sterile (High pressure | ||
| Steam) | |||
| Single use only | Sterile (gamma radiation) | ||
| Single use only | Sterile (gamma radiation) | ||
| Single use only | |||
| Biocompatibility | Established | Established | Established |
| Mechanical strength | Does not impart | ||
| mechanical strength to | |||
| surgical site | Does not impart | ||
| mechanical strength to | |||
| surgical site | Does not impart mechanical | ||
| strength to surgical site |
7 Conclusion
When compared to the predicate device, this particular device "OSferion" does not incorporate v men obtipant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 its wings spread, and three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Olympus America, Inc. % Ms. Laura Storms-Tyler 3500 Corporate Parkway P.O. Box 610 Center Valley, Pennsylvania 18034-0610
JAN 2 6 2007
Re: K061499
Trade/Device Name: OSferion Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device. Regulatory Class: Class II Product Code: MQV Dated: December 13, 2006 Received: December 26, 2006
Dear Ms. Storms-Tyler:
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. Iisting 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.
4
Page 2 – Ms. Laura Storms-Tyler
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 (240) 276-0120 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours. Mark N. Melk
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): Device Name: OSferion Indications for Use:
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure.
Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Prescription Use (Part 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)
icurrence of CDRH, Office of Device Evaluation (ODE) 10-101 Division of General, Restorative, and Neurological Devices
Experie : Minys Page
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